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Title 21-Food and Drugs–Volume 9

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Title 21-Food and Drugs–Volume 9


Part


chapter ii – Drug Enforcement Administration, Department of Justice

1300


chapter iii – Office of National Drug Control Policy

1401

CHAPTER II – DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE

PART 1300 – DEFINITIONS


Authority:21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).


Source:62 FR 13941, Mar. 24, 1997, unless otherwise noted.

§ 1300.01 Definitions relating to controlled substances.

(a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part.


(b) As used in parts 1301 through 1308, 1312, and 1317 of this chapter, the following terms shall have the meanings specified:


Act means the Controlled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).


Administration means the Drug Enforcement Administration.


Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100).


Anabolic steroid means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes:


(1) 3β,17-dihydroxy-5a-androstane

(2) 3α,17β-dihydroxy-5a-androstane

(3) 5α-androstan-3,17-dione

(4) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene)

(5) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene)

(6) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene)

(7) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene)

(8) 1-androstenedione ([5α]-androst-1-en-3,17-dione)

(9) 4-androstenedione (androst-4-en-3,17-dione)

(10) 5-androstenedione (androst-5-en-3,17-dione)

(11) bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en-3-one)

(12) boldenone (17β-hydroxyandrost-1,4-diene-3-one)

(13) boldione (androsta-1,4-diene-3,17-dione)

(14) calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4-en-3-one)

(15) clostebol (4-chloro-17β-hydroxyandrost-4-en-3-one)

(16) dehydrochloromethyltestosterone (4-chloro-17β-hydroxy-17α-methyl-androst-1,4-dien-3-one)

(17) desoxymethyltestosterone (17α-methyl-5α-androst-2-en-17β-ol) (a.k.a. ‘madol‘)

(18) Δ1-dihydrotestosterone (a.k.a.‘1-testosterone‘) (17β-hydroxy-5α-androst-1-en-3-one)

(19) 4-dihydrotestosterone (17β-hydroxy-androstan-3-one)

(20) drostanolone (17β-hydroxy-2α-methyl-5α-androstan-3-one)

(21) ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene)

(22) fluoxymesterone (9-fluoro-17α-methyl-11β,17β-dihydroxyandrost-4-en-3-one)

(23) formebolone (2-formyl-17α-methyl-11α,17β-dihydroxyandrost-1,4-dien-3-one)

(24) furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c]-furazan)

(25) 13β-ethyl-17β-hydroxygon-4-en-3-one

(26) 4-hydroxytestosterone (4,17β-dihydroxy-androst-4-en-3-one)

(27) 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4-en-3-one)

(28) mestanolone (17α-methyl-17β-hydroxy-5-androstan-3-one)

(29) mesterolone (1α-methyl-17β-hydroxy-[5α]-androstan-3-one)

(30) methandienone (17α-methyl-17β-hydroxyandrost-1,4-dien-3-one)

(31) methandriol (17α-methyl-3β,17β-dihydroxyandrost-5-ene)

(32) Methasterone (2α,17α-dimethyl-5α-androstan-17β-ol-3-one)

(33) methenolone (1-methyl-17β-hydroxy-5α-androst-1-en-3-one)

(34) 17α-methyl-3β,17β-dihydroxy-5a-androstane

(35) 17α-methyl-3α,17β-dihydroxy-5a-androstane

(36) 17α-methyl-3β,17β-dihydroxyandrost-4-ene

(37) 17α-methyl-4-hydroxynandrolone (17α-methyl-4-hydroxy-17β-hydroxyestr-4-en-3-one)

(38) methyldienolone (17α-methyl-17β-hydroxyestra-4,9(10)-dien-3-one)

(39) methyltrienolone (17α-methyl-17β-hydroxyestra-4,9,11-trien-3-one)

(40) methyltestosterone (17α-methyl-17β-hydroxyandrost-4-en-3-one)

(41) mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en-3-one)

(42) 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy-17α-methyl-5α-androst-1-en-3-one) (a.k.a. ‘17-α-methyl-1-testosterone‘)

(43) nandrolone (17β-hydroxyestr-4-en-3-one)

(44) 19-nor-4-androstenediol (3β, 17β-dihydroxyestr-4-ene)

(45) 19-nor-4-androstenediol (3α, 17β-dihydroxyestr-4-ene)

(46) 19-nor-5-androstenediol (3β, 17β-dihydroxyestr-5-ene)

(47) 19-nor-5-androstenediol (3α, 17β-dihydroxyestr-5-ene)

(48) 19-nor-4,9(10)-androstadienedione (estra-4,9(10)-diene-3,17-dione)

(49) 19-nor-4-androstenedione (estr-4-en-3,17-dione)

(50) 19-nor-5-androstenedione (estr-5-en-3,17-dione)

(51) norbolethone (13β, 17α-diethyl-17β-hydroxygon-4-en-3-one)

(52) norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one)

(53) norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3-one)

(54) normethandrolone (17α-methyl-17β-hydroxyestr-4-en-3-one)

(55) oxandrolone (17α-methyl-17β-hydroxy-2-oxa-[5α]-androstan-3-one)

(56) oxymesterone (17α-methyl-4,17β-dihydroxyandrost-4-en-3-one)

(57) oxymetholone (17α-methyl-2-hydroxymethylene-17β-hydroxy-[5α]-androstan-3-one)

(58) Prostanozol (17β-hydroxy-5α-androstano[3,2-c]pyrazole)

(59) stanozolol (17α-methyl-17β-hydroxy-[5α]-androst-2-eno[3,2-c]-pyrazole)

(60) stenbolone (17β-hydroxy-2-methyl-[5α]-androst-1-en-3-one)

(61) testolactone (13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid lactone)

(62) testosterone (17β-hydroxyandrost-4-en-3-one)

(63) tetrahydrogestrinone (13β, 17α-diethyl-17β-hydroxygon-4,9,11-trien-3-one)

(64) trenbolone (17β-hydroxyestr-4,9,11-trien-3-one)

(65) Any salt, ester, or ether of a drug or substance described in this paragraph. Except such term does not include an anabolic steroid that is expressly intended for administration through implants to cattle or other nonhuman species and that has been approved by the Secretary of Health and Human Services for such administration. If any person prescribes, dispenses, or distributes such steroid for human use, the person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of this paragraph.

Automated dispensing system means a mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information.


Basic class means, as to controlled substances listed in Schedules I and II:


(1) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in § 1308.11(b) of this chapter;


(2) Each of the opium derivatives, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.11(c) of this chapter;


(3) Each of the hallucinogenic substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.11(d) of this chapter;


(4) Each of the following substances, whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:


(i) Opium, including raw opium, opium extracts, opium fluid extracts, powdered opium, granulated opium, deodorized opium and tincture of opium;


(ii) Apomorphine;


(iii) Codeine;


(iv) Etorphine hydrochloride;


(v) Ethylmorphine;


(vi) Hydrocodone;


(vii) Hydromorphone;


(viii) Metopon;


(ix) Morphine;


(x) Oxycodone;


(xi) Oxymorphone;


(xii) Thebaine;


(xiii) Mixed alkaloids of opium listed in § 1308.12(b)(2) of this chapter;


(xiv) Cocaine; and


(xv) Ecgonine;


(5) Each of the opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, listed in § 1308.12(c) of this chapter; and


(6) Methamphetamine, its salts, isomers, and salts of its isomers;


(7) Amphetamine, its salts, optical isomers, and salts of its optical isomers;


(8) Phenmetrazine and its salts;


(9) Methylphenidate;


(10) Each of the substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, listed in § 1308.12(e) of this chapter.


Central fill pharmacy means a pharmacy which is permitted by the state in which it is located to prepare controlled substances orders for dispensing pursuant to a valid prescription transmitted to it by a registered retail pharmacy and to return the labeled and filled prescriptions to the retail pharmacy for delivery to the ultimate user. Such central fill pharmacy shall be deemed “authorized” to fill prescriptions on behalf of a retail pharmacy only if the retail pharmacy and central fill pharmacy have a contractual relationship providing for such activities or share a common owner.


Collection means to receive a controlled substance for the purpose of destruction from an ultimate user, a person lawfully entitled to dispose of an ultimate user decedent’s property, or a long-term care facility on behalf of an ultimate user who resides or has resided at that facility. The term collector means a registered manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy that is authorized under this chapter to so receive a controlled substance for the purpose of destruction.


Commercial container means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.


Competent national authority, for purposes of importation and exportation of controlled substances and listed chemicals, means an entity lawfully entitled to authorize the import and export of controlled substances, and to regulate or enforce national controls over listed chemicals, and included as such in the directory of “Competent National Authorities Under the International Drug Control Treaties” published by the United Nations Office on Drugs and Crime. For purposes of exports of narcotic drugs, the term also includes freely associated states authorized to receive such exports pursuant to 48 U.S.C. 1972.


Compounder means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.


Controlled substance has the meaning given in section 802(6) of Title 21, United States Code (U.S.C.).


Customs officer means either an Officer of the Customs as defined in 19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), or any individual duly authorized to accept entries of merchandise, to collect duties, and to enforce the customs laws of any commonwealth, territory, or possession of the United States.


Customs territory of the United States means the several States, the District of Columbia, and Puerto Rico.


Detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. There are two types of detoxification treatment: Short-term detoxification treatment and long-term detoxification treatment.


(1) Short-term detoxification treatment is for a period not in excess of 30 days.


(2) Long-term detoxification treatment is for a period more than 30 days but not in excess of 180 days.


Dispenser means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.


Export means, with respect to any article, any taking out or removal of such article from the United States (whether or not such taking out or removal constitutes an exportation within the meaning of the customs laws, export control laws enforced by other agencies, or related laws of the United States).


Exporter includes every person who exports, or who acts as an export broker for exportation of, controlled substances listed in any schedule.


Freight forwarding facility means a separate facility operated by a distributing registrant through which sealed, packaged controlled substances in unmarked shipping containers (i.e., the containers do not indicate that the contents include controlled substances) are, in the course of delivery to, or return from, customers, transferred in less than 24 hours. A distributing registrant who operates a freight forwarding facility may use the facility to transfer controlled substances from any location the distributing registrant operates that is registered with the Administration to manufacture, distribute, or import controlled substances, or, with respect to returns, registered to dispense controlled substances, provided that the notice required by § 1301.12(b)(4) of Part 1301 of this chapter has been submitted and approved. For purposes of this definition, a distributing registrant is a person who is registered with the Administration as a manufacturer, distributor (excluding reverse distributor), and/or importer.


Hearing means:


(1) In part 1301 of this chapter, any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).


(2) In part 1303 of this chapter, any hearing held regarding the determination of aggregate production quota or the issuance, adjustment, suspension, or denial of a procurement quota or an individual manufacturing quota.


(3) In part 1308 of this chapter, any hearing held for the issuance, amendment, or repeal of any rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).


Import means, with respect to any article, any bringing in or introduction of such article into the customs territory of the United States from any place outside thereof (but within the United States), or into the United States from any place outside thereof (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).


Importer includes every person who imports, or who acts as an import broker for importation of, controlled substances listed in any schedule.


Individual practitioner means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.


Institutional practitioner means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.


Interested person means any person adversely affected or aggrieved by any rule or proposed rule issuable pursuant to section 201 of the Act (21 U.S.C. 811).


Inventory means all factory and branch stocks in finished form of a basic class of controlled substance manufactured or otherwise acquired by a registrant, whether in bulk, commercial containers, or contained in pharmaceutical preparations in the possession of the registrant (including stocks held by the registrant under separate registration as a manufacturer, importer, exporter, or distributor).


Isomer means:


(1) The optical isomer, except as used in § 1308.11(d) and § 1308.12(b)(4) of this chapter. As used in § 1308.11(d) of this chapter, the term “isomer” means any optical, positional, or geometric isomer. As used in § 1308.12(b)(4) of this chapter, the term “isomer” means any optical or geometric isomer;


(2) As used in § 1308.11(d) of this chapter, the term “positional isomer” means any substance possessing the same molecular formula and core structure and having the same functional group(s) and/or substituent(s) as those found in the respective Schedule I hallucinogen, attached at any position(s) on the core structure, but in such manner that no new chemical functionalities are created and no existing chemical functionalities are destroyed relative to the respective Schedule I hallucinogen. Rearrangements of alkyl moieties within or between functional group(s) or substituent(s), or divisions or combinations of alkyl moieties, that do not create new chemical functionalities or destroy existing chemical functionalities, are allowed i.e., result in compounds which are positional isomers. For purposes of this definition, the “core structure” is the parent molecule that is the common basis for the class; for example, tryptamine, phenethylamine, or ergoline. Examples of rearrangements resulting in creation and/or destruction of chemical functionalities (and therefore resulting in compounds which are not positional isomers) include, but are not limited to: Ethoxy to alpha-hydroxyethyl, hydroxy and methyl to methoxy, or the repositioning of a phenolic or alcoholic hydroxy group to create a hydroxyamine. Examples of rearrangements resulting in compounds which would be positional isomers include: Tert-butyl to sec-butyl, methoxy and ethyl to isopropoxy, N,N-diethyl to N-methyl-N-propyl, or alpha-methylamino to N-methylamino.


Label means any display of written, printed, or graphic matter placed upon the commercial container of any controlled substance by any manufacturer of such substance.


Labeling means all labels and other written, printed, or graphic matter:


(1) Upon any controlled substance or any of its commercial containers or wrappers, or


(2) Accompanying such controlled substance.


Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients.


Maintenance treatment means the dispensing for a period in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.


Manufacture means the producing, preparation, propagation, compounding, or processing of a drug or other substance or the packaging or repackaging of such substance, or the labeling or relabeling of the commercial container of such substance, but does not include the activities of a practitioner who, as an incident to his/her administration or dispensing such substance in the course of his/her professional practice, prepares, compounds, packages or labels such substance.


Manufacturer means a person who manufactures a drug or other substance, whether under a registration as a manufacturer or under authority of registration as a researcher or chemical analyst.


Mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the State in which they practice.


Mobile Narcotic Treatment Program means a narcotic treatment program (NTP) operating from a motor vehicle, as defined in this section, that serves as a mobile component (conveyance) and is operating under the registration of the NTP, and engages in maintenance and/or detoxification treatment with narcotic drugs in schedules II-V, at a location or locations remote from, but within the same State as, its registered location. Operating a mobile NTP is a coincident activity of an existing NTP, as listed in § 1301.13(e) of this chapter.


Motor vehicle means a vehicle propelled under its own motive power and lawfully used on public streets, roads, or highways with more than three wheels in contact with the ground. This term does not include a trailer.


Name means the official name, common or usual name, chemical name, or brand name of a substance.


Narcotic drug means any of the following whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis:


(1) Opium, opiates, derivatives of opium and opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation. Such term does not include the isoquinoline alkaloids of opium.


(2) Poppy straw and concentrate of poppy straw.


(3) Coca leaves, except coca leaves and extracts of coca leaves from which cocaine, ecgonine and derivatives of ecgonine or their salts have been removed.


(4) Cocaine, its salts, optical and geometric isomers, and salts of isomers.


(5) Ecgonine, its derivatives, their salts, isomers and salts of isomers.


(6) Any compound, mixture, or preparation which contains any quantity of any of the substances referred to in paragraphs (1) through (5) of this definition.


Narcotic treatment program means a program engaged in maintenance and/or detoxification treatment with narcotic drugs.


Net disposal means, for a stated period, the quantity of a basic class of controlled substance distributed by the registrant to another person, plus the quantity of that basic class used by the registrant in the production of (or converted by the registrant into) another basic class of controlled substance or a noncontrolled substance, plus the quantity of that basic class otherwise disposed of by the registrant, less the quantity of that basic class returned to the registrant by any purchaser, and less the quantity of that basic class distributed by the registrant to another registered manufacturer of that basic class for purposes other than use in the production of, or conversion into, another basic class of controlled substance or a noncontrolled substance or in the manufacture of dosage forms of that basic class.


Person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.


Pharmacist means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.


Port of entry means, unless distinguished as being a foreign port of entry, any place at which a customs officer is duly authorized to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs laws of the United States (whether or not such place is a port of entry as defined in title 19 of the United States Code or its associated implementing regulations). Examples of ports of entry include, but are not limited to, places designated as ports of entry or customs stations in title 19 of the Code of Federal Regulations or by the governing customs authority of that area. When shipments are transported under U.S. Customs and Border Protection’s immediate transportation procedures, the port of entry shall be the port of final destination.


Port of export means, unless distinguished as being a foreign port of export, any place under the control of a customs officer where goods are loaded on an aircraft, vessel or other conveyance for export outside of the United States. For goods loaded aboard an aircraft or vessel in the United States, that stops at several ports before departing the United States, the port of export is the first port where the goods were actually loaded. For goods off-loaded from the original conveyance to another conveyance (even if the aircraft or vessel belongs to the same carrier) at any port subsequent to the port where the first on-loading occurred in the United States, the port where the goods were loaded onto the last conveyance before departing the United States is the port of export.


Prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).


Proceeding means all actions taken for the issuance, amendment, or repeal of any rule issued pursuant to section 201 of the Act (21 U.S.C. 811), commencing with the publication by the Administrator of the proposed rule, amended rule, or repeal in the Federal Register.


Purchaser means any registered person entitled to obtain and execute order forms pursuant to §§ 1305.04 and 1305.06.


Readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.


Register and registration refer only to registration required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).


Registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).


Return information means supplemental information required to be reported to the Administration following an import or export transaction containing the particulars of the transaction and any other information as the Administration may specify.


Reverse distribute means to acquire controlled substances from another registrant or law enforcement for the purpose of:


(1) Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer’s behalf; or


(2) Destruction.


Reverse distributor is a person registered with the Administration as a reverse distributor.


Supplier means any registered person entitled to fill order forms pursuant to § 1305.06 of this chapter.


United States, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States, which, in addition to the customs territory of the United States, include but are not limited to the U.S. Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.


[62 FR 13941, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 70 FR 25465, May 13, 2005; 70 FR 74656, Dec. 16, 2005; 71 FR 60427, Oct. 13, 2006; 72 FR 67852, Dec. 3, 2007; 74 FR 63609, Dec. 4, 2009; 77 FR 4230, Jan. 27, 2012; 77 FR 44461, July 30, 2012; 79 FR 53559, Sept. 9, 2014; 81 FR 97018, Dec. 30, 2016; 86 FR 33883, June 28, 2021]


§ 1300.02 Definitions relating to listed chemicals.

(a) Any term not defined in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802), except that certain terms used in part 1316 of this chapter are defined at the beginning of each subpart of that part.


(b) As used in parts 1309, 1310, and 1313 of this chapter, the following terms shall have the meaning specified:


Act means the Controlled Substances Act, as amended (84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).


Administration means the Drug Enforcement Administration.


Administrator means the Administrator of the Drug Enforcement Administration. The Administrator has been delegated authority under the Act by the Attorney General (28 CFR 0.100).


At retail, with respect to the sale or purchase of a scheduled listed chemical product, means a sale or purchase for personal use, respectively.


Broker and trader mean any individual, corporation, corporate division, partnership, association, or other legal entity which assists in arranging an international transaction in a listed chemical by –


(1) Negotiating contracts;


(2) Serving as an agent or intermediary; or


(3) Fulfilling a formal obligation to complete the transaction by bringing together a buyer and seller, a buyer and transporter, or a seller and transporter, or by receiving any form of compensation for so doing.


Chemical export means transferring ownership or control, or the sending or taking of threshold quantities of listed chemicals out of the United States (whether or not such sending or taking out constitutes an exportation within the meaning of the customs and related laws of the United States).


Chemical exporter is a regulated person who, as the principal party in interest in the export transaction, has the power and responsibility for determining and controlling the sending of the listed chemical out of the United States.


Chemical importer is a regulated person who, as the principal party in interest in the import transaction, has the power and responsibility for determining and controlling the bringing in or introduction of the listed chemical into the United States.


Chemical mixture means a combination of two or more chemical substances, at least one of which is not a listed chemical, except that such term does not include any combination of a listed chemical with another chemical that is present solely as an impurity or which has been created to evade the requirements of the Act.


Combination ephedrine product means a drug product containing ephedrine or its salts, optical isomers, or salts of optical isomers, and therapeutically significant quantities of another active medicinal ingredient.


Competent national authority, for purposes of importation and exportation of controlled substances and listed chemicals, means an entity lawfully entitled to authorize the import and export of controlled substances, and to regulate or enforce national controls over listed chemicals, and included as such in the directory of “Competent National Authorities Under the International Drug Control Treaties” published by the United Nations Office on Drugs and Crime.


Customs officer means either an Officer of the Customs as defined in 19 U.S.C. 1401(i) (that is, of the U.S. Customs and Border Protection), or any individual duly authorized to accept entries of merchandise, to collect duties, and to enforce the customs laws of any commonwealth, territory, or possession of the United States.


Customs territory of the United States means the several States, the District of Columbia, and Puerto Rico.


Drug product means an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Federal Food, Drug, and Cosmetic Act for distribution in the United States.


Encapsulating machine means any manual, semi-automatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semi-solid, or liquid material.


Established business relationship means the regulated person has imported or exported a listed chemical at least once within the past six months, or twice within the past twelve months from or to a foreign manufacturer, distributor, or end user of the chemical that has an established business with a fixed street address. A person or business that functions as a broker or intermediary is not a customer for purposes of this definition.


Established record as an importer means that the regulated person has imported a listed chemical at least once within the past six months, or twice within the past twelve months from a foreign supplier.


Export means, with respect to any article, any taking out or removal of such article from the United States (whether or not such taking out or removal constitutes an exportation within the meaning of the customs laws, export control laws enforced by other agencies, or related laws of the United States).


Hearing means any hearing held for the granting, denial, revocation, or suspension of a registration pursuant to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).


Import means, with respect to any article, any bringing in or introduction of such article into the customs territory of the United States from any place outside thereof (but within the United States), or into the United States from any place outside thereof (whether or not such bringing in or introduction constitutes an importation within the meaning of the tariff laws of the United States).


International transaction means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.


Listed chemical means any List I chemical or List II chemical.


List I chemical means a chemical specifically designated by the Administrator in § 1310.02(a) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act and is important to the manufacture of a controlled substance.


List II chemical means a chemical, other than a List I chemical, specifically designated by the Administrator in § 1310.02(b) of this chapter that, in addition to legitimate uses, is used in manufacturing a controlled substance in violation of the Act.


Mobile retail vendor means a person or entity that makes sales at retail from a stand that is intended to be temporary or is capable of being moved from one location to another, whether the stand is located within or on the premises of a fixed facility (such as a kiosk at a shopping center or an airport) or whether the stand is located on unimproved real estate (such as a lot or field leased for retail purposes).


Name means the official name, common or usual name, chemical name, or brand name of a substance.


Person includes any individual, corporation, government or governmental subdivision or agency, business trust, partnership, association, or other legal entity.


Port of entry, unless distinguished as being a foreign port of entry, means any place at which a customs officer is duly authorized to accept entries of merchandise, to collect duties, and to enforce the various provisions of the customs laws of the United States (whether or not such place is a port of entry as defined in title 19 of the United States Code or its associated implementing regulations). Examples of ports of entry include, but are not limited to, places designated as ports of entry or customs stations in title 19 of the Code of Federal Regulations or by the governing customs authority of that area. When shipments are transported under U.S. Customs and Border Protection immediate transportation procedures, the port of entry shall be the port of final destination.


Port of export means, unless distinguished as being a foreign port of export, any place under the control of a customs officer where goods are loaded on an aircraft, vessel or other conveyance for export outside of the United States. For goods loaded aboard an aircraft or vessel in the United States that stops at several ports before departing the United States, the port of export is the first port where the goods were loaded. For goods off-loaded from the original conveyance to another conveyance (even if the aircraft or vessel belongs to the same carrier) at any port subsequent to the port where the first on-loading occurred in the United States, the port where the goods were loaded onto the last conveyance before departing the United States is the port of export. For reporting purposes, in the case of an otherwise lawful export occurring by mail, the port of export is the place of mailing.


Readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.


Register and registration refer only to registration required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 823 or 957).


Registrant means any person who is registered pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 823 or 958).


Regular customer means a person with whom the regulated person has an established business relationship for a specified listed chemical or chemicals that has been reported to the Administration subject to the criteria established in part 1313 of this chapter.


Regular importer means, with respect to a listed chemical, a person that has an established record as an importer of that listed chemical that is reported to the Administrator.


Regulated person means any individual, corporation, partnership, association, or other legal entity who manufactures, distributes, imports, or exports a listed chemical, a tableting machine, or an encapsulating machine, or who acts as a broker or trader for an international transaction involving a listed chemical, tableting machine, or encapsulating machine.


Regulated seller means a retail distributor (including a pharmacy or a mobile retail vendor), except that the term does not include an employee or agent of the distributor.


Regulated transaction means:


(1) A distribution, receipt, sale, importation, or exportation of a listed chemical, or an international transaction involving shipment of a listed chemical, or if the Administrator establishes a threshold amount for a specific listed chemical, a threshold amount as determined by the Administrator, which includes a cumulative threshold amount for multiple transactions, of a listed chemical, except that such term does not include:


(i) A domestic lawful distribution in the usual course of business between agents or employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person;


(ii) A delivery of a listed chemical to or by a common or contract carrier for carriage in the lawful and usual course of the business of the common or contract carrier, or to or by a warehouseman for storage in the lawful and usual course of the business of the warehouseman, except that if the carriage or storage is in connection with the distribution, importation, or exportation of a listed chemical to a third person, this paragraph does not relieve a distributor, importer, or exporter from compliance with parts 1309, 1310, 1313, and 1315 of this chapter;


(iii) Any category of transaction or any category of transaction for a specific listed chemical or chemicals specified by regulation of the Administrator as excluded from this definition as unnecessary for enforcement of the Act;


(iv) Any transaction in a listed chemical that is contained in a drug other than a scheduled listed chemical product that may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act, subject to paragraph (1)(v) of this definition, unless –


(A) The Administrator has determined pursuant to the criteria in § 1310.10 of this chapter that the drug or group of drugs is being diverted to obtain the listed chemical for use in the illicit production of a controlled substance; and


(B) The quantity of the listed chemical contained in the drug included in the transaction or multiple transactions equals or exceeds the threshold established for that chemical;


(v) Any transaction in a scheduled listed chemical product that is a sale at retail by a regulated seller or a distributor required to submit reports under § 1310.03(c) of this chapter; or


(vi) Any transaction in a chemical mixture designated in §§ 1310.12 and 1310.13 of this chapter that the Administrator has exempted from regulation.


(2) A distribution, importation, or exportation of a tableting machine or encapsulating machine except that such term does not include a domestic lawful distribution in the usual course of business between agents and employees of a single regulated person; in this context, agents or employees means individuals under the direct management and control of the regulated person.


Retail distributor means a grocery store, general merchandise store, drug store, or other entity or person whose activities as a distributor relating to drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine are limited almost exclusively to sales for personal use, both in number of sales and volume of sales, either directly to walk-in customers or in face-to-face transactions by direct sales. Also for the purposes of this paragraph, a “grocery store” is an entity within Standard Industrial Classification (SIC) code 5411, a “general merchandise store” is an entity within SIC codes 5300 through 5399 and 5499, and a “drug store” is an entity within SIC code 5912.


Return information means supplemental information required to be reported to the Administration following an import or export transaction containing the particulars of the transaction and any other information as the Administration may specify.


Scheduled listed chemical product means:


(1) A product that contains ephedrine, pseudoephedrine, or phenylpropanolamine and may be marketed or distributed lawfully in the United States under the Federal Food, Drug, and Cosmetic Act as a nonprescription drug. Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts, optical isomers, and salts of optical isomers.


(2) Scheduled listed chemical product does not include any product that is a controlled substance under part 1308 of this chapter. In the absence of such scheduling by the Attorney General, a chemical specified in paragraph (1) of this definition may not be considered to be a controlled substance.


Tableting machine means any manual, semi-automatic, or fully automatic equipment which may be used for the compaction or molding of powdered or granular solids, or semi-solid material, to produce coherent solid tablets.


United States, when used in a geographic sense, means all places and waters, continental or insular, subject to the jurisdiction of the United States, which, in addition to the customs territory of the United States, include but are not limited to the U.S. Virgin Islands, Guam, American Samoa, and the Northern Mariana Islands.


Valid prescription means a prescription that is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.


[75 FR 16304, Mar. 31, 2010, as amended at 77 FR 4233, Jan. 27, 2012; 81 FR 97019, Dec. 30, 2016; 85 FR 68461, Oct. 29, 2020]


§ 1300.03 Definitions relating to electronic orders for controlled substances and electronic prescriptions for controlled substances.

For the purposes of this chapter, the following terms shall have the meanings specified:


Application service provider means an entity that sells electronic prescription or pharmacy applications as a hosted service, where the entity controls access to the application and maintains the software and records on its servers.


Audit trail means a record showing who has accessed an information technology application and what operations the user performed during a given period.


Authentication means verifying the identity of the user as a prerequisite to allowing access to the information application.


Authentication protocol means a well specified message exchange process that verifies possession of a token to remotely authenticate a person to an application.


Biometric authentication means authentication based on measurement of the individual’s physical features or repeatable actions where those features or actions are both distinctive to the individual and measurable.


Biometric subsystem means the hardware and software used to capture, store, and compare biometric data. The biometric subsystem may be part of a larger application. The biometric subsystem is an automated system capable of:


(1) Capturing a biometric sample from an end user.


(2) Extracting and processing the biometric data from that sample.


(3) Storing the extracted information in a database.


(4) Comparing the biometric data with data contained in one or more reference databases.


(5) Determining how well the stored data matches the newly captured data and indicating whether an identification or verification of identity has been achieved.


Cache means to download and store information on a local server or hard drive.


Certificate policy means a named set of rules that sets forth the applicability of the specific digital certificate to a particular community or class of application with common security requirements.


Certificate revocation list (CRL) means a list of revoked, but unexpired certificates issued by a certification authority.


Certification authority (CA) means an organization that is responsible for verifying the identity of applicants, authorizing and issuing a digital certificate, maintaining a directory of public keys, and maintaining a Certificate Revocation List.


Certified information systems auditor (CISA) means an individual who has been certified by the Information Systems Audit and Control Association as qualified to audit information systems and who performs compliance audits as a regular ongoing business activity.


Credential means an object or data structure that authoritatively binds an identity (and optionally, additional attributes) to a token possessed and controlled by a person.


Credential service provider (CSP) means a trusted entity that issues or registers tokens and issues electronic credentials to individuals. The CSP may be an independent third party or may issue credentials for its own use.


CSOS means controlled substance ordering system.


Digital certificate means a data record that, at a minimum –


(1) Identifies the certification authority issuing it;


(2) Names or otherwise identifies the certificate holder;


(3) Contains a public key that corresponds to a private key under the sole control of the certificate holder;


(4) Identifies the operational period; and


(5) Contains a serial number and is digitally signed by the certification authority issuing it.


Digital signature means a record created when a file is algorithmically transformed into a fixed length digest that is then encrypted using an asymmetric cryptographic private key associated with a digital certificate. The combination of the encryption and algorithm transformation ensure that the signer’s identity and the integrity of the file can be confirmed.


Digitally sign means to affix a digital signature to a data file.


Electronic prescription means a prescription that is generated on an electronic application and transmitted as an electronic data file.


Electronic prescription application provider means an entity that develops or markets electronic prescription software either as a stand-alone application or as a module in an electronic health record application.


Electronic signature means a method of signing an electronic message that identifies a particular person as the source of the message and indicates the person’s approval of the information contained in the message.


False match rate means the rate at which an impostor’s biometric is falsely accepted as being that of an authorized user. It is one of the statistics used to measure biometric performance when operating in the verification or authentication task. The false match rate is similar to the false accept (or acceptance) rate.


False non-match rate means the rate at which a genuine user’s biometric is falsely rejected when the user’s biometric data fail to match the enrolled data for the user. It is one of the statistics used to measure biometric performance when operating in the verification or authentication task. The false match rate is similar to the false reject (or rejection) rate, except that it does not include the rate at which a biometric system fails to acquire a biometric sample from a genuine user.


FIPS means Federal Information Processing Standards. These Federal standards, as incorporated by reference in § 1311.08 of this chapter, prescribe specific performance requirements, practices, formats, communications protocols, etc., for hardware, software, data, etc.


FIPS 140-2, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Security Requirements for Cryptographic Modules,” a Federal standard for security requirements for cryptographic modules.


FIPS 180-2, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Secure Hash Standard,” a Federal secure hash standard.


FIPS 180-3, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Secure Hash Standard (SHS),” a Federal secure hash standard.


FIPS 186-2, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Digital Signature Standard,” a Federal standard for applications used to generate and rely upon digital signatures.


FIPS 186-3, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Digital Signature Standard (DSS),” a Federal standard for applications used to generate and rely upon digital signatures.


Hard token means a cryptographic key stored on a special hardware device (e.g., a PDA, cell phone, smart card, USB drive, one-time password device) rather than on a general purpose computer.


Identity proofing means the process by which a credential service provider or certification authority validates sufficient information to uniquely identify a person.


Installed electronic prescription application means software that is used to create electronic prescriptions and that is installed on a practitioner’s computers and servers, where access and records are controlled by the practitioner.


Installed pharmacy application means software that is used to process prescription information and that is installed on a pharmacy’s computers or servers and is controlled by the pharmacy.


Intermediary means any technology system that receives and transmits an electronic prescription between the practitioner and pharmacy.


Key pair means two mathematically related keys having the properties that:


(1) One key can be used to encrypt a message that can only be decrypted using the other key; and


(2) Even knowing one key, it is computationally infeasible to discover the other key.


NIST means the National Institute of Standards and Technology.


NIST SP 800-63-1, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Electronic Authentication Guideline,” a Federal standard for electronic authentication.


NIST SP 800-76-1, as incorporated by reference in § 1311.08 of this chapter, means the National Institute of Standards and Technology publication entitled “Biometric Data Specification for Personal Identity Verification,” a Federal standard for biometric data specifications for personal identity verification.


Operating point means a point chosen on a receiver operating characteristic (ROC) curve for a specific algorithm at which the biometric system is set to function. It is defined by its corresponding coordinates – a false match rate and a false non-match rate. An ROC curve shows graphically the trade-off between the principal two types of errors (false match rate and false non-match rate) of a biometric system by plotting the performance of a specific algorithm on a specific set of data.


Paper prescription means a prescription created on paper or computer generated to be printed or transmitted via facsimile that meets the requirements of part 1306 of this chapter including a manual signature.


Password means a secret, typically a character string (letters, numbers, and other symbols), that a person memorizes and uses to authenticate his identity.


PDA means a Personal Digital Assistant, a handheld computer used to manage contacts, appointments, and tasks.


Pharmacy application provider means an entity that develops or markets software that manages the receipt and processing of electronic prescriptions.


Private key means the key of a key pair that is used to create a digital signature.


Public key means the key of a key pair that is used to verify a digital signature. The public key is made available to anyone who will receive digitally signed messages from the holder of the key pair.


Public Key Infrastructure (PKI) means a structure under which a certification authority verifies the identity of applicants; issues, renews, and revokes digital certificates; maintains a registry of public keys; and maintains an up-to-date certificate revocation list.


Readily retrievable means that certain records are kept by automatic data processing applications or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.


SAS 70 Audit means a third-party audit of a technology provider that meets the American Institute of Certified Public Accountants (AICPA) Statement of Auditing Standards (SAS) 70 criteria.


Signing function means any keystroke or other action used to indicate that the practitioner has authorized for transmission and dispensing a controlled substance prescription. The signing function may occur simultaneously with or after the completion of the two-factor authentication protocol that meets the requirements of part 1311 of this chapter. The signing function may have different names (e.g., approve, sign, transmit), but it serves as the practitioner’s final authorization that he intends to issue the prescription for a legitimate medical reason in the normal course of his professional practice.


SysTrust means a professional service performed by a qualified certified public accountant to evaluate one or more aspects of electronic systems.


Third-party audit means an independent review and examination of records and activities to assess the adequacy of system controls, to ensure compliance with established policies and operational procedures, and to recommend necessary changes in controls, policies, or procedures.


Token means something a person possesses and controls (typically a key or password) used to authenticate the person’s identity.


Trusted agent means an entity authorized to act as a representative of a certification authority or credential service provider in confirming practitioner identification during the enrollment process.


Valid prescription means a prescription that is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.


WebTrust means a professional service performed by a qualified certified public accountant to evaluate one or more aspects of Web sites.


[75 FR 16304, Mar. 31, 2010]


§ 1300.04 Definitions relating to the dispensing of controlled substances by means of the Internet.

(a) Any term not defined in this part or elsewhere in this chapter shall have the definition set forth in sections 102 and 309 of the Act (21 U.S.C. 802, 829).


(b) The term covering practitioner means, with respect to a patient, a practitioner who conducts a medical evaluation (other than an in-person medical evaluation) at the request of a practitioner who:


(1) Has conducted at least one in-person medical evaluation of the patient or an evaluation of the patient through the practice of telemedicine, within the previous 24 months; and


(2) Is temporarily unavailable to conduct the evaluation of the patient.


(c) The term deliver, distribute, or dispense by means of the Internet refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.


(d) The term filling new prescriptions for controlled substances in Schedule III, IV, or V means filling a prescription for an individual for a controlled substance in Schedule III, IV, or V, if:


(1) The pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter (for purposes of this definition, such a prescription shall be referred to as the “original prescription”);


(2) The pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the practitioner will authorize the issuance of a new prescription for that individual for the controlled substance described in paragraph (d)(1) of this section (i.e., the same controlled substance as described in paragraph (d)(1)); and


(3) The practitioner, acting in the usual course of professional practice, determines there is a legitimate medical purpose for the issuance of the new prescription.


(e) The term homepage means the opening or main page or screen of the Web site of an online pharmacy that is viewable on the Internet.


(f) The term in-person medical evaluation means a medical evaluation that is conducted with the patient in the physical presence of the practitioner, without regard to whether portions of the evaluation are conducted by other health professionals. Nothing in this paragraph shall be construed to imply that one in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.


(g) The term Internet means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio.


(h) The term online pharmacy means a person, entity, or Internet site, whether in the United States or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet. The term includes, but is not limited to, a pharmacy that has obtained a modification of its registration pursuant to §§ 1301.13 and 1301.19 of this chapter that currently authorizes it to dispense controlled substances by means of the Internet, regardless of whether the pharmacy is currently dispensing controlled substances by means of the Internet. The term does not include:


(1) Manufacturers or distributors registered under subsection (a), (b), (d), or (e) of section 303 of the Act (21 U.S.C. 823(a), (b), (d), or (e)) (§ 1301.13 of this chapter) who do not dispense controlled substances to an unregistered individual or entity;


(2) Nonpharmacy practitioners who are registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) and whose activities are authorized by that registration;


(3) Any hospital or other medical facility that is operated by an agency of the United States (including the Armed Forces), provided such hospital or other facility is registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter);


(4) A health care facility owned or operated by an Indian tribe or tribal organization, only to the extent such facility is carrying out a contract or compact under the Indian Self-Determination and Education Assistance Act;


(5) Any agent or employee of any hospital or facility referred to in paragraph (h)(3) or (h)(4) of this section, provided such agent or employee is lawfully acting in the usual course of business or employment, and within the scope of the official duties of such agent or employee, with such hospital or facility, and, with respect to agents or employees of health care facilities specified in paragraph (h)(4) of this section, only to the extent such individuals are furnishing services pursuant to the contracts or compacts described in such paragraph;


(6) Mere advertisements that do not attempt to facilitate an actual transaction involving a controlled substance;


(7) A person, entity, or Internet site that is not in the United States and does not facilitate the delivery, distribution, or dispensing of a controlled substance by means of the Internet to any person in the United States;


(8) A pharmacy registered under section 303(f) of the Act (21 U.S.C. 823(f)) (§ 1301.13 of this chapter) whose dispensing of controlled substances via the Internet consists solely of:


(i) Refilling prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (k) of this section; or


(ii) Filling new prescriptions for controlled substances in Schedule III, IV, or V, as defined in paragraph (d) of this section;


(9)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of filling prescriptions that were electronically prescribed in a manner authorized by this chapter and otherwise in compliance with the Act.


(ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(9)(i) of this section, it would fall outside the definition of an online pharmacy; or


(10)(i) Any registered pharmacy whose delivery, distribution, or dispensing of controlled substances by means of the Internet consists solely of the transmission of prescription information between a pharmacy and an automated dispensing system located in a long term care facility when the registration of the automated dispensing system is held by that pharmacy as described in §§ 1301.17 and 1301.27 and the pharmacy is otherwise complying with this chapter.


(ii) A registered pharmacy will be deemed to meet this exception if, in view of all of its activities other than those referred to in paragraph (h)(10)(i) of this section, it would fall outside the definition of an online pharmacy.


(i) Effective January 15, 2010, the term practice of telemedicine means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), which practice falls within a category listed in the following paragraphs (i)(1) through (7):


(1) Treatment in a hospital or clinic. The practice of telemedicine is being conducted while the patient is being treated by, and physically located in, a hospital or clinic registered under section 303(f) of the Act (21 U.S.C. 823(f)) by a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:


(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d); or


(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);


(2) Treatment in the physical presence of a practitioner. The practice of telemedicine is being conducted while the patient is being treated by, and in the physical presence of, a practitioner acting in the usual course of professional practice, who is acting in accordance with applicable State law, and who is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in the State in which the patient is located, unless the practitioner:


(i) Is exempted from such registration in all States under section 302(d) of the Act (21 U.S.C. 822(d)); or


(ii) Is an employee or contractor of the Department of Veterans Affairs who is acting in the scope of such employment or contract, and registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is using the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f);


(3) Indian Health Service or tribal organization. The practice of telemedicine is being conducted by a practitioner who is an employee or contractor of the Indian Health Service, or is working for an Indian tribe or tribal organization under its contract or compact with the Indian Health Service under the Indian Self-Determination and Education Assistance Act; who is acting within the scope of the employment, contract, or compact; and who is designated as an Internet Eligible Controlled Substances Provider by the Secretary of Health and Human Services under section 311(g)(2) of the Act (21 U.S.C. 831(g)(2));


(4) Public health emergency declared by the Secretary of Health and Human Services. The practice of telemedicine is being conducted during a public health emergency declared by the Secretary of Health and Human Services under section 319 of the Public Health Service Act (42 U.S.C. 247d), and involves patients located in such areas, and such controlled substances, as the Secretary of Health and Human Services, with the concurrence of the Administrator, designates, provided that such designation shall not be subject to the procedures prescribed by the Administrative Procedure Act (5 U.S.C. 551-559 and 701-706);


(5) Special registration. The practice of telemedicine is being conducted by a practitioner who has obtained from the Administrator a special registration under section 311(h) of the Act (21 U.S.C. 831(h));


(6) Department of Veterans Affairs medical emergency. The practice of telemedicine is being conducted:


(i) In a medical emergency situation:


(A) That prevents the patient from being in the physical presence of a practitioner registered under section 303(f) of the Act (21 U.S.C. 823(f)) who is an employee or contractor of the Veterans Health Administration acting in the usual course of business and employment and within the scope of the official duties or contract of that employee or contractor;


(B) That prevents the patient from being physically present at a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f) of the Act (21 U.S.C. 823(f));


(C) During which the primary care practitioner of the patient or a practitioner otherwise practicing telemedicine within the meaning of this paragraph is unable to provide care or consultation; and


(D) That requires immediate intervention by a health care practitioner using controlled substances to prevent what the practitioner reasonably believes in good faith will be imminent and serious clinical consequences, such as further injury or death; and


(ii) By a practitioner that:


(A) Is an employee or contractor of the Veterans Health Administration acting within the scope of that employment or contract;


(B) Is registered under section 303(f) of the Act (21 U.S.C. 823(f)) in any State or is utilizing the registration of a hospital or clinic operated by the Department of Veterans Affairs registered under section 303(f); and


(C) Issues a controlled substance prescription in this emergency context that is limited to a maximum of a five-day supply which may not be extended or refilled; or


(7) Other circumstances specified by regulation. The practice of telemedicine is being conducted under any other circumstances that the Administrator and the Secretary of Health and Human Services have jointly, by regulation, determined to be consistent with effective controls against diversion and otherwise consistent with the public health and safety.


(j) Temporary definition of practice of telemedicine. Prior to January 15, 2010, or as otherwise specified by regulation prior to that date, instead of the definition in paragraph (i), the term practice of telemedicine means the practice of medicine in accordance with applicable Federal and State laws by a practitioner (as that term is defined in section 102 of the Act (21 U.S.C. 802)) (other than a pharmacist) who is at a location remote from the patient and is communicating with the patient, or health care professional who is treating the patient, using a telecommunications system referred to in section 1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the practitioner is using an interactive telecommunications system that satisfies the requirements of section 410.78(a)(3) of title 42, Code of Federal Regulations.


(k) The term refilling prescriptions for controlled substances in Schedule III, IV, or V:


(1) Means the dispensing of a controlled substance in Schedule III, IV, or V in accordance with refill instructions issued by a practitioner as part of a valid prescription that meets the requirements of subsections (b) and (c) of section 309 of the Act (21 U.S.C. 829) and §§ 1306.21 and 1306.22 of this chapter, as appropriate; and


(2) Does not include the issuance of a new prescription to an individual for a controlled substance that individual was previously prescribed.


(l)(1) The term valid prescription means a prescription that is issued for a legitimate medical purpose in the usual course of professional practice by:


(i) A practitioner who has conducted at least one in-person medical evaluation of the patient; or


(ii) A covering practitioner.


(2) Nothing in this paragraph (l) shall be construed to imply that one in-person medical evaluation demonstrates that a prescription has been issued for a legitimate medical purpose within the usual course of professional practice.


[74 FR 15619, Apr. 6, 2009]


§ 1300.05 Definitions relating to the disposal of controlled substances.

(a) Any term not defined in this part or elsewhere in this chapter shall have the definition set forth in section 102 of the Act (21 U.S.C. 802).


(b) As used in part 1317 of this chapter, the following terms shall have the meanings specified:


Employee means an employee as defined under the general common law of agency. Some of the factors relevant to the determination of employee status include: The hiring party’s right to control the manner and means by which the product is accomplished; the skill required; the source of the instrumentalities and tools; the location of the work; the duration of the relationship between the parties; whether the hiring party has the right to assign additional projects to the hired party; the extent of the hired party’s discretion over when and how long to work; the method of payment; the hired party’s role in hiring and paying assistants; whether the work is part of the regular business of the hiring party; whether the hiring party is in business; the provision of employee benefits; and the tax treatment of the hired party. Other applicable factors may be considered and no one factor is dispositive. The following criteria will determine whether a person is an employee of a registrant for the purpose of disposal: The person is directly paid by the registrant; subject to direct oversight by the registrant; required, as a condition of employment, to follow the registrant’s procedures and guidelines pertaining to the handling of controlled substances; subject to receive a performance rating or performance evaluation on a regular/routine basis from the registrant; subject to disciplinary action by the registrant; and required to render services at the registrant’s registered location.


Law enforcement officer means a person who is described in paragraph (1), (2) or (3) of this definition:


(1) Meets all of the following criteria:


(i) Employee of either a law enforcement agency, or law enforcement component of a Federal agency;


(ii) Is under the direction and control of a Federal, State, tribal, or local government;


(iii) Acting in the course of his/her official duty; and


(iv) Duly sworn and given the authority by a Federal, State, tribal, or local government to carry firearms, execute and serve warrants, make arrests without warrant, and make seizures of property;


(2) Is a Veterans Health Administration (VHA) police officer authorized by the Department of Veterans Affairs to participate in collection activities conducted by the VHA; or


(3) Is a Department of Defense (DOD) police officer authorized by the DOD to participate in collection activities conducted by the DOD.


Non-retrievable means, for the purpose of destruction, the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance’s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. The process to achieve a non-retrievable condition or state may be unique to a substance’s chemical or physical properties. A controlled substance is considered “non-retrievable” when it cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue. The purpose of destruction is to render the controlled substance(s) to a non-retrievable state and thus prevent diversion of any such substance to illicit purposes.


On-site means located on or at the physical premises of the registrant’s registered location. A controlled substance is destroyed on-site when destruction occurs on the physical premises of the destroying registrant’s registered location. A hospital/clinic has an on-site pharmacy when it has a pharmacy located on the physical premises of the registrant’s registered location.


[79 FR 53560, Sept. 9, 2014]


PART 1301 – REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES


Authority:21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.



Source:36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

General Information

§ 1301.01 Scope of this part 1301.

Procedures governing the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances pursuant to sections 301-304 and 1007-1008 of the Act (21 U.S.C. 821-824 and 957-958) are set forth generally by those sections and specifically by the sections of this part.


[62 FR 13945, Mar. 24, 1997]


§ 1301.02 Definitions.
Link

Any term used in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13945, Mar. 24, 1997]


§ 1301.03 Information; special instructions.

Information regarding procedures under these rules and instructions supplementing these rules will be furnished upon request by writing to the Registration Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


[75 FR 10676, Mar. 9, 2010]


Registration

§ 1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.

(a) Every person who manufactures, distributes, dispenses, imports, or exports any controlled substance or who proposes to engage in the manufacture, distribution, dispensing, importation or exportation of any controlled substance shall obtain a registration unless exempted by law or pursuant to §§ 1301.22 through 1301.26. Except as provided in paragraph (b) of this section, only persons actually engaged in such activities are required to obtain a registration; related or affiliated persons who are not engaged in such activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation manufacturing controlled substances is not required to obtain a registration.)


(b) As provided in sections 303(f) and 401(h) of the Act (21 U.S.C. 823(f) and 841(h)), it is unlawful for any person who falls within the definition of “online pharmacy” (as set forth in section 102(52) of the Act (21 U.S.C. 802(52)) and § 1300.04(h) of this chapter) to deliver, distribute, or dispense a controlled substance by means of the Internet if such person is not validly registered with a modification of such registration authorizing such activity (unless such person is exempt from such modified registration requirement under the Act or this chapter). The Act further provides that the Administrator may only issue such modification of registration to a person who is registered as a pharmacy under section 303(f) of the Act (21 U.S.C. 823(f)). Accordingly, any pharmacy registered pursuant to § 1301.13 of this part that falls within the definition of an online pharmacy and proposes to dispense controlled substances by means of the Internet must obtain a modification of its registration authorizing such activity following the submission of an application in accordance with § 1301.19 of this part. This requirement does not apply to a registered pharmacy that does not fall within the definition of an online pharmacy set forth in § 1300.04(h). Under the Act, persons other than registered pharmacies are not eligible to obtain such a modification of registration but remain liable under section 401(h) of the Act (21 U.S.C. 841(h)) if they deliver, distribute, or dispense a controlled substance while acting as an online pharmacy without being validly registered with a modification authorizing such activity.


[74 FR 15621, Apr. 6, 2009]


§ 1301.12 Separate registrations for separate locations.

(a) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.


(b) The following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:


(1) A warehouse where controlled substances are stored by or on behalf of a registered person, unless such substances are distributed directly from such warehouse to registered locations other than the registered location from which the substances were delivered or to persons not required to register by virtue of subsection 302(c)(2) or subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 957(b)(1)(B));


(2) An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains such substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders; and


(3) An office used by a practitioner (who is registered at another location in the same State in which he or she practices) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained.


(4) A freight forwarding facility, as defined in § 1300.01 of this part, provided that the distributing registrant operating the facility has submitted written notice of intent to operate the facility by registered mail, return receipt requested (or other suitable means of documented delivery) and such notice has been approved. The notice shall be submitted to the Special Agent in Charge of the Administration’s offices in both the area in which the facility is located and each area in which the distributing registrant maintains a registered location that will transfer controlled substances through the facility. The notice shall detail the registered locations that will utilize the facility, the location of the facility, the hours of operation, the individual(s) responsible for the controlled substances, the security and recordkeeping procedures that will be employed, and whether controlled substances returns will be processed through the facility. The notice must also detail what state licensing requirements apply to the facility and the registrant’s actions to comply with any such requirements. The Special Agent in Charge of the DEA Office in the area where the freight forwarding facility will be operated will provide written notice of approval or disapproval to the person within thirty days after confirmed receipt of the notice. Registrants that are currently operating freight forwarding facilities under a memorandum of understanding with the Administration must provide notice as required by this section no later than September 18, 2000 and receive written approval from the Special Agent in Charge of the DEA Office in the area in which the freight forwarding facility is operated in order to continue operation of the facility.


[62 FR 13945, Mar. 24, 1997, as amended at 65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000; 71 FR 69480, Dec. 1, 2006; 81 FR 97019, Dec. 30, 2016]


§ 1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is granted and a Certificate of Registration is issued by the Administrator to such person.


(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his/her registration, except that a bulk manufacturer of Schedule I or II controlled substances or an importer of Schedule I or II controlled substances may apply to be reregistered no more than 120 days before the expiration date of their registration.


(c) At the time a manufacturer, distributor, reverse distributor, researcher, analytical lab, importer, exporter or narcotic treatment program is first registered, that business activity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last date of the month designated for that group. In assigning any of these business activities to a group, the Administration may select a group the expiration date of which is less than one year from the date such business activity was registered. If the business activity is assigned to a group which has an expiration date less than three months from the date of which the business activity is registered, the registration shall not expire until one year from that expiration date; in all other cases, the registration shall expire on the expiration date following the date on which the business activity is registered.


(d) At the time a retail pharmacy, hospital/clinic, practitioner or teaching institution is first registered, that business activity shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last day of the month designated for that group. In assigning any of the above business activities to a group, the Administration may select a group the expiration date of which is not less than 28 months nor more than 39 months from the date such business activity was registered. After the initial registration period, the registration shall expire 36 months from the initial expiration date.


(e) Any person who is required to be registered and who is not so registered, shall make application for registration for one of the following groups of controlled substances activities, which are deemed to be independent of each other. Application for each registration shall be made on the indicated form, and shall be accompanied by the indicated fee. Fee payments shall be made in the form of a personal, certified, or cashier’s check or money order made payable to the “Drug Enforcement Administration”. Generally, the application fees are not refundable; however, they may be issued in limited circumstances at the discretion of the Administrator. These circumstances include: Applicant error, such as duplicate payments, payment for incorrect business activities, or payments made by persons who are exempt under this section from application or renewal fees; DEA error; and death of a registrant within the first year of the three-year registration cycle. Any person, when registered to engage in the activities described in each subparagraph in this paragraph, shall be authorized to engage in the coincident activities described without obtaining a registration to engage in such coincident activities, provided that, unless specifically exempted, he/she complies with all requirements and duties prescribed by law for persons registered to engage in such coincident activities. Any person who engages in more than one group of independent activities shall obtain a separate registration for each group of activities, except as provided in this paragraph under coincident activities. A single registration to engage in any group of independent activities listed below may include one or more controlled substances listed in the schedules authorized in that group of independent activities. A person registered to conduct research with controlled substances listed in Schedule I may conduct research with any substances listed in Schedule I for which he/she has filed and had approved a research protocol.


(1)


Summary of Registration Requirements and Limitations

Business activity
Controlled substances
DEA application forms
Application fee

($)
Registration period

(years)
Coincident activities allowed
(i) ManufacturingSchedules I -VNew – 225

Renewal – 225a
3,6991Schedules I-V: May distribute that substance or class for which registration was issued; may not distribute or dispose any substance or class for which not registered.

Schedules II-V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a mfr. was issued.
(ii) DistributingSchedules I-VNew – 225

Renewal – 225a
1,8501May acquire Schedules II-V controlled substances from collectors for the purposes of destruction.
(iii) Reverse distributingSchedules I-VNew – 225

Renewal – 225a
1,8501
(iv) Dispensing or instructing (includes Practitioner, Hospital/Clinic, Retail Pharmacy, Online Pharmacy, Central Fill Pharmacy, Teaching Institution)Schedules II-VNew – 224 Renewal – 224a Online Pharmacy – 224c8883May conduct research and instructional activities with those controlled substances for which registration was granted, except that a mid-level practitioner may conduct such research only to the extent expressly authorized under State statute. A pharmacist may manufacturer an aqueous or oleaginous solution solid dosage form containing a narcotic controlled substance in Schedule II-V in a proportion not exceeding 20% of the complete solution, compound or mixture. A retail pharmacy may perform central fill pharmacy activities. An online pharmacy may perform activities of retail pharmacy, as well as online pharmacy activities.
(v) ResearchSchedule INew – 225

Renewal – 225a
2961A researcher may manufacture or import the basic class of substance or substances for which registration was issued, provided that such manufacture or import is set forth in the protocol required in § 1301.18 and to distribute such class to persons registered or authorized to conduct research with such class of substance or registered or authorized to conduct chemical analysis with controlled substances.
(vi) ResearchSchedules II-VNew – 225

Renewal – 225a
2961May conduct chemical analysis with controlled substances in those schedules for which registration was issued; manufacture such substances if and to the extent that such manufacture is set forth in a statement filed with the application for registration or reregistration and provided that the manufacture is not for the purposes of dosage form development; import such substances for research purposes; distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities or research with such substances, and to persons exempted from registration pursuant to § 1301.24; and conduct instructional activities with controlled substances.

(vii) Narcotic Treatment Program (including compounder)Narcotic Drugs in Schedules II-VNew-363

Renewal-363a

2961May operate one or more mobile narcotic treatment programs as defined under § 1300.01(b), provided approval has been obtained under § 1301.13(e)(4).

(viii) ImportingSchedules I-VNew – 225

Renewal – 225a
1,8501May distribute that substance or class for which registration was issued; may not distribute any substance or class for which not registered.
(ix) ExportingSchedules I-VNew – 225

Renewal – 225a
1,8501
(x) Chemical AnalysisSchedules I-VNew – 225

Renewal – 225a
2961May manufacture and import controlled substances for analytical or instructional activities; may distribute such substances to persons registered or authorized to conduct chemical analysis, instructional activities, or research with such substances and to persons exempted from registration pursuant to § 1301.24; may export such substances to persons in other countries performing chemical analysis or enforcing laws related to controlled substances or drugs in those countries; and may conduct instructional activities with controlled substances.

(2) DEA Forms 224, 225, and 363 may be obtained online at www.DEAdiversion.usdoj.gov. Only applications submitted online through the secure application portal on DEA’s website will be accepted for processing.


(3) DEA will send renewal notifications via email to registrants approximately 60 calendar days prior to their registration expiration date. Registrants are responsible for maintaining a current email address in application portal on DEA’s website. DEA Forms 224a, 225a, and 363a may be obtained online at www.DEAdiversion.usdoj.gov. Only renewal applications submitted online through the secure application portal on DEA’s website will be accepted for processing.


(4) For any narcotic treatment program (NTP) intending to operate a mobile NTP, the registrant must notify the local DEA office, in writing, of its intent to do so, and the NTP must receive explicit written approval from the local DEA office prior to operating the mobile NTP. The mobile NTP may only operate in the same State in which the NTP is registered.


(i) Registrants are not required to obtain a separate registration for conveyances (mobile components) utilized by the registrant to transport controlled substances away from registered locations for dispensing at unregistered locations as part of a mobile NTP. Vehicles must possess valid county/city and State information (e.g., a vehicle information number (license plate number) on file at the registered location of the NTP. Registrants are also required to provide proper city/county and State licensing and registration to DEA at the time of inspection, and prior to transporting controlled substances away from their registered location.


(ii) A mobile NTP is not permitted to reverse distribute, share, or transfer controlled substances from one mobile component to another mobile component while deployed away from the registered location. NTPs with mobile components are not allowed to modify their registrations to authorize their mobile components to act as collectors under 21 CFR 1301.51 and 1317.40. Mobile components of NTPs may not function as hospitals, long-term care facilities, or emergency medical service vehicles, and will not transport patients.


(iii) A mobile NTP may operate at any remote location or locations within the same State as its registered location, including correctional facilities, so long as doing so is otherwise consistent with applicable Federal, State, tribal, and local laws and regulations, and so long as the local DEA office, when notified pursuant to this section, does not otherwise direct.


(f) Each application for registration to handle any basic class of controlled substance listed in Schedule I (except to conduct chemical analysis with such classes), and each application for registration to manufacture a basic class of controlled substance listed in Schedule II shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each basic class to be covered by such registration.


(g) Each application for registration to import or export controlled substances shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each controlled substance whose importation or exportation is to be authorized by such registration. Registration as an importer or exporter shall not entitle a registrant to import or export any controlled substance not specified in such registration.


(h) Each application for registration to conduct research with any basic class of controlled substance listed in Schedule II shall include the Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, for each such basic class to be manufactured or imported as a coincident activity of that registration. A statement listing the quantity of each such basic class of controlled substance to be imported or manufactured during the registration period for which application is being made shall be included with each such application. For purposes of this paragraph only, manufacturing is defined as the production of a controlled substance by synthesis, extraction or by agricultural/horticultural means.


(i) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.


(j) Each application, attachment, or other document filed as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the Registration Unit of the Administration a power of attorney for each such individual. The power of attorney shall be signed by a person who is authorized to sign applications under this paragraph and shall contain the signature of the individual being authorized to sign applications. The power of attorney shall be valid until revoked by the applicant.


[62 FR 13946, Mar. 24, 1997, as amended at 68 FR 37409, June 24, 2003; 68 FR 41228, July 11, 2003; 68 FR 58598, Oct. 10, 2003; 71 FR 51112, Aug. 29, 2006; 74 FR 15622, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 77 FR 15248, Mar. 15, 2012; 79 FR 53560, Sept. 9, 2014; 85 FR 44732, July 24, 2020; 85 FR 61601, Sept. 30, 2020; 85 FR 67278, Oct. 22, 2020; 86 FR 33883, June 28, 2021; 87 FR 21022, Apr. 11, 2022]


§ 1301.14 Filing of application; acceptance for filing; defective applications.

(a) All applications for registration shall be submitted for filing online using the secure application portal at www.DEAdiversion.usdoj.gov.


(b) Application submitted for filing are dated by the system upon receipt. If found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will be rejected by the system, with the applicate receiving error messages at the time of application.


(c) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to § 1301.15 and has no bearing on whether the application will be granted.


[62 FR 13948, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010; 87 FR 21022, Apr. 11, 2022]


§ 1301.15 Additional information.

The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Administrator in granting or denying the application.


[62 FR 13948, Mar. 24, 1997]


§ 1301.16 Amendments to and withdrawal of applications.

(a) An application may be amended or withdrawn without permission of the Administrator at any time before the date on which the applicant receives an order to show cause pursuant to § 1301.37. An application may be amended or withdrawn with permission of the Administrator at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.


(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.


[62 FR 13949, Mar. 24, 1997]


§ 1301.17 Special procedures for certain applications.

(a) If, at the time of application for registration of a new pharmacy, the pharmacy has been issued a license from the appropriate State licensing agency, the applicant may include with his/her application an affidavit as to the existence of the State license in the following form:



Affidavit for New Pharmacy

I, __________, the __________ (Title of officer, official, partner, or other position) of __________ (Corporation, partnership, or sole proprietor), doing business as __________ (Store name) at __________ (Number and Street), __________ (City) ______ (State) ______ (Zip code), hereby certify that said store was issued a pharmacy permit No. ____ by the ________ (Board of Pharmacy or Licensing Agency) of the State of ______ on ______ (Date).


This statement is submitted in order to obtain a Drug Enforcement Administration registration number. I understand that if any information is false, the Administration may immediately suspend the registration for this store and commence proceedings to revoke under 21 U.S.C. 824(a) because of the danger to public health and safety. I further understand that any false information contained in this affidavit may subject me personally and the above-named corporation/partnership/business to prosecution under 21 U.S.C. 843, the penalties for conviction of which include imprisonment for up to 4 years, a fine of not more than $30,000 or both.




Signature (Person who signs Application for Registration)

State of

County of

Subscribed to and sworn before me this _______ day of _______, 19__.




Notary Public

(b) Whenever the ownership of a pharmacy is being transferred from one person to another, if the transferee owns at least one other pharmacy licensed in the same State as the one the ownership of which is being transferred, the transferee may apply for registration prior to the date of transfer. The Administrator may register the applicant and authorize him to obtain controlled substances at the time of transfer. Such registration shall not authorize the transferee to dispense controlled substances until the pharmacy has been issued a valid State license. The transferee shall include with his/her application the following affidavit:



Affidavit for Transfer of Pharmacy

I, __________, the __________ (Title of officer, official, partner or other position) of __________ (Corporation, partnership, or sole proprietor), doing business as __________ (Store name) hereby certify:


(1) That said company was issued a pharmacy permit No.______by the __________ (Board of Pharmacy of Licensing Agency) of the State of ______ and a DEA Registration Number __________ for a pharmacy located at __________ (Number and Street) ______ (City) ______ (State) ______ (Zip Code); and


(2) That said company is acquiring the pharmacy business of __________ (Name of Seller) doing business as__________with DEA Registration Number ______ on or about ______ (Date of Transfer) and that said company has applied (or will apply on ______ (Date) for a pharmacy permit from the board of pharmacy (or licensing agency) of the State of ______ to do business as __________ (Store name) at __________ (Number and Street) __________ (City) ______ (State) ______ (Zip Code).


This statement is submitted in order to obtain a Drug Enforcement Administration registration number.



I understand that if a DEA registration number is issued, the pharmacy may acquire controlled substances but may not dispense them until a pharmacy permit or license is issued by the State board of pharmacy or licensing agency.


I understand that if any information is false, the Administration may immediately suspend the registration for this store and commence proceedings to revoke under 21 U.S.C. 824(a) because of the danger to public health and safety. I further understand that any false information contained in this affidavit may subject me personally to prosecution under 21 U.S.C. 843, the penalties for conviction of which include imprisonment for up to 4 years, a fine of not more than $30,000 or both.




Signature (Person who signs Application for Registration)

State of

County of

Subscribed to and sworn before me this ________ day of _________, 19__.




Notary Public

(c) If at the time of application for a separate registration at a long term care facility, the retail pharmacy has been issued a license, permit, or other form of authorization from the appropriate State agency to install and operate an automated dispensing system for the dispensing of controlled substances at the long term care facility, the applicant must include with his/her application for registration (DEA Form 224) an affidavit as to the existence of the State authorization. Exact language for this affidavit may be found at the DEA Diversion Control Program Web site. The affidavit must include the following information:


(1) The name and title of the corporate officer or official signing the affidavit;


(2) The name of the corporation, partnership or sole proprietorship operating the retail pharmacy;


(3) The name and complete address (including city, state, and Zip code) of the retail pharmacy;


(4) The name and complete address (including city, state, and Zip code) of the long term care facility at which DEA registration is sought;


(5) Certification that the named retail pharmacy has been authorized by the state Board of Pharmacy or licensing agency to install and operate an automated dispensing system for the dispensing of controlled substances at the named long term care facility (including the license or permit number, if applicable);


(6) The date on which the authorization was issued;


(7) Statements attesting to the following:


(i) The affidavit is submitted to obtain a Drug Enforcement Administration registration number;


(ii) If any material information is false, the Administrator may commence proceedings to deny the application under section 304 of the Act (21 U.S.C. 824(a));


(iii) Any false or fraudulent material information contained in this affidavit may subject the person signing this affidavit and the above-named corporation/partnership/business to prosecution under section 403 of the Act (21 U.S.C. 843);


(8) Signature of the person authorized to sign the Application for Registration for the named retail pharmacy;


(9) Notarization of the affidavit.


(d) The Administrator shall follow the normal procedures for approving an application to verify the statements in the affidavit. If the statements prove to be false, the Administrator may revoke the registration on the basis of section 304(a)(1) of the Act (21 U.S.C. 824(a)(1)) and suspend the registration immediately by pending revocation on the basis of section 304(d) of the Act (21 U.S.C. 824(d)). At the same time, the Administrator may seize and place under seal all controlled substances possessed by the applicant under section 304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the affidavit procedure may subject the applicant to prosecution for fraud under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining controlled substances through registration by fraudulent means may subject the applicant to prosecution under section 403(a)(3) of the Act (21 U.S.C. 843(a)(3)). The penalties for conviction of either offense include imprisonment for up to 4 years, a fine not exceeding $30,000 or both.


[62 FR 13949, Mar. 24, 1997, as amended at 70 FR 25465, May 13, 2005]


§ 1301.18 Research protocols.

(a) A protocol to conduct research with controlled substances listed in Schedule I shall be in the following form and contain the following information where applicable:


(1) Investigator:


(i) Name, address, and DEA registration number; if any.


(ii) Institutional affiliation.


(iii) Qualifications, including a curriculum vitae and an appropriate bibliography (list of publications).


(2) Research project:


(i) Title of project.


(ii) Statement of the purpose.


(iii) Name of the controlled substances or substances involved and the amount of each needed.


(iv) Description of the research to be conducted, including the number and species of research subjects, the dosage to be administered, the route and method of administration, and the duration of the project.


(v) Location where the research will be conducted.


(vi) Statement of the security provisions for storing the controlled substances (in accordance with § 1301.75) and for dispensing the controlled substances in order to prevent diversion.


(vii) If the investigator desires to manufacture or import any controlled substance listed in paragraph (a)(2)(iii) of this section, a statement of the quantity to be manufactured or imported and the sources of the chemicals to be used or the substance to be imported.


(3) Authority:


(i) Institutional approval.


(ii) Approval of a Human Research Committee for human studies.


(iii) Indication of an approved active Notice of Claimed Investigational Exemption for a New Drug (number).


(iv) Indication of an approved funded grant (number), if any.


(b) In the case of a clinical investigation with controlled substances listed in Schedule I, the applicant shall submit three copies of a Notice of Claimed Investigational Exemption for a New Drug (IND) together with a statement of the security provisions (as proscribed in paragraph (a)(2)(vi) of this section for a research protocol) to, and have such submission approved by, the Food and Drug Administration as required in 21 U.S.C. 355(i) and § 130.3 of this title. Submission of this Notice and statement to the Food and Drug Administration shall be in lieu of a research protocol to the Administration as required in paragraph (a) of this section. The applicant, when applying for registration with the Administration, shall indicate that such notice has been submitted to the Food and Drug Administration by submitting to the Administration with his/her DEA Form 225 three copies of the following certificate:



I hereby certify that on __________ (Date), pursuant to 21 U.S.C. 355(i) and 21 CFR 130.3, I, __________ (Name and Address of IND Sponsor) submitted a Notice of Claimed Investigational Exemption for a New Drug (IND) to the Food and Drug Administration for:




(Name of Investigational Drug).



(Date)



(Signature of Applicant).

(c) In the event that the registrant desires to increase the quantity of a controlled substance used for an approved research project, he/she shall submit a request to the Registration Unit, Drug Enforcement Administration, by registered mail, return receipt requested. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The request shall contain the following information: DEA registration number; name of the controlled substance or substances and the quantity of each authorized in the approved protocol; and the additional quantity of each desired. Upon return of the receipt, the registrant shall be authorized to purchase the additional quantity of the controlled substance or substances specified in the request. The Administration shall review the letter and forward it to the Food and Drug Administration together with the Administration comments. The Food and Drug Administration shall approve or deny the request as an amendment to the protocol and so notify the registrant. Approval of the letter by the Food and Drug Administration shall authorize the registrant to use the additional quantity of the controlled substance in the research project.


(d) In the event the registrant desires to conduct research beyond the variations provided in the registrant’s approved protocol (excluding any increase in the quantity of the controlled substance requested for his/her research project as outlined in paragraph (c) of this section), he/she shall submit three copies of a supplemental protocol in accordance with paragraph (a) of this section describing the new research and omitting information in the supplemental protocol which has been stated in the original protocol. Supplemental protocols shall be processed and approved or denied in the same manner as original research protocols.


[62 FR 13949, Mar. 24, 1997, as amended at 75 FR 10676, Mar. 9, 2010]


§ 1301.19 Special requirements for online pharmacies.

(a) A pharmacy that has been issued a registration under § 1301.13 may request that the Administrator modify its registration to authorize the pharmacy to dispense controlled substances by means of the Internet as an online pharmacy. The Administrator may deny an application for a modification of registration if the Administrator determines that the issuance of a modification would be inconsistent with the public interest. In determining the public interest, the Administrator will consider the factors listed in section 303(f) of the Act (21 U.S.C. 823(f)).


(b) Each online pharmacy shall comply with the requirements of State law concerning licensure of pharmacies in each State from which it, and in each State to which it, delivers, distributes, or dispenses, or offers to deliver, distribute, or dispense controlled substances by means of the Internet.


(c) Application for a modified registration authorizing the dispensing of controlled substances by means of the Internet will be made by an online application process as specified in § 1301.13 of this part. Subsequent online pharmacy registration renewals will be accomplished by an online process.


(d) A pharmacy that seeks to discontinue its modification of registration authorizing it to dispense controlled substances by means of the Internet as an online pharmacy (but continue its business activity as a non-online pharmacy) shall so notify the Administrator by requesting to modify its registration to reflect the appropriate business activity. Once the registration has been so changed, the pharmacy may no longer dispense controlled substances by means of the Internet. A pharmacy that has so changed its registration status back to that of a non-online pharmacy remains responsible for submitting reports in accordance with § 1304.55 of this chapter with respect to any controlled substances that it dispensed while it was registered with a modification authorizing it to operate as an online pharmacy.


(e) Registrants applying for modified registrations under this section must comply with notification and reporting requirements set forth in §§ 1304.40, 1304.45, 1304.50, and 1304.55 of this chapter.


(f) No person (including a registrant) required to obtain a modification of a registration under §§ 1301.11(b) and 1301.13 of this part authorizing it to operate as an online pharmacy may engage in any activity for which such modification of registration is required until the application for such modified registration is granted and an active Certificate of Registration indicating the modification of the registration has been issued by the Administrator to such person.


[74 FR 15622, Apr. 6, 2009]


Exceptions to Registration and Fees

§ 1301.21 Exemption from fees.

(a) The Administrator shall exempt from payment of an application fee for registration or reregistration:


(1) Any hospital or other institution which is operated by an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, Space Force, and Coast Guard), of any State, or any political subdivision or agency thereof.


(2) Any individual practitioner who is required to obtain an individual registration in order to carry out his or her duties as an official of an agency of the United States (including the U.S. Army, Navy, Marine Corps, Air Force, Space Force, and Coast Guard), of any State, or any political subdivision or agency thereof.


(b) In order to claim exemption from payment of a registration or reregistration application fee, the registrant shall have completed the certification on the appropriate application form, wherein the registrant’s superior (if the registrant is an individual) or officer (if the registrant is an agency) certifies to the status and address of the registrant and to the authority of the registrant to acquire, possess, or handle controlled substances.


(c) Exemption from payment of a registration or reregistration application fee does not relieve the registrant of any other requirements or duties prescribed by law.


[62 FR 13950, Mar. 24, 1997, as amended at 86 FR 51822, Sept. 17, 2021]


§ 1301.22 Exemption of agents and employees; affiliated practitioners.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if such agent or employee is acting in the usual course of his/her business or employment.


(b) An individual practitioner who is an agent or employee of another practitioner (other than a mid-level practitioner) registered to dispense controlled substances may, when acting in the normal course of business or employment, administer or dispense (other than by issuance of prescription) controlled substances if and to the extent that such individual practitioner is authorized or permitted to do so by the jurisdiction in which he or she practices, under the registration of the employer or principal practitioner in lieu of being registered him/herself.


(c) An individual practitioner who is an agent or employee of a hospital or other institution may, when acting in the normal course of business or employment, administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution which is registered in lieu of being registered him/herself, provided that:


(1) Such dispensing, administering or prescribing is done in the usual course of his/her professional practice;


(2) Such individual practitioner is authorized or permitted to do so by the jurisdiction in which he/she is practicing;


(3) The hospital or other institution by whom he/she is employed has verified that the individual practitioner is so permitted to dispense, administer, or prescribe drugs within the jurisdiction;


(4) Such individual practitioner is acting only within the scope of his/her employment in the hospital or institution;


(5) The hospital or other institution authorizes the individual practitioner to administer, dispense or prescribe under the hospital registration and designates a specific internal code number for each individual practitioner so authorized. The code number shall consist of numbers, letters, or a combination thereof and shall be a suffix to the institution’s DEA registration number, preceded by a hyphen (e.g., APO123456-10 or APO123456-A12); and


(6) A current list of internal codes and the corresponding individual practitioners is kept by the hospital or other institution and is made available at all times to other registrants and law enforcement agencies upon request for the purpose of verifying the authority of the prescribing individual practitioner.


[62 FR 13950, Mar. 24, 1997]


§ 1301.23 Exemption of certain military and other personnel.

(a) The requirement of registration is waived for any official of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, Public Health Service, or Bureau of Prisons who is authorized to prescribe, dispense, or administer, but not to procure or purchase, controlled substances in the course of his/her official duties. Such officials shall follow procedures set forth in part 1306 of this chapter regarding prescriptions, but shall state the branch of service or agency (e.g., “U.S. Army” or “Public Health Service”) and the service identification number of the issuing official in lieu of the registration number required on prescription forms. The service identification number for a Public Health Service employee is his/her Social Security identification number.


(b) The requirement of registration is waived for any official or agency of the U.S. Army, Navy, Marine Corps, Air Force, Space Force, Coast Guard, or Public Health Service who or which is authorized to import or export controlled substances in the course of his/her official duties.


(c) If any official exempted by this section also engages as a private individual in any activity or group of activities for which registration is required, such official shall obtain a registration for such private activities.


[62 FR 13951, Mar. 24, 1997, as amended at 86 FR 51822, Sept. 17, 2021]


§ 1301.24 Exemption of law enforcement officials.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:


(1) Any officer or employee of the Administration, any customs officer, any officer or employee of the U.S. Food and Drug Administration, and any other Federal or Insular officer who is lawfully engaged in the enforcement of any Federal law relating to controlled substances, drugs, or customs, and is duly authorized to possess or to import or export controlled substances in the course of his/her official duties; and


(2) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to controlled substances and is duly authorized to possess controlled substances in the course of his/her official duties.


(b) Any official exempted by this section may, when acting in the course of his/her official duties, procure any controlled substance in the course of an inspection, in accordance with § 1316.03(d) of this chapter, or in the course of any criminal investigation involving the person from whom the substance was procured, and may possess any controlled substance and distribute any such substance to any other official who is also exempted by this section and acting in the course of his/her official duties.


(c) In order to enable law enforcement agency laboratories, including laboratories of the Administration, to obtain and transfer controlled substances for use as standards in chemical analysis, such laboratories shall obtain annually a registration to conduct chemical analysis. Such laboratories shall be exempted from payment of a fee for registration. Laboratory personnel, when acting in the scope of their official duties, are deemed to be officials exempted by this section and within the activity described in section 515(d) of the Act (21 U.S.C. 885(d)). For purposes of this paragraph, laboratory activities shall not include field or other preliminary chemical tests by officials exempted by this section.


(d) In addition to the activities authorized under a registration to conduct chemical analysis pursuant to § 1301.13(e)(1)(ix), laboratories of the Administration shall be authorized to manufacture or import controlled substances for any lawful purpose, to distribute or export such substances to any person, and to import and export such substances in emergencies without regard to the requirements of part 1312 of this chapter if a report concerning the importation or exportation is made to the Drug Operations Section of the Administration within 30 days of such importation or exportation.


[62 FR 13951, Mar. 24, 1997, as amended at 81 FR 97019, Dec. 30, 2016]


§ 1301.25 Registration regarding ocean vessels, aircraft, and other entities.

(a) If acquired by and dispensed under the general supervision of a medical officer described in paragraph (b) of this section, or the master or first officer of the vessel under the circumstances described in paragraph (d) of this section, controlled substances may be held for stocking, be maintained in, and dispensed from medicine chests, first aid packets, or dispensaries:


(1) On board any vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government;


(2) On board any aircraft operated by an air carrier under a certificate of permit issued pursuant to the Federal Aviation Act of 1958 (49 U.S.C. 1301); and


(3) In any other entity of fixed or transient location approved by the Administrator as appropriate for application of this section (e.g., emergency kits at field sites of an industrial firm).


(b) A medical officer shall be:


(1) Licensed in a state as a physician;


(2) Employed by the owner or operator of the vessel, aircraft or other entity; and


(3) Registered under the Act at either of the following locations:


(i) The principal office of the owner or operator of the vessel, aircraft or other entity or


(ii) At any other location provided that the name, address, registration number and expiration date as they appear on his/her Certificate of Registration (DEA Form 223) for this location are maintained for inspection at said principal office in a readily retrievable manner.


(c) A registered medical officer may serve as medical officer for more than one vessel, aircraft, or other entity under a single registration, unless he/she serves as medical officer for more than one owner or operator, in which case he/she shall either maintain a separate registration at the location of the principal office of each such owner or operator or utilize one or more registrations pursuant to paragraph (b)(3)(ii) of this section.


(d) If no medical officer is employed by the owner or operator of a vessel, or in the event such medical officer is not accessible and the acquisition of controlled substances is required, the master or first officer of the vessel, who shall not be registered under the Act, may purchase controlled substances from a registered manufacturer or distributor, or from an authorized pharmacy as described in paragraph (f) of this section, by following the procedure outlined below:


(1) The master or first officer of the vessel must personally appear at the vendor’s place of business, present proper identification (e.g., Seaman’s photographic identification card) and a written requisition for the controlled substances.


(2) The written requisition must be on the vessel’s official stationery or purchase order form and must include the name and address of the vendor, the name of the controlled substance, description of the controlled substance (dosage form, strength and number or volume per container) number of containers ordered, the name of the vessel, the vessel’s official number and country of registry, the owner or operator of the vessel, the port at which the vessel is located, signature of the vessel’s officer who is ordering the controlled substances and the date of the requisition.


(3) The vendor may, after verifying the identification of the vessel’s officer requisitioning the controlled substances, deliver the control substances to that officer. The transaction shall be documented, in triplicate, on a record of sale in a format similar to that outlined in paragraph (d)(4) of this section. The vessel’s requisition shall be attached to copy 1 of the record of sale and filed with the controlled substances records of the vendor, copy 2 of the record of sale shall be furnished to the officer of the vessel and retained aboard the vessel, copy 3 of the record of sale shall be forwarded to the nearest DEA Division Office within 15 days after the end of the month in which the sale is made.


(4) The vendor’s record of sale should be similar to, and must include all the information contained in, the below listed format.



Sale of Controlled Substances to Vessels

(Name of registrant)

(Address of registrant)

(DEA registration number)

Line No.
Number of packages ordered
Size of packages
Name of product
Packages distributed
Date distributed
1
2
3

Footnote: Line numbers may be continued according to needs of the vendor.


Number of lines completed

Name of vessel

Vessel’s official number

Vessel’s country of registry

Owner or operator of the vessel

Name and title of vessel’s officer who presented the requisition _____________

Signature of vessel’s officer who presented the requisition ______________

(e) Any medical officer described in paragraph (b) of this section shall, in addition to complying with all requirements and duties prescribed for registrants generally, prepare an annual report as of the date on which his/her registration expires, which shall give in detail an accounting for each vessel, aircraft, or other entity, and a summary accounting for all vessels, aircraft, or other entities under his/her supervision for all controlled substances purchased, dispensed or disposed of during the year. The medical officer shall maintain this report with other records required to be kept under the Act and, upon request, deliver a copy of the report to the Administration. The medical officer need not be present when controlled substances are dispensed, if the person who actually dispensed the controlled substances is responsible to the medical officer to justify his/her actions.


(f) Any registered pharmacy that wishes to distribute controlled substances pursuant to this section shall be authorized to do so, provided:


(1) The registered pharmacy notifies the nearest Division Office of the Administration of its intention to so distribute controlled substances prior to the initiation of such activity. This notification shall be by registered mail and shall contain the name, address, and registration number of the pharmacy as well as the date upon which such activity will commence; and


(2) Such activity is authorized by state law; and


(3) The total number of dosage units of all controlled substances distributed by the pharmacy during any calendar year in which the pharmacy is registered to dispense does not exceed the limitations imposed upon such distribution by § 1307.11(a)(1)(iv) and (b) of this chapter.


(g) Owners or operators of vessels, aircraft, or other entities described in this section shall not be deemed to possess or dispense any controlled substance acquired, stored and dispensed in accordance with this section. Additionally, owners or operators of vessels, aircraft, or other entities described in this section or in Article 32 of the Single Convention on Narcotic Drugs, 1961, or in Article 14 of the Convention on Psychotropic Substances, 1971, shall not be deemed to import or export any controlled substances purchased and stored in accordance with that section or applicable article.


(h) The Master of a vessel shall prepare a report for each calendar year which shall give in detail an accounting for all controlled substances purchased, dispensed, or disposed of during the year. The Master shall file this report with the medical officer employed by the owner or operator of his/her vessel, if any, or, if not, he/she shall maintain this report with other records required to be kept under the Act and, upon request, deliver a copy of the report to the Administration.


(i) Controlled substances acquired and possessed in accordance with this section shall be distributed only to persons under the general supervision of the medical officer employed by the owner or operator of the vessel, aircraft, or other entity, except in accordance with part 1317 of this chapter.


[62 FR 13951, Mar. 24, 1997, as amended at 79 FR 53561, Sept. 9, 2014; 84 FR 68342, Dec. 16, 2019]


§ 1301.26 Exemptions from import or export requirements for personal medical use.

Any individual who has in his/her possession a controlled substance listed in schedules II, III, IV, or V, which he/she has lawfully obtained for his/her personal medical use, or for administration to an animal accompanying him/her, may enter or depart the United States with such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 952-955), provided the following conditions are met:


(a) The controlled substance is in the original container in which it was dispensed to the individual; and


(b) The individual makes a declaration to an appropriate customs officer stating:


(1) That the controlled substance is possessed for his/her personal use, or for an animal accompanying him/her; and


(2) The trade or chemical name and the symbol designating the schedule of the controlled substance if it appears on the container label, or, if such name does not appear on the label, the name and address of the pharmacy or practitioner who dispensed the substance and the prescription number.


(c) In addition to (and not in lieu of) the foregoing requirements of this section, a United States resident may import into the United States no more than 50 dosage units combined of all such controlled substances in the individual’s possession that were obtained abroad for personal medical use. (For purposes of this section, a United States resident is a person whose residence (i.e., place of general abode – meaning one’s principal, actual dwelling place in fact, without regard to intent) is in the United States.) This 50 dosage unit limitation does not apply to controlled substances lawfully obtained in the United States pursuant to a prescription issued by a DEA registrant.


[69 FR 55347, Sept. 14, 2004, as amended at 81 FR 97019, Dec. 30, 2016]


§ 1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.

(a) A retail pharmacy may install and operate automated dispensing systems, as defined in § 1300.01 of this chapter, at long term care facilities, under the requirements of § 1301.17. No person other than a registered retail pharmacy may install and operate an automated dispensing system at a long term care facility.


(b) Retail pharmacies installing and operating automated dispensing systems at long term care facilities must maintain a separate registration at the location of each long term care facility at which automated dispensing systems are located. If more than one registered retail pharmacy operates automated dispensing systems at the same long term care facility, each retail pharmacy must maintain a registration at the long term care facility.


(c) A registered retail pharmacy applying for a separate registration to operate an automated dispensing system for the dispensing of controlled substances at a long term care facility is exempt from application fees for any such additional registrations.


[70 FR 25465, May 13, 2005]


§ 1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.

(a) An individual practitioner may dispense or prescribe Schedule III, IV, or V narcotic controlled drugs or combinations of narcotic controlled drugs which have been approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment without obtaining the separate registration required by § 1301.13(e) if all of the following conditions are met:


(1) The individual practitioner meets the conditions specified in paragraph (b) of this section.


(2) The narcotic drugs or combination of narcotic drugs meet the conditions specified in paragraph (c) of this section.


(3) The individual practitioner is in compliance with either paragraph (d) or paragraph (e) of this section.


(b)(1) The individual practitioner must submit notification to the Secretary of Health and Human Services stating the individual practitioner’s intent to dispense or prescribe narcotic drugs under paragraph (a) of this section. The notice must contain all of the following certifications:


(i) The individual practitioner is registered under § 1301.13 as an individual practitioner and is a “qualifying physician” as defined in section 303(g)(2)(G)(ii) of the Act (21 U.S.C. 823(g)(2)(G)(ii)); a “qualifying other practitioner” as defined in section 303(g)(2)(G)(iv) of the Act (21 U.S.C. 823(g)(2)(G)(iv)) who is a nurse practitioner or physician assistant; or during the period beginning on October 1, 2018 and ending on October 1, 2023, a “qualifying other practitioner” as defined in section 303(g)(2)(G)(iv) of the Act (21 U.S.C. 823(g)(2)(G)(iv)) who is clinical nurse specialist, certified registered nurse anesthetist, or certified nurse midwife.

The Secretary of Health and Human Services may, by regulation, revise the requirements for being a qualifying other practitioner.


(ii) With respect to patients to whom the practitioner will provide such drugs or combinations of drugs, the individual practitioner has the capacity to provide directly, by referral, or in such other manner as determined by the Secretary of Health and Human Services:


(A) All drugs approved by the Food and Drug Administration for the treatment of opioid use disorder, including for maintenance, detoxification, overdose reversal, and relapse prevention; and


(B) Appropriate counseling and other appropriate ancillary services.


(iii)(A) The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section at any one time will not exceed the applicable number. Except as provided in paragraphs (b)(1)(iii)(B) and (C) of this section, the applicable number is 30.


(B) The applicable number is –


(1) 100 if not sooner than 1 year after the date on which the practitioner submitted the initial notification, the practitioner submits a second notification to the Secretary of Health and Human Services of the need and intent of the practitioner to treat up to 100 patients;


(2) 100 if the practitioner holds additional credentialing, as defined in 42 CFR 8.2;


(3) 100 if the practitioner provides medication-assisted treatment using covered medications (as such terms are defined in 42 CFR 8.615) in a qualified practice setting (as described in 42 CFR 8.615); and


(4) 275 if the practitioner meets the requirements specified in 42 CFR 8.610 through 8.655.


(2) If an individual practitioner wishes to prescribe or dispense narcotic drugs pursuant to paragraph (e) of this section, the individual practitioner must provide the Secretary of Health and Human Services the following:


(i) Notification as required under paragraph (b)(1) of this section in writing, stating the individual practitioner’s name and DEA registration number issued under § 1301.13.


(ii) If the individual practitioner is a member of a group practice, the names of the other individual practitioners in the group and the DEA registration numbers issued to the other individual practitioners under § 1301.13.


(c) The narcotic drugs or combination of narcotic drugs to be dispensed or prescribed under this section must meet all of the following conditions:


(1) The drugs or combination of drugs have been approved for use in “maintenance treatment” or “detoxification treatment” under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.


(2) The drugs or combination of drugs have not been the subject of an adverse determination by the Secretary of Health and Human Services, after consultation with the Attorney General, that the use of the drugs or combination of drugs requires additional standards respecting the qualifications of practitioners or the quantities of the drugs that may be provided for unsupervised use.


(d)(1) After receiving the notification submitted under paragraph (b) of this section, the Secretary of Health and Human Services will forward a copy of the notification to the Administrator. The Secretary of Health and Human Services will have 45 days from the date of receipt of the notification to make a determination of whether the individual practitioner involved meets all requirements for a waiver under section 303(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). Health and Human Services will notify DEA of its determination regarding the individual practitioner. If the individual practitioner has the appropriate registration under § 1301.13, then the Administrator will issue the practitioner an identification number as soon as one of the following conditions occurs:


(i) The Administrator receives a positive determination from the Secretary of Health and Human Services before the conclusion of the 45-day review period, or


(ii) The 45-day review period has concluded and no determination by the Secretary of Health and Human Services has been made.


(2) If the Secretary denies certification to an individual practitioner or withdraws such certification once it is issued, then DEA will not issue the individual practitioner an identification number, or will withdraw the identification number if one has been issued.


(3) The individual practitioner must include the identification number on all records when dispensing and on all prescriptions when prescribing narcotic drugs under this section.


(e) An individual practitioner may begin to prescribe or dispense narcotic drugs to a specific individual patient under this section before receiving an identification number from the Administrator if the following conditions are met:


(1) The individual practitioner has submitted a written notification under paragraph (b) of this section in good faith to the Secretary of Health and Human Services.


(2) The individual practitioner reasonably believes that the conditions specified in paragraphs (b) and (c) of this section have been met.


(3) The individual practitioner reasonably believes that the treatment of an individual patient would be facilitated if narcotic drugs are prescribed or dispensed under this section before the sooner of:


(i) Receipt of an identification number from the Administrator, or


(ii) Expiration of the 45-day period.


(4) The individual practitioner has notified both the Secretary of Health and Human Services and the Administrator of his or her intent to begin prescribing or dispensing the narcotic drugs before expiration of the 45-day period.


(5) The Secretary has not notified the registrant that he/she is not qualified under paragraph (d) of this section.


(6) The individual practitioner has the appropriate registration under § 1301.13.


(f) If an individual practitioner dispenses or prescribes Schedule III, IV, or V narcotic drugs approved by the Food and Drug Administration specifically for maintenance or detoxification treatment in violation of any of the conditions specified in paragraphs (b), (c) or (e) of this section, the Administrator may revoke the individual practitioner’s registration in accordance with § 1301.36.


[70 FR 36342, June 23, 2005, as amended at 73 FR 29688, May 22, 2008; 83 FR 3074, Jan. 23, 2018; 85 FR 69166, Nov. 2, 2020]


§ 1301.29 [Reserved]

Action on Application for Registration: Revocation or Suspension of Registration

§ 1301.31 Administrative review generally.

The Administrator may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to subpart A of part 1316 of this chapter. The Administrator shall review the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 U.S.C. 958) of the Act have been met by the applicant.


[62 FR 13953, Mar. 24, 1997]


§ 1301.32 Action on applications for research in Schedule I substances.

(a) In the case of an application for registration to conduct research with controlled substances listed in Schedule I, the Administrator shall process the application and protocol and forward a copy of each to the Secretary of Health and Human Services (Secretary) within 7 days after receipt. The Secretary shall determine the qualifications and competency of the applicant, as well as the merits of the protocol (and shall notify the Administrator of his/her determination) within 21 days after receipt of the application and complete protocol, except that in the case of a clinical investigation, the Secretary shall have 30 days to make such determination and notify the Administrator. The Secretary, in determining the merits of the protocol, shall consult with the Administrator as to effective procedures to safeguard adequately against diversion of such controlled substances from legitimate medical or scientific use.


(b) An applicant whose protocol is defective shall be notified by the Secretary within 21 days after receipt of such protocol from the Administrator (or in the case of a clinical investigation within 30 days), and he/she shall be requested to correct the existing defects before consideration shall be given to his/her submission.


(c) If the Secretary determines the applicant qualified and competent and the research protocol meritorious, he/she shall notify the Administrator in writing of such determination. The Administrator shall issue a certificate of registration within 10 days after receipt of this notice, unless he/she determines that the certificate of registration should be denied on a ground specified in section 304(a) of the Act (21 U.S.C. 824(a)). In the case of a supplemental protocol, a replacement certificate of registration shall be issued by the Administrator.


(d) If the Secretary determines that the protocol is not meritorious and/or the applicant is not qualified or competent, he/she shall notify the Administrator in writing setting forth the reasons for such determination. If the Administrator determines that grounds exist for the denial of the application, he/she shall within 10 days issue an order to show cause pursuant to § 1301.37 and, if requested by the applicant, hold a hearing on the application pursuant to § 1301.41. If the grounds for denial of the application include a determination by the Secretary, the Secretary or his duly authorized agent shall furnish testimony and documents pertaining to his determination at such hearing.


(e) Supplemental protocols will be processed in the same manner as original research protocols. If the processing of an application or research protocol is delayed beyond the time limits imposed by this section, the applicant shall be so notified in writing.


[62 FR 13953, Mar. 24, 1997]


§ 1301.33 Application for bulk manufacture of Schedule I and II substances.

(a) In the case of an application for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, the Administrator shall, upon the filing of such application, publish in the Federal Register a notice naming the applicant and stating that such applicant has applied to be registered as a bulk manufacturer of a basic class of narcotic or nonnarcotic controlled substance, which class shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that basic class and to any other applicant therefor. Any such person may, within 60 days from the date of publication of the notice in the Federal Register, file with the Administrator written comments on or objections to the issuance of the proposed registration.


(b) In order to provide adequate competition, the Administrator shall not be required to limit the number of manufacturers in any basic class to a number less than that consistent with maintenance of effective controls against diversion solely because a smaller number is capable of producing an adequate and uninterrupted supply.


(c) Except as provided in paragraph (d) of this section, this section shall not apply to the manufacture of basic classes of controlled substances listed in Schedule I or II as an incident to research or chemical analysis as authorized in § 1301.13(e)(1).


(d) An application for registration to manufacture marihuana that involves the planting, cultivating, growing, or harvesting of marihuana shall be subject to the requirements of this section and the additional requirements set forth in part 1318 of this chapter.


[62 FR 13953, Mar. 24, 1997, as amended at 85 FR 82352, Dec. 18, 2020]


§ 1301.34 Application for importation of Schedule I and II substances.

(a) In the case of an application for registration or reregistration to import a controlled substance listed in Schedule I or II, under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator shall, upon the filing of such application, publish in the Federal Register a notice naming the applicant and stating that such applicant has applied to be registered as an importer of a Schedule I or II controlled substance, which substance shall be identified. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of that controlled substance and to any other applicant therefor. Any such person may, within 30 days from the date of publication of the notice in the Federal Register, file written comments on or objections to the issuance of the proposed registration, and may, at the same time, file a written request for a hearing on the application pursuant to § 1301.43. If a hearing is requested, the Administrator shall hold a hearing on the application in accordance with § 1301.41. Notice of the hearing shall be published in the Federal Register, and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any such person may participate in the hearing by filing a notice of appearance in accordance with § 1301.43 of this chapter. Notice of the hearing shall contain a summary of all comments and objections filed regarding the application and shall state the time and place for the hearing, which shall not be less than 30 days after the date of publication of such notice in the Federal Register. A hearing pursuant to this section may be consolidated with a hearing held pursuant to § 1301.35 or § 1301.36 of this part.


(b) The Administrator shall register an applicant to import a controlled substance listed in Schedule I or II if he/she determines that such registration is consistent with the public interest and with U.S. obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the following factors shall be considered:


(1) Maintenance of effective controls against diversion of particular controlled substances and any controlled substance in Schedule I or II compounded therefrom into other than legitimate medical, scientific research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;


(2) Compliance with applicable State and local law;


(3) Promotion of technical advances in the art of manufacturing these substances and the development of new substances;


(4) Prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;


(5) Past experience in the manufacture of controlled substances, and the existence in the establishment of effective control against diversion;


(6) That the applicant will be permitted to import only:


(i) Such amounts of crude opium, poppy straw, concentrate of poppy straw, and coca leaves as the Administrator finds to be necessary to provide for medical, scientific, or other legitimate purposes; or


(ii) Such amounts of any controlled substances listed in Schedule I or II as the Administrator shall find to be necessary to provide for the medical, scientific, or other legitimate needs of the United States during an emergency in which domestic supplies of such substances are found by the Administrator to be inadequate; or


(iii) Such amounts of any controlled substance listed in Schedule I or II as the Administrator shall find to be necessary to provide for the medical, scientific, or other legitimate needs of the United States in any case in which the Administrator finds that competition among domestic manufacturers of the controlled substance is inadequate and will not be rendered adequate by the registration of additional manufacturers under section 303 of the Act (21 U.S.C. 823); or


(iv) Such limited quantities of any controlled substance listed in Schedule I or II as the Administrator shall find to be necessary for scientific, analytical or research uses; and


(7) Such other factors as may be relevant to and consistent with the public health and safety.


(c) In determining whether the applicant can and will maintain effective controls against diversion within the meaning of paragraph (b) of this section, the Administrator shall consider among other factors:


(1) Compliance with the security requirements set forth in §§ 1301.71-1301.76; and


(2) Employment of security procedures to guard against in-transit losses.


(d) In determining whether competition among the domestic manufacturers of a controlled substance is adequate within the meaning of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the Administrator shall consider:


(1) The extent of price rigidity in the light of changes in:


(i) raw materials and other costs and


(ii) conditions of supply and demand;


(2) The extent of service and quality competition among the domestic manufacturers for shares of the domestic market including:


(i) Shifts in market shares and


(ii) Shifts in individual customers among domestic manufacturers;


(3) The existence of substantial differentials between domestic prices and the higher of prices generally prevailing in foreign markets or the prices at which the applicant for registration to import is committed to undertake to provide such products in the domestic market in conformity with the Act. In determining the existence of substantial differentials hereunder, appropriate consideration should be given to any additional costs imposed on domestic manufacturers by the requirements of the Act and such other cost-related and other factors as the Administrator may deem relevant. In no event shall an importer’s offering prices in the United States be considered if they are lower than those prevailing in the foreign market or markets from which the importer is obtaining his/her supply;


(4) The existence of competitive restraints imposed upon domestic manufacturers by governmental regulations; and


(5) Such other factors as may be relevant to the determinations required under this paragraph.


(e) In considering the scope of the domestic market, consideration shall be given to substitute products which are reasonably interchangeable in terms of price, quality and use.


(f) The fact that the number of existing manufacturers is small shall not demonstrate, in and of itself, that adequate competition among them does not exist.


[62 FR 13953, Mar. 24, 1997, as amended at 81 FR 97019, Dec. 30, 2016]


§ 1301.35 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration (DEA Form 223) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of sections 303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to § 1301.37 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 1301.41.


(b) If in response to a show cause order a hearing is requested by an applicant for registration or reregistration to manufacture in bulk a basic class of controlled substance listed in Schedule I or II, notice that a hearing has been requested shall be published in the Federal Register and shall be mailed simultaneously to the applicant and to all persons to whom notice of the application was mailed. Any person entitled to file comments or objections to the issuance of the proposed registration pursuant to § 1301.33(a) may participate in the hearing by filing notice of appearance in accordance with § 1301.43. Such persons shall have 30 days to file a notice of appearance after the date of publication of the notice of a request for a hearing in the Federal Register.


(c) The Certificate of Registration (DEA Form 223) shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the schedules and/or Administration Controlled Substances Code Number (as set forth in part 1308 of this chapter) of the controlled substances which the registrant is authorized to handle, the amount of fee paid (or exemption), and the expiration date of the registration. The registrant shall maintain the certificate of registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent or employee of the Administration or of any Federal, State, or local agency engaged in enforcement of laws relating to controlled substances.


[62 FR 13954, Mar. 24, 1997]


§ 1301.36 Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.

(a) For any registration issued under section 303 of the Act (21 U.S.C. 823), the Administrator may:


(1) Suspend the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time.


(2) Revoke the registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)).


(b) For any registration issued under section 1008 of the Act (21 U.S.C. 958), the Administrator may:


(1) Suspend the registration pursuant to section 1008(d) of the Act (21 U.S.C. 958(d)) for any period of time.


(2) Revoke the registration pursuant to section 1008(d) of the Act (21 U.S.C. 958(d)) if he/she determines that such registration is inconsistent with the public interest as defined in section 1008 or with the United States obligations under international treaties, conventions, or protocols in effect on October 12, 1984.


(c) The Administrator may limit the revocation or suspension of a registration to the particular controlled substance, or substances, with respect to which grounds for revocation or suspension exist.


(d) Before revoking or suspending any registration, the Administrator shall issue an order to show cause pursuant to § 1301.37 and, if requested by the registrant, shall hold a hearing pursuant to § 1301.41.


(e) The Administrator may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where he/she finds that there is an imminent danger to the public health or safety. If the Administrator so suspends, he/she shall serve with the order to show cause pursuant to § 1301.37 an order of immediate suspension which shall contain a statement of his findings regarding the danger to public health or safety.


(f) Upon service of the order of the Administrator suspending or revoking registration, the registrant shall immediately deliver his/her Certificate of Registration, any order forms, and any import or export permits in his/her possession to the nearest office of the Administration. The suspension or revocation of a registration shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant pursuant to part 1303 of this chapter and any import or export permits issued to the registrant pursuant to part 1312 of this chapter. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Administrator:


(1) Deliver all controlled substances in his/her possession to the nearest office of the Administration or to authorized agents of the Administration; or


(2) Place all controlled substances in his/her possession under seal as described in sections 304(f) or 1008(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).


(g) In the event that revocation or suspension is limited to a particular controlled substance or substances, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required to be paid for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration and, if appropriate, any order forms in his/her possession to the nearest office of the Administration. The suspension or revocation of a registration, when limited to a particular basic class or classes of controlled substances, shall suspend or revoke any individual manufacturing or procurement quota fixed for the registrant for such class or classes pursuant to part 1303 of this chapter and any import or export permits issued to the registrant for such class or classes pursuant to part 1312 of this chapter. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Administrator:


(1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular controlled substance or substances affected by the revocation or suspension which are in his/her possession; or


(2) Place all of such substances under seal as described in sections 304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 958(d)(6)).


(h) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Administrator or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under paragraph (e) of this section may request a hearing on the revocation or suspension of his/her registration at a time earlier than specified in the order to show cause pursuant to § 1301.37. This request shall be granted by the Administrator, who shall fix a date for such hearing as early as reasonably possible.


(i) In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Administrator has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Administrator so issues his/her order. The Administrator may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Administrator finds that such extension is not inconsistent with the public health and safety.


[62 FR 13955, Mar. 24, 1997]


§ 1301.37 Order to show cause.

(a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the registration should not be denied.


(b) If, upon information gathered by the Administration regarding any registrant, the Administrator determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the Administrator shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.


(c) The order to show cause shall call upon the applicant or registrant to appear before the Administrator at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.


(d) Upon receipt of an order to show cause, the applicant or registrant must, if he/she desires a hearing, file a request for a hearing pursuant to § 1301.43. If a hearing is requested, the Administrator shall hold a hearing at the time and place stated in the order, pursuant to § 1301.41.


(e) When authorized by the Administrator, any agent of the Administration may serve the order to show cause.


[62 FR 13955, Mar. 24, 1997]


Hearings

§ 1301.41 Hearings generally.

(a) In any case where the Administrator shall hold a hearing on any registration or application therefor, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by §§ 1301.42-1301.46 of this part, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter.


(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act or any other law of the United States.


[62 FR 13956, Mar. 24, 1997]


§ 1301.42 Purpose of hearing.

If requested by a person entitled to a hearing, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration, and the granting of any application for registration to import or to manufacture in bulk a basic class of controlled substance listed in Schedule I or II. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.


[62 FR 13956, Mar. 24, 1997]


§ 1301.43 Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34-1301.36 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause (or the date of publication of notice of the application for registration in the Federal Register in the case of § 1301.34), file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.


(b) Any person entitled to participate in a hearing pursuant to § 1301.34 or § 1301.35(b) and desiring to do so shall, within 30 days of the date of publication of notice of the request for a hearing in the Federal Register, file with the Administrator a written notice of intent to participate in such hearing in the form prescribed in § 1316.48 of this chapter. Any person filing a request for a hearing need not also file a notice of appearance.


(c) Any person entitled to a hearing or to participate in a hearing pursuant to § 1301.32 or §§ 1301.34-1301.36 may, within the period permitted for filing a request for a hearing or a notice of appearance, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding such person’s position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.


(d) If any person entitled to a hearing or to participate in a hearing pursuant to § 1301.32 or §§ 1301.34-1301.36 fails to file a request for a hearing or a notice of appearance, or if such person so files and fails to appear at the hearing, such person shall be deemed to have waived the opportunity for a hearing or to participate in the hearing, unless such person shows good cause for such failure.


(e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his/her final order pursuant to § 1301.46 without a hearing.


[62 FR 13956, Mar. 24, 1997]


§ 1301.44 Burden of proof.

(a) At any hearing on an application to manufacture any controlled substance listed in Schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any other person participating in the hearing pursuant to § 1301.35(b) shall have the burden of proving any propositions of fact or law asserted by such person in the hearing.


(b) At any hearing on the granting or denial of an applicant to be registered to conduct a narcotic treatment program or as a compounder, the applicant shall have the burden of proving that the requirements for each registration pursuant to section 303(g) of the Act (21 U.S.C. 823(g)) are satisfied.


(c) At any hearing on the granting or denial of an application to be registered to import or export any controlled substance listed in Schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to sections 1008(a) and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other person participating in the hearing pursuant to § 1301.34 shall have the burden of proving any propositions of fact or law asserted by him/her in the hearings.


(d) At any other hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 or section 1008(c) and (d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.


(e) At any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are satisfied.


[62 FR 13956, Mar. 24, 1997]


§ 1301.45 Time and place of hearing.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register (unless expedited pursuant to § 1301.36(h)) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.


[62 FR 13956, Mar. 24, 1997]


§ 1301.46 Final order.

As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall issue his/her order on the granting, denial, revocation, or suspension of registration. In the event that an application for registration to import or to manufacture in bulk a basic class of any controlled substance listed in Schedule I or II is granted, or any application for registration is denied, or any registration is revoked or suspended, the order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The Administrator shall serve one copy of his/her order upon each party in the hearing.


[62 FR 13956, Mar. 24, 1997]


Modification, Transfer and Termination of Registration

§ 1301.51 Modification in registration.

(a) Any registrant may apply to modify his/her registration to authorize the handling of additional controlled substances or to change his/her name or address by submitting a written request to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Additionally, such a request may be submitted on-line at www.DEAdiversion.usdoj.gov.


(1) The request shall contain:


(i) The registrant’s name, address, and registration number as printed on the certificate of registration;


(ii) The substances and/or schedules to be added to the registration or the new name or address; and


(iii) A signature in accordance with § 1301.13(j).


(2) If the registrant is seeking to handle additional controlled substances listed in Schedule I for the purpose of research or instructional activities, the registrant shall attach three copies of a research protocol describing each research project involving the additional substances, or two copies of a statement describing the nature, extent, and duration of such instructional activities, as appropriate.


(b) Any manufacturer, distributor, reverse distributor, narcotic treatment program, hospital/clinic with an on-site pharmacy, or retail pharmacy registered pursuant to this part, may apply to modify its registration to become authorized as a collector by submitting a written request to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Additionally, such request may be submitted on-line at www.DEAdiversion.usdoj.gov.


(1) The request shall contain:


(i) The registrant’s name, address, and registration number as printed on the certificate of registration;


(ii) The method(s) of collection the registrant intends to conduct (collection receptacle and/or mail-back program); and


(iii) A signature in accordance with § 1301.13(j).


(2) If a hospital/clinic with an on-site pharmacy or retail pharmacy is applying for a modification in registration to authorize such registrant to be a collector to maintain a collection receptacle at a long-term care facility in accordance with § 1317.80 of this chapter, the request shall also include the name and physical location of each long-term care facility at which the hospital/clinic with an on-site pharmacy, or the retail pharmacy, intends to operate a collection receptacle.


(c) No fee shall be required for modification. The request for modification shall be handled in the same manner as an application for registration. If the modification of registration is approved, the Administrator shall issue a new certificate of registration (DEA Form 223) to the registrant, who shall maintain it with the old certificate of registration until expiration.


[79 FR 53561, Sept. 9, 2014]


§ 1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business.

(a) Except as provided in paragraph (b) of this section, the registration of any person, and any modifications of that registration, shall terminate, without any further action by the Administration, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Administrator promptly of such fact. In the case of a surrender, termination shall occur upon receipt by any employee of the Administration of a duly executed DEA form 104 or any signed writing indicating the desire to surrender a registration.


(b) No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the Administration may specifically designate and then only pursuant to written consent. Any person seeking authority to transfer a registration shall submit a written request, providing full details regarding the proposed transfer of registration, to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(c) Any registrant desiring to discontinue business activities altogether or with respect to controlled substances (without transferring such business activities to another person) shall return for cancellation his/her certificate of registration, and any unexecuted order forms in his/her possession, to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Any controlled substances in his/her possession may be disposed of in accordance with part 1317 of this chapter.


(d) Any registrant desiring to discontinue business activities altogether or with respect to controlled substance (by transferring such business activities to another person) shall submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his/her area, at least 14 days in advance of the date of the proposed transfer (unless the Special Agent in Charge waives this time limitation in individual instances), the following information:


(1) The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor);


(2) The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee);


(3) Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed);


(4) Whether the registrant-transferor has a quota to manufacture or procure any controlled substance listed in Schedule I or II (if so, the basic class or class of the substance should be indicated); and


(5) The date on which the transfer of controlled substances will occur.


(e) Unless the registrant-transferor is informed by the Special Agent in Charge, before the date on which the transfer was stated to occur, that the transfer may not occur, the registrant-transferor may distribute (without being registered to distribute) controlled substances in his/her possession to the registrant-transferee in accordance with the following:


(1) On the date of transfer of the controlled substances, a complete inventory of all controlled substances being transferred shall be taken in accordance with § 1304.11 of this chapter. This inventory shall serve as the final inventory of the registrant-transferor and the initial inventory of the registrant-transferee, and a copy of the inventory shall be included in the records of each person. It shall not be necessary to file a copy of the inventory with the Administration unless requested by the Special Agent in Charge. Transfers of any substances listed in Schedule I or II shall require the use of order forms in accordance with part 1305 of this chapter.


(2) On the date of transfer of the controlled substances, all records required to be kept by the registrant-transferor with reference to the controlled substances being transferred, under part 1304 of this chapter, shall be transferred to the registrant-transferee. Responsibility for the accuracy of records prior to the date of transfer remains with the transferor, but responsibility for custody and maintenance shall be upon the transferee.


(3) In the case of registrants required to make reports pursuant to part 1304 of this chapter, a report marked “Final” will be prepared and submitted by the registrant-transferor showing the disposition of all the controlled substances for which a report is required; no additional report will be required from him, if no further transactions involving controlled substances are consummated by him. The initial report of the registrant-transferee shall account for transactions beginning with the day next succeeding the date of discontinuance or transfer of business by the transferor-registrant and the substances transferred to him shall be reported as receipts in his/her initial report.


(f) Any registrant that has been authorized as a collector and desires to discontinue its collection of controlled substances from ultimate users shall notify the Administration of its intent by submitting a written notification to the Registration Unit, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Additionally, such notice may be submitted on-line at www.DEAdiversion.usdoj.gov. When ceasing collection activities of an authorized mail-back program, the registrant shall provide the Administration with the name, registered address, and registration number of the collector that will receive the remaining mail-back packages in accordance with § 1317.70(e)(3) of this chapter.


[62 FR 13957, Mar. 24, 1997, as amended at 74 FR 15623, Apr. 6, 2009; 75 FR 10676, Mar. 9, 2010; 76 FR 61564, Oct. 5, 2011; 79 FR 53561, Sept. 9, 2014]


Security Requirements

§ 1301.71 Security requirements generally.

(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Administrator shall use the security requirements set forth in §§ 1301.72-1301.76 as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in §§ 1301.72, 1301.73 and 1301.75 may be used in lieu of the materials and construction described in those sections.


(b) Substantial compliance with the standards set forth in §§ 1301.72-1301.76 may be deemed sufficient by the Administrator after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Administrator may consider any of the following factors as he may deem relevant to the need for strict compliance with security requirements:


(1) The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, cooperative buying, etc.);


(2) The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or nonusable powders);


(3) The quantity of controlled substances handled;


(4) The location of the premises and the relationship such location bears on security needs;


(5) The type of building construction comprising the facility and the general characteristics of the building or buildings;


(6) The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;


(7) The type of closures on vaults, safes, and secure enclosures;


(8) The adequacy of key control systems and/or combination lock control systems;


(9) The adequacy of electric detection and alarm systems, if any including use of supervised transmittal lines and standby power sources;


(10) The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;


(11) The adequacy of supervision over employees having access to manufacturing and storage areas;


(12) The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;


(13) The availability of local police protection or of the registrant’s or applicant’s security personnel;


(14) The adequacy of the registrant’s or applicant’s system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations; and


(15) The applicability of the security requirements contained in all Federal, State, and local laws and regulations governing the management of waste.


(c) When physical security controls become inadequate as a result of a controlled substance being transferred to a different schedule, or as a result of a noncontrolled substance being listed on any schedule, or as a result of a significant increase in the quantity of controlled substances in the possession of the registrant during normal business operations, the physical security controls shall be expanded and extended accordingly. A registrant may adjust physical security controls within the requirements set forth in §§ 1301.72-1301.76 when the need for such controls decreases as a result of a controlled substance being transferred to a different schedule, or a result of a controlled substance being removed from control, or as a result of a significant decrease in the quantity of controlled substances in the possession of the registrant during normal business operations.


(d) Any registrant or applicant desiring to determine whether a proposed security system substantially complies with, or is the structural equivalent of, the requirements set forth in §§ 1301.72-1301.76 may submit any plans, blueprints, sketches or other materials regarding the proposed security system either to the Special Agent in Charge in the region in which the system will be used, or to the Regulatory Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(e) Physical security controls of locations registered under the Harrison Narcotic Act or the Narcotics Manufacturing Act of 1960 on April 30, 1971, shall be deemed to comply substantially with the standards set forth in §§ 1301.72, 1301.73 and 1301.75. Any new facilities or work or storage areas constructed or utilized for controlled substances, which facilities or work or storage areas have not been previously approved by the Administration, shall not necessarily be deemed to comply substantially with the standards set forth in §§ 1301.72, 1301.73 and 1301.75, notwithstanding that such facilities or work or storage areas have physical security controls similar to those previously approved by the Administration.


(f) A collector shall not employ, as an agent or employee who has access to or influence over controlled substances acquired by collection, any person who has been convicted of any felony offense relating to controlled substances or who, at any time, had an application for registration with DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. For purposes of this subsection, “for cause” means in lieu of, or as a consequence of, any Federal or State administrative, civil, or criminal action resulting from an investigation of the individual’s handling of controlled substances.


[36 FR 18729, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, 1982; 51 FR 5319, Feb. 13, 1986; 68 FR 41228, July 11, 2003; 75 FR 10677, Mar. 9, 2010; 79 FR 53561, Sept. 9, 2014]


§ 1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.

(a) Schedules I and II. Raw material, bulk materials awaiting further processing, finished products which are controlled substances listed in Schedule I or II (except GHB that is manufactured or distributed in accordance with an exemption under section 505(i) of the Federal Food Drug and Cosmetic Act which shall be subject to the requirements of paragraph (b) of this section), and sealed mail-back packages and inner liners acquired in accordance with part 1317 of this chapter, shall be stored in one of the following secured areas:


(1) Where small quantities permit, a safe or steel cabinet;


(i) Which safe or steel cabinet shall have the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;


(ii) Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and


(iii) Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system which, upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve.


(2) A vault constructed before, or under construction on, September 1, 1971, which is of substantial construction with a steel door, combination or key lock, and an alarm system; or


(3) A vault constructed after September 1, 1971:


(i) The walls, floors, and ceilings of which vault are constructed of at least 8 inches of reinforced concrete or other substantial masonry, reinforced vertically and horizontally with
1/2-inch steel rods tied 6 inches on center, or the structural equivalent to such reinforced walls, floors, and ceilings;


(ii) The door and frame unit of which vault shall conform to the following specifications or the equivalent: 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;


(iii) Which vault, if operations require it to remain open for frequent access, is equipped with a “day-gate” which is self-closing and self-locking, or the equivalent, for use during the hours of operation in which the vault door is open;


(iv) The walls or perimeter of which vault are equipped with an alarm, which upon unauthorized entry shall transmit a signal directly to a central station protection company, or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Administrator may approve, and, if necessary, holdup buttons at strategic points of entry to the perimeter area of the vault;


(v) The door of which vault is equipped with contact switches; and


(vi) Which vault has one of the following: Complete electrical lacing of the walls, floor and ceilings; sensitive ultrasonic equipment within the vault; a sensitive sound accumulator system; or such other device designed to detect illegal entry as may be approved by the Administration.


(b) Schedules III, IV and V. Raw material, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedules III, IV, and V, and GHB when it is manufactured or distributed in accordance with an exemption under section 505(i) of the FFDCA, shall be stored in the following secure storage areas:


(1) A safe or steel cabinet as described in paragraph (a)(1) of this section;


(2) A vault as described in paragraph (a)(2) or (3) of this section equipped with an alarm system as described in paragraph (b)(4)(v) of this section;


(3) A building used for storage of Schedules III through V controlled substances with perimeter security which limits access during working hours and provides security after working hours and meets the following specifications:


(i) Has an electronic alarm system as described in paragraph (b)(4)(v) of this section,


(ii) Is equipped with self-closing, self-locking doors constructed of substantial material commensurate with the type of building construction, provided, however, a door which is kept closed and locked at all times when not in use and when in use is kept under direct observation of a responsible employee or agent of the registrant is permitted in lieu of a self-closing, self-locking door. Doors may be sliding or hinged. Regarding hinged doors, where hinges are mounted on the outside, such hinges shall be sealed, welded or otherwise constructed to inhibit removal. Locking devices for such doors shall be either of the multiple-position combination or key lock type and:


(a) In the case of key locks, shall require key control which limits access to a limited number of employees, or;


(b) In the case of combination locks, the combination shall be limited to a minimum number of employees and can be changed upon termination of employment of an employee having knowledge of the combination;


(4) A cage, located within a building on the premises, meeting the following specifications:


(i) Having walls constructed of not less than No. 10 gauge steel fabric mounted on steel posts, which posts are:


(a) At least one inch in diameter;


(b) Set in concrete or installed with lag bolts that are pinned or brazed; and


(c) Which are placed no more than ten feet apart with horizontal one and one-half inch reinforcements every sixty inches;


(ii) Having a mesh construction with openings of not more than two and one-half inches across the square,


(iii) Having a ceiling constructed of the same material, or in the alternative, a cage shall be erected which reaches and is securely attached to the structural ceiling of the building. A lighter gauge mesh may be used for the ceilings of large enclosed areas if walls are at least 14 feet in height,


(iv) Is equipped with a door constructed of No. 10 gauge steel fabric on a metal door frame in a metal door flange, and in all other respects conforms to all the requirements of 21 CFR 1301.72(b)(3)(ii), and


(v) Is equipped with an alarm system which upon unauthorized entry shall transmit a signal directly to a central station protection agency or a local or state police agency, each having a legal duty to respond, or to a 24-hour control station operated by the registrant, or to such other source of protection as the Administrator may approve;


(5) An enclosure of masonry or other material, approved in writing by the Administrator as providing security comparable to a cage;


(6) A building or enclosure within a building which has been inspected and approved by DEA or its predecessor agency, BND, and continues to provide adequate security against the diversion of Schedule III through V controlled substances, of which fact written acknowledgment has been made by the Special Agent in Charge of DEA for the area in which such building or enclosure is situated;


(7) Such other secure storage areas as may be approved by the Administrator after considering the factors listed in § 1301.71(b);


(8)(i) Schedule III through V controlled substances may be stored with Schedules I and II controlled substances under security measures provided by 21 CFR 1301.72(a);


(ii) Non-controlled drugs, substances and other materials may be stored with Schedule III through V controlled substances in any of the secure storage areas required by 21 CFR 1301.72(b), provided that permission for such storage of non-controlled items is obtained in advance, in writing, from the Special Agent in Charge of DEA for the area in which such storage area is situated. Any such permission tendered must be upon the Special Agent in Charge’s written determination that such non-segregated storage does not diminish security effectiveness for Schedules III through V controlled substances.


(c) Multiple storage areas. Where several types or classes of controlled substances are handled separately by the registrant or applicant for different purposes (e.g., returned goods, or goods in process), the controlled substances may be stored separately, provided that each storage area complies with the requirements set forth in this section.


(d) Accessibility to storage areas. The controlled substances storage areas shall be accessible only to an absolute minimum number of specifically authorized employees. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through controlled substances storage areas, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.


(e) Mobile Narcotic Treatment Programs. (1) For any conveyance operated as a mobile narcotic treatment program (NTP), a safe must be installed and used to store narcotic drugs in schedules II-V for the purpose of maintenance or detoxification treatment, when not located at the registrant’s registered location. The safe must conform to the requirements set forth in paragraph (a)(1) of this section. The mobile component must also be equipped with an alarm system that conforms to the requirements set forth in paragraph (a)(1)(iii) of this section. The storage area of the mobile component must conform to the accessibility requirements in paragraph (d) of this section. The storage area for controlled substances in a mobile component of an NTP must not be accessible from outside of the vehicle. Personnel transporting the controlled substances on behalf of the mobile NTP are required to retain control over all controlled substances when transferring them between the registered location and the conveyance, while en route to and from the dispensing location or locations, and when dispensing at the dispensing location or locations. At all other times during transportation, all controlled substances must be properly secured in the safe. Upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location. After the conveyance has returned to the registered location and the controlled substances have been removed, the conveyance may be parked until its next use at the registered location or any secure, fenced-in area, once the local DEA office has been notified of the location of this secure, fenced-in area. All NTPs with mobile components shall be required to establish a standard operating procedure to ensure, if the mobile component becomes inoperable (mechanical failure, accidents, fire, etc.), that all controlled substances on the inoperable conveyance are accounted for, removed from the inoperable conveyance, and secured at the registered location.


(2) With regard to the requirement of paragraph (e)(1) of this section, that upon completion of the operation of the mobile NTP on a given day, the conveyance must be immediately returned to the registered location, and all controlled substances must be removed from the conveyance and secured within the registered location, an NTP may apply for an exception to this requirement as provided in this paragraph. The application for such an exception must be submitted in accordance with § 1307.03 of this chapter and must include the proposed alternate return period, enhanced security measures, and any other factors the applicant wishes the Administrator to consider. The Administrator may grant such an exception in his discretion and will evaluate each application on a case-by-case basis in determining whether the applicant has demonstrated exceptional circumstances that warrant the exception. In making this determination, the Administrator will consider the applicant’s security and recordkeeping as well as any other factors he deems relevant to determining whether effective controls against diversion will be maintained.


[36 FR 18730, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


Editorial Note:For Federal Register citations affecting § 1301.72, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.

All manufacturing activities (including processing, packaging and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following:


(a) All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If such security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or state police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.


(b) Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area. “Limited access” may be provided, in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted: Provided, That he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.


(c) During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests, or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.


[36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 39 FR 37984, Oct. 25, 1974]


§ 1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the Administration or with the appropriate State controlled substances registration agency, if any, to determine that the person is registered to possess the controlled substance.


(b) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances. The registrant shall inform the Field Division Office of the Administration in his area of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.


(c) The registrant must notify the Field Division Office of the Administration in his or her area, in writing, of any theft or significant loss of any controlled substances within one business day of discovery of the theft or loss. Unless the theft or loss occurs during an import or export transaction, the supplier is responsible for reporting all in-transit losses of controlled substances by their agent or the common or contract carrier selected pursuant to paragraph (e) of this section, within one business day of discovery of such theft or loss. In an import transaction, once a shipment has been released by the customs officer at the port of entry, the importer is responsible for reporting all in-transit losses of controlled substances by their agent or the common or contract carrier selected pursuant to paragraph (e) of this section, within one business day of discovery of such theft or loss. In an export transaction, the exporter is responsible for reporting all in-transit losses of controlled substances by their agent or the common or contract carrier selected pursuant to paragraph (e) of this section within one business day of discovery of such theft or loss, until the shipment has been released by the customs officer at the port of export. The registrant must also complete, and submit to the Field Division Office in his or her area, DEA Form 106 regarding the theft or loss. Thefts and significant losses must be reported whether or not the controlled substances are subsequently recovered or the responsible parties are identified and action taken against them. When determining whether a loss is significant, a registrant should consider, among others, the following factors:


(1) The actual quantity of controlled substances lost in relation to the type of business;


(2) The specific controlled substances lost;


(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;


(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,


(5) Whether the specific controlled substances are likely candidates for diversion;


(6) Local trends and other indicators of the diversion potential of the missing controlled substance.


(d) The registrant shall not distribute any controlled substance listed in Schedules II through V as a complimentary sample to any potential or current customer (1) without the prior written request of the customer, (2) to be used only for satisfying the legitimate medical needs of patients of the customer, and (3) only in reasonable quantities. Such request must contain the name, address, and registration number of the customer and the name and quantity of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements of part 1305 of the chapter shall be complied with for any distribution of a controlled substance listed in Schedule II. For purposes of this paragraph, the term “customer” includes a person to whom a complimentary sample of a substance is given in order to encourage the prescribing or recommending of the substance by the person.


(e) When shipping controlled substances, a registrant is responsible for selecting common or contract carriers which provide adequate security to guard against in-transit losses. When storing controlled substances in a public warehouse, a registrant is responsible for selecting a warehouseman which will provide adequate security to guard against storage losses; wherever possible, the registrant shall store controlled substances in a public warehouse which complies with the requirements set forth in § 1301.72. In addition, the registrant shall employ precautions (e.g., assuring that shipping containers do not indicate that contents are controlled substances) to guard against storage or in-transit losses.


(f) When distributing controlled substances through agents (e.g., detailmen), a registrant is responsible for providing and requiring adequate security to guard against theft and diversion while the substances are being stored or handled by the agent or agents.


(g) Before the initial distribution of thiafentanil, carfentanil, etorphine hydrochloride and/or diprenorphine to any person, the registrant must verify that the person is authorized to handle the substance(s) by contacting the Drug Enforcement Administration.


(h) The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual designated in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.


(i) Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either (1) the licensed practitioner, (2) a registered nurse under the direction of the licensed practitioner, (3) a licensed practical nurse under the direction of the licensed practitioner, or (4) a pharmacist under the direction of the licensed practitioner.


(j) Persons enrolled in any narcotic treatment program (NTP), including those receiving treatment at a mobile NTP, will be required to wait in an area that is physically separated from the narcotic storage and dispensing area by a physical entrance such as a door or other entryway. Patients must wait outside of a mobile NTP component if that conveyance does not have seating or a reception area that is separated from the narcotic storage and dispensing area. This requirement will be enforced by the program practitioner and NTP employees.


(k) All NTPs, including mobile NTPs, must comply with standards established by the Secretary of Health and Human Services (after consultation with the Administration) respecting the quantities of narcotic drugs which may be provided to persons enrolled in a NTP or mobile NTP for unsupervised use (e.g., take home or non-directly observed therapy).


(l) DEA may exercise discretion regarding the degree of security required in NTPs, including mobile NTPs, based on such factors as the location of a program, the number of patients enrolled in a program, and the number of practitioners, staff members, and security guards. Personnel that are authorized to dispense controlled substances for narcotic treatment must ensure proper security measures and patient dosage. Similarly, DEA will consider such factors when evaluating existing security or requiring new security at a narcotic treatment program or mobile NTP.


(m) Any controlled substances being transported for disposal from the dispensing location of a mobile NTP shall be secured and disposed of in compliance with part 1317, and all other applicable Federal, State, tribal, and local laws and regulations.


(n) A conveyance used as part of a mobile NTP may only be supplied with narcotic drugs by the registered NTP that operates such conveyance. Persons permitted to dispense controlled substances to mobile NTPs shall not:


(1) Receive controlled substances from other mobile NTPs or any other entity;


(2) Deliver controlled substances to other mobile NTPs or any other entity; or


(3) Conduct reverse distribution of controlled substances on a mobile NTP.


(o) A reverse distributor shall not employ, as an agent or employee who has access to or influence over controlled substances, any person who has been convicted of any felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or suspended, or has surrendered a DEA registration for cause. For purposes of this subsection, “for cause” means in lieu of, or as a consequence of, any Federal or State administrative, civil, or criminal action resulting from an investigation of the individual’s handling of controlled substances.


[36 FR 7778, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


Editorial Note:For Federal Register citations affecting § 1301.74, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1301.75 Physical security controls for practitioners.

(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.


(b) Controlled substances listed in Schedules II, III, IV, and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies and institutional practitioners may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.


(c) Sealed mail-back packages and inner liners collected in accordance with part 1317 of this chapter shall only be stored at the registered location in a securely locked, substantially constructed cabinet or a securely locked room with controlled access, except as authorized by § 1317.80(d).


(d) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.


(e) Thiafentanil, carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.


[39 FR 3674, Jan. 29, 1974, as amended at 39 FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, 1989; 62 FR 13957, Mar. 24, 1997; 79 FR 53562, Sept. 9, 2014; 81 FR 58839, Aug. 26, 2016]


§ 1301.76 Other security controls for practitioners.

(a) The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration revoked or has surrendered a DEA registration for cause. For purposes of this subsection, the term “for cause” means a surrender in lieu of, or as a consequence of, any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.


(b) The registrant shall notify the Field Division Office of the Administration in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft. When determining whether a loss is significant, a registrant should consider, among others, the following factors:


(1) The actual quantity of controlled substances lost in relation to the type of business;


(2) The specific controlled substances lost;


(3) Whether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals, or whether the loss can be attributed to unique activities that may take place involving the controlled substances;


(4) A pattern of losses over a specific time period, whether the losses appear to be random, and the results of efforts taken to resolve the losses; and, if known,


(5) Whether the specific controlled substances are likely candidates for diversion;


(6) Local trends and other indicators of the diversion potential of the missing controlled substance.


(c) Whenever the registrant distributes a controlled substance (without being registered as a distributor as permitted in §§ 1301.13(e)(1), 1307.11, 1317.05, and/or 1317.10 of this chapter), he/she shall comply with the requirements imposed on non-practitioners in § 1301.74(a), (b), and (e).


(d) Central fill pharmacies must comply with § 1301.74(e) when selecting private, common or contract carriers to transport filled prescriptions to a retail pharmacy for delivery to the ultimate user. When central fill pharmacies contract with private, common or contract carriers to transport filled prescriptions to a retail pharmacy, the central fill pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106. Retail pharmacies must comply with § 1301.74(e) when selecting private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy. When retail pharmacies contract with private, common or contract carriers to retrieve filled prescriptions from a central fill pharmacy, the retail pharmacy is responsible for reporting in-transit losses upon discovery of such loss by use of a DEA Form 106.


[36 FR 7778, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997; 68 FR 37409, June 24, 2003; 70 FR 47097, Aug. 12, 2005; 79 FR 53562, Sept. 9, 2014]


§ 1301.77 Security controls for freight forwarding facilities.

(a) All Schedule II-V controlled substances that will be temporarily stored at the freight forwarding facility must be either:


(1) stored in a segregated area under constant observation by designated responsible individual(s); or


(2) stored in a secured area that meets the requirements of Section 1301.72(b) of this Part. For purposes of this requirement, a facility that may be locked down (i.e., secured against physical entry in a manner consistent with requirements of Section 1301.72(b)(3)(ii) of this part) and has a monitored alarm system or is subject to continuous monitoring by security personnel will be deemed to meet the requirements of Section 1301.72(b)(3) of this Part.


(b) Access to controlled substances must be kept to an absolute minimum number of specifically authorized individuals. Non-authorized individuals may not be present in or pass through controlled substances storage areas without adequate observation provided by an individual authorized in writing by the registrant.


(c) Controlled substances being transferred through a freight forwarding facility must be packed in sealed, unmarked shipping containers.


[65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000]


Employee Screening – Non-Practitioners

§ 1301.90 Employee screening procedures.

It is the position of DEA that the obtaining of certain information by non-practitioners is vital to fairly assess the likelihood of an employee committing a drug security breach. The need to know this information is a matter of business necessity, essential to overall controlled substances security. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry. It is, therefore, assumed that the following questions will become a part of an employer’s comprehensive employee screening program:



Question. Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not include any traffic violations, juvenile offenses or military convictions, except by general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date and sentence.


Question. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician? If the answer is yes, furnish details.


Advice. An authorization, in writing, that allows inquiries to be made of courts and law enforcement agencies for possible pending charges or convictions must be executed by a person who is allowed to work in an area where access to controlled substances clearly exists. A person must be advised that any false information or omission of information will jeopardize his or her position with respect to employment. The application for employment should inform a person that information furnished or recovered as a result of any inquiry will not necessarily preclude employment, but will be considered as part of an overall evaluation of the person’s qualifications. The maintaining of fair employment practices, the protection of the person’s right of privacy, and the assurance that the results of such inquiries will be treated by the employer in confidence will be explained to the employee.


[40 FR 17143, Apr. 17, 1975]


§ 1301.91 Employee responsibility to report drug diversion.

Reports of drug diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge of drug diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of drug diversion will be considered in determining the feasibility of continuing to allow an employee to work in a drug security area. The employer shall inform all employees concerning this policy.


[40 FR 17143, Apr. 17, 1975]


§ 1301.92 Illicit activities by employees.

It is the position of DEA that employees who possess, sell, use or divert controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee’s violation, the position of responsibility held by the employee, past record of employment, etc., in determining whether to suspend, transfer, terminate or take other action against the employee.


[40 FR 17143, Apr. 17, 1975]


§ 1301.93 Sources of information for employee checks.

DEA recommends that inquiries concerning employees’ criminal records be made as follows:



Local inquiries. Inquiries should be made by name, date and place of birth, and other identifying information, to local courts and law enforcement agencies for records of pending charges and convictions. Local practice may require such inquiries to be made in person, rather than by mail, and a copy of an authorization from the employee may be required by certain law enforcement agencies.


DEA inquiries. Inquiries supplying identifying information should also be furnished to DEA Field Division Offices along with written consent from the concerned individual for a check of DEA files for records of convictions. The Regional check will result in a national check being made by the Field Division Office.


[40 FR 17143, Apr. 17, 1975, as amended at 47 FR 41735, Sept. 22, 1982]


PART 1302 – LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES


Authority:21 U.S.C. 821, 825, 871(b), 958(e).


Source:36 FR 7785, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

§ 1302.01 Scope of part 1302.

Requirements governing the labeling and packaging of controlled substances pursuant to sections 1305 and 1008(d) of the Act (21 U.S.C. 825 and 958(d)) are set forth generally by those sections and specifically by the sections of this part.


[36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1302.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13958, Mar. 24, 1997]


§ 1302.03 Symbol required; exceptions.

(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Administrator pursuant to § 1308.31 of this chapter) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part.


(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed.


(c) The following symbols shall designate the schedule corresponding thereto:


Schedule

Schedule ICI or C-I.
Schedule IICII or C-II.
Schedule IIICIII or C-III.
Schedule IVCIV or C-IV.
Schedule VCV or C-V.

The word “schedule” need not be used. No distinction need be made between narcotic and nonnarcotic substances.

(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.


(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.


(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind and double blind studies.


[36 FR 7785, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1302.04 Location and size of symbol on label and labeling.

The symbol shall be prominently located on the label or the labeling of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance. The symbol on labels shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser’s shelf. The symbol on all other labeling shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.


[62 FR 13958, Mar. 24, 1997]


§ 1302.05 Effective dates of labeling requirements.

All labels on commercial containers of, and all labeling of, a controlled substance which either is transferred to another schedule or is added to any schedule shall comply with the requirements of § 1302.03, on or before the effective date established in the final order for the transfer or addition.


[62 FR 13958, Mar. 24, 1997]


§ 1302.06 Sealing of controlled substances.

On each bottle, multiple dose vial, or other commercial container of any controlled substance, there shall be securely affixed to the stopper, cap, lid, covering, or wrapper or such container a seal to disclose upon inspection any tampering or opening of the container.


[62 FR 13958, Mar. 24, 1997]


§ 1302.07 Labeling and packaging requirements for imported and exported substances.

(a) The symbol requirements of §§ 1302.03 through 1302.05 apply to every commercial container containing, and to all labeling of, controlled substances imported into the customs territory of the United States from any place outside thereof (but within the United States), or imported into the United States from any place outside thereof.


(b) The symbol requirements of §§ 1302.03 through 1302.05 do not apply to any commercial containers containing, or any labeling of, a controlled substance intended for export.


(c) The sealing requirements of § 1302.06 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV imported into the customs territory of the United States from any place outside thereof (but within the United States), or imported into the United States from any place outside thereof. The sealing requirements of § 1302.06 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in schedule I or II, or any narcotic controlled substance listed in schedule III or IV, exported or intended for export from the United States. These sealing and labeling requirements are in addition to any sealing requirements required under applicable customs laws.


[81 FR 97020, Dec. 30, 2016]


PART 1303 – QUOTAS


Authority:21 U.S.C. 821, 826, 871(b).

General Information

§ 1303.01 Scope of part 1303.

Procedures governing the establishment of production and manufacturing quotas on basic classes of controlled substances listed in schedules I and II pursuant to section 306 of the Act (21 U.S.C. 826) are governed generally by that section and specifically by the sections of this part.


[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13958, Mar. 24, 1997]


Aggregate Production and Procurement Quotas

§ 1303.11 Aggregate production quotas.

(a) The Administrator shall determine the total quantity of each basic class of controlled substance listed in Schedule I or II necessary to be manufactured during the following calendar year to provide for the estimated medical, scientific, research and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks.


(b) In making his determinations, the Administrator shall consider the following factors:


(1) Total net disposal of the class by all manufacturers during the current and 2 preceding years;


(2) Trends in the national rate of net disposal of the class;


(3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation;


(4) Projected demand for such class as indicated by procurement quotas requested pursuant to § 1303.12;


(5) The extent of any diversion of the controlled substance in the class;


(6) Relevant information obtained from the Department of Health and Human Services, including from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services, and relevant information obtained from the states; and


(7) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.


(c) The Administrator shall, on or before May 1 of each year, publish in the Federal Register, general notice of an aggregate production quota for any basic class determined by him under this section. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class and transmitted to each state attorney general. The Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice the time during which such filings may be made. The Administrator may, but shall not be required to, hold a public hearing on one or more issues raised by the comments and objections filed with him, except that the Administrator shall hold a hearing if he determines it is necessary to resolve an issue of material fact raised by a state objecting to the proposed quantity for the class as excessive for legitimate United States’ needs. In the event the Administrator decides to hold a hearing, he shall publish notice of the hearing in the Federal Register, which notice shall summarize the issues to be heard and shall set the time for the hearing, which shall not be less than 30 days after the date of publication of the notice. After consideration of any comments or objections, or after a hearing if one is ordered by the Administrator, the Administrator shall issue and publish in the Federal Register his final order determining the aggregate production quota for the basic class of controlled substances. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. A copy of said order shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class and transmitted to each state attorney general.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 77 FR 4235, Jan. 27, 2012; 83 FR 32789, July 16, 2018]


§ 1303.12 Procurement quotas.

(a) In order to determine the estimated needs for, and to insure an adequate and uninterrupted supply of, basic classes of controlled substances listed in Schedules I and II (except raw opium being imported by the registrant pursuant to an import permit) the Administrator shall issue procurement quotas authorizing persons to procure and use quantities of each basic class of such substances for the purpose of manufacturing such class into dosage forms or into other substances.


(b) Any person who is registered to manufacture controlled substances listed in any schedule and who desires to use during the next calendar year any basic class of controlled substances listed in Schedule I or II (except raw opium being imported by the registrant pursuant to an import permit) for purposes of manufacturing, shall apply on DEA Form 250 for a procurement quota for such basic class.

A separate application must be made for each basic class desired to be procured or used.

The applicant shall state whether he intends to manufacture the basic class himself or purchase it from another manufacturer.

The applicant shall state separately each purpose for which the basic class is desired, the quantity desired for that purpose during the next calendar year, and the quantities used and estimated to be used, if any, for that purpose during the current and preceding 2 calendar years.

If the purpose is to manufacture the basic class into dosage form, the applicant shall state the official name, common or usual name, chemical name, or brand name of that form. The Administrator may require additional information from an applicant which, in the Administrator’s judgment, may be helpful in detecting or preventing diversion, including customer identities and amounts of the controlled substance sold to each customer.

If the purpose is to manufacture another substance, the applicant shall state the official name, common or usual name, chemical name, or brand name of the substance, and, if a controlled substance listed in any schedule, the schedule number and Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, of the substance. If the purpose is to manufacture another basic class of controlled substance listed in Schedule I or II, the applicant shall also state the quantity of the other basic class which the applicant has applied to manufacture pursuant to § 1303.22 and the quantity of the first basic class necessary to manufacture a specified unit of the second basic class. DEA Form 250 shall be filed on or before April 1 of the year preceding the calendar year for which the procurement quota is being applied. Copies of DEA Form 250 may be obtained from, and shall be filed with, the UN Reporting and Quota Section, Diversion Control Division. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(c) The Administrator shall, on or before July 1 of the year preceding the calendar year during which the quota shall be effective, issue to each qualified applicant a procurement quota authorizing him to procure and use:


(1) All quantities of such class necessary to manufacture all quantities of other basic classes of controlled substances listed in Schedules I and II which the applicant is authorized to manufacture pursuant to § 1303.23; and


(2) Such other quantities of such class as the applicant has applied to procure and use and are consistent with his past use, his estimated needs, and the total quantity of such class that will be produced.


(d) Any person to whom a procurement quota has been issued may at any time request an adjustment in the quota by applying to the Administrator with a statement showing the need for the adjustment. Such application shall be filed with the UN Reporting and Quota Section, Diversion Control Division. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The Administrator shall increase or decrease the procurement quota of such person if and to the extent that he finds, after considering the factors enumerated in paragraph (c) of this section and any occurrences since the issuance of the procurement quota, that the need justifies an adjustment.


(e) The following persons need not obtain a procurement quota:


(1) Any person who is registered to manufacture a basic class of controlled substance listed in Schedule I or II and who uses all of the quantity he manufactures in the manufacture of a substance not controlled under the Act;


(2) Any person who is registered or authorized to conduct chemical analysis with controlled substances (for controlled substances to be used in such analysis only); and


(3) Any person who is registered to conduct research with a basic class of controlled substance listed in Schedule I or II and who is authorized to manufacture a quantity of such class pursuant to § 1301.13 of this chapter.


(f) Any person to whom a procurement quota has been issued, authorizing that person to procure and use a quantity of a basic class of controlled substances listed in Schedules I or II during the current calendar year, shall, at or before the time of giving an order to another manufacturer requiring the distribution of a quantity of such basic class, certify in writing to such other manufacturer that the quantity of such basic class ordered does not exceed the person’s unused and available procurement quota of such basic class for the current calendar year. The written certification shall be executed by the same individual who signed the DEA Form 222 transmitting the order. Manufacturers shall not fill an order from persons required to apply for a procurement quota under paragraph (b) of this section unless the order is accompanied by a certification as required under this section. The certification required by this section shall contain the following: The date of the certification; the name and address of the bulk manufacturer to whom the certification is directed; a reference to the number of the DEA Form 222 to which the certification applies; the name of the person giving the order to which the certification applies; the name of the basic class specified in the DEA Form 222 to which the certification applies; the appropriate schedule within which is listed the basic class specified in the DEA Form 222 to which the certification applies; a statement that the quantity (expressed in grams) of the basic class specified in the DEA Form 222 to which the certification applies does not exceed the unused and available procurement quota of such basic class, issued to the person giving the order, for the current calendar year; and the signature of the individual who signed the DEA Form 222 to which the certification applies.


[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


Editorial Note:For Federal Register citations affecting § 1303.12, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1303.13 Adjustments of aggregate production quotas.

(a) The Administrator may at any time increase or reduce the aggregate production quota for a basic class of controlled substance listed in Schedule I or II which he has previously fixed pursuant to § 1303.11.


(b) In determining to adjust the aggregate production quota, the Administrator shall consider the following factors:


(1) Changes in the demand for that class, changes in the national rate of net disposal of the class, changes in the rate of net disposal of the class by registrants holding individual manufacturing quotas for that class, and changes in the extent of any diversion in the class;


(2) Whether any increased demand for that class, the national and/or individual rates of net disposal of that class are temporary, short term, or long term;


(3) Whether any increased demand for that class can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to § 1303.24(b);


(4) Whether any decreased demand for that class will result in excessive inventory accumulation by all persons registered to handle that class (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be suspended pursuant to § 1303.24(b) or abandoned pursuant to § 1303.27;


(5) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances which are manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.


(c) The Administrator in the event he determines to increase or reduce the aggregate production quota for a basic class of controlled substance, shall publish in the Federal Register general notice of an adjustment in the aggregate production quota for that class determined by him under this section. A copy of said notice shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class and transmitted to each state attorney general. The Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice the time during which such filings may be made. The Administrator may, but shall not be required to, hold a public hearing on one or more issues raised by the comments and objections filed with him, except that the Administrator shall hold a hearing if he determines it is necessary to resolve an issue of material fact raised by a state objecting to the proposed adjusted quota as excessive for legitimate United States’ needs. In the event the Administrator decides to hold a hearing, he shall publish notice of the hearing in the Federal Register, which notice shall summarize the issues to be heard and shall set the time for the hearing, which shall not be less than 10 days after the date of publication of the notice. After consideration of any comments or objections, or after a hearing if one is ordered by the Administrator, the Administrator shall issue and publish in the Federal Register his final order determining the aggregate production for the basic class of controlled substance. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. A copy of said order shall be mailed simultaneously to each person registered as a bulk manufacturer of the basic class and transmitted to each state attorney general.


[37 FR 15919, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 83 FR 32790, July 16, 2018]


Individual Manufacturing Quotas

§ 1303.21 Individual manufacturing quotas.

(a) The Administrator shall, on or before July 1 of each year, fix for and issue to each person who is registered to manufacture a basic class of controlled substance listed in Schedule I or II, and who applies for a manufacturing quota, an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that basic class. Any manufacturing quota fixed and issued by the Administrator shall be subject to his authority to reduce or limit it at a later date pursuant to § 1303.26 and to his authority to revoke or suspend it at any time pursuant to § 1301.36 of this chapter.


(b) No individual manufacturing quota shall be required for registrants listed in § 1303.12(e).


[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997; 83 FR32790, July 16, 2018]


§ 1303.22 Procedure for applying for individual manufacturing quotas.

Any person who is registered to manufacture any basic class of controlled substance listed in Schedule I or II and who desires to manufacture a quantity of such class shall apply on DEA Form 189 for a manufacturing quota for such quantity of such class. Copies of DEA Form 189 may be obtained from, and shall be filed (on or before May 1 of the year preceding the calendar year for which the manufacturing quota is being applied) with, the UN Reporting and Quota Section, Diversion Control Division. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A separate application must be made for each basic class desired to be manufactured. The applicant shall state:


(a) The name and Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, of the basic class.


(b) For the basic class in each of the current and preceding 2 calendar years,


(1) The authorized individual manufacturing quota, if any;


(2) The actual or estimated quantity manufactured;


(3) The actual or estimated net disposal;


(4) The actual or estimated inventory allowance pursuant to § 1303.24; and


(5) The actual or estimated inventory as of December 31;


(c) For the basic class in the next calendar year,


(1) The desired individual manufacturing quota; and


(2) Any additional factors which the applicant finds relevant to the fixing of his individual manufacturing quota, including the trend of (and recent changes in) his and the national rates of net disposal, his production cycle and current inventory position, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes) and recent unforeseen emergencies such as floods and fires.


(d) The Administrator may require additional information from an applicant which, in the Administrator’s judgment, may be helpful in detecting or preventing diversion, including customer identities and amounts of the controlled substance sold to each customer.


[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010; 81 FR 97020, Dec. 30, 2016; 83 FR 32790, July 16, 2018]


§ 1303.23 Procedure for fixing individual manufacturing quotas.

(a) In fixing individual manufacturing quotas for a basic class of controlled substance listed in Schedule I or II, the Administrator shall allocate to each applicant who is currently manufacturing such class a quota equal to 100 percent of the estimated net disposal of that applicant for the next calendar year, adjusted –


(1) By the amount necessary to increase or reduce the estimated inventory of the applicant on December 31 of the current year to his estimated inventory allowance for the next calendar year, pursuant to § 1303.24, and


(2) By any other factors which the Administrator deems relevant to the fixing of the individual manufacturing quota of the applicant, including the trend of (and recent changes in) his and the national rates of net disposal, his production cycle and current inventory position, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), the extent of any diversion of the controlled substance, and recent unforeseen emergencies such as floods and fires.


(b) In fixing individual manufacturing quotas for a basic class of controlled substance listed in Schedule I or II, the Administrator shall allocate to each applicant who is not currently manufacturing such class a quota equal to 100 percent of the reasonably estimated net disposal of that applicant for the next calendar year, as determined by the Administrator, adjusted –


(1) By the amount necessary to provide the applicant his estimated inventory allowance for the next calendar year, pursuant to § 1303.24, and


(2) By any other factors which the Administrator deems relevant to the fixing of the individual manufacturing quota of the applicant, including the trend of (and recent changes in) the national rate of net disposal, his production cycle and current inventory position, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), any risk of diversion of the controlled substance, and recent unforeseen emergencies such as floods and fires.


(c) The Administrator shall, on or before March 1 of each year, adjust the individual manufacturing quota allocated for that year to each applicant in paragraph (a) of this section by the amount necessary to increase or reduce the actual inventory of the applicant to December 31 of the preceding year to his estimated inventory allowance for the current calendar year, pursuant to § 1303.24.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973; 83 FR 32790, July 16, 2018]


§ 1303.24 Inventory allowance.

(a) For the purpose of determining individual manufacturing quotas pursuant to § 1303.23, each registered manufacturer shall be allowed as a part of such quota an amount sufficient to maintain an inventory equal to,


(1) For current manufacturers, 50 percent of his average estimated net disposal for the current calendar year and the last preceding calendar year; or


(2) For new manufacturers, 50 percent of his reasonably estimated net disposal for the next calendar year as determined by the Administrator.


(b) During each calendar year each registered manufacturer shall be allowed to maintain an inventory of a basic class not exceeding 65 percent of his estimated net disposal of that class for that year, as determined at the time his quota for that year was determined. At any time the inventory of a basic class held by a manufacturer exceeds 65 percent of his estimated net disposal, his quota for that class is automatically suspended and shall remain suspended until his inventory is less than 60 percent of his estimated net disposal. The Administrator may, upon application and for good cause shown, permit a manufacturer whose quota is, or is likely to be, suspended pursuant to this paragraph to continue manufacturing and to accumulate an inventory in excess of 65 percent of his estimated net disposal, upon such conditions and within such limitations as the Administrator may find necessary or desirable.


(c) If, during a calendar year, a registrant has manufactured the entire quantity of a basic class allocated to him under an individual manufacturing quota, and his inventory of that class is less than 40 percent of his estimated net disposal of that class for that year, the Administrator may, upon application pursuant to § 1303.25, increase the quota of such registrant sufficiently to allow restoration of the inventory to 50 percent of the estimated net disposal for that year.


[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.25 Increase in individual manufacturing quotas.

(a) Any registrant who holds an individual manufacturing quota for a basic class of controlled substance listed in Schedule I or II may file with the Administrator an application on Administration Form 189 for an increase in such quota in order for him to meet his estimated net disposal, inventory and other requirements during the remainder of such calendar year.


(b) The Administrator, in passing upon a registrant’s application for an increase in his individual manufacturing quota, shall take into consideration any occurrences since the filing of such registrant’s initial quota application that may require an increased manufacturing rate by such registrant during the balance of the calendar year. In passing upon such application the Administrator may also take into consideration the amount, if any, by which his determination of the total quantity for the basic class of controlled substance to be manufactured under § 1303.11 exceeds the aggregate of all the individual manufacturing quotas for the basic class of controlled substance, and the equitable distribution of such excess among other registrants.


[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.26 Reduction in individual manufacturing quotas.

The Administrator may at any time reduce an individual manufacturing quota for a basic class of controlled substance listed in Schedule I or II which he has previously fixed in order to prevent the aggregate of the individual manufacturing quotas and import permits outstanding or to be granted from exceeding the aggregate production quota which has been established for that class pursuant of § 1303.11, as adjusted pursuant to § 1303.13. If a quota assigned to a new manufacturer pursuant to § 1303.23(b), or if a quota assigned to any manufacturer is increased pursuant to § 1303.24(c), or if an import permit issued to an importer pursuant to part 1312 of this chapter, causes the total quantity of a basic class to be manufactured and imported during the year to exceed the aggregate production quota which has been established for that class pursuant to § 1303.11, as adjusted pursuant to § 1303.13, the Administrator may proportionately reduce the individual manufacturing quotas and import permits of all other registrants to keep the aggregate production quota within the limits originally established, or, alternatively, the Administrator may reduce the individual manufacturing quota of any registrant whose quota is suspended pursuant to § 1303.24(b) or § 1301.36 of this chapter, or is abandoned pursuant to § 1303.27.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997]


§ 1303.27 Abandonment of quota.

Any manufacturer assigned an individual manufacturing quota for any basic class pursuant to § 1303.23 may at any time abandon his right to manufacture all or any part of such quota by filing with the Drug & Chemical Evaluation Section a written notice of such abandonment, stating the name and Administration Controlled Substances Code Number, as set forth in part 1308 of this chapter, of the substance and the amount which he has chosen not to manufacture. The Administrator may, in his discretion, allocate such amount among the other manufacturers in proportion to their respective quotas.


[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, Mar. 24, 1997]


Hearings

§ 1303.31 Hearings generally.

(a) In any case where the Administrator shall hold a hearing regarding the determination of an aggregate production quota pursuant to § 1303.11(c), or regarding the adjustment of an aggregate production quota pursuant to § 1303.13(c), the procedures for such hearing shall be governed generally by the rule making procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by section 306 of the Act (21 U.S.C. 826), by §§ 1303.32-1303.37, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter.


(b) In any case where the Administrator shall hold a hearing regarding the issuance, adjustment, suspension, or denial of a procurement quota pursuant to § 1303.12, or the issuance, adjustment, suspension, or denial of an individual manufacturing quota pursuant to §§ 1303.21-1303.27, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedures Act (5 U.S.C. 551-559) and specifically by section 306 of the Act (21 U.S.C. 826), by §§ 1303.32-1303.37, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41-1316.67 of this chapter.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.32 Purpose of hearing.

(a) The Administrator may, in his sole discretion, and shall, if determined by the Administrator to be necessary under § 1303.11(c) or 1303.13(c) based on objection by a state, hold a hearing for the purpose of receiving factual evidence regarding any one or more issues (to be specified by him) involved in the determination or adjustment of any aggregate production quota.


(b) If requested by a person applying for or holding a procurement quota or an individual manufacturing quota, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the issuance, adjustment, suspension, or denial of such quota to such person, but the Administrator need not hold a hearing on the suspension of a quota pursuant to § 1301.36 of this chapter separate from a hearing on the suspension of registration pursuant to those sections.


(c) Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997; 83 FR 32790, July 16, 2018]


§ 1303.33 Waiver or modification of rules.

The Administrator or the presiding officer (with respect to matters pending before him) may modify or waive any rule in this part by notice in advance of the hearing, if he determines that no party in the hearing will be unduly prejudiced and the ends of justice will thereby be served. Such notice of modification or waiver shall be made a part of the record of the hearing.


[36 FR 7786, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.34 Request for hearing or appearance; waiver.

(a) Any applicant or registrant who desires a hearing on the issuance, adjustment, suspension, or denial of his procurement and/or individual manufacturing quota shall, within 30 days after the date of receipt of the issuance, adjustment, suspension, or denial of such quota, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter. Any interested person who desires a hearing on the determination of an aggregate production quota shall, within the time prescribed in § 1303.11(c), file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter, including in the request a statement of the grounds for a hearing.


(b) Any interested person who desires to participate in a hearing on the determination or adjustment of an aggregate production quota, which hearing is ordered by the Administrator pursuant to § 1303.11(c) or § 1303.13(c) may do so by filing with the Administrator, within 30 days of the date of publication of notice of the hearing in the Federal Register, a written notice of his intention to participate in such hearing in the form prescribed in § 1316.48 of this chapter.


(c) Any person entitled to a hearing or to participate in a hearing pursuant to paragraph (b) of this section, may, within the period permitted for filing a request for a hearing of notice of appearance, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.


(d) If any person entitled to a hearing or to participate in a hearing pursuant to paragraph (b) of this section, fails to file a request for a hearing or notice of appearance, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing or to participate in the hearing, unless he shows good cause for such failure.


(e) If all persons entitled to a hearing or to participate in a hearing waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to § 1303.37 without a hearing.


[36 FR 7786, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.35 Burden of proof.

(a) At any hearing regarding the determination or adjustment of an aggregate production quota, each interested person participating in the hearing shall have the burden of proving any propositions of fact or law asserted by him in the hearing.


(b) At any hearing regarding the issuance, adjustment, suspension, or denial of a procurement or individual manufacturing quota, the Administration shall have the burden of proving that the requirements of this part for such issuance, adjustment, suspension, or denial are satisfied.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13958, Mar. 24, 1997]


§ 1303.36 Time and place of hearing.

(a) If any applicant or registrant requests a hearing on the issuance, adjustment, suspension, or denial of his procurement and/or individual manufacturing quota pursuant to § 1303.34, the Administrator shall hold such hearing. Notice of the hearing shall be given to the applicant or registrant of the time and place at least 30 days prior to the hearing, unless the applicant or registrant waives such notice and requests the hearing be held at an earlier time, in which case the Administrator shall fix a date for such hearing as early as reasonably possible.


(b) The hearing will commence at the place and time designated in the notice given pursuant to paragraph (a) of this section or in the notice of hearing published in the Federal Register pursuant to § 1303.11(c) or § 1303.13 (c), but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]


§ 1303.37 Final order.

As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall issue his order on the determination or adjustment of the aggregate production quota or on the issuance, adjustment, suspension, or denial of the procurement quota or individual manufacturing quota, as case may be. The order shall include the findings of fact and conclusions of law upon which the order is based. The order shall specify the date on which it shall take effect. The Administrator shall serve one copy of his order upon each party in the hearing.


[36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973]


PART 1304 – RECORDS AND REPORTS OF REGISTRANTS


Authority:21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 965, unless otherwise noted.

General Information

§ 1304.01 Scope of part 1304.

Inventory and other records and reports required under section 307, section 311, or section 1008(e) of the Act (21 U.S.C. 827, 831, and 958(e)) shall be in accordance with, and contain the information required by, those sections and by the sections of this part.


[74 FR 15623, Apr. 6, 2009]


§ 1304.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or § 1300.01, § 1300.03, § 1300.04, or § 1300.05 of this chapter.


[81 FR 97020, Dec. 30, 2016]


§ 1304.03 Persons required to keep records and file reports.

(a) Every registrant, including collectors, shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant that is authorized to conduct other activities without being registered to conduct those activities, pursuant to §§ 1301.22(b), 1307.11, 1307.13, or part 1317 of this chapter, shall maintain the records and inventories and shall file the reports required by this part for persons registered or authorized to conduct such activities. This latter requirement should not be construed as requiring stocks of controlled substances being used in various activities under one registration to be stored separately, nor that separate records are required for each activity. The intent of the Administration is to permit the registrant to keep one set of records which are adapted by the registrant to account for controlled substances used in any activity. Also, the Administration does not wish to require separate stocks of the same substance to be purchased and stored for separate activities. Otherwise, there is no advantage gained by permitting several activities under one registration. Thus, when a researcher manufactures a controlled item, he must keep a record of the quantity manufactured; when he distributes a quantity of the item, he must use and keep invoices or order forms to document the transfer; when he imports a substance, he keeps as part of his records the documentation required of an importer; and when substances are used in chemical analysis, he need not keep a record of this because such a record would not be required of him under a registration to do chemical analysis. All of these records may be maintained in one consolidated record system. Similarly, the researcher may store all of his controlled items in one place, and every two years take inventory of all items on hand, regardless of whether the substances were manufactured by him, imported by him, or purchased domestically by him, of whether the substances will be administered to subjects, distributed to other researchers, or destroyed during chemical analysis.


(b) A registered individual practitioner is required to keep records, as described in § 1304.04, of controlled substances in Schedules II, III, IV, and V which are dispensed, other than by prescribing or administering in the lawful course of professional practice.


(c) Except as provided in § 1304.06, a registered individual practitioner is not required to keep records of controlled substances in Schedules II, III, IV, and V that are prescribed in the lawful course of professional practice, unless such substances are prescribed in the course of maintenance or detoxification treatment of an individual.


(d) A registered individual practitioner is not required to keep records of controlled substances listed in Schedules II, III, IV and V which are administered in the lawful course of professional practice unless the practitioner regularly engages in the dispensing or administering of controlled substances and charges patients, either separately or together with charges for other professional services, for substances so dispensed or administered. Records are required to be kept for controlled substances administered in the course of maintenance or detoxification treatment of an individual.


(e) Each registered mid-level practitioner shall maintain in a readily retrievable manner those documents required by the state in which he/she practices which describe the conditions and extent of his/her authorization to dispense controlled substances and shall make such documents available for inspection and copying by authorized employees of the Administration. Examples of such documentation include protocols, practice guidelines or practice agreements.


(f) Registered persons using any controlled substances while conducting preclinical research, in teaching at a registered establishment which maintains records with respect to such substances or conducting research in conformity with an exemption granted under section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i) or 360b(j)) at a registered establishment which maintains records in accordance with either of those sections, are not required to keep records if he/she notifies the Administration of the name, address, and registration number of the establishment maintaining such records. This notification shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.


(g) A distributing registrant who utilizes a freight forwarding facility shall maintain records to reflect transfer of controlled substances through the facility. These records must contain the date, time of transfer, number of cartons, crates, drums or other packages in which commercial containers of controlled substances are shipped and authorized signatures for each transfer. A distributing registrant may, as part of the initial request to operate a freight forwarding facility, request permission to store records at a central location. Approval of the request to maintain central records would be implicit in the approval of the request to operate the facility. Otherwise, a request to maintain records at a central location must be submitted in accordance with § 1304.04 of this part. These records must be maintained for a period of two years.


(h) A person is required to keep the records and file the reports specified in § 1304.06 and part 1311 of this chapter if they are either of the following:


(1) An electronic prescription application provider.


(2) An electronic pharmacy application provider.


[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 40523, Oct. 4, 1985; 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, Mar. 24, 1997; 65 FR 44679, July 19, 2000; 75 FR 16306, Mar. 31, 2010; 77 FR 4235, Jan. 27, 2012; 79 FR 53562, Sept. 9, 2014]


§ 1304.04 Maintenance of records and inventories.

(a) Except as provided in paragraphs (a)(1) and (a)(2) of this section, every inventory and other records required to be kept under this part must be kept by the registrant and be available, for at least 2 years from the date of such inventory or records, for inspection and copying by authorized employees of the Administration.


(1) Financial and shipping records (such as invoices and packing slips but not executed order forms subject to §§ 1305.17 and 1305.27 of this chapter) may be kept at a central location, rather than at the registered location, if the registrant has notified the Administration of his intention to keep central records. Written notification must be submitted by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the Administration in the area in which the registrant is located. Unless the registrant is informed by the Special Agent in Charge that permission to keep central records is denied, the registrant may maintain central records commencing 14 days after receipt of his notification by the Special Agent in Charge. All notifications must include the following:


(i) The nature of the records to be kept centrally.


(ii) The exact location where the records will be kept.


(iii) The name, address, DEA registration number and type of DEA registration of the registrant whose records are being maintained centrally.


(iv) Whether central records will be maintained in a manual, or computer readable, form.


(2) A registered retail pharmacy that possesses additional registrations for automated dispensing systems at long term care facilities may keep all records required by this part for those additional registered sites at the retail pharmacy or other approved central location.


(3) A collector that is authorized to maintain a collection receptacle at a long-term care facility shall keep all records required by this part relating to those collection receptacles at the registered location, or other approved central location.


(b) All registrants that are authorized to maintain a central recordkeeping system under paragraph (a) of this section shall be subject to the following conditions:


(1) The records to be maintained at the central record location shall not include executed order forms and inventories, which shall be maintained at each registered location.


(2) If the records are kept on microfilm, computer media or in any form requiring special equipment to render the records easily readable, the registrant shall provide access to such equipment with the records. If any code system is used (other than pricing information), a key to the code shall be provided to make the records understandable.


(3) The registrant agrees to deliver all or any part of such records to the registered location within two business days upon receipt of a written request from the Administration for such records, and if the Administration chooses to do so in lieu of requiring delivery of such records to the registered location, to allow authorized employees of the Administration to inspect such records at the central location upon request by such employees without a warrant of any kind.


(4) In the event that a registrant fails to comply with these conditions, the Special Agent in Charge may cancel such central recordkeeping authorization, and all other central recordkeeping authorizations held by the registrant without a hearing or other procedures. In the event of a cancellation of central recordkeeping authorizations under this paragraph the registrant shall, within the time specified by the Special Agent in Charge, comply with the requirements of this section that all records be kept at the registered location.


(c) Registrants need not notify the Special Agent in Charge or obtain central recordkeeping approval in order to maintain records on an in-house computer system.


(d) ARCOS participants who desire authorization to report from other than their registered locations must obtain a separate central reporting identifier. Request for central reporting identifiers will be submitted to the ARCOS Unit. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(e) All central recordkeeping permits previously issued by the Administration expired September 30, 1980.


(f) Each registered manufacturer, distributor, importer, exporter, mobile narcotic treatment program, narcotic treatment program and compounder for narcotic treatment program shall maintain inventories and records of controlled substances as follows:


(1) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; and


(2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.


(g) Each registered individual practitioner required to keep records and institutional practitioner shall maintain inventories and records of controlled substances in the manner prescribed in paragraph (f) of this section.


(h) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:


(1) Inventories and records of all controlled substances listed in Schedule I and II shall be maintained separately from all other records of the pharmacy.


(2) Paper prescriptions for Schedule II controlled substances shall be maintained at the registered location in a separate prescription file.


(3) Inventories and records of Schedules III, IV, and V controlled substances shall be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy.


(4) Paper prescriptions for Schedules III, IV, and V controlled substances shall be maintained at the registered location either in a separate prescription file for Schedules III, IV, and V controlled substances only or in such form that they are readily retrievable from the other prescription records of the pharmacy. Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the face of the prescription is stamped in red ink in the lower right corner with the letter “C” no less than 1 inch high and filed either in the prescription file for controlled substances listed in Schedules I and II or in the usual consecutively numbered prescription file for noncontrolled substances. However, if a pharmacy employs a computer application for prescriptions that permits identification by prescription number and retrieval of original documents by prescriber name, patient’s name, drug dispensed, and date filled, then the requirement to mark the hard copy prescription with a red “C” is waived.


(5) Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of part 1311 of this chapter. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the Administration or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sortable by prescriber name, patient name, drug dispensed, and date filled.


(Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100)

[36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, 1986; 62 FR 13959, Mar. 24, 1997; 70 FR 25466, May 13, 2005; 75 FR 10677, Mar. 9, 2010; 75 FR 16306, Mar. 31, 2010; 79 FR 53562, Sept. 9, 2014; 86 FR 33885, June 28, 2021]


§ 1304.05 Records of authorized central fill pharmacies and retail pharmacies.

(a) Every retail pharmacy that utilizes the services of a central fill pharmacy must keep a record of all central fill pharmacies, including name, address and DEA number, that are authorized to fill prescriptions on its behalf. The retail pharmacy must also verify the registration for each central fill pharmacy authorized to fill prescriptions on its behalf. These records must be made available upon request for inspection by DEA.


(b) Every central fill pharmacy must keep a record of all retail pharmacies, including name, address and DEA number, for which it is authorized to fill prescriptions. The central fill pharmacy must also verify the registration for all retail pharmacies for which it is authorized to fill prescriptions. These records must be made available upon request for inspection by DEA.


[68 FR 37410, June 24, 2003]


§ 1304.06 Records and reports for electronic prescriptions.

(a) As required by § 1311.120 of this chapter, a practitioner who issues electronic prescriptions for controlled substances must use an electronic prescription application that retains the following information:


(1) The digitally signed record of the information specified in part 1306 of this chapter.


(2) The internal audit trail and any auditable event identified by the internal audit as required by § 1311.150 of this chapter.


(b) An institutional practitioner must retain a record of identity proofing and issuance of the two-factor authentication credential, where applicable, as required by § 1311.110 of this chapter.


(c) As required by § 1311.205 of this chapter, a pharmacy that processes electronic prescriptions for controlled substances must use an application that retains the following:


(1) All of the information required under § 1304.22(c) and part 1306 of this chapter.


(2) The digitally signed record of the prescription as received as required by § 1311.210 of this chapter.


(3) The internal audit trail and any auditable event identified by the internal audit as required by § 1311.215 of this chapter.


(d) A registrant and application service provider must retain a copy of any security incident report filed with the Administration pursuant to §§ 1311.150 and 1311.215 of this chapter.


(e) An electronic prescription or pharmacy application provider must retain third party audit or certification reports as required by § 1311.300 of this chapter.


(f) An application provider must retain a copy of any notification to the Administration regarding an adverse audit or certification report filed with the Administration on problems identified by the third-party audit or certification as required by § 1311.300 of this chapter.


(g) Unless otherwise specified, records and reports must be retained for two years.


[75 FR 16306, Mar. 31, 2010]


Inventory Requirements

§ 1304.11 Inventory requirements.

(a) General requirements. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered, except as provided in paragraph (e)(4) of this section. In the event controlled substances in the possession or under the control of the registrant are stored at a location for which he/she is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.


(b) Initial inventory date. Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he/she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with paragraph (e) of this section as applicable. In the event a person commences business with no controlled substances on hand, he/she shall record this fact as the initial inventory.


(c) Biennial inventory date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date.


(d) Inventory date for newly controlled substances. On the effective date of a rule by the Administrator pursuant to §§ 1308.45, 1308.46, or 1308.47 of this chapter adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter, such substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section.


(e) Inventories of manufacturers, distributors, registrants that reverse distribute, importers, exporters, chemical analysts, dispensers, researchers, and collectors. Each person registered or authorized (by §§ 1301.13, 1307.11, 1307.13, or part 1317 of this chapter) to manufacture, distribute, reverse distribute, dispense, import, export, conduct research or chemical analysis with controlled substances, or collect controlled substances from ultimate users, and required to keep records pursuant to § 1304.03 shall include in the inventory the information listed below.


(1) Inventories of manufacturers. Each person registered or authorized to manufacture controlled substances shall include the following information in the inventory:


(i) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or non-controlled substances in finished form, the inventory shall include:


(A) The name of the substance and


(B) The total quantity of the substance to the nearest metric unit weight consistent with unit size.


(ii) For each controlled substance in the process of manufacture on the inventory date, the inventory shall include:


(A) The name of the substance;


(B) The quantity of the substance in each batch and/or stage of manufacture, identified by the batch number or other appropriate identifying number; and


(C) The physical form which the substance is to take upon completion of the manufacturing process (e.g., granulations, tablets, capsules, or solutions), identified by the batch number or other appropriate identifying number, and if possible the finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number or volume thereof.


(iii) For each controlled substance in finished form the inventory shall include:


(A) The name of the substance;


(B) Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);


(C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and


(D) The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).


(iv) For each controlled substance not included in paragraphs (e)(1) (i), (ii) or (iii) of this section (e.g., damaged, defective or impure substances awaiting disposal, substances held for quality control purposes, or substances maintained for extemporaneous compoundings) the inventories shall include:


(A) The name of the substance;


(B) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and


(C) The reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form.


(2) Inventories of distributors. Each person registered or authorized to distribute controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section.


(3) Inventories of registrants that reverse distribute. Each person registered or authorized to reverse distribute controlled substances shall include in the inventory, the following information:


(i) The name of the substance, and


(ii) The total quantity of the substance:


(A) For controlled substances in bulk form, to the nearest metric unit weight consistent with unit size;


(B) For each controlled substance in finished form: Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); the number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and the number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials); and


(C) For controlled substances in a commercial container, carton, crate, drum, or other receptacle that has been opened: If the substance is listed in Schedule I or II, make an exact count or measure of the contents; or if the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents shall be made; or


(iii) For controlled substances acquired from collectors and law enforcement: The number and size (e.g., five 10-gallon liners, etc.) of sealed inner liners on hand, or


(iv) For controlled substances acquired from law enforcement: the number of sealed mail-back packages on hand.


(4) Inventories of importers and exporters. Each person registered or authorized to import or export controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such person who is also registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that are actually separated from his stocks as a manufacturer or as a distributor (e.g., in transit or in storage for shipment).


(5) Inventories of chemical analysts. Each person registered or authorized to conduct chemical analysis with controlled substances shall include in his inventory the same information required of manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this section as to substances which have been manufactured, imported, or received by such person. If less than 1 kilogram of any controlled substance (other than a hallucinogenic controlled substance listed in Schedule I), or less than 20 grams of a hallucinogenic substance listed in Schedule I (other than lysergic acid diethylamide), or less than 0.5 gram of lysergic acid diethylamide, is on hand at the time of inventory, that substance need not be included in the inventory. Laboratories of the Administration may possess up to 150 grams of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those substances. No inventory is required of known or suspected controlled substances received as evidentiary materials for analysis.


(6) Inventories of dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall include in the inventory the same information required of manufacturers pursuant to paragraphs (e)(1)(iii) and (iv) of this section. In determining the number of units of each finished form of a controlled substance in a commercial container that has been opened, the dispenser or researcher shall do as follows:


(i) If the substance is listed in Schedules I or II, make an exact count or measure of the contents; or


(ii) If the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.


(7) Inventories of collectors. Each registrant authorized to collect controlled substances from ultimate users shall include in the inventory the following information:


(i) For registrants authorized to collect through a mail-back program, the record shall include the following information about each unused mail-back package and each returned mail-back package on hand awaiting destruction:


(A) The date of the inventory;


(B) The number of mail-back packages; and


(C) The unique identification number of each package on hand, whether unused or awaiting destruction.


(ii) For registrants authorized to collect through a collection receptacle, the record shall include the following information about each unused inner liner on hand and each sealed inner liner on hand awaiting destruction:


(A) The date of the inventory;


(B) The number and size of inner liners (e.g., five 10-gallon liners, etc.);


(C) The unique identification number of each inner liner.


[62 FR 13959, Mar. 24, 1997, as amended at 68 FR 41228, July 11, 2003; 79 FR 53562, Sept. 9, 2014]


Continuing Records

§ 1304.21 General requirements for continuing records.

(a) Every registrant required to keep records pursuant to § 1304.03 shall maintain, on a current basis, a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him/her, and each inner liner, sealed inner liner, and unused and returned mail-back package, except that no registrant shall be required to maintain a perpetual inventory.


(b) Separate records shall be maintained by a registrant for each registered location except as provided in § 1304.04 (a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substances shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.


(c) Separate records shall be maintained by a registrant for each independent activity and collection activity for which he/she is registered or authorized, except as provided in § 1304.22(d).


(d) In recording dates of receipt, distribution, other transfers, or destruction, the date on which the controlled substances are actually received, distributed, otherwise transferred, or destroyed will be used as the date of receipt, distribution, transfer, or destruction (e.g., invoices or packing slips, or DEA Form 41). In maintaining records concerning imports and exports, the registrant must record the anticipated date of release by a customs official for permit applications and declarations and the date on which the controlled substances are released by a customs officer at the port of entry or port of export for return information.


(e) Record of destruction. In addition to any other recordkeeping requirements, any registered person that destroys a controlled substance pursuant to § 1317.95(d), or causes the destruction of a controlled substance pursuant to § 1317.95(c), shall maintain a record of destruction on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the two employees who witnessed the destruction. Except, destruction of a controlled substance dispensed by a practitioner for immediate administration at the practitioner’s registered location, when the substance is not fully exhausted (e.g., some of the substance remains in a vial, tube, or syringe after administration but cannot or may not be further utilized), shall be properly recorded in accordance with § 1304.22(c), and such record need not be maintained on a DEA Form 41.


[36 FR 7792, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13960, Mar. 24, 1997; 79 FR 53563, Sept. 9, 2014; 81 FR 97020, Dec. 30, 2016]


§ 1304.22 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, registrants that reverse distribute, and collectors.

Each person registered or authorized (by §§ 1301.13(e), 1307.11, 1307.13, or part 1317 of this chapter) to manufacture, distribute, dispense, import, export, reverse distribute, destroy, conduct research with controlled substances, or collect controlled substances from ultimate users, shall maintain records with the information listed in paragraphs (a) through (f) of this section.


(a) Records for manufacturers. Each person registered or authorized to manufacture controlled substances shall maintain records with the following information:


(1) For each controlled substance in bulk form to be used in, or capable of use in, or being used in, the manufacture of the same or other controlled or noncontrolled substances in finished form,


(i) The name of the substance;


(ii) The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;


(iii) The quantity received from other persons, including the date and quantity of each receipt and the name, address, and registration number of the other person from whom the substance was received;


(iv) The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him/her, including the date, quantity, and import permit or declaration number for each importation;


(v) The quantity used to manufacture the same substance in finished form, including:


(A) The date and batch or other identifying number of each manufacture;


(B) The quantity used in the manufacture;


(C) The finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter);


(D) The number of units of finished form manufactured;


(E) The quantity used in quality control;


(F) The quantity lost during manufacturing and the causes therefore, if known;


(G) The total quantity of the substance contained in the finished form;


(H) The theoretical and actual yields; and


(I) Such other information as is necessary to account for all controlled substances used in the manufacturing process;


(vi) The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in paragraph (a)(1)(v) of this section;


(vii) The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address, and registration number of each person to whom a distribution was made;


(viii) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exportation;


(ix) The quantity distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity distributed or disposed; and


(x) The originals of all written certifications of available procurement quotas submitted by other persons (as required by § 1303.12(f) of this chapter) relating to each order requiring the distribution of a basic class of controlled substance listed in Schedule I or II.


(2) For each controlled substance in finished form,


(i) The name of the substance;


(ii) Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter) and the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);


(iii) The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required pursuant to paragraph (a)(1)(v) of this section;


(iv) The number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired;


(v) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;


(vi) The number of units and/or commercial containers manufactured by the registrant from units in finished form received from others or imported, including:


(A) The date and batch or other identifying number of each manufacture;


(B) The operation performed (e.g., repackaging or relabeling);


(C) The number of units of finished form used in the manufacture, the number manufactured and the number lost during manufacture, with the causes for such losses, if known; and


(D) Such other information as is necessary to account for all controlled substances used in the manufacturing process;


(vii) The number of commercial containers distributed to other persons, including the date of and number of containers in each reduction from inventory, and the name, address, and registration number of the person to whom the containers were distributed; (viii) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and


(ix) The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant (e.g., by distribution of complimentary samples or by destruction), including the date and manner of distribution or disposal, the name, address, and registration number of the person to whom distributed, and the quantity in finished form distributed or disposed.


(b) Records for distributors. Except as provided in paragraph (e) of this section, each person registered or authorized to distribute controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraphs (a)(2)(i), (ii), (iv), (v), (vii), (viii) and (ix) of this section.


(c) Records for dispensers and researchers. Each person registered or authorized to dispense or conduct research with controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraph (a)(2)(i), (ii), (iv), (vii), and (ix) of this section. In addition, records shall be maintained of the number of units or volume of such finished form dispensed, including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance on behalf of the dispenser. In addition to the requirements of this paragraph, practitioners dispensing gamma-hydroxybutyric acid under a prescription must also comply with § 1304.26.


(d) Records for importers and exporters. Each person registered or authorized to import or export controlled substances shall maintain records with the same information required of manufacturers pursuant to paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In addition, the quantity disposed of in any other manner by the registrant (except quantities used in manufacturing by an importer under a registration as a manufacturer), which quantities are to be recorded pursuant to paragraphs (a)(1) (iv) and (v) of this section; and the quantity (or number of units or volume in finished form) exported, including the date, quantity (or number of units or volume), and the export permit or declaration number for each exportation, but excluding all quantities (and number of units and volumes) manufactured by an exporter under a registration as a manufacturer, which quantities (and numbers of units and volumes) are to be recorded pursuant to paragraphs (a)(1)(xiii) or (a)(2)(xiii) of this section.


(e) Records for registrants that reverse distribute. Each person registered or authorized to reverse distribute controlled substances shall maintain records with the following information for each controlled substance:


(1) For controlled substances acquired for the purpose of return or recall to the manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer’s behalf pursuant to part 1317 of this chapter:


(i) The date of receipt; the name and quantity of each controlled substance received; the name, address, and registration number of the person from whom the substance was received; and the reason for return (e.g., recall or return); and


(ii) The date of return to the manufacturer or other registrant authorized by the manufacturer to accept returns on the manufacturer’s behalf; the name and quantity of each controlled substance returned; the name, address, and registration number of the person from whom the substance was received; the name, address, and registration number of the registrant to whom the substance was returned; and the method of return (e.g., common or contract carrier).


(2) For controlled substances acquired from registrant inventory for destruction pursuant to § 1317.05(a)(2), (b)(2), and (b)(4) of this chapter:


(i) The date of receipt; the name and quantity of each controlled substance received; and the name, address, and registration number of the person from whom the substance was received; and


(ii) The date, place, and method of destruction; the name and quantity of each controlled substance destroyed; the name, address, and registration number of the person from whom the substance was received; and the name and signatures of the two employees of the registrant that witnessed the destruction.


(3) The total quantity of each controlled substance shall be recorded in accordance with the following:


(i) For controlled substances in bulk form: To the nearest metric unit weight or volume consistent with unit size;


(ii) For controlled substances in finished form: Each finished form (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter); the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and the number of commercial containers of each such finished form (e.g., four 100-tablet bottles or six 3-milliliter vials); and


(iii) For controlled substances in a commercial container, carton, crate, drum, or other receptacle that has been opened: If the substance is listed in Schedule I or II make an exact count or measure of the contents; or if the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case an exact count of the contents shall be made.


(4) For each sealed inner liner acquired from collectors or law enforcement and each sealed mail-back package acquired from law enforcement pursuant to § 1317.55 of this chapter:


(i) The number of sealed inner liners acquired from other persons, including the date of acquisition, the number and, for sealed inner liners the size (e.g., five 10-gallon liners, etc.), of all sealed inner liners and mail-back packages acquired to inventory, the unique identification number of each sealed inner liner and mail-back package, and the name, address, and, for registrants, the registration number of the person from whom the sealed inner liners and mail-back packages were received, and


(ii) The date, place, and method of destruction; the number of sealed inner liners and mail-back packages destroyed; the name, address, and, for registrants, the registration number of the person from whom the sealed inner liners and mail-back packages were received; the number and, for sealed inner liners the size (e.g., five 10-gallon liners, etc.), of all sealed inner liners and mail-back packages destroyed; the unique identification number of each sealed inner liner and sealed mail-back package destroyed; and the name and signatures of the two employees of the registrant that witnessed the destruction.


(5) For all records, the record of receipt shall be maintained together with the corresponding record of return or destruction (DEA Form 41).


(f) Records for collectors. Each person registered or authorized to collect controlled substances from ultimate users shall maintain the following records:


(1) Mail-Back Packages:


(i) For unused packages that the collector makes available to ultimate users and other authorized non-registrants at the collector’s registered address: The date made available, the number of packages, and the unique identification number of each package;


(ii) For unused packages provided to a third party to make available to ultimate users and other authorized non-registrants: The name of the third party and physical address of the location receiving the unused packages, date sent, and the number of unused packages sent with the corresponding unique identification numbers;


(iii) For sealed mail-back packages received by the collector: Date of receipt and the unique identification number on the individual package; and


(iv) For sealed mail-back packages destroyed on-site by the collector: Number of sealed mail-back packages destroyed, the date and method of destruction, the unique identification number of each mail-back package destroyed, and the names and signatures of the two employees of the registrant who witnessed the destruction.


(2) Collection receptacle inner liners:


(i) Date each unused inner liner acquired, unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each unused inner liner acquired;


(ii) Date each inner liner is installed, the address of the location where each inner liner is installed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each installed inner liner, the registration number of the collector, and the names and signatures of the two employees that witnessed each installation;


(iii) Date each inner liner is removed and sealed, the address of the location from which each inner liner is removed, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each inner liner removed, the registration number of the collector, and the names and signatures of the two employees that witnessed each removal;


(iv) Date each sealed inner liner is transferred to storage, the unique identification number and size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner stored, and the names and signatures of the two employees that transferred each sealed inner liner to storage;


(v) Date each sealed inner liner is transferred for destruction, the address and registration number of the reverse distributor or distributor to whom each sealed inner liner was transferred, the unique identification number and the size (e.g., 5-gallon, 10-gallon, etc.) of each sealed inner liner transferred, and the names and signatures of the two employees that transferred each sealed inner liner to the reverse distributor or distributor; and


(vi) For sealed inner liners destroyed on-site by the collector: The same information required of reverse distributors in paragraph (e)(4)(ii) of this section.


[62 FR 13960, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 293, Jan. 4, 2005; 79 FR 53564, Sept. 9, 2014]


§ 1304.23 Records for chemical analysts.

(a) Each person registered or authorized (by § 1301.22(b) of this chapter) to conduct chemical analysis with controlled substances shall maintain records with the following information (to the extent known and reasonably ascertainable by him) for each controlled substance:


(1) The name of the substance;


(2) The form or forms in which the substance is received, imported, or manufactured by the registrant (e.g., powder, granulation, tablet, capsule, or solution) and the concentration of the substance in such form (e.g., C.P., U.S.P., N.F., 10-milligram tablet or 10-milligram concentration per milliliter);


(3) The total number of the forms received, imported or manufactured (e.g., 100 tablets, thirty 1-milliliter vials, or 10 grams of powder), including the date and quantity of each receipt, importation, or manufacture and the name, address, and registration number, if any, of the person from whom the substance was received;


(4) The quantity distributed, exported, or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation, or destruction, and the name, address, and registration number, if any, of each person to whom the substance was distributed or exported.


(b) Records of controlled substances used in chemical analysis or other laboratory work are not required.


(c) Records relating to known or suspected controlled substances received as evidentiary material for analysis are not required under paragraph (a) of this section.


[36 FR 7793, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13961, Mar. 24, 1997]


§ 1304.24 Records for maintenance treatment programs, mobile narcotic treatment programs, and detoxification treatment programs.

(a) Each person registered or authorized (by § 1301.22 of this chapter) to maintain and/or detoxify controlled substance users in a narcotic treatment program (NTP), including a mobile NTP, shall maintain records with the following information for each narcotic controlled substance:


(1) Name of substance;


(2) Strength of substance;


(3) Dosage form;


(4) Date dispensed;


(5) Adequate identification of patient (consumer);


(6) Amount consumed;


(7) Amount and dosage form taken home by patient; and


(8) Dispenser’s initials.


(b) The records required by paragraph (a) of this section will be maintained in a dispensing log at the NTP site, or in the case of a mobile NTP, at the registered site of the NTP, and will be maintained in compliance with § 1304.22 without reference to § 1304.03.


(1) As an alternative to maintaining a paper dispensing log, an NTP or its mobile component may also use an automated/computerized data processing system for the storage and retrieval of the program’s dispensing records, if the following conditions are met:


(i) The automated system maintains the information required in paragraph (a);


(ii) The automated system has the capability of producing a hard copy printout of the program’s dispensing records;


(iii) The NTP or its mobile component prints a hard copy of each day’s dispensing log, which is then initialed appropriately by each person who dispensed medication to the program’s patients;


(iv) The automated system is approved by DEA;


(v) The NTP or its mobile component maintains an off-site back-up of all computer generated program information; and


(vi) The automated system is capable of producing accurate summary reports for both the registered site of the NTP and any mobile component, for any time-frame selected by DEA personnel during an investigation. If these summary reports are maintained in hard copy form, they must be kept in a systematically organized file located at the registered site of the NTP.


(2) The NTP must retain all records for the NTP as well as any mobile component two years from the date of execution, in accordance with § 1304.04(a). However, if the State in which the NTP is located requires that records be retained longer than two years, the NTP should contact its State opioid treatment authority for information about State requirements.


(c) All sites which compound a bulk narcotic solution from bulk narcotic powder to liquid for on-site use must keep a separate batch record of the compounding.


(d) Records of identity, diagnosis, prognosis, or treatment of any patients which are maintained in connection with the performance of a narcotic treatment program shall be confidential, except that such records may be disclosed for purposes and under the circumstances authorized by part 310 and 42 CFR part 2.


[39 FR 37985, Oct. 25, 1974. Redesignated and amended at 62 FR 13961, Mar. 24, 1997; 86 FR 33885, June 28, 2021]


§ 1304.25 Records for treatment programs that compound narcotics for treatment programs and other locations.

Each person registered or authorized by § 1301.22 of this chapter to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug:


(a) For each narcotic controlled substance in bulk form to be used in, or capable of use in, or being used in, the compounding of the same or other noncontrolled substances in finished form:


(1) The name of the substance;


(2) The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded;


(3) The quantity received from other persons, including the date and quantity of each receipt and the name, address and registration number of the other person from whom the substance was received;


(4) The quantity imported directly by the registrant (under a registration as an importer) for use in compounding by him, including the date, quantity and import permit or declaration number of each importation;


(5) The quantity used to compound the same substance in finished form, including:


(i) The date and batch or other identifying number of each compounding;


(ii) The quantity used in the compound;


(iii) The finished form (e.g., 10-milligram tablets or 10-milligram concentration per fluid ounce or milliliter;


(iv) The number of units of finished form compounded;


(v) The quantity used in quality control;


(vi) The quantity lost during compounding and the causes therefore, if known;


(vii) The total quantity of the substance contained in the finished form;


(viii) The theoretical and actual yields; and


(ix) Such other information as is necessary to account for all controlled substances used in the compounding process;


(6) The quantity used to manufacture other controlled and non-controlled substances; including the name of each substance manufactured and the information required in paragraph (a)(5) of this section;


(7) The quantity distributed in bulk form to other programs, including the date and quantity of each distribution and the name, address and registration number of each program to whom a distribution was made;


(8) The quantity exported directly by the registrant (under a registration as an exporter), including the date, quantity, and export permit or declaration number of each exploration; and


(9) The quantity disposed of by destruction, including the reason, date, and manner of destruction.


(b) For each narcotic controlled substance in finished form:


(1) The name of the substance;


(2) Each finished form (e.g., 10-milligram tablet or 10 milligram concentration per fluid ounce or milliliter) and the number of units or volume or finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);


(3) The number of containers of each such commercial finished form compounded from bulk form by the registrant, including the information required pursuant to paragraph (a)(5) of this section;


(4) The number of units of finished forms and/or commercial containers received from other persons, including the date of and number of units and/or commercial containers in each receipt and the name, address and registration number of the person from whom the units were received;


(5) The number of units of finished forms and/or commercial containers imported directly by the person (under a registration or authorization to import), including the date of, the number of units and/or commercial containers in, and the import permit or declaration number for, each importation;


(6) The number of units and/or commercial containers compounded by the registrant from units in finished form received from others or imported, including:


(i) The date and batch or other identifying number of each compounding;


(ii) The operation performed (e.g., repackaging or relabeling);


(iii) The number of units of finished form used in the compound, the number compounded and the number lost during compounding, with the causes for such losses, if known; and


(iv) Such other information as is necessary to account for all controlled substances used in the compounding process;


(7) The number of containers distributed to other programs, including the date, the number of containers in each distribution, and the name, address and registration number of the program to whom the containers were distributed;


(8) The number of commercial containers exported directly by the registrant (under a registration as an exporter), including the date, number of containers and export permit or declaration number for each exportation; and


(9) The number of units of finished forms and/or commercial containers destroyed in any manner by the registrant, including the reason, date, and manner of destruction.


[39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997; 79 FR 53564, Sept. 9, 2014]


§ 1304.26 Additional recordkeeping requirements applicable to drug products containing gamma-hydroxybutyric acid.

In addition to the recordkeeping requirements for dispensers and researchers provided in § 1304.22, practitioners dispensing gamma-hydroxybutyric acid that is manufactured or distributed in accordance with an application under section 505 of the Federal Food, Drug, and Cosmetic Act must maintain and make available for inspection and copying by the Attorney General, all of the following information for each prescription:


(a) Name of the prescribing practitioner.


(b) Prescribing practitioner’s Federal and State registration numbers, with the expiration dates of these registrations.


(c) Verification that the prescribing practitioner possesses the appropriate registration to prescribe this controlled substance.


(d) Patient’s name and address.


(e) Patient’s insurance provider, if available.


[70 FR 293, Jan. 4, 2005]


Reports

§ 1304.31 Reports from manufacturers importing narcotic raw material.

(a) Every manufacturer which imports or manufactures from narcotic raw material (opium, poppy straw, and concentrate of poppy straw) shall submit information which accounts for the importation and for all manufacturing operations performed between importation and the production in bulk or finished marketable products, standardized in accordance with the U.S. Pharmacopeia, National Formulary or other recognized medical standards. Reports shall be signed by the authorized official and submitted quarterly on company letterhead to the UN Reporting and Quota Section, Diversion Control Division, on or before the 15th day of the month immediately following the period for which it is submitted. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) The following information shall be submitted for each type of narcotic raw material (quantities are expressed as grams of anhydrous morphine alkaloid):


(1) Beginning inventory;


(2) Gains on reweighing;


(3) Imports;


(4) Other receipts;


(5) Quantity put into process;


(6) Losses on reweighing;


(7) Other dispositions and


(8) Ending inventory.


(c) The following information shall be submitted for each narcotic raw material derivative including morphine, codeine, thebaine, oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude alkaloids and other derivatives (quantities are expressed as grams of anhydrous base or anhydrous morphine alkaloid for manufacturing opium and medicinal opium):


(1) Beginning inventory;


(2) Gains on reweighing;


(3) Quantity extracted from narcotic raw material;


(4) Quantity produced/manufactured/synthesized;


(5) Quantity sold;


(6) Quantity returned to conversion processes for reworking;


(7) Quantity used for conversion;


(8) Quantity placed in process;


(9) Other dispositions;


(10) Losses on reweighing and


(11) Ending inventory.


(d) The following information shall be submitted for importation of each narcotic raw material:


(1) Import permit number;


(2) Date shipment arrived at the United States port of entry;


(3) Actual quantity shipped;


(4) Assay (percent) of morphine, codeine and thebaine and


(5) Quantity shipped, expressed as anhydrous morphine alkaloid.


(e) Upon importation of crude opium, samples will be selected and assays made by the importing manufacturer in the manner and according to the method specified in the U.S. Pharmacopoeia. Where final assay data is not determined at the time of rendering report, the report shall be made on the basis of the best data available, subject to adjustment, and the necessary adjusting entries shall be made on the next report.


(f) Where factory procedure is such that partial withdrawals of opium are made from individual containers, there shall be attached to each container a stock record card on which shall be kept a complete record of all withdrawals therefrom.


(g) All in-process inventories should be expressed in terms of end-products and not precursors. Once precursor material has been changed or placed into process for the manufacture of a specified end-product, it must no longer be accounted for as precursor stocks available for conversion or use, but rather as end-product in-process inventories.


[62 FR 13961, Mar. 24, 1997, as amended at 75 FR 10677, Mar. 9, 2010; 81 FR 97020, Dec. 30, 2016]


§ 1304.32 Reports of manufacturers importing coca leaves.

(a) Every manufacturer importing or manufacturing from raw coca leaves shall submit information accounting for the importation and for all manufacturing operations performed between the importation and the manufacture of bulk or finished products standardized in accordance with U.S. Pharmacopoeia, National Formulary, or other recognized standards. The reports shall be submitted quarterly on company letterhead to the UN Reporting and Quota Section, Diversion Control Division, on or before the 15th day of the month immediately following the period for which it is submitted. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) The following information shall be submitted for raw coca leaf, ecgonine, ecgonine for conversion or further manufacture, benzoylecgonine, manufacturing coca extracts (list for tinctures and extracts; and others separately), other crude alkaloids and other derivatives (quantities should be reported as grams of actual quantity involved and the cocaine alkaloid content or equivalency):


(1) Beginning inventory;


(2) Imports;


(3) Gains on reweighing;


(4) Quantity purchased;


(5) Quantity produced;


(6) Other receipts;


(7) Quantity returned to processes for reworking;


(8) Material used in purification for sale;


(9) Material used for manufacture or production;


(10) Losses on reweighing;


(11) Material used for conversion;


(12) Other dispositions and


(13) Ending inventory.


(c) The following information shall be submitted for importation of coca leaves:


(1) Import permit number;


(2) Date the shipment arrived at the United States port of entry;


(3) Actual quantity shipped;


(4) Assay (percent) of cocaine alkaloid and


(5) Total cocaine alkaloid content.


(d) Upon importation of coca leaves, samples will be selected and assays made by the importing manufacturer in accordance with recognized chemical procedures. These assays shall form the basis of accounting for such coca leaves, which shall be accounted for in terms of their cocaine alkaloid content or equivalency or their total anhydrous coca alkaloid content. Where final assay data is not determined at the time of submission, the report shall be made on the basis of the best data available, subject to adjustment, and the necessary adjusting entries shall be made on the next report.


(e) Where factory procedure is such that partial withdrawals of medicinal coca leaves are made from individual containers, there shall be attached to the container a stock record card on which shall be kept a complete record of withdrawals therefrom.


(f) All in-process inventories should be expressed in terms of end-products and not precursors. Once precursor material has been changed or placed into process for the manufacture of a specified end-product, it must no longer be accounted for as precursor stocks available for conversion or use, but rather as end-product in-process inventories.


[62 FR 13962, Mar. 24, 1997, as amended at 75 FR 10678, Mar. 9, 2010; 81 FR 97020, Dec. 30, 2016]


§ 1304.33 Reports to Automation of Reports and Consolidated Orders System (ARCOS).

(a) Reports generally. All reports required by this section shall be filed with the Pharmaceutical Investigations Section, Diversion Control Division, Drug Enforcement Administration on DEA Form 333, or on media which contains the data required by DEA Form 333 and which is acceptable to the Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) Frequency of reports. Acquisition/Distribution transaction reports shall be filed every quarter not later than the 15th day of the month succeeding the quarter for which it is submitted; except that a registrant may be given permission to file more frequently (but not more frequently than monthly), depending on the number of transactions being reported each time by that registrant. Inventories shall provide data on the stocks of each reported controlled substance on hand as of the close of business on December 31 of each year, indicating whether the substance is in storage or in process of manufacturing. These reports shall be filed not later than January 15 of the following year. Manufacturing transaction reports shall be filed annually for each calendar year not later than January 15 of the following year, except that a registrant may be given permission to file more frequently (but not more frequently than quarterly).


(c) Persons reporting. For controlled substances in Schedules I, II, narcotic controlled substances in Schedule III, and gamma-hydroxybutyric acid drug product controlled substances in Schedule III, each person who is registered to manufacture in bulk or dosage form, or to package, repackage, label or relabel, and each person who is registered to distribute, including each person who is registered to reverse distribute, shall report acquisition/distribution transactions. In addition to reporting acquisition/distribution transactions, each person who is registered to manufacture controlled substances in bulk or dosage form shall report manufacturing transactions on controlled substances in Schedules I and II, each narcotic controlled substance listed in Schedules III, IV, and V, gamma-hydroxybutyric acid drug product controlled substances in Schedule III, and on each psychotropic controlled substance listed in Schedules III and IV as identified in paragraph (d) of this section.


(d) Substances covered. (1) Manufacturing and acquisition/distribution transaction reports shall include data on each controlled substance listed in Schedules I and II, on each narcotic controlled substance listed in Schedule III (but not on any material, compound, mixture or preparation containing a quantity of a substance having a stimulant effect on the central nervous system, which material, compound, mixture or preparation is listed in Schedule III or on any narcotic controlled substance listed in Schedule V), and on gamma-hydroxybutyric acid drug products listed in Schedule III. Additionally, reports on manufacturing transactions shall include the following psychotropic controlled substances listed in Schedules III and IV:


(i) Schedule III


(A) Benzphetamine;


(B) Cyclobarbital;


(C) Methyprylon; and


(D) Phendimetrazine.


(ii) Schedule IV


(A) Barbital;


(B) Diethylpropion (Amfepramone);


(C) Ethchlorvynol;


(D) Ethinamate;


(E) Lefetamine (SPA);


(F) Mazindol;


(G) Meprobamate;


(H) Methylphenobarbital;


(I) Phenobarbital;


(J) Phentermine; and


(K) Pipradrol.


(2) Data shall be presented in such a manner as to identify the particular form, strength, and trade name, if any, of the product containing the controlled substancefor which the report is being made. For this purpose, persons filing reports shall utilize the National Drug Code Number assigned to the product under the National Drug Code System of the Food and Drug Administration.


(e) Transactions reported. Acquisition/distribution transaction reports shall provide data on each acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a customer, or supply by the Federal Government) and each reduction from inventory (identifying whether it is, e.g., by sale or transfer, theft, destruction or seizure by Government agencies). Manufacturing reports shall provide data on material manufactured, manufacture from other material, use in manufacturing other material and use in producing dosage forms.


(f) Exceptions. (1) A registered institutional practitioner that repackages or relabels exclusively for distribution or that distributes exclusively to (for dispensing by) agents, employees, or affiliated institutional practitioners of the registrant may be exempted from filing reports under this section by applying to the Pharmaceutical Investigations Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(2) Registrants that acquire recalled controlled substances from ultimate users pursuant to § 1317.85 of this chapter may report as a single transaction all recalled controlled substances of the same name and finished form (e.g., all 10-milligram tablets or all 5-milligram concentration per fluid ounce or milliliter) received from ultimate users for the purpose of reporting acquisition transactions.


(g) Exemptions. (1) Collectors that acquire controlled substances from ultimate users are exempt from the ARCOS reporting requirements only with respect to controlled substances collected through mail-back programs and collection receptacles for the purpose of disposal.


(2) Reverse distributors and distributors that acquire controlled substances pursuant to § 1317.55(a) or (b) of this chapter are exempt from the ARCOS reporting requirements in this section with regard to any controlled substances acquired pursuant to § 1317.55(a) or (b) of this chapter.


(Approved by the Office of Management and Budget under control number 1117-0003)

[62 FR 13962, Mar. 24, 1997, as amended at 68 FR 41229, July 11, 2003; 70 FR 294, Jan. 4, 2005; 75 FR 10678, Mar. 9, 2010; 79 FR 53564, Sept. 9, 2014; 81 FR 97020, Dec. 30, 2016]


Online Pharmacies

§ 1304.40 Notification by online pharmacies.

(a) Thirty days prior to offering a controlled substance for sale, delivery, distribution, or dispensing by means of the Internet, an online pharmacy shall:


(1) Notify the Administrator of its intent to do so by submitting an application for a modified registration in accordance with §§ 1301.13 and 1301.19 of this chapter, with such application containing the information required by this section; and


(2) Notify the State boards of pharmacy in any States in which the online pharmacy offers to sell, deliver, distribute, or dispense controlled substances.


(b) The following information must be included in the notification submitted under paragraph (a) of this section:


(1) The pharmacy’s Internet Pharmacy Site Disclosure information required to be posted on the homepage of the online pharmacy’s Internet site under section 311(c) of the Act (21 U.S.C. 831(c)) and § 1304.45 of this part.


(2) Certification that the information disclosed on its Internet site under the Internet Pharmacy Site Disclosure is true and accurate. The statement shall be in a form similar to the following: “The above-named pharmacy, a DEA registrant, certifies, under penalty of perjury, that the information contained in this statement is true and accurate.”


(3) Each Internet site address utilized by the online pharmacy and a certification that the online pharmacy shall notify the Administrator of any change in any such Internet address at least 30 days in advance. In the event that a pharmacy delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, more than one Web site, the pharmacy shall provide, for purposes of complying with this paragraph, the Internet site address of each such site.


(4) The DEA registration numbers of:


(i) Every pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of, each Web site referred to in paragraph (b)(3) of this section; and


(ii) Every practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the Web site or at the request of the owner or operator of the Web site, or any employee or agent thereof.


(c) It is unlawful for any online pharmacy to deliver, distribute, or dispense a controlled substance by means of the internet unless such online pharmacy is validly registered with a modification of such registration authorizing such activity.


(d) On and after the date an online pharmacy makes the notifications required under this section, each online pharmacy shall display on the homepage of its Internet site, a declaration that it has made such notifications to the Administrator in the following form: “In accordance with the Controlled Substances Act and the DEA regulations, this online pharmacy has made the notifications to the DEA Administrator required by 21 U.S.C. 831 and 21 CFR 1304.40.”


(e)(1) Except as provided in paragraphs (e)(2) and (e)(3) of this section, if any of the information required to be submitted under this section changes after the online pharmacy submits the notification to the Administrator, the online pharmacy shall notify the Administrator of the updated information no later than 30 days before the change becomes effective via the online process.


(2) If a pharmacy referred to in paragraph (b)(4)(i) of this section ceases to deliver, distribute, or dispense controlled substances pursuant to orders made on, through, or on behalf of, each Web site referred to in paragraph (b)(3) of this section, the online pharmacy shall notify the Administrator no later than 30 days after the change becomes effective via the online process.


(3) If a practitioner referred to in paragraph (b)(4)(ii) of this section ceases to have a contractual relationship with the online pharmacy, the online pharmacy shall notify the Administrator no later than 30 days after the change becomes effective via the online process.


[74 FR 15623, Apr. 6, 2009, as amended at 85 FR 61601, Sept. 30, 2020]


§ 1304.45 Internet Web site disclosure requirements.

(a) Each online pharmacy shall display, at all times and in a visible and clear manner, on its homepage a statement that it complies with the requirements of section 311 of the Act (21 U.S.C. 831) with respect to the delivery or sale or offer for sale of controlled substances. This statement must include the name of the pharmacy as it appears on the DEA Certificate of Registration.


(b) Each online pharmacy shall clearly display the following information on the homepage of each Internet site it operates, or on a page directly linked to the homepage. If the information is displayed on a page directly linked to the homepage, that link on the homepage must be visible and clear. The information must be displayed for each pharmacy that delivers, distributes, or dispenses controlled substances pursuant to orders made on, through, or on behalf of that Web site.


(1) The name and address of the pharmacy as it appears on the pharmacy’s DEA Certificate of Registration.


(2) The pharmacy’s telephone number and e-mail address.


(3) The name, professional degree, and States of licensure of the pharmacist-in-charge, and a telephone number at which the pharmacist-in-charge can be contacted.


(4) A list of the States in which the pharmacy is licensed to dispense controlled substances.


(5) A certification that the pharmacy is registered under part 1301 of this chapter with a modification of its registration authorizing it to deliver, distribute, or dispense controlled substances by means of the Internet.


(6) The name, address, telephone number, professional degree, and States of licensure with State license number of any practitioner who has a contractual relationship to provide medical evaluations or issue prescriptions for controlled substances, through referrals from the Web site or at the request of the owner or operator of the Web site, or any employee or agent thereof.


(7) The following statement: “This online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regulations. As part of this obligation, this online pharmacy has obtained a modified DEA registration authorizing it to operate as an online pharmacy. In addition, this online pharmacy will only dispense a controlled substance to a person who has a valid prescription issued for a legitimate medical purpose based upon a medical relationship with a prescribing practitioner. This includes at least one prior in-person medical evaluation in accordance with section 309 of the Controlled Substances Act (21 U.S.C. 829) or a medical evaluation via telemedicine in accordance with section 102(54) of the Controlled Substances Act (21 U.S.C. 802(54)).”


[74 FR 15623, Apr. 6, 2009]


§ 1304.50 Disclosure requirements for Web sites of nonpharmacy practitioners that dispense controlled substances by means of the Internet.

For a Web site to identify itself as being exempt from the definition of an online pharmacy by virtue of section 102(52)(B)(ii) of the Act (21 U.S.C. 802(52)(B)(ii)) and § 1300.04(h)(2) of this chapter, the Web site shall post in a visible and clear manner on its homepage, or on a page directly linked thereto in which the hyperlink is also visible and clear on the homepage, a list of the DEA-registered nonpharmacy practitioners who are affiliated with the Web site. Any nonpharmacy practitioner affiliated with such a Web site is responsible for compliance with this section. An institutional practitioner that otherwise complies with the requirements of the Act and this chapter will be deemed to meet the requirements of this section if, in lieu of posting the names of each affiliated individual practitioner, it posts its name (as it appears on its Certificate of Registration) in a visible and clear manner on its homepage and in a manner that identifies itself as being responsible for the operation of the Web site.


[74 FR 15623, Apr. 6, 2009]


§ 1304.55 Reports by online pharmacies.

(a) Each online pharmacy shall report to the Administrator the total quantity of each controlled substance that the pharmacy has dispensed each calendar month. The report must include the total quantity of such dispensing by any means, regardless of whether the controlled substances are dispensed by means of the Internet. Thus, such reporting shall include all controlled substances dispensed via Internet transactions, mail-order transactions, face-to-face transactions, or any other means. However, the pharmacy is not required to describe in its report to the Administrator such means of dispensing. Such reporting is required for every calendar month in which the total quantity of controlled substances dispensed by the pharmacy meets or exceeds one of the following thresholds:


(1) 100 or more prescriptions for controlled substances filled; or


(2) 5,000 or more dosage units dispensed of all controlled substances combined.


(b) Each online pharmacy shall report a negative response if, during a given calendar month, its total dispensing of controlled substances falls below both of the thresholds in paragraph (a) of this section.


(c) The reporting requirements of this section apply to every pharmacy that, at any time during a calendar month, holds a modified registration authorizing it to operate as an online pharmacy, regardless of whether the online pharmacy dispenses any controlled substances by means of the Internet during the month.


(d) Reports will be submitted to DEA electronically via online reporting, electronic file upload, or other means as approved by DEA.


(e) Reports shall be filed every month not later than the fifteenth day of the month succeeding the month for which they are submitted.


(f) An online pharmacy filing a report under paragraph (a) of this section shall utilize the National Drug Code number assigned to the product under the National Drug Code System of the Food and Drug Administration, and indicate the total number of dosage units dispensed for each such National Drug Code number.


(g) Records required to be kept under this section must be kept by the registrant for at least two years from the date of such records. The information shall be readily retrievable from the ordinary business records of the registrant and available for inspection and copying by authorized employees of the Administration.


[74 FR 15623, Apr. 6, 2009]


PART 1305 – ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES


Authority:21 U.S.C. 821, 828, 871(b), unless otherwise noted.


Source:70 FR 16911, Apr. 1, 2005, unless otherwise noted.

Subpart A – General Requirements

§ 1305.01 Scope of part 1305.

Procedures governing the issuance, use, and preservation of orders for Schedule I and II controlled substances are set forth generally by section 308 of the Act (21 U.S.C. 828) and specifically by the sections of this part.


§ 1305.02 Definitions.

Any term contained in this part shall have the definition set forth in the Act or part 1300 of this chapter.


§ 1305.03 Distributions requiring a Form 222 or a digitally signed electronic order.

Either a DEA Form 222 or its electronic equivalent as set forth in subpart C of this part and Part 1311 of this chapter is required for each distribution of a Schedule I or II controlled substance except for the following:


(a) Distributions to persons exempted from registration under Part 1301 of this chapter.


(b) Exports from the United States that conform with the requirements of the Act.


(c) Deliveries to a registered analytical laboratory or its agent approved by DEA.


(d) Delivery from a central fill pharmacy, as defined in § 1300.01 of this chapter, to a retail pharmacy.


(e) Deliveries to an authorized DEA registrant by an ultimate user, a long-term care facility on behalf of an ultimate user who resides or has resided at that facility, or a person authorized to dispose of the ultimate user decedent’s property.


(f) Distributions to reverse distributors and distributors by collectors and law enforcement pursuant to § 1317.55 of this chapter.


(g) Deliveries of controlled substances from ultimate users for the purpose of recalls pursuant to § 1317.85 of this chapter.


[70 FR 16911, Apr. 1, 2005, as amended at 77 FR 4235, Jan. 27, 2012; 79 FR 53564, Sept. 9, 2014]


§ 1305.04 Persons entitled to order Schedule I and II controlled substances.

(a) Only persons who are registered with DEA under section 303 of the Act (21 U.S.C. 823) to handle Schedule I or II controlled substances, and persons who are registered with DEA under section 1008 of the Act (21 U.S.C. 958) to export these substances may obtain and use DEA Form 222 (order forms) or issue electronic orders for these substances. Persons not registered to handle Schedule I or II controlled substances and persons registered only to import controlled substances are not entitled to obtain Form 222 or issue electronic orders for these substances.


(b) An order for Schedule I or II controlled substances may be executed only on behalf of the registrant named on the order and only if his or her registration for the substances being purchased has not expired or been revoked or suspended.


§ 1305.05 Power of attorney.

(a) A registrant may authorize one or more individuals, whether or not located at his or her registered location, to issue orders for Schedule I and II controlled substances on the registrant’s behalf by executing a power of attorney for each such individual, if the power of attorney is retained in the files, with executed Forms 222 where applicable, for the same period as any order bearing the signature of the attorney. The power of attorney must be available for inspection together with other order records.


(b) A registrant may revoke any power of attorney at any time by executing a notice of revocation.


(c) The power of attorney and notice of revocation must be similar to the following format:


Power of Attorney for DEA Forms 222 and Electronic Orders




(Name of registrant)



(Address of registrant)



(DEA registration number)

I, ____________ (name of person granting power), the undersigned, who am authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or Controlled Substances Import and Export Act, have made, constituted, and appointed, and by these presents, do make, constitute, and appoint ____ (name of attorney-in-fact), my true and lawful attorney for me in my name, place, and stead, to execute applications for Forms 222 and to sign orders for Schedule I and II controlled substances, whether these orders be on Form 222 or electronic, in accordance with 21 U.S.C. 828 and Part 1305 of Title 21 of the Code of Federal Regulations. I hereby ratify and confirm all that said attorney must lawfully do or cause to be done by virtue hereof.





(Signature of person granting power)

I, ____________ (name of attorney-in-fact), hereby affirm that I am the person named herein as attorney-in-fact and that the signature affixed hereto is my signature.

(signature of attorney-in-fact)

Witnesses:

1. _____________


2. _____________


Signed and dated on the ____ day of ____, (year), at ___________________ .

Notice of Revocation

The foregoing power of attorney is hereby revoked by the undersigned, who is authorized to sign the current application for registration of the above-named registrant under the Controlled Substances Act or the Controlled Substances Import and Export Act. Written notice of this revocation has been given to the attorney-in-fact _______________ this same day.





(Signature of person revoking power)

Witnesses:

1. ______ ________


2. ______ ________


Signed and dated on the ____ day of ____, (year), at _____?_________.

(d) A power of attorney must be executed by:


(1) The registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust or other entity;


(2) The person to whom the power of attorney is being granted; and


(3) Two witnesses.


(e) A power of attorney must be revoked by the person who signed the most recent application for DEA registration or reregistration, and two witnesses.


(f) A power of attorney executed under this section may be signed electronically, by any or all of the persons required to sign.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019]


§ 1305.06 Persons entitled to fill orders for Schedule I and II controlled substances.

An order for Schedule I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act (21 U.S.C. 823) or as an importer of such substances pursuant to section 1008 of the Act (21 U.S.C. 958), except for the following:


(a) A person registered with DEA to dispense the substances, or to export the substances, if he/she is discontinuing business or if his/her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his/her possession with a DEA Form 222 or an electronic order in accordance with § 1301.52 of this chapter.


(b) A purchaser who has obtained any Schedule I or II controlled substance by either a DEA Form 222 or an electronic order may return the substance to the supplier of the substance with either a DEA Form 222 or an electronic order from the supplier.


(c) A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in § 1307.11 of this chapter.


(d) A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis, instructional activities, or research with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, instructional activities, or research.


(e) A person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill either a DEA Form 222 or an electronic order for distribution of narcotic drugs to off-site narcotic treatment programs only.


§ 1305.07 Special procedure for filling certain orders.

A supplier of thiafentanil, carfentanil, etorphine hydrochloride, or diprenorphine, if he or she determines that the purchaser is a veterinarian engaged in zoo and exotic animal practice, wildlife management programs, or research, and is authorized by the Administrator to handle these substances, may fill the order in accordance with the procedures set forth in § 1305.17 except that:


(a) A DEA Form 222 or an electronic order for thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances in reasonable quantities.


(b) The substances must be shipped, under secure conditions using substantial packaging material with no markings on the outside that would indicate the content, only to the purchaser’s registered location.


[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016]


Subpart B – DEA Form 222

§ 1305.11 Procedure for obtaining DEA Forms 222.

(a) DEA Forms 222 are issued in mailing envelopes containing a predetermined number of forms based on the business activity of the registrant, each form consisting of one single-sheet. A limit, which is based on the business activity of the registrant, will be imposed on the number of DEA Forms 222 that will be furnished upon a requisition for order forms unless additional forms are specifically requested and a reasonable need for such additional forms is shown.


(b) Any person with an active registration that is authorized to order schedule I and II controlled substances is entitled to obtain a DEA Form 222, which will be supplied at any time after the DEA registration is granted. Any person holding a registration authorizing the person to obtain a DEA Form 222 may requisition the forms through a DEA secured network connection or by contacting any Division Office or the Registration Section of the Administration through the customer service center.


(c) Each requisition must show the name, address, and registration number of the registrant and the number of DEA Forms 222 desired.


(d) DEA Forms 222 will have an order form number and be issued with the name, address and registration number of the registrant, the authorized activity, and schedules of the registrant. This information cannot be altered or changed by the registrant; the registrant must report any errors to the local Division Office or the Registration Section of the Administration to modify the registration.


[84 FR 51374, Sept. 30, 2019]


§ 1305.12 Procedure for executing DEA Forms 222.

(a) A purchaser must prepare and execute a DEA Form 222 by use of a typewriter, computer printer, pen, or indelible pencil.


(b) Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances.


(c) The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form. The supplier’s DEA registration number may be entered by the purchaser or the supplier.


(d) Each DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a Form 222 under § 1305.05. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space.


(e) Unexecuted DEA Forms 222 may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019; 86 FR 38232, July 20, 2021]


§ 1305.13 Procedure for filling DEA Forms 222.

(a) A purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. The copy retained by the purchaser may be in paper or electronic form.


(b) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on the original DEA Form 222 its DEA registration number (if not previously entered by the purchaser) and the number of commercial or bulk containers furnished on each item and the date on which containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the DEA Form 222. No DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (f) of this section.


(c) The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the DEA Form 222, except as specified in paragraph (f) of this section.


(d) The supplier must retain the original DEA Form 222 for the supplier’s files in accordance with § 1305.17(c). Any supplier who is not required to report acquisition/disposition transactions to the Automation of Reports and Consolidated Orders System (ARCOS) under § 1304.33(c) (such as a practitioner) must make and submit a copy of the original DEA Form 222 to DEA, either by mail to the Registration Section, or by email to [email protected] The copy must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, the copy must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.


(e) The purchaser must record on its copy of the DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.


(f) DEA Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51374, Sept. 30, 2019; 86 FR 38232, July 20, 2021]


§ 1305.14 Procedure for endorsing DEA Forms 222.

(a) A DEA Form 222, made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in § 1305.13, may be endorsed to another supplier for filling. The endorsement must be made only by the supplier to whom the DEA Form 222 was first made, must state (in the spaces provided in Part 3 on the original DEA Form 222) the DEA number of the second supplier, and must be signed and dated by a person authorized to obtain and execute DEA Forms 222 on behalf of the first supplier.

The first supplier may not fill any part of an order on an endorsed form. The second supplier may fill the order, if possible and if the supplier desires to do so, in accordance with § 1305.13(b), (c), and (d), including shipping all substances directly to the purchaser.


(b) Distributions made on endorsed DEA Forms 222 must be reported by the second supplier in the same manner as all other distributions.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]


§ 1305.15 Unaccepted and defective DEA Forms 222.

(a) A DEA Form 222 must not be filled if either of the following apply:


(1) The order is not complete, legible, or properly prepared, executed, or endorsed.


(2) The order shows any alteration, erasure, or change of any description.


(b) If a DEA Form 222 cannot be filled for any reason under this section, the supplier must return the original DEA Form 222 to the purchaser with a statement as to the reason (e.g., illegible or altered).


(c) A supplier may for any reason refuse to accept any order and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph.


(d) When a purchaser receives an unaccepted order, the original DEA Form 222 and the statement must be retained in the files of the purchaser in accordance with § 1305.17. A defective DEA Form 222 may not be corrected; it must be replaced by a new DEA Form 222 for the order to be filled.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]


§ 1305.16 Lost and stolen DEA Forms 222.

(a) If a purchaser ascertains that an unfilled DEA Form 222 has been lost, the purchaser must execute another and attach a statement containing the order form number and date of the lost form, and stating that the goods covered by the first DEA Form 222 were not received through loss of that DEA Form 222. A copy of the second form and a copy of the statement must be retained with a copy of the DEA Form 222 first executed. A copy of the statement must be attached to a copy of the second DEA Form 222 sent to the supplier. If the first DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face “Not accepted” and return the original DEA Form 222 to the purchaser, who must attach it to the statement.


(b) Whenever any used or unused DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost.


(c) If the theft or loss includes any original DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers.


(d) If any DEA Forms 222 are lost or stolen, and the purchaser is unable to state the order form numbers of the DEA Forms 222, the purchaser must report, in lieu of numbers of the forms, the date or approximate date of issuance.


(e) If any unused DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located must immediately be notified.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]


§ 1305.17 Preservation of DEA Forms 222.

(a) The purchaser must retain a copy of each executed DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.


(b) The supplier must retain the original of each DEA Form 222 that it has filled.


(c) DEA Forms 222 must be maintained separately from all other records of the registrant. DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain a copy of the executed DEA Form 222 and any attached statements or other related documents (not including unexecuted DEA Forms 222, which may be kept elsewhere under § 1305.12(e)), at the registered location printed on the DEA Form 222.


(d) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain DEA Forms 222 for these substances separately from all other DEA Forms 222 and records required to be maintained by the registrant.


(e) Electronic copies of DEA Forms 222 will be deemed to be maintained separately from all other records of the registrant, for the purposes of this section, if such copies are readily retrievable separately from all other records. Electronic copies of DEA Forms 222 may be stored on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.


[70 FR 16911, Apr. 1, 2005, as amended at 81 FR 58839, Aug. 26, 2016; 84 FR 51375, Sept. 30, 2019]


§ 1305.18 Return of unused DEA Forms 222.

If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser’s registration) or is suspended or revoked under § 1301.36 of this chapter for all Schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused DEA Forms 222 to the Registration Section.


[84 FR 51375, Sept. 30, 2019]


§ 1305.19 Cancellation and voiding of DEA Forms 222.

(a) A purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped.


(b) A supplier may void part or all of an order on a DEA Form 222 by notifying the purchaser in writing of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation in paragraph (a) of this section.


[70 FR 16911, Apr. 1, 2005, as amended at 84 FR 51375, Sept. 30, 2019]


§ 1305.20 Transition provisions allowing continued use of existing stocks of triplicate DEA Forms 222.

Registrants may continue to use existing stocks of the triplicate DEA Form 222 until October 30, 2021. In any case, as soon as a registrant’s supply of triplicate DEA Forms 222 is exhausted, the registrant must use the new single-sheet DEA Form 222. The provisions of this part are applicable to the use of triplicate forms, except for the specific rules as provided in this section.


(a) Procedure for obtaining triplicate DEA Forms 222. The DEA will no longer issue triplicate forms. Triplicate DEA Forms 222 will not be accepted after October 30, 2021.


(b) Procedure for executing triplicate DEA Forms 222. (1) A purchaser must prepare and execute a triplicate DEA Form 222 simultaneously by means of interleaved carbon sheets that are part of the triplicate DEA Form 222. Triplicate DEA Form 222 must be prepared by use of a typewriter, pen, or indelible pencil.


(2) Only one item may be entered on each numbered line. An item must consist of one or more commercial or bulk containers of the same finished or bulk form and quantity of the same substance. The number of lines completed must be noted on that form at the bottom of the form, in the space provided. Triplicate DEA Forms 222 for carfentanil, etorphine hydrochloride, and diprenorphine must contain only these substances.


(3) The name and address of the supplier from whom the controlled substances are being ordered must be entered on the form. Only one supplier may be listed on any form.


(4) Each triplicate DEA Form 222 must be signed and dated by a person authorized to sign an application for registration or a person granted power of attorney to sign a DEA Form 222 under § 1305.05. The name of the purchaser, if different from the individual signing the DEA Form 222, must also be inserted in the signature space.


(5) Unexecuted DEA Forms 222 may be kept and may be executed at a location other than the registered location printed on the form, provided that all unexecuted forms are delivered promptly to the registered location upon an inspection of the location by any officer authorized to make inspections, or to enforce, any Federal, State, or local law regarding controlled substances.


(c) Procedure for filling triplicate DEA Forms 222. (1) A purchaser must submit Copy 1 and Copy 2 of the triplicate DEA Form 222 to the supplier and retain Copy 3 in the purchaser’s files.


(2) A supplier may fill the order, if possible and if the supplier desires to do so, and must record on Copies 1 and 2 the number of commercial or bulk containers furnished on each item and the date on which the containers are shipped to the purchaser. If an order cannot be filled in its entirety, it may be filled in part and the balance supplied by additional shipments within 60 days following the date of the triplicate DEA Form 222. No triplicate DEA Form 222 is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (c)(6) of this section.


(3) The controlled substances must be shipped only to the purchaser and the location printed by the Administration on the triplicate DEA Form 222, except as specified in paragraph (c)(6) of this section.


(4) The supplier must retain Copy 1 of the triplicate DEA Form 222 for his or her files in accordance with paragraph (g)(3) of this section and forward Copy 2 to the Special Agent in Charge of the Drug Enforcement Administration in the area in which the supplier is located. Copy 2 must be forwarded at the close of the month during which the order is filled. If an order is filled by partial shipments, Copy 2 must be forwarded at the close of the month during which the final shipment is made or the 60-day validity period expires.


(5) The purchaser must record on Copy 3 of the triplicate DEA Form 222 the number of commercial or bulk containers furnished on each item and the dates on which the containers are received by the purchaser.


(6) DEA triplicate Forms 222 submitted by registered procurement officers of the Defense Supply Center of the Defense Logistics Agency for delivery to armed services establishments within the United States may be shipped to locations other than the location printed on the triplicate DEA Form 222, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.


(d) Procedure for endorsing triplicate DEA Forms 222. (1) A triplicate DEA Form 222, made out to any supplier who cannot fill all or a part of the order within the time limitation set forth in paragraph (c) of this section, may be endorsed to another supplier for filling. The endorsement must be made only by the supplier to whom the triplicate DEA Form 222 was first made, must state (in the spaces provided on the reverse sides of Copies 1 and 2 of the triplicate DEA Form 222) the name and address of the second supplier, and must be signed by a person authorized to obtain and execute triplicate DEA Forms 222 on behalf of the first supplier. The first supplier may not fill any part of an order on an endorsed form. The second supplier may fill the order, if possible and if the supplier desires to do so, in accordance with paragraphs (c)(2) through (4) of this section, including shipping all substances directly to the purchaser.


(2) Distributions made on endorsed triplicate DEA Forms 222 must be reported by the second supplier in the same manner as all other distributions.


(e) Unaccepted and defective triplicate DEA Forms 222. (1) A triplicate DEA Form 222 must not be filled if either of the following apply:


(i) The order is not complete, legible, or properly prepared, executed, or endorsed.


(ii) The order shows any alteration, erasure, or change of any description.


(2) If a triplicate DEA Form 222 cannot be filled for any reason under this section, the supplier must return Copies 1 and 2 to the purchaser with a statement as to the reason (e.g. illegible or altered).


(3) A supplier may for any reason refuse to accept any order and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph.


(4) When a purchaser receives an unaccepted order, Copies 1 and 2 of the triplicate DEA Form 222 and the statement must be attached to Copy 3 and retained in the files of the purchaser in accordance with paragraph (g) of this section. A defective triplicate DEA Form 222 may not be corrected; it must be replaced by a new triplicate DEA Form 222 for the order to be filled.


(f) Lost and stolen triplicate DEA Forms 222. (1) If a purchaser ascertains that an unfilled triplicate DEA Form 222 has been lost, the purchaser must execute another in triplicate and attach a statement containing the serial number and date of the lost form, and stating that the goods covered by the first triplicate DEA Form 222 were not received through loss of that triplicate DEA Form 222. Copy 3 of the second form and a copy of the statement must be retained with Copy 3 of the triplicate DEA Form 222 first executed. A copy of the statement must be attached to Copies 1 and 2 of the second triplicate DEA Form 222 sent to the supplier. If the first triplicate DEA Form 222 is subsequently received by the supplier to whom it was directed, the supplier must mark upon the face “Not accepted” and return Copies 1 and 2 to the purchaser, who must attach it to Copy 3 and the statement. However, if the registrant no longer can use triplicate forms, then the registrant shall proceed by issuing a new single-sheet form in accordance with § 1305.16.


(2) Whenever any used or unused triplicate DEA Forms 222 are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier must immediately upon discovery of the theft or loss, report the theft or loss to the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost.


(3) If the theft or loss includes any original triplicate DEA Forms 222 received from purchasers and the supplier is unable to state the serial numbers of the triplicate DEA Forms 222, the supplier must report the date or approximate date of receipt and the names and addresses of the purchasers.


(4) If an entire book of triplicate DEA Forms 222 is lost or stolen, and the purchaser is unable to state the serial numbers of the triplicate DEA Forms 222 in the book, the purchaser must report, in lieu of the numbers of the forms contained in the book, the date or approximate date of issuance.


(5) If any unused triplicate DEA Form 222 reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located must immediately be notified.


(g) Preservation of triplicate DEA Forms 222. (1) The purchaser must retain Copy 3 of each executed triplicate DEA Form 222 and all copies of unaccepted or defective forms with each statement attached.


(2) The supplier must retain Copy 1 of each triplicate DEA Form 222 that it has filled.


(3) Triplicate DEA Forms 222 must be maintained separately from all other records of the registrant. Triplicate DEA Forms 222 are required to be kept available for inspection for a period of two years. If a purchaser has several registered locations, the purchaser must retain Copy 3 of the executed triplicate DEA Form 222 and any attached statements or other related documents (not including unexecuted triplicate DEA Forms 222, which may be kept elsewhere under paragraph (b)(5) of this section), at the registered location printed on the triplicate DEA Form 222.


(4) The supplier of thiafentanil, carfentanil, etorphine hydrochloride, and diprenorphine must maintain triplicate DEA Forms 222 for these substances separately from all other DEA triplicate Forms 222 and records required to be maintained by the registrant.


(h) Return of unused triplicate DEA Forms 222. If the registration of any purchaser terminates (because the purchaser dies, ceases legal existence, discontinues business or professional practice, or changes the name or address as shown on the purchaser’s registration) or is suspended or revoked under § 1301.36 of this chapter for all schedule I and II controlled substances for which the purchaser is registered, the purchaser must return all unused triplicate DEA Forms 222 to the Registration Section.


(i) Cancellation and voiding of triplicate DEA Forms 222. (1) A purchaser may cancel part or all of an order on a triplicate DEA Form 222 by notifying the supplier in writing of the cancellation. The supplier must indicate the cancellation on Copies 1 and 2 of the triplicate DEA Form 222 by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped.


(2) A supplier may void part or all of an order on a triplicate DEA Form 222 by notifying the purchaser in writing of the voiding. The supplier must indicate the voiding in the manner prescribed for cancellation in paragraph (i)(1) of this section.


[84 FR 51375, Sept. 30, 2019]


Subpart C – Electronic Orders

§ 1305.21 Requirements for electronic orders.

(a) To be valid, the purchaser must sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser’s agent, by DEA as provided in part 1311 of this chapter.


(b) The following data fields must be included on an electronic order for Schedule I and II controlled substances:


(1) A unique number the purchaser assigns to track the order. The number must be in the following 9-character format: the last two digits of the year, X, and six characters as selected by the purchaser.


(2) The purchaser’s DEA registration number.


(3) The name of the supplier.


(4) The complete address of the supplier (may be completed by either the purchaser or the supplier).


(5) The supplier’s DEA registration number (may be completed by either the purchaser or the supplier).


(6) The date the order is signed.


(7) The name (including strength where appropriate) of the controlled substance product or the National Drug Code (NDC) number (the NDC number may be completed by either the purchaser or the supplier).


(8) The quantity in a single package or container.


(9) The number of packages or containers of each item ordered.


(c) An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances.


§ 1305.22 Procedure for filling electronic orders.

(a) A purchaser must submit the order to a specific supplier. The supplier may initially process the order (e.g., entry of the order into the computer system, billing functions, inventory identification, etc.) centrally at any location, regardless of the location’s registration with DEA. Following centralized processing, the supplier may distribute the order to one or more registered locations maintained by the supplier for filling. The registrant must maintain control of the processing of the order at all times.


(b) A supplier may fill the order for a Schedule I or II controlled substance, if possible and if the supplier desires to do so and is authorized to do so under § 1305.06.


(c) A supplier must do the following before filling the order:


(1) Verify the integrity of the signature and the order by using software that complies with Part 1311 of this chapter to validate the order.


(2) Verify that the digital certificate has not expired.


(3) Check the validity of the certificate holder’s certificate by checking the Certificate Revocation List. The supplier may cache the Certificate Revocation List until it expires.


(4) Verify the registrant’s eligibility to order the controlled substances by checking the certificate extension data.


(d) The supplier must retain an electronic record of every order, and, linked to each order, a record of the number of commercial or bulk containers furnished on each item and the date on which the supplier shipped the containers to the purchaser. The linked record must also include any data on the original order that the supplier completes. Software used to handle digitally signed orders must comply with part 1311 of this chapter.


(e) If an order cannot be filled in its entirety, a supplier may fill it in part and supply the balance by additional shipments within 60 days following the date of the order. No order is valid more than 60 days after its execution by the purchaser, except as specified in paragraph (h) of this section.


(f) A supplier must ship the controlled substances to the registered location associated with the digital certificate used to sign the order, except as specified in paragraph (h) of this section.


(g) When a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received. The record must be electronically linked to the original order and archived.


(h) Registered procurement officers of the Defense Supply Center of the Defense Logistics Agency may order controlled substances for delivery to armed services establishments within the United States. These orders may be shipped to locations other than the registered location, and in partial shipments at different times not to exceed six months from the date of the order, as designated by the procurement officer when submitting the order.


§ 1305.23 Endorsing electronic orders.

A supplier may not endorse an electronic order to another supplier to fill.


§ 1305.24 Central processing of orders.

(a) A supplier that has one or more registered locations and maintains a central processing computer system in which orders are stored may have one or more of the supplier’s registered locations fill an electronic order if the supplier does the following:


(1) Assigns each item on the order to a specific registered location for filling.


(2) Creates a record linked to the central file noting both which items a location filled and the location identity.


(3) Ensures that no item is filled by more than one location.


(4) Maintains the original order with all linked records on the central computer system.


(b) A company that has central processing of orders must assign responsibility for filling parts of orders only to registered locations that the company owns and operates.


§ 1305.25 Unaccepted and defective electronic orders.

(a) No electronic order may be filled if:


(1) The required data fields have not been completed.


(2) The order is not signed using a digital certificate issued by DEA.


(3) The digital certificate used had expired or had been revoked prior to signature.


(4) The purchaser’s public key will not validate the digital signature.


(5) The validation of the order shows that the order is invalid for any reason.


(b) If an order cannot be filled for any reason under this section, the supplier must notify the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order, and if a supplier refuses to accept the order, a statement that the order is not accepted is sufficient for purposes of this paragraph.


(c) When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original order and the statement must be retained in accordance with § 1305.27.


(d) Neither a purchaser nor a supplier may correct a defective order; the purchaser must issue a new order for the order to be filled.


§ 1305.26 Lost electronic orders.

(a) If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order.


(b) If the purchaser executes an order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the first order and retain them.


(c) If the supplier to whom the order was directed subsequently receives the first order, the supplier must indicate that it is “Not Accepted” and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement.


§ 1305.27 Preservation of electronic orders.

(a) A purchaser must, for each order filled, retain the original signed order and all linked records for that order for two years. The purchaser must also retain all copies of each unaccepted or defective order and each linked statement.


(b) A supplier must retain each original order filled and the linked records for two years.


(c) If electronic order records are maintained on a central server, the records must be readily retrievable at the registered location.


§ 1305.28 Canceling and voiding electronic orders.

(a) A supplier may void all or part of an electronic order by notifying the purchaser of the voiding. If the entire order is voided, the supplier must make an electronic copy of the order, indicate on the copy “Void,” and return it to the purchaser. The supplier is not required to retain a record of orders that are not filled.


(b) The purchaser must retain an electronic copy of the voided order.


(c) To partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided.


§ 1305.29 Reporting to DEA.

A supplier must, for each electronic order filled, forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within two business days.


PART 1306 – PRESCRIPTIONS


Authority:21 U.S.C. 821, 823, 829, 829a, 831, 871(b) unless otherwise noted.


Source:36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

General Information

§ 1306.01 Scope of part 1306.

Rules governing the issuance, filling and filing of prescriptions pursuant to section 309 of the Act (21 U.S.C. 829) are set forth generally in that section and specifically by the sections of this part.


§ 1306.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13964, Mar. 24, 1997]


§ 1306.03 Persons entitled to issue prescriptions.

(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:


(1) Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and


(2) Either registered or exempted from registration pursuant to §§ 1301.22(c) and 1301.23 of this chapter.


(b) A prescription issued by an individual practitioner may be communicated to a pharmacist by an employee or agent of the individual practitioner.


[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13966, Mar. 24, 1997]


§ 1306.04 Purpose of issue of prescription.

(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.


(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.


(c) A prescription may not be issued for “detoxification treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in § 1301.28 of this chapter.


(d) A prescription may be issued by a qualifying practitioner, as defined in section 303(g)(2)G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii), in accordance with § 1306.05 for a Schedule III, IV, or V controlled substance for the purpose of maintenance or detoxification treatment for the purposes of administration in accordance with section 309A of the Act (21 U.S.C. 829a) and § 1306.07(f). Such prescription issued by a qualifying practitioner shall not be used to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients.


[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 39 FR 37986, Oct. 25, 1974; 70 FR 36343, June 23, 2005; 85 FR 69167, Nov. 2, 2020]


§ 1306.05 Manner of issuance of prescriptions.

(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address and registration number of the practitioner.


(b) A prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for “detoxification treatment” or “maintenance treatment” must include the identification number issued by the Administrator under § 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of § 1301.28(e) of this chapter.


(c) Where a prescription is for gamma-hydroxybutyric acid, the practitioner shall note on the face of the prescription the medical need of the patient for the prescription.


(d) A practitioner may sign a paper prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, paper prescriptions shall be written with ink or indelible pencil, typewriter, or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed.


(e) Electronic prescriptions shall be created and signed using an application that meets the requirements of part 1311 of this chapter.


(f) A prescription may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations. A corresponding liability rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations.


(g) An individual practitioner exempted from registration under § 1301.22(c) of this chapter shall include on all prescriptions issued by him the registration number of the hospital or other institution and the special internal code number assigned to him by the hospital or other institution as provided in § 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each paper prescription shall have the name of the practitioner stamped, typed, or handprinted on it, as well as the signature of the practitioner.


(h) An official exempted from registration under § 1301.23(a) of this chapter must include on all prescriptions issued by him his branch of service or agency (e.g., “U.S. Army” or “Public Health Service”) and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each paper prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer.


[75 FR 16307, Mar. 31, 2010]


§ 1306.06 Persons entitled to fill prescriptions.

A prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy, a registered central fill pharmacy, or registered institutional practitioner.


[68 FR 37410, June 24, 2003, as amended at 70 FR 36343, June 23, 2005]


§ 1306.07 Administering or dispensing of narcotic drugs.

(a) A practitioner may administer or dispense directly (but not prescribe) a narcotic drug listed in any schedule to a narcotic dependant person for the purpose of maintenance or detoxification treatment if the practitioner meets both of the following conditions:


(1) The practitioner is separately registered with DEA as a narcotic treatment program.


(2) The practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs pursuant to the Act.


(b) Nothing in this section shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one day’s medication may be administered to the person or for the person’s use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.


(c) This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.


(d) A practitioner may administer or dispense (including prescribe) any Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to a narcotic dependent person if the practitioner complies with the requirements of § 1301.28 of this chapter.


(e) [Reserved]


(f) Notwithstanding the definition of dispense under section 102(10) of the Act (21 U.S.C 802(10)), a pharmacy may deliver a controlled substance to a practitioner, pursuant to a prescription that meets the requirements under § 1306.04 for the purpose of administering the controlled substance by the practitioner if:


(1) The controlled substance is delivered by the pharmacy to the prescribing practitioner or the practitioner administering the controlled substance, as applicable, at the location, listed on the practitioner’s certificate of registration;


(2) The controlled substance is to be administered for the purpose of maintenance or detoxification treatment under section 303(g)(2)(G)(iii) of the Act (21 U.S.C. 823(g)(2)(G)(iii)); and


(i) The practitioner who issued the prescription is a qualifying practitioner as defined in section 303(g) of the Act (21 U.S.C. 823(g)); and


(ii) The controlled substance is to be administered by injection or implantation;


(3) The pharmacy and the practitioner are authorized to conduct such activities specified in this paragraph (f) under the law of the State in which such activities take place;


(4) The prescription is not issued to supply any practitioner with a stock of controlled substances for the purpose of general dispensing to patients;


(5) The controlled substance is to be administered only to the patient named on the prescription not later than 14 days after the date of receipt of the controlled substance by the practitioner; and


(6) Notwithstanding any exceptions under section 307 of the Act (21 U.S.C. 827), the prescribing practitioner, and the practitioner administering the controlled substance, as applicable, shall maintain complete and accurate records of all controlled substances delivered, received, administered, or otherwise disposed of, under this paragraph (f), including the persons to whom the controlled substances were delivered and such other information as may be required under this chapter.


[39 FR 37986, Oct. 25, 1974, as amended at 70 FR 36344, June 23, 2005; 85 FR 69167, Nov. 2, 2020]


§ 1306.08 Electronic prescriptions.

(a) An individual practitioner may sign and transmit electronic prescriptions for controlled substances provided the practitioner meets all of the following requirements:


(1) The practitioner must comply with all other requirements for issuing controlled substance prescriptions in this part;


(2) The practitioner must use an application that meets the requirements of part 1311 of this chapter; and


(3) The practitioner must comply with the requirements for practitioners in part 1311 of this chapter.


(b) A pharmacy may fill an electronically transmitted prescription for a controlled substance provided the pharmacy complies with all other requirements for filling controlled substance prescriptions in this part and with the requirements of part 1311 of this chapter.


(c) To annotate an electronic prescription, a pharmacist must include all of the information that this part requires in the prescription record.


(d) If the content of any of the information required under § 1306.05 for a controlled substance prescription is altered during the transmission, the prescription is deemed to be invalid and the pharmacy may not dispense the controlled substance.


[75 FR 16307, Mar. 31, 2010]


§ 1306.09 Prescription requirements for online pharmacies.

(a) No controlled substance that is a prescription drug may be delivered, distributed, or dispensed by means of the Internet without a valid prescription.


(b) In accordance with the Act, it is unlawful for any person to knowingly or intentionally fill a prescription for a controlled substance that was issued in a manner that constitutes dispensing by means of the Internet unless such person is a pharmacist who is acting in the usual course of his professional practice and is acting on behalf of a pharmacy whose registration has been modified under sections 1301.13 and 1301.19 of this chapter to authorize it to operate as an online pharmacy.


(c) Any online pharmacy that participates in the transfer between pharmacies of prescription information must do so in accordance with the requirements of §§ 1306.15 and 1306.25 of this part.


[74 FR 15624, Apr. 6, 2009]


Controlled Substances Listed in Schedule II

§ 1306.11 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance listed in Schedule II that is a prescription drug as determined under section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to a written prescription signed by the practitioner, except as provided in paragraph (d) of this section. A paper prescription for a Schedule II controlled substance may be transmitted by the practitioner or the practitioner’s agent to a pharmacy via facsimile equipment, provided that the original manually signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except as noted in paragraph (e), (f), or (g) of this section. The original prescription shall be maintained in accordance with § 1304.04(h) of this chapter.


(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to § 1306.07.


(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user.


(d) In the case of an emergency situation, as defined by the Secretary in § 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:


(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a paper or electronic prescription signed by the prescribing individual practitioner);


(2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in § 1306.05, except for the signature of the prescribing individual practitioner;


(3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and


(4) Within 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of § 1306.05, the prescription shall have written on its face “Authorization for Emergency Dispensing,” and the date of the oral order. The paper prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 7-day period. Upon receipt, the dispensing pharmacist must attach this paper prescription to the oral emergency prescription that had earlier been reduced to writing. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order. The pharmacist must notify the nearest office of the Administration if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.


(5) Central fill pharmacies shall not be authorized under this paragraph to prepare prescriptions for a controlled substance listed in Schedule II upon receiving an oral authorization from a retail pharmacist or an individual practitioner.


(e) A prescription prepared in accordance with § 1306.05 written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner’s agent to the pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (e) and it shall be maintained in accordance with § 1304.04(h) of this chapter.


(f) A prescription prepared in accordance with § 1306.05 written for Schedule II substance for a resident of a Long Term Care Facility may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The facsimile serves as the original written prescription for purposes of this paragraph (f) and it shall be maintained in accordance with § 1304.04(h).


(g) A prescription prepared in accordance with § 1306.05 written for a Schedule II narcotic substance for a patient enrolled in a hospice care program certified and/or paid for by Medicare under Title XVIII or a hospice program which is licensed by the state may be transmitted by the practitioner or the practitioner’s agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner’s agent will note on the prescription that the patient is a hospice patient. The facsimile serves as the original written prescription for purposes of this paragraph (g) and it shall be maintained in accordance with § 1304.04(h).


[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 53 FR 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. 24, 1997; 65 FR 45713, July 25, 2000; 68 FR 37410, June 24, 2003; 75 FR 16307, Mar. 31, 2010]


§ 1306.12 Refilling prescriptions; issuance of multiple prescriptions.

(a) The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.


(b)(1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:


(i) Each separate prescription is issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice;


(ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;


(iii) The individual practitioner concludes that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse;


(iv) The issuance of multiple prescriptions as described in this section is permissible under the applicable state laws; and


(v) The individual practitioner complies fully with all other applicable requirements under the Act and these regulations as well as any additional requirements under state law.


(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days when prescribing Schedule II controlled substances. Rather, individual practitioners must determine on their own, based on sound medical judgment, and in accordance with established medical standards, whether it is appropriate to issue multiple prescriptions and how often to see their patients when doing so.


[72 FR 64929, Nov. 19, 2007]


§ 1306.13 Partial filling of prescriptions.

(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he makes a notation of the quantity supplied on the face of the written prescription, written record of the emergency oral prescription, or in the electronic prescription record. The remaining portion of the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall notify the prescribing individual practitioner. No further quantity may be supplied beyond 72 hours without a new prescription.


(b) A prescription for a Schedule II controlled substance written for a patient in a Long Term Care Facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units. If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is “terminally ill” or an “LTCF patient.” A prescription that is partially filled and does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been filled in violation of the Act. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed 60 days from the issue date unless sooner terminated by the discontinuance of medication.


(c) Information pertaining to current Schedule II prescriptions for patients in a LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if this system has the capability to permit:


(1) Output (display or printout) of the original prescription number, date of issue, identification of prescribing individual practitioner, identification of patient, address of the LTCF or address of the hospital or residence of the patient, identification of medication authorized (to include dosage, form, strength and quantity), listing of the partial fillings that have been dispensed under each prescription and the information required in § 1306.13(b).


(2) Immediate (real time) updating of the prescription record each time a partial filling of the prescription is conducted.


(3) Retrieval of partially filled Schedule II prescription information is the same as required by § 1306.22(b) (4) and (5) for Schedule III and IV prescription refill information.


(Authority: 21 U.S.C. 801, et seq.)

[36 FR 7799, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 45 FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 FR 13965, Mar. 24, 1997; 75 FR 16308, Mar. 31, 2010]


§ 1306.14 Labeling of substances and filling of prescriptions.

(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label showing date of filling, the pharmacy name and address, the serial number of the prescription, the name of the patient, the name of the prescribing practitioner, and directions for use and cautionary statements, if any, contained in such prescription or required by law.


(b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy’s DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section.


(c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: Provided, That:


(1) Not more than 7-day supply of the controlled substance listed in Schedule II is dispensed at one time;


(2) The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;


(3) The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and


(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.


(d) All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of § 1304.04(h) of this chapter.


(e) Where a prescription that has been prepared in accordance with section 1306.12(b) contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date.


[36 FR 13368, July 21, 1971, as amended at 37 FR 15921, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR 13965, Mar. 24, 1997; 68 FR 37410, June 24, 2003; 72 FR 64930, Nov. 19, 2007]


§ 1306.15 Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances.

Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. The following requirements shall also apply:


(a) Prescriptions for controlled substances listed in Schedule II may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:


(1) Write the words “CENTRAL FILL” on the face of the original paper prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal. For electronic prescriptions the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted, the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal must be added to the electronic prescription record.


(2) Ensure that all information required to be on a prescription pursuant to Section 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);


(3) Maintain the original prescription for a period of two years from the date the prescription was filled;


(4) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery.


(b) The central fill pharmacy receiving the transmitted prescription must:


(1) Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription;


(2) Keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling of the prescription;


(3) Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common or contract carrier).


[68 FR 37410, June 24, 2003, as amended at 75 FR 16308, Mar. 31, 2010]


Controlled Substances Listed in Schedules III, IV, and V

§ 1306.21 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V that is a prescription drug as determined under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)) only pursuant to either a paper prescription signed by a practitioner, a facsimile of a signed paper prescription transmitted by the practitioner or the practitioner’s agent to the pharmacy, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist containing all information required in § 1306.05, except for the signature of the practitioner.


(b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, IV, or V in the course of his/her professional practice without a prescription, subject to § 1306.07.


(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule III, IV, or V only pursuant to a paper prescription signed by an individual practitioner, a facsimile of a paper prescription or order for medication transmitted by the practitioner or the practitioner’s agent to the institutional practitioner-pharmacist, an electronic prescription that meets the requirements of this part and part 1311 of this chapter, or an oral prescription made by an individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in § 1306.05 except for the signature of the individual practitioner), or pursuant to an order for medication made by an individual practitioner that is dispensed for immediate administration to the ultimate user, subject to § 1306.07.


[62 FR 13965, Mar. 24, 1997, as amended at 75 FR 16308, Mar. 31, 2010]


§ 1306.22 Refilling of prescriptions.

(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued. No prescription for a controlled substance listed in Schedule III or IV authorized to be refilled may be refilled more than five times.


(b) Each refilling of a prescription shall be entered on the back of the prescription or on another appropriate document or electronic prescription record. If entered on another document, such as a medication record, or electronic prescription record, the document or record must be uniformly maintained and readily retrievable.


(c) The following information must be retrievable by the prescription number:


(1) The name and dosage form of the controlled substance.


(2) The date filled or refilled.


(3) The quantity dispensed.


(4) The initials of the dispensing pharmacist for each refill.


(5) The total number of refills for that prescription.


(d) If the pharmacist merely initials and dates the back of the prescription or annotates the electronic prescription record, it shall be deemed that the full face amount of the prescription has been dispensed.


(e) The prescribing practitioner may authorize additional refills of Schedule III or IV controlled substances on the original prescription through an oral refill authorization transmitted to the pharmacist provided the following conditions are met:


(1) The total quantity authorized, including the amount of the original prescription, does not exceed five refills nor extend beyond six months from the date of issue of the original prescription.


(2) The pharmacist obtaining the oral authorization records on the reverse of the original paper prescription or annotates the electronic prescription record with the date, quantity of refill, number of additional refills authorized, and initials the paper prescription or annotates the electronic prescription record showing who received the authorization from the prescribing practitioner who issued the original prescription.


(3) The quantity of each additional refill authorized is equal to or less than the quantity authorized for the initial filling of the original prescription.


(4) The prescribing practitioner must execute a new and separate prescription for any additional quantities beyond the five-refill, six-month limitation.


(f) As an alternative to the procedures provided by paragraphs (a) through (e) of this section, a computer application may be used for the storage and retrieval of refill information for original paper prescription orders for controlled substances in Schedule III and IV, subject to the following conditions:


(1) Any such proposed computerized application must provide online retrieval (via computer monitor or hard-copy printout) of original prescription order information for those prescription orders that are currently authorized for refilling. This shall include, but is not limited to, data such as the original prescription number; date of issuance of the original prescription order by the practitioner; full name and address of the patient; name, address, and DEA registration number of the practitioner; and the name, strength, dosage form, quantity of the controlled substance prescribed (and quantity dispensed if different from the quantity prescribed), and the total number of refills authorized by the prescribing practitioner.


(2) Any such proposed computerized application must also provide online retrieval (via computer monitor or hard-copy printout) of the current refill history for Schedule III or IV controlled substance prescription orders (those authorized for refill during the past six months). This refill history shall include, but is not limited to, the name of the controlled substance, the date of refill, the quantity dispensed, the identification code, or name or initials of the dispensing pharmacist for each refill and the total number of refills dispensed to date for that prescription order.


(3) Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application. If such an application provides a hard-copy printout of each day’s controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith). This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date. This printout of the day’s controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill.


(4) Any such computerized application shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both). Such a printout must include name of the prescribing practitioner, name and address of the patient, quantity dispensed on each refill, date of dispensing for each refill, name or identification code of the dispensing pharmacist, and the number of the original prescription order. In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (e.g., postmark).


(5) In the event that a pharmacy which employs such a computerized application experiences system down-time, the pharmacy must have an auxiliary procedure which will be used for documentation of refills of Schedule III and IV controlled substance prescription orders. This auxiliary procedure must ensure that refills are authorized by the original prescription order, that the maximum number of refills has not been exceeded, and that all of the appropriate data are retained for online data entry as soon as the computer system is available for use again.


(g) When filing refill information for original paper, fax, or oral prescription orders for Schedule III or IV controlled substances, a pharmacy may use only one of the two applications described in paragraphs (a) through (e) or (f) of this section.


(h) When filing refill information for electronic prescriptions, a pharmacy must use an application that meets the requirements of part 1311 of this chapter.


[75 FR 16308, Mar. 31, 2010]


§ 1306.23 Partial filling of prescriptions.

The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:


(a) Each partial filling is recorded in the same manner as a refilling,


(b) The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and


(c) No dispensing occurs after 6 months after the date on which the prescription was issued.


[36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 51 FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, 1997]


§ 1306.24 Labeling of substances and filling of prescriptions.

(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a label showing the pharmacy name and address, the serial number and date of initial filling, the name of the patient, the name of the practitioner issuing the prescription, and directions for use and cautionary statements, if any, contained in such prescription as required by law.


(b) If the prescription is filled at a central fill pharmacy, the central fill pharmacy shall affix to the package a label showing the retail pharmacy name and address and a unique identifier, (i.e. the central fill pharmacy’s DEA registration number) indicating that the prescription was filled at the central fill pharmacy, in addition to the information required under paragraph (a) of this section.


(c) The requirements of paragraph (a) of this section do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized: Provided, That:


(1) Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time;


(2) The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration;


(3) The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V; and


(4) The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.


(d) All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with § 1304.04(h) of this chapter.


[62 FR 13965, Mar. 24, 1997, as amended at 68 FR 37411, June 24, 2003]


§ 1306.25 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.

(a) The transfer of original prescription information for a controlled substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis only. However, pharmacies electronically sharing a real-time, online database may transfer up to the maximum refills permitted by law and the prescriber’s authorization.


(b) Transfers are subject to the following requirements:


(1) The transfer must be communicated directly between two licensed pharmacists.


(2) The transferring pharmacist must do the following:


(i) Write the word “VOID” on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record.


(ii) Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record.


(iii) Record the date of the transfer and the name of the pharmacist transferring the information.


(3) For paper prescriptions and prescriptions received orally and reduced to writing by the pharmacist pursuant to § 1306.21(a), the pharmacist receiving the transferred prescription information must write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription pursuant to § 1306.05 and include:


(i) Date of issuance of original prescription.


(ii) Original number of refills authorized on original prescription.


(iii) Date of original dispensing.


(iv) Number of valid refills remaining and date(s) and locations of previous refill(s).


(v) Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription information was transferred.


(vi) Name of pharmacist who transferred the prescription.


(vii) Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription was originally filled.


(4) For electronic prescriptions being transferred electronically, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data:


(i) The date of the original dispensing.


(ii) The number of refills remaining and the date(s) and locations of previous refills.


(iii) The transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing.


(iv) The name of the pharmacist transferring the prescription.


(v) The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different.


(5) The pharmacist receiving a transferred electronic prescription must create an electronic record for the prescription that includes the receiving pharmacist’s name and all of the information transferred with the prescription under paragraph (b)(4) of this section.


(c) The original and transferred prescription(s) must be maintained for a period of two years from the date of last refill.


(d) Pharmacies electronically accessing the same prescription record must satisfy all information requirements of a manual mode for prescription transferal.


(e) The procedure allowing the transfer of prescription information for refill purposes is permissible only if allowable under existing State or other applicable law.


[75 FR 16309, Mar. 31, 2010]


§ 1306.26 Dispensing without prescription.

A controlled substance listed in Schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:


(a) Such dispensing is made only by a pharmacist (as defined in part 1300 of this chapter), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist);


(b) Not more than 240 cc. (8 ounces) of any such controlled substance containing opium, nor more than 120 cc. (4 ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period;


(c) The purchaser is at least 18 years of age;


(d) The pharmacist requires every purchaser of a controlled substance under this section not known to him to furnish suitable identification (including proof of age where appropriate);


(e) A bound record book for dispensing of controlled substances under this section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of § 1304.04 of this chapter); and


(f) A prescription is not required for distribution or dispensing of the substance pursuant to any other Federal, State or local law.


(g) Central fill pharmacies may not dispense controlled substances to a purchaser at retail pursuant to this section.


[36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13966, Mar. 24, 1997; 68 FR 37411, June 24, 2003]


§ 1306.27 Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances.

Prescription information may be provided to an authorized central fill pharmacy by a retail pharmacy for dispensing purposes. The following requirements shall also apply:


(a) Prescriptions for controlled substances listed in Schedule III, IV or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile. The retail pharmacy transmitting the prescription information must:


(1) Write the word “CENTRAL FILL” on the face of the original prescription and record the name, address, and DEA registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmacy pharmacist transmitting the prescription, and the date of transmittal;


(2) Ensure that all information required to be on a prescription pursuant to § 1306.05 of this part is transmitted to the central fill pharmacy (either on the face of the prescription or in the electronic transmission of information);


(3) Indicate in the information transmitted the number of refills already dispensed and the number of refills remaining;


(4) Maintain the original prescription for a period of two years from the date the prescription was last refilled;


(5) Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common or contract carrier) and the name of the retail pharmacy employee accepting delivery.


(b) The central fill pharmacy receiving the transmitted prescription must:


(1) Keep a copy of the prescription (if sent via facsimile) or an electronic record of all the information transmitted by the retail pharmacy, including the name, address, and DEA registration number of the retail pharmacy transmitting the prescription;


(2) Keep a record of the date of receipt of the transmitted prescription, the name of the licensed pharmacist filling the prescription, and dates of filling or refilling of the prescription;


(3) Keep a record of the date the filled prescription was delivered to the retail pharmacy and the method of delivery (i.e. private, common or contract carrier).


[68 FR 37411, June 24, 2003]


PART 1307 – MISCELLANEOUS


Authority:21 U.S.C. 821, 822(d), 871(b), unless otherwise noted.


Source:36 FR 7801, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

General Information

§ 1307.01 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13966, Mar. 24, 1997]


§ 1307.02 Application of State law and other Federal law.

Nothing in this chapter shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he/she desires to do such act nor shall compliance with such parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws.


[62 FR 13966, Mar. 24, 1997]


§ 1307.03 Exceptions to regulations.

Any person may apply for an exception to the application of any provision of this chapter by filing a written request with the Office of Diversion Control, Drug Enforcement Administration, stating the reasons for such exception. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The Administrator may grant an exception in his discretion, but in no case shall he/she be required to grant an exception to any person which is otherwise required by law or the regulations cited in this section.


[75 FR 10678, Mar. 9, 2010]


Special Exceptions for Manufacture and Distribution of Controlled Substances

§ 1307.11 Distribution by dispenser to another practitioner.

(a) A practitioner who is registered to dispense a controlled substance may distribute (without being registered to distribute) a quantity of such substance to –


(1) Another practitioner for the purpose of general dispensing by the practitioner to patients, provided that –


(i) The practitioner to whom the controlled substance is to be distributed is registered under the Act to dispense that controlled substance;


(ii) The distribution is recorded by the distributing practitioner in accordance with § 1304.22(c) of this chapter and by the receiving practitioner in accordance with § 1304.22(c) of this chapter;


(iii) If the substance is listed in Schedule I or II, an order form is used as required in part 1305 of this chapter; and


(iv) The total number of dosage units of all controlled substances distributed by the practitioner pursuant to this section and § 1301.25 of this chapter during each calendar year in which the practitioner is registered to dispense does not exceed 5 percent of the total number of dosage units of all controlled substances distributed and dispensed by the practitioner during the same calendar year.


(2) [Reserved]


(b) If, during any calendar year in which the practitioner is registered to dispense, the practitioner has reason to believe that the total number of dosage units of all controlled substances which will be distributed by him pursuant to paragraph (a)(1) of this section and § 1301.25 of this chapter will exceed 5 percent of this total number of dosage units of all controlled substances distributed and dispensed by him during that calendar year, the practitioner shall obtain a registration to distribute controlled substances.


(c) The distributions that a registered retail pharmacy makes to automated dispensing systems at long term care facilities for which the retail pharmacy also holds registrations do not count toward the 5 percent limit in paragraphs (a)(1)(iv) and (b) of this section.


[68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005; 79 FR 53565, Sept. 9, 2014]


§ 1307.13 Incidental manufacture of controlled substances.

Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance as a result of the manufacture of a controlled substance or basic class of controlled substance for which he is registered and has been issued an individual manufacturing quota pursuant to part 1303 of this chapter (if such substance or class is listed in Schedule I or II) shall be exempt from the requirement of registration pursuant to part 1301 of this chapter and, if such incidentally manufactured substance is listed in Schedule I or II, shall be exempt from the requirement of an individual manufacturing quota pursuant to part 1303 of this chapter, if such substances are disposed of in accordance with part 1317 of this chapter.


[79 FR 53565, Sept. 9, 2014]


Disposal of Controlled Substances

§ 1307.22 Delivery of surrendered and forfeited controlled substances.

Any controlled substance surrendered by delivery to the Administration under part 1317 of this chapter or forfeited pursuant to section 511 of the Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agency of the United States or of any State upon proper application addressed to the Office of Diversion Control, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The application shall show the name, address, and official title of the person or agency to whom the controlled drugs are to be delivered, including the name and quantity of the substances desired and the purpose for which intended. The delivery of such controlled drugs shall be ordered by the Administrator, if, in his opinion, there exists a medical or scientific need therefor.


[75 FR 10678, Mar. 9, 2010, as amended at 79 FR 53565, Sept. 9, 2014]


Special Exempt Persons

§ 1307.31 Native American Church.

The listing of peyote as a controlled substance in Schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the Native American Church so using peyote are exempt from registration. Any person who manufactures peyote for or distributes peyote to the Native American Church, however, is required to obtain registration annually and to comply with all other requirements of law.


PART 1308 – SCHEDULES OF CONTROLLED SUBSTANCES


Authority:21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.


Source:38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

General Information

§ 1308.01 Scope of this part.

Schedules of controlled substances established by section 202 of the Act (21 U.S.C. 812) and nonnarcotic substances, chemical preparations, veterinary anabolic steroid implant products, prescription products, anabolic steroid products, and cannabis plant material and products made therefrom that contain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 U.S.C. 811), as they are changed, updated, and republished from time to time, are set forth in this part.


[81 FR 97021, Dec. 30, 2016]


§ 1308.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13967, Mar. 24, 1997]


§ 1308.03 Administration Controlled Substances Code Number.

(a) Each controlled substance, or basic class thereof, has been assigned an “Administration Controlled Substances Code Number” for purposes of identification of the substances or class on certain Certificates of Registration issued by the Administration pursuant to §§ 1301.35 of this chapter and on certain order forms issued by the Administration pursuant to § 1305.05(d) of this chapter. Applicants for procurement and/or individual manufacturing quotas must include the appropriate code number on the application as required in §§ 1303.12(b) and 1303.22(a) of this chapter. Applicants for import and export permits must include the appropriate code number on the application as required in §§ 1312.12(a) and 1312.22(a) of this chapter. Authorized registrants who desire to import or export a controlled substance for which an import or export permit is not required must include the appropriate Administration Controlled Substances Code Number beneath or beside the name of each controlled substance listed on the DEA Form 236 (Controlled Substance Import/Export Declaration) which is executed for such importation or exportation as required in §§ 1312.18(c) and 1312.27(b) of this chapter.


(b) Except as stated in paragraph (a) of this section, no applicant or registrant is required to use the Administration Controlled Substances Code Number for any purpose.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 51 FR 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997]


Schedules

§ 1308.11 Schedule I.

(a) Schedule I shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.


(b) Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters and ethers, whenever the existence of such isomers, esters, ethers and salts is possible within the specific chemical designation (for purposes of 3-methylthiofentanyl only, the term isomer includes the optical and geometric isomers):




(1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2-phenethyl)-4-piperidinyl]-N-phenylacetamide)9815
(2) Acetylmethadol9601
(3) Acetyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821
(4) Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide; also known as acryloylfentanyl)9811
(5) AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)9551
(6) Allylprodine9602
(7) Alphacetylmethadol (except levo-alphacetylmethadol also known as levoalpha-acetylmethadol, levomethadyl acetate, or LAAM)9603
(8) Alphameprodine9604
(9) Alphamethadol9605
(10) alpha-Methylfentanyl (N-[1-(alpha-methyl-beta-phenyl)ethyl-4-piperidyl]propionanilide; 1-(1-methyl-2-phenylethyl)-4-(N-propanilido)piperidine)9814
(11) alpha-Methylthiofentanyl (N-[1-methyl-2-(2-thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide)9832
(12) Benzethidine9606
(13) Betacetylmethadol9607
(14) beta-Hydroxyfentanyl (N-[1-(2-hydroxy-2-phenethyl)-4-piperidinyl]-N-phenylpropanamide)9830
(15) beta-Hydroxy-3-methylfentanyl (N-[1-(2-hydroxy-2-phenylethyl)-3-methyl-4-piperidinyl]-N-phenylpropanamide)9831
(16) beta-Hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide)9836
(17) Betameprodine9608
(18) Betamethadol9609
(19) beta-Methyl fentanyl (N-phenyl-N-(1-(2-phenylpropyl)piperidin-4-yl)propionamide; also known as β-methyl fentanyl)9856
(20) beta′-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N,3-diphenylpropanamide; also known as β′-phenyl fentanyl; 3-phenylpropanoyl fentanyl)9842
(21) Betaprodine9611
(22) Butyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbutyramide)9822
(23) Clonitazene9612
(24) Crotonyl fentanyl ((E)-N-(1-phenethylpiperidin-4-yl)-N-phenylbut-2-enamide)9844
(25) Cyclopentyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopentanecarboxamide)9847
(26) Cyclopropyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylcyclopropanecarboxamide)9845
(27) Dextromoramide9613
(28) Diampromide9615
(29) Diethylthiambutene9616
(30) Difenoxin9168
(31) Dimenoxadol9617
(32) Dimepheptanol9618
(33) Dimethylthiambutene9619
(34) Dioxaphetyl butyrate9621
(35) Dipipanone9622
(36) Ethylmethylthiambutene9623
(37) Etonitazene9624
(38) Etoxeridine9625
(39) Fentanyl carbamate (ethyl (1-phenethylpiperidin-4-yl)(phenyl)carbamate)9851
(40) 4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide; also known as para-fluoroisobutyryl fentanyl)9824
(41) 2′-Fluoro ortho-fluorofentanyl (N-(1-(2-fluorophenethyl)piperidin-4-yl)-N-(2-fluorophenyl)propionamide; also known as 2′-fluoro 2-fluorofentanyl)9855
(42) Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide)9834
(43) Furethidine9626
(44) Hydroxypethidine9627
(45) Isobutyryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylisobutyramide)9827
(46) Isotonitazene (N,N-diethyl-2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine)9614
(47) Ketobemidone9628
(48) Levomoramide9629
(49) Levophenacylmorphan9631
(50) Methoxyacetyl fentanyl (2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9825
(51) 4′-Methyl acetyl fentanyl (N-(1-(4-methylphenethyl)piperidin-4-yl)-N-phenylacetamide)9819
(52) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4-piperidyl]-N-phenylpropanamide)9813
(53) 3-Methylthiofentanyl (N-[3-methyl-1-(2-thienylethyl)-4-piperidinyl]-N-phenylpropanamide)9833
(54) Morpheridine9632
(55) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine)9661
(56) MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)9560
(57) Noracymethadol9633
(58) Norlevorphanol9634
(59) Normethadone9635
(60) Norpipanone9636
(61) Ocfentanil (N-(2-fluorophenyl)-2-methoxy-N-(1-phenethylpiperidin-4-yl)acetamide)9838
(62) ortho-Fluoroacryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)acrylamide)9852
(63) ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide; also known as 2-fluorobutyryl fentanyl)9846
(64) ortho-Fluorofentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide); also known as 2-fluorofentanyl)9816
(65) ortho-Fluoroisobutyryl fentanyl (N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)9853
(66) ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also known as 2-methyl acetylfentanyl)9848
(67) ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2-methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide; also known as 2-methyl methoxyacetyl fentanyl)9820
(68) para-Chloroisobutyryl fentanyl (N-(4-chlorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)9826
(69) para-Fluorobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)butyramide)9823
(70) para-Fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2-phenylethyl)-4-piperidinyl]propanamide)9812
(71) para-Fluoro furanyl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)furan-2-carboxamide)9854
(72) para-Methoxybutyryl fentanyl (N-(4-methoxyphenyl)-N-(1-phenethylpiperidin-4-yl)butyramide)9837
(73) para-Methylfentanyl (N-(4-methylphenyl)-N-(1-phenethylpiperidin-4-yl)propionamide; also known as 4-methylfentanyl)9817
(74) PEPAP (1-(2-phenylethyl)-4-phenyl-4-acetoxypiperidine)9663
(75) Phenadoxone9637
(76) Phenampromide9638
(77) Phenomorphan9647
(78) Phenoperidine9641
(79) Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylbenzamide; also known as benzoyl fentanyl)9841
(80) Piritramide9642
(81) Proheptazine9643
(82) Properidine9644
(83) Propiram9649
(84) Racemoramide9645
(85) Tetrahydrofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide)9843
(86) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4-piperidinyl]propanamide)9835
(87) Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylthiophene-2-carboxamide; also known as 2-thiofuranyl fentanyl; thiophene fentanyl)9839
(88) Tilidine9750
(89) Trimeperidine9646
(90) U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide)9547
(91) Valeryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylpentanamide)9840


(c) Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) Acetorphine9319
(2) Acetyldihydrocodeine9051
(3) Benzylmorphine9052
(4) Codeine methylbromide9070
(5) Codeine-N-Oxide9053
(6) Cyprenorphine9054
(7) Desomorphine9055
(8) Dihydromorphine9145
(9) Drotebanol9335
(10) Etorphine (except hydrochloride salt)9056
(11) Heroin9200
(12) Hydromorphinol9301
(13) Methyldesorphine9302
(14) Methyldihydromorphine9304
(15) Morphine methylbromide9305
(16) Morphine methylsulfonate9306
(17) Morphine-N-Oxide9307
(18) Myrophine9308
(19) Nicocodeine9309
(20) Nicomorphine9312
(21) Normorphine9313
(22) Pholcodine9314
(23) Thebacon9315

(d) Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation, which contains any quantity of the following hallucinogenic substances, or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (for purposes of this paragraph only, the term “isomer” includes the optical, position and geometric isomers):


(1) Alpha-ethyltryptamine7249
Some trade or other names: etryptamine; Monase; α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) indole; α-ET; and AET.
(2) 4-bromo-2,5-dimethoxy-amphetamine7391
Some trade or other names: 4-bromo-2,5-dimethoxy-α-methylphenethylamine; 4-bromo-2,5-DMA
(3) 4-Bromo-2,5-dimethoxyphenethylamine7392
Some trade or other names: 2-(4-bromo-2,5-dimethoxyphenyl)-1-aminoethane; alpha-desmethyl DOB; 2C-B, Nexus.
(4) 2,5-dimethoxyamphetamine7396
Some trade or other names: 2,5-dimethoxy-α-methylphenethylamine; 2,5-DMA
(5) 2,5-dimethoxy-4-ethylamphet-amine7399
Some trade or other names: DOET
(6) 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C-T-7)7348
(7) 4-methoxyamphetamine7411
Some trade or other names: 4-methoxy-α-methylphenethylamine; paramethoxyamphetamine, PMA
(8) 5-methoxy-3,4-methylenedioxy-amphetamine7401
(9) 4-methyl-2,5-dimethoxy-amphetamine7395
Some trade and other names: 4-methyl-2,5-dimethoxy-α-methylphenethylamine; “DOM”; and “STP”
(10) 3,4-methylenedioxy amphetamine7400
(11) 3,4-methylenedioxymethamphetamine (MDMA)7405
(12) 3,4-methylenedioxy-N-ethylamphetamine (also known as N-ethyl-alpha-methyl-3,4(methylenedioxy)-phenethylamine, N-ethyl MDA, MDE, MDEA7404
(13) N-hydroxy-3,4-methylenedioxyamphetamine (also known as N-hydroxy-alpha-methyl-3,4(methylenedioxy)-phenethylamine, and N-hydroxy MDA7402
(14) 3,4,5-trimethoxy amphetamine7390
(15) 5-methoxy-N,N-dimethyltryptamine Some trade or other names: 5-methoxy-3-[2-(dimethylamino)ethyl]indole; 5-MeO-DMT7431
(16) Alpha-methyltryptamine (other name: AMT)7432
(17) Bufotenine7433
Some trade and other names: 3-(β-Dimethylaminoethyl)-5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-dimethylserotonin; 5-hydroxy-N,N-dimethyltryptamine; mappine
(18) Diethyltryptamine7434
Some trade and other names: N,N-Diethyltryptamine; DET
(19) Dimethyltryptamine7435
Some trade or other names: DMT
(20) 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeO-DIPT)7439
(21) Ibogaine7260
Some trade and other names: 7-Ethyl-6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9-methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b] indole; Tabernanthe iboga
(22) Lysergic acid diethylamide7315
(23) Marihuana7360
(24) Mescaline7381
(25) Parahexyl – 7374; some trade or other names: 3-Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl.
(26) Peyote7415
Meaning all parts of the plant presently classified botanically as Lophophora williamsii Lemaire, whether growing or not, the seeds thereof, any extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, or preparation of such plant, its seeds or extracts
(Interprets 21 USC 812(c), Schedule I(c) (12))
(27) N-ethyl-3-piperidyl benzilate7482
(28) N-methyl-3-piperidyl benzilate7484
(29) Psilocybin7437
(30) Psilocyn7438
(31) Tetrahydrocannabinols7370
(i) Meaning tetrahydrocannabinols, except as in paragraph (d)(31)(ii) of this section, naturally contained in a plant of the genus Cannabis (cannabis plant), as well as synthetic equivalents of the substances contained in the cannabis plant, or in the resinous extractives of such plant, and/or synthetic substances, derivatives, and their isomers with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following:
1 cis or trans tetrahydrocannabinol, and their optical isomers
6 cis or trans tetrahydrocannabinol, and their optical isomers
3, 4 cis or trans tetrahydrocannabinol, and its optical isomers
(Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions covered.)
(ii) Tetrahydrocannabinols does not include any material, compound, mixture, or preparation that falls within the definition of hemp set forth in 7 U.S.C. 1639o.
(32) Ethylamine analog of phencyclidine7455
Some trade or other names: N-ethyl-1-phenylcyclohexylamine, (1-phenylcyclohexyl)ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE
(33) Pyrrolidine analog of phencyclidine7458
Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine, PCPy, PHP
(34) Thiophene analog of phencyclidine7470
Some trade or other names: 1-[1-(2-thienyl)-cyclohexyl]-piperidine, 2-thienylanalog of phencyclidine, TPCP, TCP
(35) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine7473
Some other names: TCPy
(36) 4-methylmethcathinone (Mephedrone)1248
(37) 3,4-methylenedioxypyrovalerone (MDPV)7535
(38) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E)7509
(39) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D)7508
(40) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C)7519
(41) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I)7518
(42) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2)7385
(43) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4)7532
(44) 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H)7517
(45) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N)7521
(46) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C-P)7524
(47) 3,4-Methylenedioxy-N-methylcathinone (Methylone)7540
(48) (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (UR-144)(7144)
(49) [1-(5-fluoro-pentyl)-1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone (5-fluoro-UR-144, XLR11)(7011)
(50) N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide (APINACA, AKB48)(7048)
(51) quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate (PB-22; QUPIC)(7222)
(52) quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (5-fluoro-PB-22; 5F-PB-22)(7225)
(53) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (AB-FUBINACA)(7012)
(54) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (ADB-PINACA)(7035)
(55) 2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe, 2C-I-NBOMe)(7538)
(56) 2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe, 2C-C-NBOMe)(7537)
(57) 2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe, 2C-B-NBOMe)(7536)
(58) Marihuana Extract7350
Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, containing greater than 0.3% delta-9-tetrahydrocannabinol on a dry weight basis, other than the separated resin (whether crude or purified) obtained from the plant.
(59) 4-methyl-N-ethylcathinone (4-MEC)(1249)
(60) 4-methyl-alpha-pyrrolidinopropiophenone (4-MePPP)(7498)
(61) alpha-pyrrolidinopentiophenone (α-PVP)(7545)
(62) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB)(7541)
(63) 2-(methylamino)-1-phenylpentan-1-one (pentedrone)(1246)
(64) 1-(1,3-benzodioxol-5-yl)-2-(methylamino)pentan-1-one (pentylone, bk-MBDP)(7542)
(65) 4-fluoro-N-methylcathinone (4-FMC; flephedrone)(1238)
(66) 3-fluoro-N-methylcathinone (3-FMC)(1233)
(67) 1-(naphthalen-2-yl)-2-(pyrrolidin-1-yl)pentan-1-one (naphyrone)(1258)
(68) alpha-pyrrolidinobutiophenone (α-PBP)(7546)
(69) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA)(7031)
(70) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA)(7023)
(71) [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201)(7024)
(72) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (MAB-CHMINACA; ADB-CHMINACA)(7032)
(73) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: 5F-ADB; 5F-MDMB-PINACA)7034
(74) methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (Other names: 5F-AMB)7033
(75) N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (Other names: 5F-APINACA, 5F-AKB48)7049
(76) N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (Other names: ADB-FUBINACA)7010
(77) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-CHMICA, MMB-CHMINACA)7042
(78) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (Other names: MDMB-FUBINACA)7020
(79) methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate, (FUB-AMB, MMB-FUBINACA, AMB-FUBINACA)(7021)
(80) 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)propan-1-one (ethylone)7547

(81) Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate (Other names: NM2201; CBL2201)7221
(82) N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide (Other name: 5F-AB-PINACA)7025
(83) 1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (Other names: 4-CN-CUMYL-BUTINACA; 4-cyano-CUMYL-BUTINACA; 4-CN-CUMYL BINACA; CUMYL-4CN-BINACA; SGT-78)7089
(84) methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate (Other names: MMB-CHMICA; AMB-CHMICA)7044
(85) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide (Other name: 5F-CUMYL-P7AICA)7085

(86) N-ethylpentylone (Other names: ephylone, 1-(1,3-benzodioxol-5-yl)-2-(ethylamino)pentan-1-one)7543

(87) methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (4F-MDMB-BINACA, 4F-MDMB-BUTINACA)7043
(88) 1-(4-methoxyphenyl)-N-methylpropan-2-amine (other names: para-methoxymethamphetamine, PMMA)(1245)
(89) ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate (other name: 5F-EDMB-PINACA)7036
(90) methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate (other names: 5F-MDMB-PICA; 5F-MDMB-2201)7041
(91) N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide (other names: FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL))7047
(92) 1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide (other names: 5F-CUMYL-PINACA; SGT-25)7083
(93) (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone (other name: FUB-144)7014
(94) N-Ethylhexedrone (Other names: α-ethylaminohexanophenone; 2-(ethylamino)-1-phenylhexan-1-one)7246
(95) alpha-Pyrrolidinohexanophenone (Other names: αPHP; α-pyrrolidinohexanophenone; 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-one)7544
(96) 4-Methyl-alpha-ethylaminopentiophenone (Other names: 4-MEAP; 2-(ethylamino)-1-(4-methylphenyl)pentan-1-one)7245
(97) 4′-Methyl-alpha-pyrrolidinohexiophenone (Other names: MPHP; 4′-methyl-alpha-pyrrolidinohexanophenone; 1-(4-methylphenyl)-2-(pyrrolidin-1-yl)hexan-1-one)7446
(98) alpha-Pyrrolidinoheptaphenone (Other names: PV8; 1-phenyl-2-(pyrrolidin-1-yl)heptan-1-one)7548
(99) 4′-Chloro-alpha-pyrrolidinovalerophenone (Other names: 4-chloro-α-PVP; 4′-chloro-α-pyrrolidinopentiophenone; 1-(4-chlorophenyl)-2-(pyrrolidin-1-yl)pentan-1-one)7443

(100) 2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine, MXE)7286

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) gamma-hydroxybutyric acid (some other names include GHB; gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutanoic acid; sodium oxybate; sodium oxybutyrate)2010
(2) Mecloqualone2572
(3) Methaqualone2565

(f) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:


(1) Aminorex (Some other names: aminoxaphen; 2-amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5-phenly-2-oxazolamine)1585
(2) N-Benzylpiperazine (some other names: BZP, 1-benzylpiperazine)7493
(3) Cathinone1235
Some trade or other names: 2-amino-1-phenyl-1-propanone, alpha-aminopropiophenone, 2-aminopropiophenone, and norephedrone
(4) 4,4′-Dimethylaminorex (4,4′-DMAR; 4,5-dihydro-4-methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5-(4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine)1595
(5) Fenethylline1503
(6) Methcathinone (Some other names: 2-(methylamino)-propiophenone; alpha-(methylamino)propiophenone; 2-(methylamino)-1-phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone; methylcathinone; AL-464; AL-422; AL-463 and UR1432), its salts, optical isomers and salts of optical isomers1237
(7) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-methyl-5-phenyl-2-oxazolamine)1590
(8) N-ethylamphetamine1475
(9) N,N-dimethylamphetamine (also known as N,N-alpha-trimethyl-benzeneethanamine; N,N-alpha-trimethylphenethylamine)1480

(g) Cannabimimetic agents. Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (CP-47,497)7297
(2) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog)7298
(3) 1-pentyl-3-(1-naphthoyl)indole (JWH-018 and AM678)7118
(4) 1-butyl-3-(1-naphthoyl)indole (JWH-073)7173
(5) 1-hexyl-3-(1-naphthoyl)indole (JWH-019)7019
(6) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole (JWH-200)7200
(7) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH-250)6250
(8) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH-081)7081
(9) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH-122)7122
(10) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH-398)7398
(11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201)7201
(12) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694)7694
(13) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR-19 and RCS-4)7104
(14) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole 7008 (SR-18 and RCS-8)7008
(15) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH-203)7203

(h) Temporary listing of substances subject to emergency scheduling. Any material, compound, mixture or preparation which contains any quantity of the following substances:


(1)-(29) [Reserved]
(30) Fentanyl-related substances, their isomers, esters, ethers, salts and salts of isomers, esters and ethers9850

(i) Fentanyl-related substance means any substance not otherwise listed under another Administration Controlled Substance Code Number, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355], that is structurally related to fentanyl by one or more of the following modifications:


(A) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;


(B) Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino or nitro groups;


(C) Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino or nitro groups;


(D) Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or


(E) Replacement of the N-propionyl group by another acyl group.


(ii) This definition includes, but is not limited to, the following substances: (A)-(B) [Reserved]


(31)-(48) [Reserved]

(49) 1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)-1,3-dihydro-2H-benzo[d]imidazol-2-one, its isomers, esters, ethers, salts and salts of isomers, esters and ethers (Other names: brorphine; 1-[1-[1-(4-bromophenyl)ethyl]-4-piperidinyl]-1,3-dihydro-2H-benzimidazol-2-one)9098

(50) 2-(2-(4-butoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other name: Butonitazene)9751

(51) 2-(2-(4-ethoxybenzyl)-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other names: Etodesnitazene; etazene)9765

(52) N,N-diethyl-2-(2-(4-fluorobenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other name: Flunitazene)9756

(53) N,N-diethyl-2-(2-(4-methoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other name: Metodesnitazene)9764

(54) N,N-diethyl-2-(2-(4-methoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other name: Metonitazene)9757

(55) 2-(4-ethoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1H-benzimidazole, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other names: N-pyrrolidino etonitazene; etonitazepyne)9758
(56) N,N-diethyl-2-(5-nitro-2-(4-propoxybenzyl)-1H-benzimidazol-1-yl)ethan-1-amine, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (Other name: Protonitazene)9759


[39 FR 22141, June 20, 1974]


Editorial Note:For Federal Register citations affecting § 1308.11, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.


Effective Date Notes:

1.At 83 FR 5191, Feb. 6, 2018, § 1308.11 was amended by adding paragraph (h)(30), effective Feb. 6, 2018, through Feb. 6, 2020. Effective Feb. 6, 2020, Congress extended the effective period for paragraph (h)(30) until May 6, 2021, by Public Law 116-114. Effective May 4, 2021, Congress extended the effective period for paragraph (h)(30) until October 22, 2021, by Public Law 117-12. Effective Sept. 30, 2021, Congress extended the effective period for paragraph (h)(30) until Jan. 28, 2022, by Public Law 117-43. Effective Jan. 13, 2022, Congress extended the effective period for paragraph (h)(30) until Feb. 18, 2022, by Public Law 117-70. Effective Feb. 18, 2022, Congress extended the effective period for paragraph (h)(30) until Mar. 11, 2022, by Public Law 117-86. Effective Mar. 11, 2022, Congress extended the effective period for paragraph (h)(30) until Mar. 15, 2022 by Public Law 117-95. Effective Mar. 15, 2022, Congress extended the effective period for paragraph (h)(30) until Dec. 31, 2022 by Public Law No. 117-103.

2. At 86 FR 11866, Mar. 1, 2021, § 1308.11 was amended by adding paragraph (h)(49), effective Mar. 1, 2021 through Mar. 1, 2023.

3. At 87 FR 21561, Apr. 12, 2022, § 1308.11 was amended by adding paragraphs (h)(50) through (h)(56), effective Apr. 12, 2022 through Apr. 12, 2024.


§ 1308.12 Schedule II.

(a) Schedule II shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.


(b) Substances, vegetable origin or chemical synthesis. Unless specifically excepted or unless listed in another schedule, any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis:


(1) Opium and opiate, and any salt, compound, derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol, naloxone, 6β-naltrexol, naltrexone, and samidorphan, and their respective salts, but including the following:


(i) Codeine9050
(ii) Dihydroetorphine9334
(iii) Ethylmorphine9190
(iv) Etorphine hydrochloride9059
(v) Granulated opium9640
(vi) Hydrocodone9193
(vii) Hydromorphone9150
(viii) Metopon9260
(ix) Morphine9300
(x) Noroxymorphone9668
(xi) Opium extracts9610
(xii) Opium fluid9620
(xiii) Oripavine9330
(xiv) Oxycodone9143
(xv) Oxymorphone9652
(xvi) Powdered opium9639
(xvii) Raw opium9600
(xviii) Thebaine9333
(xix) Tincture of opium9630

(2) Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in paragraph (b) (1) of this section, except that these substances shall not include the isoquinoline alkaloids of opium.


(3) Opium poppy and poppy straw.


(4) Coca leaves (9040) and any salt, compound, derivative or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, isomers, derivatives and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include:


(i) Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine; or


(ii) [
123I]ioflupane.


(5) Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid or powder form which contains the phenanthrene alkaloids of the opium poppy), 9670.


(c) Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts and salts of isomers, esters and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:


(1) Alfentanil9737
(2) Alphaprodine9010
(3) Anileridine9020
(4) Bezitramide9800
(5) Bulk dextropropoxyphene (non-dosage forms)9273
(6) Carfentanil9743
(7) Dihydrocodeine9120
(8) Diphenoxylate9170
(9) Fentanyl9801
(10) Isomethadone9226
(11) Levo-alphacetylmethadol9648
[Some other names: levo-alpha-acetylmethadol, levomethadyl acetate, LAAM]
(12) Levomethorphan9210
(13) Levorphanol9220
(14) Metazocine9240
(15) Methadone9250
(16) Methadone-Intermediate, 4-cyano-2-dimethylamino-4,4-diphenyl butane9254
(17) Moramide-Intermediate, 2-methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid9802
(18) Oliceridine (N-[(3-methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine)9245

(19) Pethidine (meperidine)9230
(20) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine9232
(21) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate9233
(22) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-carboxylic acid9234
(23) Phenazocine9715
(24) Piminodine9730
(25) Racemethorphan9732
(26) Racemorphan9733
(27) Remifentanil9739
(28) Sufentanil9740
(29) Tapentadol9780
(30) Thiafentanil9729

(d) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system:


(1) Amphetamine, its salts, optical isomers, and salts of its optical isomers1100
(2) Methamphetamine, its salts, isomers, and salts of its isomers1105
(3) Phenmetrazine and its salts1631
(4) Methylphenidate1724
(5) Lisdexamfetamine, its salts, isomers, and salts of its isomers1205.

(e) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) Amobarbital2125
(2) Glutethimide2550
(3) Pentobarbital2270
(4) Phencyclidine7471
(5) Secobarbital2315

(f) Hallucinogenic substances.


(1) Nabilone7379
[Another name for nabilone: (±)-trans-3-(1,1-dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hydroxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one]
(2) Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration(7365)

(g) Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:


(1) Immediate precursor to amphetamine and methamphetamine:


(i) Phenylacetone8501
Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone;

(2) Immediate precursors to phencyclidine (PCP):


(i) 1-phenylcyclohexylamine7460
(ii) 1-piperidinocyclohexanecarbonitrile (PCC)8603

(3) Immediate precursor to fentanyl:


(i) 4-anilino-N-phenethylpiperidine (ANPP)8333
(ii) N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl)8366

[39 FR 22142, June 20, 1974]


Editorial Note:For Federal Register citations affecting § 1308.12, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1308.13 Schedule III.

(a) Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.


(b) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers (whether optical, positional, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in schedule II which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under § 1308.32, and any other drug of the quantitative composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances1405
(2) Benzphetamine1228
(3) Chlorphentermine1645
(4) Clortermine1647
(5) Phendimetrazine1615

(c) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system:


(1) Any compound, mixture or preparation containing:
(i) Amobarbital2126
(ii) Secobarbital2316
(iii) Pentobarbital2271
or any salt thereof and one or more other active medicinal ingredients which are not listed in any schedule.
(2) Any suppository dosage form containing:
(i) Amobarbital2126
(ii) Secobarbital2316
(iii) Pentobarbital2271
or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository.
(3) Any substance which contains any quantity of a derivative of barbituric acid or any salt thereof2100
(4) Chlorhexadol2510
(5) Embutramide2020
(6) Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomers, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act2012
(7) Ketamine, its salts, isomers, and salts of isomers7285
[Some other names for ketamine: (±)-2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone]
(8) Lysergic acid7300
(9) Lysergic acid amide7310
(10) Methyprylon2575
(11) Perampanel, and its salts, isomers, and salts of isomers2261
(12) Sulfondiethylmethane2600
(13) Sulfonethylmethane2605
(14) Sulfonmethane2610
(15) Tiletamine and zolazepam or any salt thereof7295
Some trade or other names for a tiletamine-zolazepam combination product:
Telazol
Some trade or other names for tiletamine:
2-(ethylamino)-2-(2-thienyl)-cyclohexanone
Some trade or other names for zolazepam:
4-(2-fluorophenyl)-6,8-dihydro-1,3,8-trimethylpyrazolo-[3,4-e] [1,4]-diazepin-7(1H)-one, flupyrazapon

(d) Nalorphine 9400.


(e) Narcotic drugs. Unless specifically excepted or unless listed in another schedule:


(1) Any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:
(i) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium9803
(ii) Not more than 1.8 grams of codeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9804
(iii) Not more than 1.8 grams of dihydrocodeine per 100 milliliters or not more than 90 milligrams per dosage unit, with one or more active nonnarcotic ingredients in recognized therapeutic amounts9807
(iv) Not more than 300 milligrams of ethylmorphine per 100 milliliters or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9808
(v) Not more than 500 milligrams of opium per 100 milliliters or per 100 grams or not more than 25 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9809
(vi) Not more than 50 milligrams of morphine per 100 milliliters or per 100 grams, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts9810
(2) Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below:
(i) Buprenorphine9064
(ii) [Reserved]

(f) Anabolic Steroids. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation containing any quantity of the following substances, including its salts, esters and ethers:


(1) Anabolic steroids (see § 1300.01 of this chapter) – 4000


(2) [Reserved]


(g) Hallucinogenic substances. (1) Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved product – 7369.



[Some other names for dronabinol: (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)-delta-9-(trans)-tetrahydrocannabinol]

(2) [Reserved]


[39 FR 22142, June 20, 1974]


Editorial Note:For Federal Register citations affecting § 1308.13, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1308.14 Schedule IV.

(a) Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.


(b) Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below:


(1) Not more than 1 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit9167
(2) Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane)9278
(3) 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol, its salts, optical and geometric isomers and salts of these isomers (including tramadol)9752

(c) Depressants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:


(1) Alfaxalone2731
(2) Alprazolam2882
(3) Barbital2145
(4) Brexanolone2400
(5) Bromazepam2748
(6) Camazepam2749
(7) Carisoprodol8192
(8) Chloral betaine2460
(9) Chloral hydrate2465
(10) Chlordiazepoxide2744
(11) Clobazam2751
(12) Clonazepam2737
(13) Clorazepate2768
(14) Clotiazepam2752
(15) Cloxazolam2753
(16) Daridorexant2410
(17) Delorazepam2754
(18) Diazepam2765
(19) Dichloralphenazone2467
(20) Estazolam2756
(21) Ethchlorvynol2540
(22) Ethinamate2545
(23) Ethyl loflazepate2758
(24) Fludiazepam2759
(25) Flunitrazepam2763
(26) Flurazepam2767
(27) Fospropofol2138
(28) Halazepam2762
(29) Haloxazolam2771
(30) Ketazolam2772
(31) Lemborexant2245
(32) Loprazolam2773
(33) Lorazepam2885
(34) Lormetazepam2774
(35) Mebutamate2800
(36) Medazepam2836
(37) Meprobamate2820
(38) Methohexital2264
(39) Methylphenobarbital (mephobarbital)2250
(40) Midazolam2884
(41) Nimetazepam2837
(42) Nitrazepam2834
(43) Nordiazepam2838
(44) Oxazepam2835
(45) Oxazolam2839
(46) Paraldehyde2585
(47) Petrichloral2591
(48) Phenobarbital2285
(49) Pinazepam2883
(50) Prazepam2764
(51) Quazepam2881
(52) Remimazolam2846
(53) Suvorexant2223
(54) Temazepam2925
(55) Tetrazepam2886
(56) Triazolam2887
(57) Zaleplon2781
(58) Zolpidem2783
(59) Zopiclone2784

(d) Fenfluramine. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible:


(1) Fenfluramine1670

(e) Lorcaserin. Any material, compound, mixture, or preparation which contains any quantity of the following substances, including its salts, isomers, and salts of such isomers, whenever the existence of such salts, isomers, and salts of isomers is possible:


(1) Lorcaserin1625

(f) Stimulants. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers and salts of isomers:


(1) Cathine ((+)-norpseudoephedrine)1230
(2) Diethylpropion1610
(3) Fencamfamin1760
(4) Fenproporex1575
(5) Mazindol1605
(6) Mefenorex1580
(7)Modafinil1680
(8) Pemoline (including organometallic complexes and chelates thereof)1530
(9) Phentermine1640
(10) Pipradrol1750
(11) Serdexmethylphenidate1729
(12) Sibutramine1675
(13) Solriamfetol (2-amino-3-phenylpropyl carbamate; benzenepropanol, beta-amino-, carbamate (ester))1650
(14) SPA ((-)-1-dimethylamino- 1,2-diphenylethane)1635

(g) Other substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following substances, including its salts:


(1) Pentazocine9709
(2) Butorphanol (including its optical isomers)9720
(3) Eluxadoline (5-[[[(2S)-2-amino-3-[4-aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid) (including its optical isomers) and its salts, isomers, and salts of isomers (9725).

[39 FR 22143, June 20, 1974]


Editorial Note:For Federal Register citations affecting § 1308.14, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1308.15 Schedule V.

(a) Schedule V shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section.


(b) Narcotic drugs. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs and their salts, as set forth below:


(1) [Reserved]


(2) [Reserved]


(c) Narcotic drugs containing non-narcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as set forth below, which shall include one or more non-narcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by narcotic drugs alone:


(1) Not more than 200 milligrams of codeine per 100 milliliters or per 100 grams.


(2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or per 100 grams.


(3) Not more than 100 milligrams of ethylmorphine per 100 milliliters or per 100 grams.


(4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit.


(5) Not more than 100 milligrams of opium per 100 milliliters or per 100 grams.


(6) Not more than 0.5 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.


(d) Stimulants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers and salts of isomers:


(1) Pyrovalerone1485.
(2) [Reserved]

(e) Depressants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a depressant effect on the central nervous system, including its salts:


(1) Brivaracetam ((2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl] butanamide) (also referred to as BRV; UCB-34714; Briviact) (including its salts)2710
(2) Cenobamate ([(1R)-1-(2-chlorophenyl)-2-(tetrazol-2-yl)ethyl] carbamate; 2H-tetrazole-2-ethanol, alpha-(2-chlorophenyl)-, carbamate (ester), (alphaR)-; carbamic acid (R)-(+)-1-(2-chlorophenyl)-2-(2H-tetrazol-2-yl)ethyl ester)2720
(3) Ezogabine [N-[2-amino-4-(4-fluorobenzylamino)-phenyl]-carbamic acid ethyl ester]2779
(4) Ganaxolone (3α-hydroxy-3β-methyl-5α-pregnan-20-one)2401
(5) Lacosamide [(R)-2-acetoamido-N-benzyl-3-methoxy-propionamide]2746
(6) Lasmiditan [2,4,6-trifluoro-N-(6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]2790
(7) Pregabalin [(S)-3-(aminomethyl)-5-methylhexanoic acid]2782

[39 FR 22143, June 20, 1974, as amended at 43 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31, 2020; 85 FR 13746, Mar. 10, 2020; 85 FR 51645, Aug. 21, 2020; 87 FR 32996, June 1, 2022]


Excluded Nonnarcotic Substances

§ 1308.21 Application for exclusion of a nonnarcotic substance.

(a) Any person seeking to have any nonnarcotic drug that may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, excluded from any schedule, pursuant to section 201(g)(1) of the Act (21 U.S.C. 811(g)(1)), may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) An application for an exclusion under this section shall contain the following information:


(1) The name and address of the applicant;


(2) The name of the substance for which exclusion is sought; and


(3) The complete quantitative composition of the substance.


(c) Within a reasonable period of time after the receipt of an application for an exclusion under this section, the Administrator shall notify the applicant of his acceptance or nonacceptance of his application, and if not accepted, the reason therefore. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraph (b) of this section. If the application is accepted for filing, the Administrator shall issue and publish in the Federal Register his order on the application, which shall include a reference to the legal authority under which the order is issued and the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order within 60 days of the date of publication of his order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.


(d) The Administrator may at any time revoke any exclusion granted pursuant to section 201(g) of the Act (21 U.S.C. 811(g)) by following the procedures set forth in paragraph (c) of this section for handling an application for an exclusion which has been accepted for filing.


[38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1308.22 Excluded substances.

The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):


Excluded Nonnarcotic Products

Company
Trade name
NDC code
Form
Controlled substance
(mg or mg/ml)
Aphena Pharma Solutions – New York, LLCNasal Decongestant Inhaler/Vapor InhalerINLevmetamfetamine (l-Desoxyephedrine)50.00
Bioline LaboratoriesTheophed00719-1945TBPhenobarbital8.00
Goldline LaboratoriesGuiaphed Elixir00182-1377ELPhenobarbital4.00
Goldline LaboratoriesTedrigen Tablets00182-0134TBPhenobarbital8.00
Hawthorne Products IncChoate’s Leg FreezeLQChloral hydrate246.67
Parke-Davis & CoTedral00071-0230TBPhenobarbital8.00
Parke-Davis & CoTedral Elixir00071-0242EXPhenobarbital40.00
Parke-Davis & CoTedral S.A.00071-0231TBPhenobarbital8.00
Parke-Davis & CoTedral Suspension00071-0237SUPhenobarbital80.00
Parmed PharmacyAsma-Ese00349-2018TBPhenobarbital8.10
Procter & Gamble Co., TheVicks VapoInhaler37000-686-01INLevmetamfetamine (l-Desoxyephedrine)50.00
Rondex LabsAzma-Aids00367-3153TBPhenobarbital8.00
Smith Kline ConsumerBenzedrex49692-0928INPropylhexedrine250.00
Sterling Drug, IncBronkolixir00057-1004ELPhenobarbital0.80
Sterling Drug, IncBronkotabs00057-1005TBPhenobarbital8.00
White Hall LabsPrimatene (P-tablets)00573-2940TBPhenobarbital8.00

[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]


Exempt Chemical Preparations

§ 1308.23 Exemption of certain chemical preparations; application.

(a) The Administrator may, by regulation, exempt from the application of all or any part of the Act any chemical preparation or mixture containing one or more controlled substances listed in any schedule, which preparation or mixture is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or other animal, if the preparation or mixture either:


(1) Contains no narcotic controlled substance and is packaged in such a form or concentration that the packaged quantity does not present any significant potential for abuse (the type of packaging and the history of abuse of the same or similar preparations may be considered in determining the potential for abuse of the preparation or mixture); or


(2) Contains either a narcotic or nonnarcotic controlled substance and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion, or concentration, that the preparation or mixture does not present any potential for abuse. If the preparation or mixture contains a narcotic controlled substance, the preparation or mixture must be formulated in such a manner that it incorporates methods of denaturing or other means so that the preparation or mixture is not liable to be abused or have ill effects, if abused, and so that the narcotic substance cannot in practice be removed.


(b) Any person seeking to have any preparation or mixture containing a controlled substance and one or more noncontrolled substances exempted from the application of all or any part of the Act, pursuant to paragraph (a) of this section, may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(c) An application for an exemption under this section shall contain the following information:


(1) The name, address, and registration number, if any, of the applicant;


(2) The name, address, and registration number, if any, of the manufacturer or importer of the preparation or mixture, if not the applicant;


(3) The exact trade name or other designation of the preparation or mixture;


(4) The complete qualitative and quantitative composition of the preparation or mixture (including all active and inactive ingredients and all controlled and noncontrolled substances);


(5) The form of the immediate container in which the preparation or mixture will be distributed with sufficient descriptive detail to identify the preparation or mixture (e.g., bottle, packet, vial, soft plastic pillow, agar gel plate, etc.);


(6) The dimensions or capacity of the immediate container of the preparation or mixture;


(7) The label and labeling, as defined in part 1300 of this chapter, of the immediate container and the commercial containers, if any, of the preparation or mixture;


(8) A brief statement of the facts which the applicant believes justify the granting of an exemption under this paragraph, including information on the use to which the preparation or mixture will be put;


(9) The date of the application; and


(10) Which of the information submitted on the application, if any, is deemed by the applicant to be a trade secret or otherwise confidential and entitled to protection under subsection 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) or any other law restricting public disclosure of information.


(d) The Administrator may require the applicant to submit such documents or written statements of fact relevant to the application as he deems necessary to determine whether the application should be granted.


(e) Within a reasonable period of time after the receipt of an application for an exemption under this section, the Administrator shall notify the applicant of his acceptance or nonacceptance of his application, and if not accepted, the reason therefor. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (c) or requested pursuant to paragraph (d) is lacking or is not set forth as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraphs (c) and (d) of this section. If the application is accepted for filing, the Administrator shall issue and publish in the Federal Register his order on the application, which shall include a reference to the legal authority under which the order is based. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order within 60 days of the date of publication of his order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.


(f) The Administrator may at any time revoke or modify any exemption granted pursuant to this section by following the procedures set forth in paragraph (e) of this section for handling an application for an exemption which has been accepted for filing. The Administrator may also modify or revoke the criteria by which exemptions are granted (and thereby modify or revoke all preparations and mixtures granted under the old criteria) and modify the scope of exemptions at any time.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1308.24 Exempt chemical preparations.

(a) The chemical preparations and mixtures approved pursuant to § 1308.23 are exempt from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 825-829, 952-954) and § 1301.74 of this chapter, to the extent described in paragraphs (b) to (h) of this section. Substances set forth in paragraph (j) of this section shall be exempt from the application of sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 825-829, 952-954) and §§ 1301.71-1301.73 and 1301.74 (a), (b), (d), (e) and (f) of this chapter to the extent as hereinafter may be provided.


(b) Registration and security: Any person who manufactures an exempt chemical preparation or mixture must be registered under the Act and comply with all relevant security requirements regarding controlled substances being used in the manufacturing process until the preparation or mixture is in the form described in paragraph (i) of this section. Any other person who handles an exempt chemical preparation after it is in the form described in paragraph (i) of this section is not required to be registered under the Act to handle that preparation, and the preparation is not required to be stored in accordance with security requirements regarding controlled substances.


(c) Labeling: In lieu of the requirements set forth in part 1302 of this chapter, the label and the labeling of an exempt chemical preparation must be prominently marked with its full trade name or other description and the name of the manufacturer or supplier as set forth in paragraph (i) of this section, in such a way that the product can be readily identified as an exempt chemical preparation. The label and labeling must also include in a prominent manner the statement “For industrial use only” or “For chemical use only” or “For in vitro use only – not for human or animal use” or “Diagnostic reagent – for professional use only” or a comparable statement warning the person reading it that human or animal use is not intended. The symbol designating the schedule of the controlled substance is not required on either the label or the labeling of the exempt chemical preparation, nor is it necessary to list all ingredients of the preparation.


(d) Records and reports: Any person who manufactures an exempt chemical preparation or mixture must keep complete and accurate records and file all reports required under part 1304 of this chapter regarding all controlled substances being used in the manufacturing process until the preparation or mixture is in the form described in paragraph (i) of this section. In lieu of records and reports required under part 1304 of this chapter regarding exempt chemical preparations, the manufacturer need only record the name, address, and registration number, if any, of each person to whom the manufacturer distributes any exempt chemical preparation. Each importer or exporter of an exempt narcotic chemical preparation must submit a semiannual report of the total quantity of each substance imported or exported in each calendar half-year within 30 days of the close of the period to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Any other person who handles an exempt chemical preparation after it is in the form described in paragraph (i) of this section is not required to maintain records or file reports.


(e) Quotas, order forms, prescriptions, import, export, and transshipment requirements: Once an exempt chemical preparation is in the form described in paragraph (i) of this section, the requirements regarding quotas, order forms, prescriptions, import permits and declarations, export permit and declarations, and transshipment and intransit permits and declarations do not apply. These requirements do apply, however, to any controlled substances used in manufacturing the exempt chemical preparation before it is in the form described in paragraph (i) of this section.


(f) Criminal penalties: No exemption granted pursuant to § 1308.23 affects the criminal liability for illegal manufacture, distribution, or possession of controlled substances contained in the exempt chemical preparation. Distribution, possession, and use of an exempt chemical preparation are lawful for registrants and nonregistrants only as long as such distribution, possession, or use is intended for laboratory, industrial, or educational purposes and not for immediate or subsequent administration to a human being or other animal.


(g) Bulk materials: For materials exempted in bulk quantities, the Administrator may prescribe requirements other than those set forth in paragraphs (b) through (e) of this section on a case-by-case basis.


(h) Changes in chemical preparations: Any change in the quantitative or qualitative composition of the preparation or mixture after the date of application, or change in the trade name or other designation of the preparation or mixture, set forth in paragraph (i) of this section, requires a new application for exemption.


(i) A listing of exempt chemical preparations may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(j) The following substances are designated as exempt chemical preparations for the purposes set forth in this section.


(1) Chloral. When packaged in a sealed, oxygen-free environment, under nitrogen pressure, safeguarded against exposure to the air.


(2) Emit
R Phenobarbital Enzyme Reagent B. In one liter quantities each with a 5 ml. retention sample for repackaging as an exempt chemical preparation only.


[38 FR 8255, Mar. 30, 1973]


Editorial Note:For Federal Register citations affecting § 1308.24, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

Excluded Veterinary Anabolic Steroid Implant Products

§ 1308.25 Exclusion of a veterinary anabolic steroid implant product; application.

(a) Any person seeking to have any anabolic steroid product, which is expressly intended for administration through implants to cattle or other nonhuman species and which has been approved by the Secretary of Health and Human Services for such administration, identified as being excluded from any schedule, pursuant to section 102(41)(B)(i) of the Act (21 U.S.C. 802(41)(B)(i)), may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration . See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) An application for any exclusion under this section shall be submitted in triplicate and contain the following information:


(1) The name and address of the applicant;


(2) The name of the product;


(3) The chemical structural formula or description for any anabolic steroid contained in the product;


(4) A complete description of dosage and quantitative composition of the dosage form;.


(5) The conditions of use including whether or not Federal law restricts this product to use by or on the order of a licensed veterinarian;


(6) A description of the delivery system in which the dosage form will be distributed with sufficient detail to identify the product (e.g. 20 cartridge brown plastic belt);


(7) The label and labeling of the immediate container and the commercial containers, if any, of the product;.


(8) The name and address of the manufacturer of the dosage form if different from that of the applicant; and


(9) Evidence that the product has been approved by the Secretary of Health and Human Services for administration through implant to cattle or other nonhuman species.


(c) Within a reasonable period of time after the receipt of an application for an exclusion under this section, the Administrator shall notify the applicant of his acceptance or nonacceptance of the application, and if not accepted, the reason therefore. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth as to be readily understood. The applicant may amend the application to meet the requirements of paragraph (b) of this section. If the application is accepted for filing, the Administrator shall issue and have published in the Federal Register his order on the application, which shall include a reference to the legal authority under which the order is issued and the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it will take effect. The Administrator shall permit any interested person to file written comments on or objections to the order within 60 days of the date of publication in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.


(d) The Administrator may at any time revoke or modify any designation of excluded status granted pursuant to this section by following the procedures set forth in paragraph (c) of this section for handling an application for an exclusion which has been accepted for filing.


[56 FR 42936, Aug. 30, 1991, as amended at 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1308.26 Excluded veterinary anabolic steroid implant products.

(a) Products containing an anabolic steroid, that are expressly intended for administration through implants to cattle or other nonhuman species and which have been approved by the Secretary of Health and Human Services for such administration are excluded from all schedules pursuant to section 102(41)(B)(i) of the Act (21 U.S.C. 802(41)(B)(i)). A listing of the excluded products may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) In accordance with section 102(41)(B)(ii) of the Act (21 U.S.C. 802(41)(B)(ii)) if any person prescribes, dispenses, or distributes a product listed in paragraph (a) of this section for human use, such person shall be considered to have prescribed, dispensed, or distributed an anabolic steroid within the meaning of section 102(41)(A) of the Act (21 U.S.C. 802(41)(A)).


[56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, Mar. 9, 2010]


Exempted Prescription Products

§ 1308.31 Application for exemption of a nonnarcotic prescription product.

(a) Any person seeking to have any compound, mixture, or preparation containing any nonnarcotic controlled substance listed in § 1308.12(e), or in § 1308.13(b) or (c), or in § 1308.14, or in § 1308.15, exempted from application of all or any part of the Act pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A)) may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(b) An application for an exemption under this section shall contain the following information:


(1) The complete quantitative composition of the dosage form.


(2) Description of the unit dosage form together with complete labeling.


(3) A summary of the pharmacology of the product including animal investigations and clinical evaluations and studies, with emphasis on the psychic and/or physiological dependence liability (this must be done for each of the active ingredients separately and for the combination product).


(4) Details of synergisms and antagonisms among ingredients.


(5) Deterrent effects of the noncontrolled ingredients.


(6) Complete copies of all literature in support of claims.


(7) Reported instances of abuse.


(8) Reported and anticipated adverse effects.


(9) Number of dosage units produced for the past 2 years.


(c) Within a reasonable period of time after the receipt of an application for an exemption under this section, the Administrator shall notify the applicant of his acceptance or non-acceptance of the application, and if not accepted, the reason therefor. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the applicant desires, he may amend the application to meet the requirements of paragraph (b) of this section. If accepted for filing, the Administrator shall publish in the Federal Register general notice of this proposed rulemaking in granting or denying the application. Such notice shall include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule granting or denying an exemption, and, in the discretion of the Administrator, a summary of the subjects and issues involved. The Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice of proposed rule making the time during which such filings may be made. After consideration of the application and any comments on or objections to his proposed rulemaking, the Administrator shall issue and publish in the Federal Register his final order on the application, which shall set forth the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it shall take effect, which shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.


(d) The Administrator may revoke any exemption granted pursuant to section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following the procedures set forth in paragraph (c) of this section for handling an application for an exemption which has been accepted for filing.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1308.32 Exempted prescription products.

The compounds, mixtures, or preparations that contain a nonnarcotic controlled substance listed in § 1308.12(e) or in § 1308.13(b) or (c) or in § 1308.14 or in § 1308.15 listed in the Table of Exempted Prescription Products have been exempted by the Administrator from the application of sections 302 through 305, 307 through 309, and 1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and §§ 1301.13, 1301.22, and §§ 1301.71 through 1301.76 of this chapter for administrative purposes only. An exception to the above is that those products containing butalbital shall not be exempt from the requirement of 21 U.S.C. 952-954 concerning importation, exportation, transshipment and in-transit shipment of controlled substances. Any deviation from the quantitative composition of any of the listed drugs shall require a petition of exemption in order for the product to be exempted. A listing of the Exempted Prescription Products may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


[75 FR 10679, Mar. 9, 2010]


Exempt Anabolic Steroid Products

§ 1308.33 Exemption of certain anabolic steroid products; application.

(a) The Administrator, upon the recommendation of Secretary of Health and Human Services, may, by regulation, exempt from the application of all or any part of the Act any compound, mixture, or preparation containing an anabolic steroid as defined in part 1300 of this chapter, which is intended for administration to a human being or animal, if, because of its concentration, preparation, formulation, or delivery system, it has no significant potential for abuse.


(b) Any person seeking to have any compound, mixture, or preparation containing an anabolic steroid as defined in part 1300 of this chapter exempted from the application of all or any part of the Act, pursuant to paragraph (a) of this section, may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(c) An application for an exemption under this section shall be submitted in triplicate and contain the following information:


(1) The name and address of the applicant;


(2) The name of the product;


(3) The chemical structural formula or description for any anabolic steroid contained in the product;


(4) The complete description of dosage and quantitative composition of the dosage form;


(5) A description of the delivery system, if applicable;


(6) The indications and conditions for use in which species, including whether or not this product is a prescription drug;


(7) Information to facilitate identification of the dosage form, such as shape, color, coating, and scoring;


(8) The label and labeling of the immediate container and the commercial containers, if any, of the product;


(9) The units in which the dosage form is ordinarily available; and


(10) The facts which the applicant believes justify:


(i) A determination that the product has no significant potential for abuse and


(ii) a granting of an exemption under this section.


(d) Within a reasonable period of time after the receipt of the application for an exemption under this section, the Administrator shall notify the applicant of his acceptance or nonacceptance of the application, and if not accepted, the reason therefor. The Administrator need not accept an application for filing if any of the requirements prescribed in paragraph (c) of this section is lacking or is not set forth so as to be readily understood. The applicant may amend the application to meet the requirements of paragraph (c) of this section. If accepted for filing, the Administrator will request from the Secretary for Health and Human Services his recommendation, as to whether such product which contains an anabolic steroid should be considered for exemption from certain portions of the Controlled Substances Act. On receipt of the recommendation of the Secretary, the Administrator shall make a determination as to whether the evidence submitted or otherwise available sufficiently establishes that the product possesses no significant potential for abuse. The Administrator shall issue and publish in the Federal Register his order on the application, which shall include a reference to the legal authority under which the order is issued, and the findings of fact and conclusions of law upon which the order is based. This order shall specify the date on which it will take effect. The Administrator shall permit any interested person to file written comments on or objections to the order within 60 days of the date of publication of his order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.


(e) The Administrator may revoke any exemption granted pursuant to section 1903(a) of Public Law 101-647 by following the procedures set forth in paragraph (d) of this section for handling an application for an exemption which has been accepted for filing.


[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at 62 FR 13968, Mar. 24, 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1308.34 Exempt anabolic steroid products.

The list of compounds, mixtures, or preparations that contain an anabolic steroid that have been exempted by the Administrator from application of sections 302 through 309 and 1002 through 1004 of the Act (21 U.S.C. 822-829 and 952-954) and §§ 1301.13, 1301.22, and 1301.71 through 1301.76 of this chapter for administrative purposes only may be obtained by submitting a written request to the Drug and Chemical Evaluation Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


[75 FR 10679, Mar. 9, 2010]


Exempt Cannabis Plant Material, and Products Made Therefrom, that Contain Tetrahydrocannabinols

§ 1308.35 Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.

(a) Any processed plant material or animal feed mixture containing any amount of tetrahydrocannabinols (THC) that is both:


(1) Made from any portion of a plant of the genus Cannabis excluded from the definition of marijuana under the Act [i.e., the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination] and


(2) Not used, or intended for use, for human consumption, has been exempted by the Administrator from the application of the Act and this chapter.


(b) As used in this section, the following terms shall have the meanings specified:


(1) The term processed plant material means cannabis plant material that has been subject to industrial processes, or mixed with other ingredients, such that it cannot readily be converted into any form that can be used for human consumption.


(2) The term animal feed mixture means sterilized cannabis seeds mixed with other ingredients (not derived from the cannabis plant) in a formulation that is designed, marketed, and distributed for animal consumption (and not for human consumption).


(3) The term used for human consumption means either:


(i) Ingested orally or


(ii) Applied by any means such that THC enters the human body.


(4) The term intended for use for human consumption means any of the following:


(i) Designed by the manufacturer for human consumption;


(ii) Marketed for human consumption; or


(iii) Distributed, exported, or imported, with the intent that it be used for human consumption.


(c) In any proceeding arising under the Act or this chapter, the burden of going forward with the evidence that a material, compound, mixture, or preparation containing THC is exempt from control pursuant to this section shall be upon the person claiming such exemption, as set forth in section 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). In order to meet this burden with respect to a product or plant material that has not been expressly exempted from control by the Administrator pursuant to § 1308.23, the person claiming the exemption must present rigorous scientific evidence, including well-documented scientific studies by experts trained and qualified to evaluate the effects of drugs on humans.


[66 FR 51544, Oct. 9, 2001]


Hearings

§ 1308.41 Hearings generally.

In any case where the Administrator shall hold a hearing on the issuance, amendment, or repeal of rules pursuant to section 201 of the Act, the procedures for such hearing and accompanying proceedings shall be governed generally by the rulemaking procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by section 201 of the Act (21 U.S.C. 811), by §§ 1308.42-1308.51, and by §§ 1316.41-1316.67 of this chapter.


§ 1308.42 Purpose of hearing.

If requested by any interested person after proceedings are initiated pursuant to § 1308.43, the Administrator shall hold a hearing for the purpose of receiving factual evidence and expert opinion regarding the issues involved in the issuance, amendment or repeal of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law. Additional information relating to hearings to include waivers or modification of rules, request for hearing, burden of proof, time and place, and final order are set forth in part 1316 of this chapter.


[62 FR 13968, Mar. 24, 1997]


§ 1308.43 Initiation of proceedings for rulemaking.

(a) Any interested person may submit a petition to initiate proceedings for the issuance, amendment, or repeal of any rule or regulation issuable pursuant to the provisions of section 201 of the Act.


(b) Petitions shall be submitted in quintuplicate to the Administrator. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. Petitions shall be in the following form:



__________ (Date)

Administrator, Drug Enforcement Administration ______ (Mailing Address)

Dear Sir: The undersigned ________ hereby petitions the Administrator to initiate proceedings for the issuance (amendment or repeal) of a rule or regulation pursuant to section 201 of the Controlled Substances Act.


Attached hereto and constituting a part of this petition are the following:


(A) The proposed rule in the form proposed by the petitioner. (If the petitioner seeks the amendment or repeal of an existing rule, the existing rule, together with a reference to the section in the Code of Federal Regulations where it appears, should be included.)


(B) A statement of the grounds which the petitioner relies for the issuance (amendment or repeal) of the rule. (Such grounds shall include a reasonably concise statement of the facts relied upon by the petitioner, including a summary of any relevant medical or scientific evidence known to the petitioner.)


All notices to be sent regarding this petition should be addressed to:


__________ (Name)

__________ (Street Address)

__________ (City and State)

Respectfully yours,


__________ (Signature of petitioner)

(c) Within a reasonable period of time after the receipt of a petition, the Administrator shall notify the petitioner of his acceptance or nonacceptance of the petition, and if not accepted, the reason therefor. The Administrator need not accept a petition for filing if any of the requirements prescribed in paragraph (b) of this section is lacking or is not set forth so as to be readily understood. If the petitioner desires, he may amend the petition to meet the requirements of paragraph (b) of this section. If accepted for filing, a petition may be denied by the Administrator within a reasonable period of time thereafter if he finds the grounds upon which the petitioner relies are not sufficient to justify the initiation of proceedings.


(d) The Administrator shall, before initiating proceedings for the issuance, amendment, or repeal of any rule either to control a drug or other substance, or to transfer a drug or other substance from one schedule to another, or to remove a drug or other substance entirely from the schedules, and after gathering the necessary data, request from the Secretary a scientific and medical evaluation and the Secretary’s recommendations as to whether such drug or other substance should be so controlled, transferred, or removed as a controlled substance. The recommendations of the Secretary to the Administrator shall be binding on the Administrator as to such scientific and medical matters, and if the Secretary recommends that a drug or other substance not be controlled, the Administrator shall not control that drug or other substance.


(e) If the Administrator determines that the scientific and medical evaluation and recommendations of the Secretary and all other relevant data constitute substantial evidence of potential for abuse such as to warrant control or additional control over the drug or other substance, or substantial evidence that the drug or other substances should be subjected to lesser control or removed entirely from the schedules, he shall initiate proceedings for control, transfer, or removal as the case may be.


(f) If and when the Administrator determines to initiate proceedings, he shall publish in the Federal Register general notice of any proposed rule making to issue, amend, or repeal any rule pursuant to section 201 of the Act. Such published notice shall include a statement of the time, place, and nature of any hearings on the proposal in the event a hearing is requested pursuant to § 1308.44. Such hearings may not be commenced until after the expiration of at least 30 days from the date the general notice is published in the Federal Register. Such published notice shall also include a reference to the legal authority under which the rule is proposed, a statement of the proposed rule, and, in the discretion of the Administrator, a summary of the subjects and issues involved.


(g) The Administrator may permit any interested persons to file written comments on or objections to the proposal and shall designate in the notice of proposed rule making the time during which such filings may be made.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13968, Mar. 24, 1997; 75 FR 10679, Mar. 9, 2010]


§ 1308.44 Request for hearing or appearance; waiver.

(a) Any interested person desiring a hearing on a proposed rulemaking, shall, within 30 days after the date of publication of notice of the proposed rulemaking in the Federal Register, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.


(b) Any interested person desiring to participate in a hearing pursuant to § 1308.41 shall, within 30 days after the date of publication of the notice of hearing in the Federal Register, file with the Administrator a written notice of his intention to participate in such hearing in the form prescribed in § 1316.48 of this chapter. Any person filing a request for a hearing need not also file a notice of appearance; the request for a hearing shall be deemed to be a notice of appearance.


(c) Any interested person may, within the period permitted for filing a request for a hearing, file with the Administrator a waiver of an opportunity for a hearing or to participate in a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.


(d) If any interested person fails to file a request for a hearing; or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing or to participate in the hearing, unless he shows good cause for such failure.


(e) If all interested persons waive or are deemed to waive their opportunity for the hearing or to participate in the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to § 1308.45 without a hearing.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated and amended at 62 FR 13968, Mar. 24, 1997]


§ 1308.45 Final order.

As soon as practicable after the presiding officer has certified the record to the Administrator, the Administrator shall cause to be published in the Federal Register his order in the proceeding, which shall set forth the final rule and the findings of fact and conclusions of law upon which the rule is based. This order shall specify the date on which it shall take effect, which shall not be less than 30 days from the date of publication in the Federal Register unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997]


§ 1308.46 Control required under international treaty.

Pursuant to section 201(d) of the Act (21 U.S.C. 811(d)), where control of a substance is required by U.S. obligations under international treaties, conventions, or protocols in effect on May 1, 1971, the Administrator shall issue and publish in the Federal Register an order controlling such substance under the schedule he deems most appropriate to carry out obligations. Issuance of such an order shall be without regard to the findings required by subsections 201(a) or 202(b) of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the procedures prescribed by § 1308.41 or subsections 201 (a) and (b) of the Act (21 U.S.C. 811 (a) and (b)). An order controlling a substance shall become effective 30 days from the date of publication in the Federal Register, unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997]


§ 1308.47 Control of immediate precursors.

Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the Administrator may, without regard to the findings required by subsection 201(a) or 202 (b) of the Act (21 U.S.C. 811(a) or 812(b)) and without regard to the procedures prescribed by § 1308.41 or subsections 201 (a) and (b) of the Act (21 U.S.C. 811(a) and (b)), issue and publish in the Federal Register an order controlling an immediate precursor. The order shall designate the schedule in which the immediate precursor is to be placed, which shall be the same schedule in which the controlled substance of which it is an immediate precursor is placed or any other schedule with a higher numerical designation. An order controlling an immediate precursor shall become effective 30 days from the date of publication in the Federal Register, unless the Administrator finds that conditions of public health or safety necessitate an earlier effective date, in which event the Administrator shall specify in the order his findings as to such conditions.


[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesignated at 62 FR 13968, Mar. 24, 1997]


§ 1308.49 Temporary scheduling.

(a) Pursuant to 21 U.S.C. 811(h) and without regard to the requirements of 21 U.S.C. 811(b) relating to the scientific and medical evaluation of the Secretary of Health and Human Services, the Drug Enforcement Administration may place a substance into Schedule I on a temporary basis, if it determines that such action is necessary to avoid an imminent hazard to the public safety. An order issued under this section may not be effective before the expiration of 30 calendar days from:


(1) The date of publication by the Administration of a notice in the Federal Register of its intention to issue such order and the grounds upon which such order is to be issued; and


(2) The date the Administration has transmitted notification to the Secretary of Health and Human Services of the Administration’s intention to issue such order.


(b) An order issued under this section will be vacated upon the conclusion of a subsequent rulemaking proceeding initiated under section 201(a) (21 U.S.C. 811(a)) with respect to such substance or at the end of two years from the effective date of the order scheduling the substance, except that during the pendency of proceedings under section 201(a) (21 U.S.C. 811(a)) with respect to the substance, the Administration may extend the temporary scheduling for up to one year.


[81 FR 97021, Dec. 30, 2016]


PART 1309 – REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS


Authority:21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 877, 886a, 952, 953, 957, 958.


Source:60 FR 32454, June 22, 1995, unless otherwise noted.

General Information

§ 1309.01 Scope of part 1309.

Procedures governing the registration of manufacturers, distributors, importers and exporters of List I chemicals pursuant to Sections 102, 302, 303, 1007 and 1008 of the Act (21 U.S.C. 802, 822, 823, 957 and 958) are set forth generally by those sections and specifically by the sections of this part.


§ 1309.02 Definitions.

Any term used in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13968, Mar. 24, 1997]


§ 1309.03 Information; special instructions.

Information regarding procedures under these rules and instructions supplementing these rules will be furnished upon request by writing to the Registration Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


[75 FR 10680, Mar. 9, 2010]


Fees for Registration and Reregistration

§ 1309.11 Fee Amounts.

(a) For each application for registration or reregistration to manufacture for distribution the applicant shall pay an annual fee of $3,699.


(b) For each application for registration or reregistration to distribute (either retail distribution or non-retail distribution), import, or export a list I chemical, the applicant shall pay an annual fee of $1,850.


[85 FR 44734, July 24, 2020]


§ 1309.12 Time and method of payment; refund.

(a) For each application for registration or reregistration to manufacture, distribute, import, or export the applicant shall pay the fee when the application for registration or reregistration is submitted for filing online using the secure application portal at www.DEAdiversion.usdoj.gov.


(b) Payment shall be made online by Automated Clearing House funds transfer, by credit card, or by any other means made available at the time of submission using the secure application portal at www.DEAdiversion.usdoj.gov.


[87 FR 21022, Apr. 11, 2022]


Requirements for Registration

§ 1309.21 Persons required to register.

(a) Unless exempted by law or under §§ 1309.24 through 1309.26 or §§ 1310.12 through 1310.13 of this chapter, the following persons must annually obtain a registration specific to the List I chemicals to be handled:


(1) Every person who manufactures or imports or proposes to manufacture or import a List I chemical or a drug product containing ephedrine, pseudoephedrine, or phenylpropanolamine.


(2) Every person who distributes or exports or proposes to distribute or export any List I chemical, other than those List I chemicals contained in a product exempted under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter.


(b) Only persons actually engaged in the activities are required to obtain a registration; related or affiliated persons who are not engaged in the activities are not required to be registered. (For example, a stockholder or parent corporation of a corporation distributing List I chemicals is not required to obtain a registration.)


(c) The registration requirements are summarized in the following table:


Summary of Registration Requirements and Limitations

Business activity
Chemicals
DEA forms
Application fee
Registration period

(years)
Coincident activities allowed
(1) ManufacturingList I,

Drug products containing ephedrine, pseudoephedrine, phenylpropanolamine
New-510

Renewal-510a
3,6991May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
(2) DistributingList I,

Scheduled listed chemical products
New-510

Renewal-510a
1,8501
(3) ImportingList I,

Drug Products containing ephedrine, pseudoephedrine, phenylpropanolamine
New-510

Renewal-510a
1,8501May distribute that chemical for which registration was issued; may not distribute any chemical for which not registered.
(4) ExportingList I,

Scheduled listed chemical products
New-510

Renewal-510a
1,8501

[75 FR 4980, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 27, 2012; 77 FR 15250, Mar. 15, 2012; 85 FR 44734, July 24, 2020]


§ 1309.22 Separate registration for independent activities.

(a) The following groups of activities are deemed to be independent of each other:


(1) Manufacturing of List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine.


(2) Distributing of List I chemicals and scheduled listed chemical products.


(3) Importing List I chemicals or drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine.


(4) Exporting List I chemicals and scheduled listed chemical products.


(b) Except as provided in paragraphs (c) and (d) of this section, every person who engages in more than one group of independent activities must obtain a separate registration for each group of activities, unless otherwise exempted by the Act or §§ 1309.24 through 1309.26.


(c) A person registered to import any List I chemical shall be authorized to distribute that List I chemical after importation, but no other chemical that the person is not registered to import.


(d) A person registered to manufacture any List I chemical shall be authorized to distribute that List I chemical after manufacture, but no other chemical that the person is not registered to manufacture.


[75 FR 4981, Feb. 1, 2010]


§ 1309.23 Separate registration for separate locations.

(a) A separate registration is required for each principal place of business at one general physical location where List I chemicals are manufactured, distributed, imported, or exported by a person.


(b) The following locations shall be deemed to be places not subject to the registration requirement:


(1) A warehouse where List I chemicals are stored by or on behalf of a registered person, unless such chemicals are distributed directly from such warehouse to locations other than the registered location from which the chemicals were originally delivered; and


(2) An office used by agents of a registrant where sales of List I chemicals are solicited, made, or supervised but which neither contains such chemicals (other than chemicals for display purposes) nor serves as a distribution point for filling sales orders.


[60 FR 32454, June 22, 1995, as amended at 75 FR 4981, Feb. 1, 2010]


§ 1309.24 Waiver of registration requirement for certain activities.

(a) The requirement of registration is waived for any agent or employee of a person who is registered to engage in any group of independent activities, if the agent or employee is acting in the usual course of his or her business or employment.


(b) The requirement of registration is waived for any person who manufactures or distributes a scheduled listed chemical product or other product containing a List I chemical that is described and included in paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter, if that person is registered with the Administration to engage in the same activity with a controlled substance.


(c) The requirement of registration is waived for any person who imports or exports a scheduled listed chemical product or other product containing a List I chemical that is described and included in paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter, if that person is registered with the Administration to engage in the same activity with a controlled substance.


(d) The requirement of registration is waived for any person who only distributes a prescription drug product containing a List I chemical that is regulated pursuant to paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter.


(e) The requirement of registration is waived for any person whose activities with respect to List I chemicals are limited to the distribution of red phosphorus, white phosphorus, or hypophosphorous acid (and its salts) to another location operated by the same firm solely for internal end-use, or an EPA or State licensed waste treatment or disposal firm for the purpose of waste disposal.


(f) The requirement of registration is waived for any person whose distribution of red phosphorus or white phosphorus is limited solely to residual quantities of chemical returned to the producer, in reusable rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2,500 gallons in a single container).


(g) The requirement of registration is waived for any person whose activities with respect to List I chemicals are limited solely to the distribution of Lugol’s Solution (consisting of 5 percent iodine and 10 percent potassium iodide in an aqueous solution) in original manufacturer’s packaging of one fluid ounce (30 ml) or less.


(h) The requirement of registration is waived for any manufacturer of a List I chemical, if that chemical is produced solely for internal consumption by the manufacturer and there is no subsequent distribution or exportation of the List I chemical.


(i) If any person exempted under paragraph (b), (c), (d), (e), or (f) of this section also engages in the distribution, importation, or exportation of a List I chemical, other than as described in such paragraph, the person shall obtain a registration for the activities, as required by § 1309.21.


(j) The Administrator may, upon finding that continuation of the waiver would not be in the public interest, suspend or revoke a waiver granted under paragraph (b), (c), (d), (e), or (f) of this section pursuant to the procedures set forth in §§ 1309.43 through 1309.46 and §§ 1309.51 through 1309.55. In considering the revocation or suspension of a person’s waiver granted pursuant to paragraph (b) or (c) of this section, the Administrator shall also consider whether action to revoke or suspend the person’s controlled substance registration pursuant to section 304 of the Act (21 U.S.C. 824) is warranted.


(k) Any person exempted from the registration requirement under this section must comply with the security requirements set forth in §§ 1309.71 through 1309.73 and the recordkeeping and reporting requirements set forth under Parts 1310, 1313, 1314, and 1315 of this chapter.


[75 FR 4981, Feb. 1, 2010, as amended at 77 FR 4236, Jan. 25, 2012]


§ 1309.25 Temporary exemption from registration for chemical registration applicants.

(a) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a combination ephedrine product is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before July 12, 1997. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in this part 1309 and parts 1310, and 1313 of this chapter remain in full force and effect.


(b) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a pseudoephedrine or phenylpropanolamine drug product is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before October 3, 1997. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in this part 1309 and parts 1310 and 1313 of this chapter remain in full force and effect.


(c) Each person required by sections 302 or 1007 of the Act (21 U.S.C. 822 or 957) to obtain a registration to manufacture or import prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before March 3, 2010. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied the application. This exemption applies only to registration; all other chemical control requirements set forth in this part and parts 1310, 1313, and 1315 of this chapter remain in full force and effect.


[67 FR 14860, Mar. 28, 2002, as amended at 75 FR 4982, Feb. 1, 2010]


§ 1309.26 Exemption of law enforcement officials.

(a) The requirement of registration is waived for the following persons in the circumstances described in this section:


(1) Any officer or employee of the Administration, any customs officer, any officer or employee of the U.S. Food and Drug Administration, and any Federal or Insular officer who is lawfully engaged in the enforcement of any federal law relating to listed chemicals, controlled substances, drugs, or customs, and is duly authorized to possess and distribute List I chemicals in the course of his/her official duties; and


(2) Any officer or employee of any State, or any political subdivision or agency thereof, who is engaged in the enforcement of any State or local law relating to listed chemicals and controlled substances and is duly authorized to possess and distribute List I chemicals in the course of his official duties.


(b) Any official exempted by this section may, when acting in the course of official duties, possess any List I chemical and distribute any such chemical to any other official who is also exempted by this section and acting in the course of official duties.


[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]


Application for Registration

§ 1309.31 Time for application for registration; expiration date.

(a) Any person who is required to be registered and who is not so registered may apply for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is approved and a Certificate of Registration is issued by the Administrator to such person.


(b) Any person who is registered may apply to be reregistered not more than 60 days before the expiration date of his registration.


(c) At the time a person is first registered, that person shall be assigned to one of twelve groups, which shall correspond to the months of the year. The expiration date of the registrations of all registrants within any group will be the last day of the month designated for that group. In assigning any of the above persons to a group, the Administration may select a group the expiration date of which is less than one year from the date such business activity was registered. If the person is assigned to a group which has an expiration date less than eleven months from the date of which the person is registered, the registration shall not expire until one year from that expiration date; in all other cases, the registration shall expire on the expiration date following the date on which the person is registered.


§ 1309.32 Application forms; contents; signature.

(a) Any person who is required to be registered pursuant to § 1309.21 and is not so registered, shall apply on DEA Form 510 using the secure application portal at www.DEAdiversion.usdoj.gov.


(b) Any person who is registered pursuant to § 1309.21, shall apply for reregistration on DEA Form 510a using the secure application portal at www.DEAdiversion.usdoj.gov.


(c) DEA Forms 510 and 510a may be obtained online at www.DEAdiversion.usdoj.gov. DEA will send renewal notifications via email to registrants approximately calendar 60 days prior to their registration expiration date. Registrants are responsible for keeping their email address current in the secure application portal on DEA’s website throughout the duration of their registration. Only applications submitted online through the secure application portal on DEA’s website will be accepted for processing.


(d) Each application for registration must include the Administration Chemical Code Number, as set forth in § 1310.02 of this chapter, for each List I chemical to be manufactured, distributed, imported, or exported.


(e) Registration shall not entitle a person to engage in any activity with any List I chemical not specified in his or her application.


(f) Each application shall include all information called for in the form, unless the item is not applicable, in which case this fact shall be indicated.


(g) Each application, attachment, or other document filed as part of an application, shall be signed by the applicant, if an individual; by a partner of the applicant, if a partnership; or by an officer of the applicant, if a corporation, corporate division, association, trust or other entity. An applicant may authorize one or more individuals, who would not otherwise be authorized to do so, to sign applications for the applicant by filing with the application or other document a power of attorney for each such individual. The power of attorney shall be signed by a person who is authorized to sign applications under this paragraph and shall contain the signature of the individual being authorized to sign the application or other document. The power of attorney shall be valid until revoked by the applicant.


[60 FR 32454, June 22, 1995, as amended at 75 FR 10680, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016; 87 FR 21023, Apr. 11, 2022]


§ 1309.33 Filing of application; joint filings.

All applications for registration shall be submitted online at www.DEAdiversion.usdoj.gov for filing. The appropriate registration fee and any required attachments must accompany the application.


[87 FR 21023, Apr. 11, 2022]


§ 1309.34 Acceptance for filing; defective applications.

(a) Applications submitted for filing are dated upon receipt. If the application is found to be complete, the application will be accepted for filing. Applications failing to comply with the requirements of this part will not be accepted for filing.


(b) Accepting an application for filing does not preclude any subsequent request for additional information pursuant to § 1309.35 and has no bearing on whether the application will be granted.


[60 FR 32454, June 22, 1995, as amended at 87 FR 21023, Apr. 11, 2022]


§ 1309.35 Additional information.

The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he deems necessary to determine whether the application should be granted. The failure of the applicant to provide such documents or statements within a reasonable time after being requested to do so shall be deemed to be a waiver by the applicant of an opportunity to present such documents or facts for consideration by the Administrator in granting or denying the application.


§ 1309.36 Amendments to and withdrawals of applications.

(a) An application may be amended or withdrawn without permission of the Administration at any time before the date on which the applicant receives an order to show cause pursuant to § 1309.46. An application may be amended or withdrawn with permission of the Administrator at any time where good cause is shown by the applicant or where the amendment or withdrawal is in the public interest.


(b) After an application has been accepted for filing, the request by the applicant that it be returned or the failure of the applicant to respond to official correspondence regarding the application, including a request that the applicant submit the required fee, when sent by registered or certified mail, return receipt requested, shall be deemed to be a withdrawal of the application.


Action on Applications for Registration: Revocation or Suspension of Registration

§ 1309.41 Administrative review generally.

The Administrator may inspect, or cause to be inspected, the establishment of an applicant or registrant, pursuant to subpart A of part 1316 of this chapter. The Administrator shall review the application for registration and other information gathered by the Administrator regarding an applicant in order to determine whether the applicable standards of Section 303 of the Act (21 U.S.C. 823) have been met by the applicant.


§ 1309.42 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration (DEA Form 511) to an applicant if the issuance of registration or reregistration is required under the applicable provisions of section 303 of the Act (21 U.S.C. 823). In the event that the issuance of registration or reregistration is not required, the Administrator shall deny the application. Before denying any application, the Administrator shall issue an order to show cause pursuant to Section 1309.46 and, if requested by the applicant, shall hold a hearing on the application pursuant to § 1309.51.


(b) The Certificate of Registration (DEA Form 511) shall contain the name, address, and registration number of the registrant, the activity authorized by the registration, the amount of fee paid, and the expiration date of the registration. The registrant shall maintain the certificate of registration at the registered location in a readily retrievable manner and shall permit inspection of the certificate by any official, agent or employee of the Administration or of any Federal, State, or local agency engaged in enforcement of laws relating to List I chemicals or controlled substances.


§ 1309.43 Suspension or revocation of registration.

(a) The Administrator may suspend any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) for any period of time he determines.


(b) The Administrator may revoke any registration pursuant to section 304(a) of the Act (21 U.S.C. 824(a)).


(c) Before revoking or suspending any registration, the Administrator shall issue an order to show cause pursuant to Section 1309.46 and, if requested by the registrant, shall hold a hearing pursuant to Section 1309.51. Notwithstanding the requirements of this Section, however, the Administrator may suspend any registration pending a final order pursuant to § 1309.44.


(d) Upon service of the order of the Administrator suspending or revoking registration, the registrant shall immediately deliver his or her Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration, the registrant shall, as instructed by the Administrator:


(1) Deliver all List I chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, to the nearest office of the Administration or to authorized agents of the Administration; or


(2) Place all such List I chemicals in his or her possession under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).


(e) In the event that revocation or suspension is limited to a particular chemical or chemicals, the registrant shall be given a new Certificate of Registration for all substances not affected by such revocation or suspension; no fee shall be required for the new Certificate of Registration. The registrant shall deliver the old Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of the Administrator revoking or suspending registration with respect to a particular chemical or chemicals, the registrant shall, as instructed by the Administrator:


(1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular chemical or chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, which are affected by the revocation or suspension; or


(2) Place all of such chemicals under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).


[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]


§ 1309.44 Suspension of registration pending final order.

(a) The Administrator may suspend any registration simultaneously with or at any time subsequent to the service upon the registrant of an order to show cause why such registration should not be revoked or suspended, in any case where he finds that there is an imminent danger to the public health or safety. If the Administrator so suspends, he shall serve with the order to show cause pursuant to § 1309.46 an order of immediate suspension that shall contain a statement of his findings regarding the danger to public health or safety.


(b) Upon service of the order of immediate suspension, the registrant shall promptly return his Certificate of Registration to the nearest office of the Administration. Also, upon service of the order of immediate suspension, the registrant shall, as instructed by the Administrator:


(1) Deliver to the nearest office of the Administration or to authorized agents of the Administration all of the particular chemical or chemicals in his or her possession that were obtained under the authority of a registration or an exemption from registration granted by the Administrator by regulation, which are affected by the revocation or suspension; or


(2) Place all of such chemicals under seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).


(c) Any suspension shall continue in effect until the conclusion of all proceedings upon the revocation or suspension, including any judicial review thereof, unless sooner withdrawn by the Administrator or dissolved by a court of competent jurisdiction. Any registrant whose registration is suspended under this section may request a hearing on the revocation or suspension of his registration at a time earlier than specified in the order to show cause pursuant to Section 1309.46, which request shall be granted by the Administrator, who shall fix a date for such hearing as early as reasonably possible.


[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997]


§ 1309.45 Extension of registration pending final order.

In the event that an applicant for reregistration (who is doing business under a registration previously granted and not revoked or suspended) has applied for reregistration at least 45 days before the date on which the existing registration is due to expire, and the Administrator has issued no order on the application on the date on which the existing registration is due to expire, the existing registration of the applicant shall automatically be extended and continue in effect until the date on which the Administrator so issues his order. The Administrator may extend any other existing registration under the circumstances contemplated in this section even though the registrant failed to apply for reregistration at least 45 days before expiration of the existing registration, with or without request by the registrant, if the Administrator finds that such extension is not inconsistent with the public health and safety.


§ 1309.46 Order to show cause.

(a) If, upon examination of the application for registration from any applicant and other information gathered by the Administration regarding the applicant, the Administrator is unable to make the determinations required by the applicable provisions of section 303 of the Act (21 U.S.C. 823) to register the applicant, the Administrator shall serve upon the applicant an order to show cause why the application for registration should not be denied.


(b) If, upon information gathered by the Administration regarding any registrant, the Administrator determines that the registration of such registrant is subject to suspension or revocation pursuant to section 304 of the Act (21 U.S.C. 824), the Administrator shall serve upon the registrant an order to show cause why the registration should not be revoked or suspended.


(c) The order to show cause shall call upon the applicant or registrant to appear before the Administrator at a time and place stated in the order, which shall not be less than 30 days after the date of receipt of the order. The order to show cause shall also contain a statement of the legal basis for such hearing and for the denial, revocation, or suspension of registration and a summary of the matters of fact and law asserted.


(d) Upon Receipt of an order to show cause, the applicant or registrant must, if he desires a hearing, file a request for a hearing pursuant to § 1309.53. If a hearing is requested, the Administrator shall hold a hearing at the time and place stated in the order, pursuant to § 1309.51.


(e) When authorized by the Administrator, any agent of the Administration may serve the order to show cause.


[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]


Hearings

§ 1309.51 Hearings generally.

(a) In any case where the Administrator shall hold a hearing on any registration or application therefore, the procedures for such hearing shall be governed generally by the adjudication procedures set forth in the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by sections 303 and 304 of the Act (21 U.S.C. 823-824), by §§ 1309.52 through 1309.55, and by the procedures for administrative hearings under the Act set forth in §§ 1316.41 through 1316.67 of this chapter.


(b) Any hearing under this part shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under the Act or any other law of the United States.


[60 FR 32454, June 22, 1995, as amended at 81 FR 97021, Dec. 30, 2016]


§ 1309.52 Purpose of hearing.

If requested by a person entitled to a hearing, the Administrator shall hold a hearing for the purpose of receiving factual evidence regarding the issues involved in the denial, revocation, or suspension of any registration. Extensive argument should not be offered into evidence but rather presented in opening or closing statements of counsel or in memoranda or proposed findings of fact and conclusions of law.


§ 1309.53 Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to §§ 1309.42 and 1309.43 and desiring a hearing shall, within 30 days after the date of receipt of the order to show cause, file with the Administrator a written request for a hearing in the form prescribed in § 1316.47 of this chapter.


(b) Any person entitled to a hearing pursuant to §§ 1309.42 and 1309.43 may, within the period permitted for filing a request for a hearing, file with the Administrator a waiver of an opportunity for a hearing, together with a written statement regarding his position on the matters of fact and law involved in such hearing. Such statement, if admissible, shall be made a part of the record and shall be considered in light of the lack of opportunity for cross-examination in determining the weight to be attached to matters of fact asserted therein.


(c) If any person entitled to a hearing pursuant to §§ 1309.42 and 1309.43 fails to file a request for a hearing, or if he so files and fails to appear at the hearing, he shall be deemed to have waived his opportunity for the hearing, unless he shows good cause for such failure.


(d) If any person entitled to a hearing waives or is deemed to waive his or her opportunity for the hearing, the Administrator may cancel the hearing, if scheduled, and issue his final order pursuant to § 1309.57 without a hearing.


[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]


§ 1309.54 Burden of proof.

(a) At any hearing for the denial of a registration, the Administration shall have the burden of proving that the requirements for such registration pursuant to section 303 of the Act (21 U.S.C. 823) are not satisfied.


(b) At any hearing for the revocation or suspension of a registration, the Administration shall have the burden of proving that the requirements for such revocation or suspension pursuant to section 304(a) of the Act (21 U.S.C. 824(a)) are satisfied.


[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]


§ 1309.55 Time and place of hearing.

The hearing will commence at the place and time designated in the order to show cause or notice of hearing published in the Federal Register (unless expedited pursuant to Section 1309.44(c)) but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without notice other than announcement thereof by the presiding officer at the hearing.


[60 FR 32454, June 22, 1995. Redesignated at 62 FR 13968, Mar. 24, 1997]


Modification, Transfer and Termination of Registration

§ 1309.61 Modification in registration.

Any registrant may apply to modify his or her registration to authorize the handling of additional List I chemicals or to change his or her name or address, by submitting a letter of request to the Registration Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. The letter shall contain the registrant’s name, address, and registration number as printed on the certificate of registration, and the List I chemicals to be added to his registration or the new name or address and shall be signed in accordance with § 1309.32(g). No fee shall be required to be paid for the modification. The request for modification shall be handled in the same manner as an application for registration. If the modification in registration is approved, the Administrator shall issue a new certificate of registration (DEA Form 511) to the registrant, who shall maintain it with the old certificate of registration until expiration.


[75 FR 10680, Mar. 9, 2010]


§ 1309.62 Termination of registration.

(a) The registration of any person shall terminate, without any further action by the Administration, if and when such person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration. Any registrant who ceases legal existence or discontinues business or professional practice shall promptly notify the Special Agent in Charge of the Administration in the area in which the person is located of such fact and seek authority and instructions to dispose of any List I chemicals obtained under the authority of that registration. Any registrant who ceases legal existence or discontinues business or professional practice or wishes to surrender a registration shall notify the Special Agent in Charge of the Administration in the area in which the person is located of such fact and seek authority and instructions to dispose of any List I chemicals obtained under the authority of that registration.


(b) The Special Agent in Charge shall authorize and instruct the person to dispose of the List I chemical in one of the following manners:


(1) By transfer to person registered under the Act and authorized to possess the substances;


(2) By delivery to an agent of the Administration or to the nearest office of the Administration;


(3) By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized persons.


[60 FR 32454, June 22, 1995, as amended at 62 FR 5916, Feb. 10, 1997; 76 FR 61564, Oct. 5, 2011; 77 FR 4236, Jan. 27, 2012]


§ 1309.63 Transfer of registration.

No registration or any authority conferred thereby shall be assigned or otherwise transferred except upon such conditions as the Administrator may specifically designate and then only pursuant to his written consent.


Security Requirements

§ 1309.71 General security requirements.

(a) All applicants and registrants must provide effective controls and procedures to guard against theft and diversion of List I chemicals. Chemicals must be stored in containers sealed in such a manner as to indicate any attempts at tampering with the container. Where chemicals cannot be stored in sealed containers, access to the chemicals should be controlled through physical means or through human or electronic monitoring.


(b) In evaluating the effectiveness of security controls and procedures, the Administrator shall consider the following factors:


(1) The type, form, and quantity of List I chemicals handled;


(2) The location of the premises and the relationship such location bears on the security needs;


(3) The type of building construction comprising the facility and the general characteristics of the building or buildings;


(4) The availability of electronic detection and alarm systems;


(5) The extent of unsupervised public access to the facility;


(6) The adequacy of supervision over employees having access to List I chemicals;


(7) The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel in areas where List I chemicals are processed or stored; and


(8) The adequacy of the registrant’s or applicant’s systems for monitoring the receipt, distribution, and disposition of List I chemicals in its operations.


(c) Any registrant or applicant desiring to determine whether a proposed system of security controls and procedures is adequate may submit materials and plans regarding the proposed security controls and procedures either to the Special Agent in Charge in the region in which the security controls and procedures will be used, or to the Regulatory Section, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


[60 FR 32454, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 67 FR 14861, Mar. 28, 2002; 71 FR 56023, Sept. 26, 2006; 75 FR 10680, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]


§ 1309.72 Felony conviction; employer responsibilities.

(a) The registrant shall exercise caution in the consideration of employment of persons who will have access to listed chemicals, who have been convicted of a felony offense relating to controlled substances or listed chemicals, or who have, at any time, had an application for registration with the DEA denied, had a DEA registration revoked, or surrendered a DEA registration for cause. (For purposes of this subsection, the term “for cause” means a surrender in lieu of, or as a consequence of, any Federal or State administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances or listed chemicals.) The registrant should be aware of the circumstances regarding the action against the potential employee and the rehabilitative efforts following the action. The registrant shall assess the risks involved in employing such persons, including the potential for action against the registrant pursuant to § 1309.43, If such person is found to have diverted listed chemicals, and, in the event of employment, shall institute procedures to limit the potential for diversion of List I chemicals.


(b) It is the position of DEA that employees who possess, sell, use or divert listed chemicals or controlled substances will subject themselves not only to State or Federal prosecution for any illicit activity, but shall also immediately become the subject of independent action regarding their continued employment. The employer will assess the seriousness of the employee’s violation, the position of responsibility held by the employee, past record of employment, etc., in determining whether to suspend, transfer, terminate or take other action against the employee.


§ 1309.73 Employee responsibility to report diversion.

Reports of listed chemical diversion by fellow employees is not only a necessary part of an overall employee security program but also serves the public interest at large. It is, therefore, the position of DEA that an employee who has knowledge of diversion from his employer by a fellow employee has an obligation to report such information to a responsible security official of the employer. The employer shall treat such information as confidential and shall take all reasonable steps to protect the confidentiality of the information and the identity of the employee furnishing information. A failure to report information of chemical diversion will be considered in determining the feasibility of continuing to allow an employee to work in an area with access to chemicals. The employer shall inform all employees concerning this policy.


PART 1310 – RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES


Authority:21 U.S.C. 802, 827(h), 830, 871(b) 890.


Source:54 FR 31665, Aug. 1, 1989, unless otherwise noted.

§ 1310.01 Definitions.

Any term used in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[62 FR 13968, Mar. 24, 1997]


§ 1310.02 Substances covered.

The following chemicals have been specifically designated by the Administrator of the Drug Enforcement Administration as the listed chemicals subject to the provisions of this part and parts 1309 and 1313 of this chapter. Each chemical has been assigned the DEA Chemical Code Number set forth opposite it.


(a) List I chemicals


(1) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN)8512
(2) Anthranilic acid, its esters, and its salts8530
(3) Benzyl cyanide8735
(4) Ephedrine, its salts, optical isomers, and salts of optical isomers8113
(5) Ergonovine and its salts8675
(6) Ergotamine and its salts8676
(7) N-Acetylanthranilic acid, its esters, and its salts8522
(8) Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers8317
(9) Phenylacetic acid, its esters, and its salts8791
(10) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers1225
(11) Piperidine and its salts2704
(12) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers8112
(13) 3,4-Methylenedioxyphenyl-2-propanone8502
(14) Methylamine and its salts8520
(15) Ethylamine and its salts8678
(16) Propionic anhydride8328
(17) Isosafrole8704
(18) Safrole8323
(19) Piperonal8750
(20) N-Methylephedrine, its salts, optical isomers, and salts of optical isomers (N-Methylephedrine)8115
(21) N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers8119
(22) Hydriodic Acid6695
(23) Benzaldehyde8256
(24) Nitroethane6724
(25) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2 (3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)2011
(26) Red phosphorus6795
(27) White phosphorus (Other names: Yellow Phosphorus)6796
(28) Hypophosphorous acid and its salts (Including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite and sodium hypophosphite)6797
(29) N-phenethyl-4-piperidone (NPP)8332
(30) Iodine6699
(31) Ergocristine and its salts8612
(32)N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts8334
(33)N-phenylpiperidin-4-amine(4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), its amides, its carbamates, and its salts8335
(34) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers8535

(35) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers 8525
(36) Alpha-phenylacetoacetamide (APAA) and its optical isomers8515
(37) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers8795

(b) List II chemicals:


(1) Acetic anhydride8519
(2) Acetone6532
(3) Benzyl chloride8570
(4) Ethyl ether6584
(5) Potassium permanganate6579
(6) 2-Butanone (or Methyl Ethyl Ketone or MEK)6714
(7) Toluene6594
(8) Hydrochloric acid (including anhydrous hydrogen chloride)6545
(9) Sulfuric acid6552
(10) Methyl Isobutyl Ketone (MIBK)6715
(11) Sodium Permanganate6588

(c) The Administrator may add or delete a substance as a listed chemical by publishing a final rule in the Federal Register following a proposal which shall be published at least 30 days prior to the final rule.


(d) Any person may petition the Administrator to have any substance added or deleted from paragraphs (a) or (b) of this section.


(e) Any petition under this section shall contain the following information:


(1) The name and address of the petitioner;


(2) The name of the chemical to which the petition pertains;


(3) The name and address of the manufacturer(s) of the chemical (if known);


(4) A complete statement of the facts which the petitioner believes justifies the addition or deletion of the substance from paragraphs (a) or (b) of this section;


(5) The date of the petition.


(f) The Administrator may require the petitioner to submit such documents or written statements of fact relevant to the petition as he deems necessary in making a determination.


(g) Within a reasonable period of time after the receipt of the petition, the Administrator shall notify the petitioner of his decision and the reason therefor. The Administrator need not accept a petition if any of the requirements prescribed in paragraph (e) of this section or requested pursuant to paragraph (f) of this section are lacking or are not clearly set forth as to be readily understood. If the petitioner desires, he may amend and resubmit the petition to meet the requirements of paragraphs (e) and (f) of this section.


(h) If a petition is granted or the Administrator, upon his own motion, proposes to add or delete substances as listed chemicals as set forth in paragraph (c) of this section, he shall issue and publish in the Federal Register a proposal to add or delete a substance as a listed chemical. The Administrator shall permit any interested person to file written comments regarding the proposal within 30 days of the date of publication of his order in the Federal Register. The Administrator will consider any comments filed by interested persons and publish a final rule in accordance with his decision in the matter.


[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 48733, Sept. 26, 1991; 57 FR 43615, Sept. 22, 1992; 60 FR 19510, Apr. 19, 1995; 60 FR 32460, June 22, 1995; 62 FR 5917, Feb. 10, 1997; 65 FR 21647, Apr. 24, 2000; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 71 FR 60826, Oct. 17, 2006; 72 FR 20046, Apr. 23, 2007; 72 FR 35391, July 2, 2007; 72 FR 40238, July 24, 2007; 76 FR 17781, Mar. 31, 2011; 82 FR 32460, July 14, 2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24707, May 10, 2021; 86 FR 64366, Nov. 18, 2021]


§ 1310.03 Persons required to keep records and file reports.

(a) Each regulated person who engages in a regulated transaction involving a listed chemical, a tableting machine, or an encapsulating machine shall keep a record of the transaction as specified by § 1310.04 and file reports as specified by § 1310.05. However, a non-regulated person who acquires listed chemicals for internal consumption or “end use” and becomes a regulated person by virtue of infrequent or rare distribution of a listed chemical from inventory, shall not be required to maintain receipt records of listed chemicals under this section.


(b) Each regulated person who manufactures a List I or List II chemical shall file reports regarding such manufacture as specified in § 1310.05.


(c)(1) Each regulated person who engages in a transaction with a nonregulated person which:


(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma hydroxybutyric acid (including drug products containing these chemicals or controlled substance); and


(ii) Uses or attempts to use the U.S. Postal Service or any private or commercial carrier must, on a monthly basis, report to the Administration each such transaction conducted during the previous month as specified in §§ 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA Diversion Control Division secure network application.


(2) Each regulated person who engages in an export transaction which:


(i) Involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma hydroxybutyric acid (including drug products containing these chemicals or controlled substance); and


(ii) Uses or attempts to use the U.S. Postal Service or any private or commercial carrier must, on a monthly basis, report each such transaction conducted during the previous month as specified in §§ 1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA Diversion Control Division secure network application.


[54 FR 31665, Aug. 1, 1989, as amended at 56 FR 8277, Feb. 28, 1991; 61 FR 14023, Mar. 29, 1996; 67 FR 14861, Mar. 28, 2002; 68 FR 57804, Oct. 7, 2003; 70 FR 294, Jan. 4, 2005; 81 FR 97022, Dec. 30, 2016]


§ 1310.04 Maintenance of records.

(a) Every record required to be kept subject to § 1310.03 for a List I chemical, a tableting machine, or an encapsulating machine shall be kept by the regulated person for 2 years after the date of the transaction.


(b) Every record required to be kept subject to Section 1310.03 for List II chemical shall be kept by the regulated person for two years after the date of the transaction.


(c) A record under this section shall be kept at the regulated person’s place of business where the transaction occurred, except that records may be kept at a single, central location of the regulated person if the regulated person has notified the Administration of the intention to do so. Written notification must be submitted by registered or certified mail, return receipt requested, to the Special Agent in Charge of the DEA Divisional Office for the area in which the records are required to be kept.


(d) The records required to be kept under this section shall be readily retrievable and available for inspection and copying by authorized employees of the Administration under the provisions of 21 U.S.C. 880.


(e) The regulated person with more than one place of business where records are required to be kept shall devise a system to detect any party purchasing from several individual locations of the regulated person thereby seeking to avoid the application of the cumulative threshold or evading the requirements of the Act.


(f) For those listed chemicals for which thresholds have been established, the quantitative threshold or the cumulative amount for multiple transactions within a calendar month, to be utilized in determining whether a receipt, sale, importation or exportation is a regulated transaction is as follows:


(1) List I chemicals:


(i) Except as provided in paragraph (f)(1)(ii) of this section, the following thresholds have been established for List I chemicals.


Code
Chemical
Threshold by base weight
8522N-Acetylanthranilic acid, its esters, and its salts40 kilograms.
8530Anthranilic acid, its esters, and its salts30 kilograms.
8256Benzaldehyde4 kilograms.
8735Benzyl cyanide1 kilogram.
8675Ergonovine and its salts10 grams.
8676Ergotamine and its salts20 grams.
8678Ethylamine and its salts1 kilogram.
6695Hydriodic acid1.7 kilograms (or 1 liter by volume).
8704Isosafrole4 kilograms.
8520Methylamine and its salts1 kilogram.
85023,4-Methylenedioxyphenyl-2-propanone4 kilograms.
8115N-Methylephedrine, its salts, optical isomers, and salts of optical isomers1 kilogram.
8119N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers1 kilogram.
6724Nitroethane2.5 kilograms.
8317Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers2.5 kilograms.
8791Phenylacetic acid, its esters, and its salts1 kilogram.
2704Piperidine and its salts500 grams.
8750Piperonal (also called heliotropine)4 kilograms.
8328Propionic anhydride1 gram.
8323Safrole4 kilograms.

(ii) For List I chemicals that are contained in scheduled listed chemical products as defined in § 1300.02 of this chapter, the thresholds established in paragraph (g) of this section apply only to non-retail distribution, import, and export. Sales of these products at retail are subject to the requirements of part 1314 of this chapter.


(2) List II Chemicals:


(i) Imports and Exports


Chemical
Threshold by volume
Threshold by weight
(A) Acetic anhydride250 gallons1,023 kilograms.
(B) Acetone500 gallons1,500 kilograms.
(C) Benzyl chlorideN/A4 kilograms.
(D) Ethyl ether500 gallons1,364 kilograms.
(E) Potassium permanganateN/A500 kilograms.
(F) 2-Butanone (MEK)500 gallons1,455 kilograms.
(G) Toluene500 gallons1,591 kilograms.
(H) Sodium permanganateN/A500 kilograms

(ii) Domestic Sales


Chemical
Threshold by volume
Threshold by weight
(A) Acetic anhydride250 gallons1,023 kilograms.
(B) Acetone50 gallons150 kilograms.
(C) Benzyl chlorideN/A1 kilogram.
(D) Ethyl ether50 gallons135.8 kilograms.
(E) Potassium permanganateN/A55 kilograms.
(F) 2-Butanone (MEK)50 gallons145 kilograms.
(G) Toluene50 gallons159 kilograms.
(H) Anhydrous Hydrogen chlorideN/A0.0 kilograms.
(I) Sodium permanganateN/A55 kilograms

(iii) The cumulative threshold is not applicable to domestic sales of Acetone, 2-Butanone (MEK), and Toluene.


(iv) Exports, Transshipments and International Transactions to Designated Countries as Set Forth in § 1310.08(b).


Chemical
Threshold by

volume
Threshold by weight
(A) Hydrochloric acid50 gallons
(1) Anhydrous Hydrogen chloride27 kilograms.
(B) Sulfuric acid50 gallons

(v) Export and International Transactions to Designated Countries, and Importations for Transshipment or Transfer to Designated Countries


Chemical
Threshold by volume
Threshold by weight
(A) Methyl Isobutyl Ketone (MIBK)500 gallons1523 kilograms.
(B) Reserved.

(g) For listed chemicals for which no thresholds have been established, the size of the transaction is not a factor in determining whether the transaction meets the definition of a regulated transaction as set forth in § 1300.02 of this chapter. All such transactions, regardless of size, are subject to recordkeeping and reporting requirements as set forth in this part and notification provisions as set forth in part 1313 of this chapter.


(1) Listed chemicals for which no thresholds have been established:


(i) Alpha-phenylacetoacetamide (APAA) and its optical isomers


(ii) Alpha-phenylacetoacetonitrile and its salts, optical isomers, and salts of optical isomers (APAAN)


(iii) Ephedrine, its salts, optical isomers, and salts of optical isomers;


(iv) Ergocristine and its salts


(v) Gamma-Butyrolactone (Other names include: GBL; Dihydro-2(3H)-furanone; 1,2-Butanolide; 1,4-Butanolide; 4-Hydroxybutanoic acid lactone; gamma-hydroxybutyric acid lactone)


(vi) Hypophosphorous acid and its salts (including ammonium hypophosphite, calcium hypophosphite, iron hypophosphite, potassium hypophosphite, manganese hypophosphite, magnesium hypophosphite, and sodium hypophosphite)


(vii) Iodine


(viii) 3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers


(ix) 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers


(x) methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers


(xi) N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts


(xii) N-phenethyl-4-piperidone (NPP)


(xiii) N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), its amides, its carbamates, and its salts


(xiv) Pseudoephedrine, its salts, optical isomers, and salts of optical isomers


(xv) Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers


(xvi) Red phosphorus


(xvii) White phosphorus (Other names: Yellow Phosphorus)


(2) [Reserved]


(h) The thresholds and conditions in paragraphs (f) and (g) of this section will apply to transactions involving regulated chemical mixtures. For purposes of determining whether the weight or volume of a chemical mixture meets or exceeds the applicable quantitative threshold, the following rules apply:


(1) For chemical mixtures containing List I chemicals or List II chemicals other than those in paragraph (h)(2) of this section, the threshold is determined by the weight of the listed chemical in the chemical mixture.


(2) For the List II chemicals acetone, ethyl ether, 2-butanone, toluene, and methyl isobutyl ketone, the threshold is determined by the weight of the entire chemical mixture.


(3) If two or more listed chemicals are present in a chemical mixture, and the quantity of any of these chemicals equals or exceeds the threshold applicable to that chemical, then the transaction is regulated.


[54 FR 31665, Aug. 1, 1989]


Editorial Note:For Federal Register citations affecting § 1310.04, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

§ 1310.05 Reports.

(a)(1) Each regulated person must report to the Special Agent in Charge of the DEA Divisional Office for the area in which the regulated person making the report is located any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this part. The regulated person will orally report to the Special Agent in Charge of the DEA Divisional Office at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved and as much in advance of the conclusion of the transaction as possible. The regulated person must file a written report of the transaction(s) with the Special Agent in Charge of the DEA Divisional Office as set forth in § 1310.06 within 15 calendar days after the regulated person becomes aware of the circumstances of the event.


(2) Each regulated person must report to the Special Agent in Charge of the DEA Divisional Office for the area in which the regulated person making the report is located any proposed regulated transaction with a person whose description or other identifying characteristic the Administration has previously furnished to the regulated person. The regulated person will orally report to the Special Agent in Charge of the DEA Divisional Office at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved. A transaction may not be completed with a person whose description or identifying characteristic has previously been furnished to the regulated person by the Administration unless the transaction is approved by the Administration.


(b)(1) Each regulated person must report to the Special Agent in Charge of the DEA Divisional Office for the area in which the regulated person making the report is located any unusual or excessive loss or disappearance of a listed chemical under the control of the regulated person. The regulated person will orally report to the Special Agent in Charge of the DEA Divisional Office at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved. Unless the loss or disappearance occurs during an import or export transaction, the supplier is responsible for reporting all in-transit losses of any listed chemical by their agent or the common or contract carrier. In an import transaction, once a shipment has been released by the customs officer at the port of entry, the importer is responsible for reporting all in-transit losses of any listed chemical by their agent or the common or contract carrier. In an export transaction, the exporter is responsible for reporting all in-transit losses of any listed chemical by their agent or the common or contract carrier until the shipment has been released by the customs officer at the port of export. The regulated person must also file a complete and accurate DEA Form 107, in accordance with § 1310.06(d), with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after becoming aware of the circumstances requiring the report. Unusual or excessive losses or disappearances must be reported whether or not the listed chemical is subsequently recovered or the responsible parties are identified and action taken against them. When determining whether a loss or disappearance of a listed chemical was unusual or excessive, the regulated persons should consider, among others, the following factors:


(i) The actual quantity of a listed chemical;


(ii) The specific listed chemical involved;


(iii) Whether the loss or disappearance of the listed chemical can be associated with access to those listed chemicals by specific individuals, or whether the loss or disappearance can be attributed to unique activities that may take place involving the listed chemical; and


(iv) A pattern of losses or disappearances over a specific time period, whether the losses or disappearances appear to be random, and the result of efforts taken to resolve the losses.


(v) If known, the regulated person should also consider whether the specific listed chemical was a likely candidate for diversion as well as local trends and other indicators of the diversion potential of the listed chemical.


(2) Each regulated person must orally report any domestic regulated transaction in a tableting machine or an encapsulating machine to the Special Agent in Charge of the DEA Divisional Office for the area in which the regulated person making the report is located when the order is placed with the seller. The regulated person also must file a report of the transaction (on DEA Form 452) with the Administration through the DEA Diversion Control Division secure network application within 15 calendar days after the order has been shipped by the seller. A report (DEA Form 452) may list more than one machine for a single transaction. Upon receipt and review, the Administration will assign a completed report a transaction identification number. The report will not be deemed filed until a transaction identification number has been issued by the Administration.


(c) Imports and exports of tableting machines and encapsulating machines. (1) Each regulated person who imports or exports a tableting machine, or encapsulating machine, must file a report of such importation or exportation on DEA Form 452 with the Administration through the DEA Diversion Control Division secure network application, at least 15 calendar days before the anticipated arrival at the port of entry or port of export. In order to facilitate the importation or exportation of any tableting machine or encapsulating machine and implement the purpose of the Act, regulated persons may report to the Administration as far in advance as possible. A separate report (DEA Form 452) must be filed for each shipment, in accordance with § 1310.06(e). Upon receipt and review, the Administration will assign a completed report a transaction identification number. The report will not be deemed filed until a transaction identification number has been issued by the Administration. The importer or exporter may only proceed with the transaction once the transaction identification number has been issued. Any tableting machine or encapsulating machine may be imported or exported if that machine is needed for medical, commercial, scientific, or other legitimate uses. However, an importation or exportation of a tableting machine or encapsulating machine may not be completed with a person whose description or identifying characteristic has previously been furnished to the regulated person by the Administration unless the transaction is approved by the Administration.


(2) Denied release at the port of entry. In the event that a shipment of tableting or encapsulating machine(s) has been denied release by a customs officer at the port of entry for any reason, the importer who attempted to import the shipment must, within 5 business days of the denial, report to the Administration that the shipment was denied, the basis for denial, and such other information as is required by § 1310.06(g). Such report must be transmitted to the Administration through the DEA Diversion Control Division secure network application. Upon the importer’s report of a denied entry, DEA will assign the report a transaction identification number and the original import notification will be void and of no effect. No shipment of tableting machines or encapsulating machines denied entry for any reason will be allowed entry without a subsequent refiling of an amended DEA Form 452 by the regulated person. In such circumstances, the regulated person may proceed with the release of the tableting machines or encapsulating machines upon receipt of a transaction identification number for the refiled and amended DEA Form 452 without regard to the 15-day advance filing requirement in paragraph (c)(1) of this section, so long as the article is otherwise cleared for entry under U.S. customs laws.


(d) Each regulated bulk manufacturer of a listed chemical must submit manufacturing, inventory and use data on an annual basis as set forth in § 1310.06(j). This data must be submitted annually to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration, on or before the 15th day of March of the year immediately following the calendar year for which submitted. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A business entity which manufactures a listed chemical may elect to report separately by individual location or report as an aggregate amount for the entire business entity provided that they inform the DEA of which method they will use. This reporting requirement does not apply to drugs or other products that are exempted under paragraph (1)(iv) or (v) of the definition of regulated transaction in § 1300.02 of this chapter except as set forth in § 1310.06(i)(5). Bulk manufacturers that produce a listed chemical solely for internal consumption are not required to report for that listed chemical. For purposes of these reporting requirements, internal consumption consists of any quantity of a listed chemical otherwise not available for further resale or distribution. Internal consumption includes (but is not limited to) quantities used for quality control testing, quantities consumed in-house, or production losses. Internal consumption does not include the quantities of a listed chemical consumed in the production of exempted products. If an existing standard industry report contains the information required in § 1310.06(j) and such information is separate or readily retrievable from the report, that report may be submitted in satisfaction of this requirement. Each report must be submitted to the DEA under company letterhead and signed by an appropriate, responsible official. For purposes of this paragraph (d) only, the term regulated bulk manufacturer of a listed chemical means a person who manufactures a listed chemical by means of chemical synthesis or by extraction from other substances. The term bulk manufacturer does not include persons whose sole activity consists of the repackaging or relabeling of listed chemical products or the manufacture of drug dosage forms of products which contain a listed chemical.


(e) Each regulated person required to report pursuant to § 1310.03(c) must file a report containing the transaction identification number for each such transaction (if the regulated person is required to obtain a transaction identification number under part 1313

of this chapter) and information set forth in § 1310.06(k), on or before the 15th day of each month following the month in which the distributions took place.


(f) Except as provided in paragraph (g) of this section, the following distributions to nonregulated persons, and the following export transactions, are not subject to the reporting requirements in § 1310.03(c):


(1) Distributions of sample packages of drug products when those packages contain not more than two solid dosage units or the equivalent of two dosage units in liquid form, not to exceed 10 milliliters of liquid per package, and not more than one package is distributed to an individual or residential address in any 30-day period.


(2) Distributions of drug products by retail distributors that may not include face-to-face transactions to the extent that such distributions are consistent with the activities authorized for a retail distributor as defined in § 1300.02 of this chapter, except that this paragraph does not apply to sales of scheduled listed chemical products at retail.


(3) Distributions of drug products to a resident of a long term care facility or distributions of drug products to a long term care facility for dispensing to or for use by a resident of that facility.


(4) Distributions of drug products in accordance with a valid prescription.


(5) Exports which have been reported to the Administrator under §§ 1313.31 and 1313.32 of this chapter or which are subject to a waiver granted under § 1313.21 of this chapter.


(g) The Administrator may revoke any or all of the exemptions listed in paragraph (f) of this section for an individual regulated person if the Administrator finds that drug products distributed by the regulated person are being used in violation of the regulations in this chapter or the Controlled Substances Act. The Administrator will notify the regulated person of the revocation, as provided in § 1313.41(a) of this chapter. The revocation will be effective upon receipt of the notice by the person. The regulated person has the right to an expedited hearing regarding the revocation, as provided in § 1313.56(a) of this chapter.


[54 FR 31665, Aug. 1, 1989, as amended at 57 FR 2461, Jan. 22, 1992; 61 FR 14024, Mar. 29, 1996; 61 FR 17958, Apr. 23, 1996; 62 FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 67 FR 49569, July 31, 2002; 68 FR 57804, Oct. 7, 2003; 71 FR 56024, Sept. 26, 2006; 75 FR 10680, Mar. 9, 2010; 77 FR 4236, Jan. 27, 2012; 81 FR 97022, Dec. 30, 2016]


§ 1310.06 Content of records and reports.

(a) Each record required by § 1310.03(a) must include the following:


(1) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address (es), etc.), and, if required, DEA registration number of each party to the regulated transaction.


(2) The date of the regulated transaction.


(3) The quantity, chemical name, and, if applicable, National Drug Code (NDC) number. If NDC number is not applicable, the form of packaging of the listed chemical or a description of the tableting machine or encapsulating machine (including make, model, serial number, if any, and whether the machine is manual or electric).


(4) The method of transfer (company truck, picked up by customer, etc.).


(5) The type of identification used by the purchaser and any unique number on that identification.


(b) For purposes of this section, normal business records will be considered adequate if they contain the information listed in paragraph (a) of this section and are readily retrievable from other business records of the regulated person. For prescription drug products, prescription and hospital records kept in the normal course of medical treatment will be considered adequate for satisfying the requirements of paragraph (a) of this section with respect to dispensing to patients, and records required to be maintained pursuant to the U.S. Food and Drug Administration regulations relating to the distribution of prescription drugs, as set forth in 21 CFR part 205, will be considered adequate for satisfying the requirements of paragraph (a) of this section with respect to distributions.


(c)(1) Each report required by § 1310.05(a) must include the information as specified by paragraph (a) of this section, the basis for making the report, and, where obtainable, the registration number of the other party, if such party is registered. A report of an uncommon method of payment or delivery submitted in accordance with § 1310.05(a)(1) must also include a reason why the method of payment or delivery was uncommon.


(2) A suggested format for the reports in § 1310.05(a)(1) is provided below:



Shipping Address (if different than purchaser Address):


Street

City

State

Zip

Date of Shipment

Description of Listed Chemical:


Chemical Name

Quantity

National Drug Code (NDC) Number(s), or Form(s) of Packaging

Other:


The basis (i.e., reason) for making the report:

Any additional pertinent information:

(d) Each report of an unusual or excessive loss or disappearance of a listed chemical required by § 1310.05(b)(1) (on DEA Form 107), must include the following information:


(1) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address (es), etc.), and, if applicable, DEA registration number of each party to the regulated transaction.


(2) The date (or estimated date) on which unusual or excessive loss or disappearance occurred, and the actual date on which the unusual or excessive loss or disappearance was discovered by the regulated person.


(3) The quantity, chemical name, and National Drug Code (NDC) number, if applicable or if not the form of packaging of the listed chemical.


(4) The type of business conducted by the regulated person, (e.g., grocery store, pharmacy/drug store, discount department store, warehouse club or superstore, convenience store, specialty food store, gas station, mobile retail vendor, mail-order, etc.) if the regulated person is not a DEA registrant.


(e)(1) Each report of an importation of a tableting machine or an encapsulating machine required by § 1310.05(c)(1) (on DEA Form 452) must include the following information:


(i) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the regulated person; the name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the import broker or forwarding agent, if any;


(ii) A description of each machine (including make, model, serial number, if any, and whether the machine is manual or electric) and the number of machines being received;


(iii) The anticipated date of arrival at the port of entry, and the anticipated port of entry;


(iv) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the consignor in the foreign country of exportation;


(v) The intended medical, commercial, scientific, or other legitimate use of the machine; and


(vi) Any proposed changes in identifying information of the imported machines (e.g., name, brand, serial number, if any, etc.) that will take place after importation.


(2) Each report of an exportation of a tableting machine or an encapsulating machine required by § 1310.05(c)(1) (on DEA Form 452) must include the following information:


(i) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the regulated person; the name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the export broker (if applicable);


(ii) A description of each machine (including make, model, serial number, if any, and whether the machine is manual or electric) and the number of machines being received;


(iii) The anticipated date of arrival at the port of export, the foreign port and country of entry; and


(iv) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the consignee in the country where the shipment is destined; the name(s)/business name(s) and address(es)/business address(es), and contact information (e.g., telephone number(s), email address(es), etc.) of the intermediate consignee(s) (if any).


(f) Each report of a domestic regulated transaction in a tableting machine or encapsulating machine required by § 1310.05(b)(2) (on DEA Form 452) must include the following information:


(1) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the regulated person; the name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) of the purchaser;


(2) A description of each machine (including make, model, serial number, if any, and whether the machine is manual or electric) and the number of machines being received; and


(3) Any changes made by the regulated person in identifying information of the machines (e.g., name, brand, serial number, etc.).


(g) Each report of a denied release by a customs officer at the port of entry of a tableting machine or an encapsulating machine required by § 1310.05(c)(2) must include the following information: the quantity of machines denied release; a concise description of the machines denied release; the date on which release was denied; the port where the denial of release was issued from; and the basis for the denial.


(h) Return information. (1) Within 30 calendar days after actual receipt of a tableting or encapsulating machine, or within 10 calendar days after receipt of a written request by the Administration to the importer, whichever is sooner, the importer must file a report with the Administration (on DEA Form 452) specifying the particulars of the transaction utilizing the DEA Diversion Control Division secure network application. This report must include the following information: The date on which a customs officer at the port of entry released the machine(s); the date on which the machine(s) arrived at the final destination; the port of entry where the machine(s) were actually released by a customs officer; the actual quantity of machines released by a customs officer; the actual quantity of machines that arrived at the final destination; a description of each tableting or encapsulating machine imported (including make, model, and serial number, if any); any changes in identifying information of the imported machines (e.g., name, brand, serial number, if any, etc.) that will take place after importation; and any other information as the Administration may from time to time specify. Upon receipt and review, the Administration will assign a transaction identification number to a completed report. The report will not be deemed filed until the Administration has issued a transaction identification number. A single return declaration may include the particulars of both the importation and distribution. For DEA reporting purposes, import responsibilities are concluded upon the receipt of the machines by the importer. Once machines are received by the importer, domestic transaction reporting requirements commence. Distributions of tableting and encapsulating machines from the importer to their customers must be reported as domestic regulated transactions in accordance with § 1310.05(b)(2).


(2) Within 30 calendar days after the tableting or encapsulating machine is released by a customs officer at the port of export, or within 10 calendar days after receipt of a written request by the Administration to the exporter, whichever is sooner, the exporter must file a report with the Administration (on DEA Form 452) through the DEA Diversion Control Division secure network application specifying the particulars of the transaction. This report must include the following information: The date on which the machine(s) was (were) released by a customs officer at the port of export; the actual quantity of machines released; a description of each tableting or encapsulating machine released (including make, model, serial number, if any, and whether the machine is manual or electric); and any other information as the Administration may from time to time specify.


(i) Declared exports of machines which are refused, rejected, or otherwise deemed undeliverable may be returned to the U.S. exporter of record. A brief written report outlining the circumstances must be filed with the Administration through the DEA Diversion Control Division secure network application, following the return at the earliest practicable opportunity after the regulated person becomes aware of the circumstances involved. This provision does not apply to shipments that have cleared foreign customs, been delivered, and accepted by the foreign consignee. Returns to third parties in the United States will be regarded as imports.


(j) Each annual report required by § 1310.05(d) must provide the following information for each listed chemical manufactured:


(1) The name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) and chemical registration number (if any) of the manufacturer.


(2) The aggregate quantity of each listed chemical that the company manufactured during the preceding calendar year.


(3) The year-end inventory of each listed chemical as of the close of business on the 31st day of December of each year. (For each listed chemical, if the prior period’s ending inventory has not previously been reported to DEA, this report should also detail the beginning inventory for the period.) For purposes of this requirement, inventory shall reflect the quantity of listed chemicals, whether in bulk or non-exempt product form, held in storage for later distribution. Inventory does not include waste material for destruction, material stored as an in-process intermediate or other in-process material.


(4) The aggregate quantity of each listed chemical used for internal consumption during the preceding calendar year, unless the chemical is produced solely for internal consumption.


(5) The aggregate quantity of each listed chemical manufactured which becomes a component of a product exempted from paragraph (1)(iv) or (v) of the definition of regulated transaction in § 1300.02 of this chapter during the preceding calendar year.


(6) Data shall identify the specific isomer, salt or ester when applicable but quantitative data shall be reported as anhydrous base or acid in kilogram units of measure.


(k) Each monthly report required by §§ 1310.03(c) and 1310.05(e) (on DEA Form 453) must provide the following information for each transaction:


(1) Supplier name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.) and registration number.


(2) Purchaser’s name/business name, address/business address, and contact information (e.g., telephone number(s), email address(es), etc.).


(3) Name/business name, address/business address shipped to (if different from purchaser’s name/address).


(4) Chemical name, National Drug Code (NDC) number, if applicable, and total amount shipped.


(5) Date of shipment.


(6) Product name (if drug product).


(7) Dosage form (if drug product) (e.g., pill, tablet, liquid).


(8) Dosage strength (if drug product) (e.g., 30mg, 60mg, per dose etc.).


(9) Number of dosage units (if drug product) (e.g., 100 doses per package).


(10) Package type (if drug product) (e.g., bottle, blister pack, etc.).


(11) Number of packages (if drug product) (e.g., 10 bottles).


(12) Lot number (if drug product).


(l) Information provided in reports required by § 1310.05(e) which is exempt from disclosure under section 552(a) of title 5, by reason of section 552(b)(6) of title 5, will be provided the same protections from disclosure as are provided in section 310(c) of the Act (21 U.S.C. 830(c)) for confidential business information.


[81 FR 97023, Dec. 30, 2016]


§ 1310.07 Proof of identity.

(a) Each regulated person who engages in a regulated transaction must identify the other party to the transaction. For domestic transaction, this shall be accomplished by having the other party present documents which would verify the identity, or registration status if a registrant, of the other party to the regulated person at the time the order is placed. For export transactions, this shall be accomplished by good faith inquiry through reasonably available research documents or publicly available information which would indicate the existence of the foreign customer. No proof of identity is required for foreign suppliers.


(b) The regulated person must verify the existence and apparent validity of a business entity ordering a listed chemical, tableting machine or encapsulating machine. For domestic transactions, this may be accomplished by such methods as checking the telephone directory, the local credit bureau, the local Chamber of Commerce or the local Better Business Bureau, or, if the business entity is a registrant, by verification of the registration. For export transactions, a good faith inquiry to verify the existence and apparent validity of a foreign business entity may be accomplished by such methods as verifying the business telephone listing through international telephone information, the firm’s listing in international or foreign national chemical directories or other commerce directories or trade publications, confirmation through foreign subsidiaries of the U.S. regulated person, verification through the country of destination’s embassy Commercial Attache, or official documents provided by the purchaser which confirm the existence and apparent validity of the business entity.


(c) When transacting business with a new representative of a firm, the regulated person must verify the claimed agency status of the representative.


(d) For sales to individuals or cash purchasers, the type of documents and other evidence of proof must consist of at least a signature of the purchaser, a driver’s license and one other form of identification. Any exports to individuals or exports paid in cash are suspect and should be handled as such. For such exports, the regulated person shall diligently obtain from the purchaser or independently seek to confirm clear documentation which proves the person is properly identified such as through foreign identity documents, driver’s license, passport information and photograph, etc. Any regulated person who fails to adequately prove the identity of the other party to the transaction may be subject to the specific penalties provided for violations of law related to regulated transactions in listed chemicals.


(e) For a new customer who is not an individual or cash customer, the regulated person shall establish the identity of the authorized purchasing agent or agents and have on file that person’s signature, electronic password, or other identification. Once the authorized purchasing agent has been established, the agent list may be updated annually rather than on each order. The regulated person must ensure that shipments are not made unless the order is placed by an authorized agent of record.


(f) With respect to electronic orders, the identity of the purchaser shall consist of a computer password, identification number or some other means of identification consistent with electronic orders and with § 1310.07(e).


[54 FR 31665, Aug. 1, 1989, as amended at 60 FR 32461, June 22, 1995]


§ 1310.08 Excluded transactions.

Pursuant to 21 U.S.C. 802(39)(A)(iii), regulation of the following transactions has been determined to be unnecessary for the enforcement of the Chemical Diversion and Trafficking Act and, therefore, they have been excluded from the definitions of regulated transactions:


(a) Domestic and import transactions of hydrochloric and sulfuric acids but not including anhydrous hydrogen chloride.


(b) Exports, transshipments, and international transactions of hydrochloric (including anhydrous hydrogen chloride) and sulfuric acids, except for exports, transshipments and international transactions to the following countries:


(1) Argentina


(2) Bolivia


(3) Brazil


(4) Chile


(5) Colombia


(6) Ecuador


(7) French Guiana


(8) Guyana


(9) Panama


(10) Paraguay


(11) Peru


(12) Suriname


(13) Uruguay


(14) Venezuela


(c) Domestic transactions of Methyl Isobutyl Ketone (MIBK).


(d) Import transactions of Methyl Isobutyl Ketone (MIBK) destined for the United States.


(e) Export transactions, international transactions, and import transactions for transshipment or transfer of Methyl Isobutyl Ketone (MIBK) destined for Canada or any country outside of the Western Hemisphere.


(f) Domestic and international transactions of Lugol’s Solution (consisting of 5 percent iodine and 10 percent potassium iodide in an aqueous solution) in original manufacturer’s packaging of one-fluid-ounce (30 milliliters) or less, and no greater than one package per transaction.


(g) Import transactions of anhydrous hydrogen chloride.


(h) Domestic distribution of anhydrous hydrogen chloride weighing 12,000 pounds (net weight) or more in a single container.


(i) Domestic distribution of anhydrous hydrogen chloride by pipeline.


(j) Domestic and international return shipments of reusable containers from customer to producer containing residual quantities of red phosphorus or white phosphorus in rail cars and intermodal tank containers which conform to International Standards Organization specifications (with capacities greater than or equal to 2,500 gallons in a single container).


(k) Domestic, import, and export distributions of gamma-butyrolactone weighing 4,000 kilograms (net weight) or more in a single container.


(l) Domestic and import transactions in chemical mixtures that contain acetone, ethyl ether, 2-butanone, and/or toluene, unless regulated because of being formulated with other List I or List II chemical(s) above the concentration limit.


[57 FR 43615, Sept. 22, 1992, as amended at 60 FR 19510, Apr. 19, 1995; 60 FR 32461, June 22, 1995; 62 FR 13968, Mar. 24, 1997; 65 FR 47316, Aug. 2, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 37414, June 24, 2003; 68 FR 53292, Sept. 10, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR 10928, Mar. 12, 2007; 72 FR 35931, July 2, 2007]


§ 1310.09 Temporary exemption from registration.

(a) Each person required by section 302 of the act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a combination ephedrine product is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before July 12, 1997. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(b) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export a drug product that contains pseudoephedrine or phenylpropanolamine that is regulated pursuant to paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before December 3, 1997.The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(c) Each person required by section 302 of the act (21 U.S.C. 822) to obtain a registration to distribute, import, or export GBL is temporarily exempted from the registration requirement, provided that the DEA receives a proper application for registration on or before July 24, 2000. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(d) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export the List I chemicals red phosphorus, white phosphorus, and hypophosphorous acid (and its salts), is temporarily exempted from the registration requirement, provided that the person submits a proper application for registration on or before December 17, 2001. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(e) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export regulated chemical mixtures which contain ephedrine, N-methylephedrine, N-methylpseudoephedrine, norpseudoephedrine, phenylpropanolamine, and/or pseudoephedrine, pursuant to §§ 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that DEA receives a proper application for registration or application for exemption on or before June 30, 2003. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect. Any person who distributes, imports or exports a chemical mixture whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for these persons, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has not been approved. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(f) Except for chemical mixtures containing the listed chemicals in paragraph (e) of this section, each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to distribute, import, or export regulated chemical mixtures, pursuant to §§ 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that DEA receives a proper application for registration or application for exemption on or before February 14, 2005. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(g) Any person who distributes, imports, or exports a chemical mixture whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for these persons, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has not been approved. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(h) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated N-phenethyl-4-piperidone (NPP), including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a proper application for registration or application for exemption for a chemical mixture containing NPP pursuant to § 1310.13 on or before June 22, 2007. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect. Any person who manufactures, distributes, imports or exports a chemical mixture containing N-phenethyl-4-piperidone (NPP) whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(i) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to manufacture, distribute, import, or export regulated iodine, including regulated iodine chemical mixtures pursuant to §§ 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that the Administration receives a proper application for registration or application for exemption for a chemical mixture containing iodine on or before August 31, 2007. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, and 1313 of this chapter remain in full force and effect. Any person who distributes, imports, or exports a chemical mixture containing iodine whose application for exemption is subsequently denied by the Administration must obtain a registration with the Administration. A temporary exemption from the registration requirement will also be provided for these persons, provided that the Administration receives a properly completed application for registration on or before 30 days following the date of official Administration notification that the application for exemption has not been approved. The temporary exemption for such persons will remain in effect until the Administration takes final action on their registration application.


(j) Each person required by section 302 of the Act (21 U.S.C. 822) to obtain a registration to manufacture, distribute, import, or export regulated chemical mixtures which contain ephedrine, and/or pseudoephedrine, pursuant to Sections 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption on or before August 24, 2007. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, 1313, and 1315 of this chapter remain in full force and effect. Any person who manufactures, distributes, imports, or exports a chemical mixture whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for these persons, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has not been approved. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(k)(1) Each person required by sections 302 or 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated GBL-containing chemical mixtures, pursuant to sections 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption on or before July 29, 2010. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports or exports a GBL-containing chemical mixture whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(l)(1) Each person required under sections 302 and 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated ergocristine and its salts, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing ergocristine and its salts pursuant to § 1310.13 on or before May 2, 2011. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing ergocristine and its salts whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(m)(1) Each person required by Sections 302 or 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated chemical mixtures which contain red phosphorus, white phosphorus, hypophosphorous acid (and its salts), pursuant to §§ 1310.12 and 1310.13, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption on or before July 5, 2011. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in parts 1309, 1310, and 1313 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports, or exports a chemical mixture which contains red phosphorus, white phosphorus, hypophosphorous acid (and its salts) whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has not been approved. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(n)(1) Each person required under sections 302 and 1007 of the Act (21 U.S.C. 822, 957) to obtain a registration to manufacture, distribute, import, or export regulated alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that the DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers, pursuant to § 1310.13 on or before August 14, 2017. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports or exports a chemical mixture containing alpha-phenylacetoacetonitrile (APAAN) and its salts, optical isomers, and salts of optical isomers whose application for exemption is subsequently denied by the DEA must obtain a registration with the DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that the DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until the DEA takes final action on their registration application.


(o)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a proper application for registration or application for exemption for a chemical mixture containing benzylfentanyl pursuant to § 1310.13 on or before May 15, 2020. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl) and its salts whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption is denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(p)(1) Each person required under 21 U.S.C. 822 and 21 U.S.C. 957 to obtain a registration to manufacture, distribute, import, or export regulated N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine, 4-AP) and its amides, its carbamates, and its salts, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a proper application for registration or application for exemption for a chemical mixture containing 4-anilinopiperidine pursuant to § 1310.13 on or before May 15, 2020. The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) and its amides, its carbamates, and its salts whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose application for exemption is denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(q)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a registration to manufacture, distribute, import, or export regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), and alpha-phenylacetoacetamide (APAA), including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), or alpha-phenylacetoacetamide (APAA) pursuant to § 1310.13 on or before (30 days after publication of a rule implementing regulations regarding these three chemicals). The exemption will remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports or exports a chemical mixture containing regulated forms of 3,4-MDP-2-P methyl glycidate (PMK glycidate), 3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid), or alpha-phenylacetoacetamide (APAA) whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement will also be provided for those persons whose applications for exemption are denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons will remain in effect until DEA takes final action on their registration application.


(r)(1) Each person required under 21 U.S.C. 822 and 957 to obtain a registration to manufacture, distribute, import, or export regulated forms of methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers, including regulated chemical mixtures pursuant to § 1310.12, is temporarily exempted from the registration requirement, provided that DEA receives a properly completed application for registration or application for exemption for a chemical mixture containing regulated forms of MAPA pursuant to § 1310.13 on or before December 20, 2021. The exemption would remain in effect for each person who has made such application until the Administration has approved or denied that application. This exemption applies only to registration; all other chemical control requirements set forth in the Act and parts 1309, 1310, 1313, and 1316 of this chapter remain in full force and effect.


(2) Any person who manufactures, distributes, imports, or exports a chemical mixture containing regulated forms of methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers whose application for exemption is subsequently denied by DEA must obtain a registration with DEA. A temporary exemption from the registration requirement would also be provided for those persons whose application for exemption is denied, provided that DEA receives a properly completed application for registration on or before 30 days following the date of official DEA notification that the application for exemption has been denied. The temporary exemption for such persons would remain in effect until DEA takes final action on their registration application.


[62 FR 27693, May 21, 1997, as amended at 62 FR 53960, Oct. 17, 1997; 65 FR 21647, Apr. 24, 2000; 66 FR 52675, Oct. 17, 2001; 68 FR 23203, May 1, 2003; 69 FR 74971, Dec. 15, 2004; 72 FR 20046, Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40239, July 24, 2007; 72 FR 40744, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 31829, June 2, 2011; 77 FR 4237, Jan. 27, 2012; 82 FR 32460, July 14, 2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24707, May 7, 2021; 86 FR 64366, Nov. 18, 2021]


§ 1310.10 Removal of the exemption of drugs distributed under the Federal Food, Drug and Cosmetic Act.

(a) The Administrator may remove from exemption under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter any drug or group of drugs that the Administrator finds is being diverted to obtain a listed chemical for use in the illicit production of a controlled substance. In removing a drug or group of drugs from the exemption the Administrator shall consider:


(1) The scope, duration, and significance of the diversion;


(2) Whether the drug or group of drugs is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and


(3) Whether the listed chemical can be readily recovered from the drug or group of drugs.


(b) Upon determining that a drug or group of drugs should be removed from the exemption under paragraph (a) of this section, the Administrator shall issue and publish in the Federal Register his proposal to remove the drug or group of drugs from the exemption, which shall include a reference to the legal authority under which the proposal is based. The Administrator shall permit any interested person to file written comments on or objections to the proposal. After considering any comments or objections filed, the Administrator shall publish in the Federal Register his final order.


(c) The Administrator shall limit the removal of a drug or group of drugs from exemption under paragraph (a) of this section to the most identifiable type of the drug or group of drugs for which evidence of diversion exists unless there is evidence, based on the pattern of diversion and other relevant factors, that the diversion will not be limited to that particular drug or group of drugs.


(d) Any manufacturer seeking reinstatement of a particular drug product that has been removed from an exemption may apply to the Administrator for reinstatement of the exemption for that particular drug product on the grounds that the particular drug product is manufactured and distributed in a manner that prevents diversion. In determining whether the exemption should be reinstated the Administrator shall consider:


(1) The package sizes and manner of packaging of the drug product;


(2) The manner of distribution and advertising of the drug product;


(3) Evidence of diversion of the drug product;


(4) Any actions taken by the manufacturer to prevent diversion of the drug product; and


(5) Such other factors as are relevant to and consistent with the public health and safety, including the factors described in paragraph (a) of this section as applied to the drug product.


(e) Within a reasonable period of time after receipt of the application for reinstatement of the exemption, the Administrator shall notify the applicant of his acceptance or non-acceptance of his application, and if not accepted, the reason therefor. If the application is accepted for filing, the Administrator shall issue and publish in the Federal Register his order on the reinstatement of the exemption for the particular drug product, which shall include a reference to the legal authority under which the order is based. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order. If any such comments raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.


(f) Unless the Administrator has evidence that the drug product is being diverted, as determined by applying the factors set forth in paragraph (a) of this section, and the Administrator so notifies the applicant, transactions involving a specific drug product will not be considered regulated transactions during the following periods:


(1) While a bonafide application for reinstatement of exemption under paragraph (d) of this section for the specific drug product is pending resolution, provided that the application for reinstatement is filed not later than 60 days after the publication of the final order removing the exemption; and


(2) For a period of 60 days following the Administrator’s denial of an application for reinstatement.


(g) An order published by the Administrator in the Federal Register, pursuant to paragraph (e) of this section, to reinstate an exemption may be modified or revoked with respect to a particular drug product upon a finding that:


(1) Applying the factors set forth in paragraph (a) of this section to the particular drug product, the drug product is being diverted; or


(2) There is a significant change in the data that led to the issuance of the final rule.


[60 FR 32461, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997; 67 FR 14862, Mar. 28, 2002; 75 FR 38922, July 7, 2010; 77 FR 4237, Jan. 27, 2012]


§ 1310.11 Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

(a) The Administrator has reinstated the exemption for the drug products listed in paragraph (e) of this section from application of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823, 830, and 957-958), to the extent described in paragraphs (b), (c), and (d) of this section.


(b) No reinstated exemption granted pursuant to 1310.10 affects the criminal liability for illegal possession or distribution of listed chemicals contained in the exempt drug product.


(c) Changes in exempt drug product compositions: Any change in the quantitative or qualitative composition, trade name or other designation of an exempt drug product listed in paragraph (d) requires a new application for reinstatement of the exemption.


(d) The following drug products, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as reinstated exempt drug products for the purposes set forth in this section:


Exempt Drug Products

Supplier
Product name
Form
Date
[Reserved]

[60 FR 32462, June 22, 1995]


§ 1310.12 Exempt chemical mixtures.

(a) The chemical mixtures meeting the criteria in paragraphs (c) or (d) of this section are exempted by the Administrator from application of sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971) to the extent described in paragraphs (b) and (c) of this section.


(b) No exemption granted pursuant to this § 1310.12 or § 1310.13 affects the criminal liability for illegal possession, distribution, exportation, or importation of listed chemicals contained in the exempt chemical mixture or the civil liability for unlawful acts related to exempt chemical mixtures, including distribution in violation of 21 U.S.C. 842(a)(11).


(c) Mixtures containing a listed chemical in concentrations equal to or less than those specified in the “Table of Concentration Limits” are designated as exempt chemical mixtures for the purpose set forth in this section. The concentration is determined for liquid-liquid mixtures by using the volume or weight and for mixtures containing solids or gases by using the unit of weight.


Table of Concentration Limits


DEA chemical code number
Concentration
Special conditions
List I Chemicals
N-Acetylanthranilic acid, its salts and esters852220% by WeightConcentration based on any combination of N-acetylanthranilic acid and its salts and esters.
Alpha-phenylacetoacetamide (APAA) and its optical isomers8515Not exempt at any concentrationChemical mixtures containing any amount of this chemical are not exempt.

Alpha-phenylacetoacetonitrile, and its salts, optical isomers, and salts of optical isomers. (APAAN)8512Not exempt at any concentrationChemical mixtures containing any amount of APAAN are not exempt.

Anthranilic acid, and its salts and esters853050% by WeightConcentration is based on any combination of anthranilic acid and its salts and esters.
Benzaldehyde825650% by Weight or Volume
Benzyl cyanide857020% by Weight or Volume
N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (benzylfentanyl), including its salts8334Not exempt at any concentrationChemical mixtures containing any amount of benzylfentanyl are not exempt.
Ephedrine, its salts, optical isomers, and salts of optical isomers8113Not exempt at any concentrationChemical mixtures containing any amount of ephedrine and/or pseudoephedrine, and their salts, optical isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted.
Ergocristine and its salts8612Not exempt at any concentrationChemical mixtures containing any amount of ergocristine and its salts are not exempt.
Ergonovine and its salts8675Not exempt at any concentrationChemical mixtures containing any amount of ergonovine, including its salts, are not exempt.
Ergotamine and its salts8676Not exempt at any concentrationChemical mixtures containing amount of any ergotamine, including its salts, are not exempt.
Ethylamine and its salts867820% by Weight or VolumeEthylamine or its salts in an inert carrier solvent is not considered a mixture. Concentration is based on ethylamine in the mixture and not the combination of ethylamine and carrier solvent, if any.
Gamma-Butyrolactone201170% by weight or volume.
Hydriodic acid669520% by Weight or Volume
Hypophosphorous acid and its salts679730% by weight if a solid, weight or volume if a liquidThe weight is determined by measuring the mass of hypophosphorous acid and its salts in the mixture, the concentration limit is calculated by summing the concentrations of all forms of hypophosphorous acid and its salts in the mixture. The Administration does not consider a chemical mixture to mean the combination of a listed chemical and an inert carrier. Therefore, any solution consisting of hypophosphorous acid (and its salts), dispersed in water, alcohol, or another inert carrier, is not considered a chemical mixture and is therefore subject to chemical regulatory controls at all concentrations.
Iodine66992.2Calculated as weight/volume (w/v).
Isosafrole870420% by Weight or VolumeConcentration in a mixture cannot exceed 20% if taken alone or in any combination with safrole.
methyl alpha-phenylacetoacetate (MAPA; methyl 3-oxo-2-phenylbutanoate) and its optical isomers8795Not exempt at any concentrationChemical mixtures containing any amount of MAPA and its optical isomers are not exempt.
Methylamine and its salts852020% by WeightMethylamine or its salts in an inert carrier solvent is not considered a mixture. Weight is based on methylamine in the mixture and not the combined weight of carrier solvent, if any.
3,4-Methylenedioxyphenyl-2-propanone850220% by Weight
N-Methylephedrine, its salts, optical isomers, and salts of optical isomers81150.1% by WeightConcentration based on any combination of salts N-methylephedrine, N-methylpseudoephedrine and their salts, optical isomers and salts of optical isomers.
3,4-MDP-2-P methyl glycidate (PMK glycidate) and its optical and geometric isomers8535Not exempt at any concentrationChemical mixtures containing any amount of this chemical are not exempt.

3,4-MDP-2-P methyl glycidic acid (PMK glycidic acid) and its salts, optical and geometric isomers, and salts of isomers8525Not exempt at any concentrationChemical mixtures containing any amount of this chemical are not exempt.

N-Methylpseudoephedrine, its salts, optical isomers, and salts of optical isomers81190.1% by WeightConcentration based on any combination of N-methylpseudoephedrine, N-methylephedrine, and their salts, optical isomers and salts of optical isomers.
Nitroethane672420% by Weight or Volume

Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers83170.6% by WeightConcentration based on any combination of norpseudoephedrine, phenylpropanolamine and their salts, optical isomers and salts of optical isomers.

N-phenethyl-4-piperidone (NPP)8332Not exempt at any concentrationChemical mixtures containing any amount of NPP are not exempt.

Phenylacetic acid, and its salts and esters879140% by WeightConcentration is based on any combination of phenylacetic acid and its salts and esters.

N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), including its amides, its carbamates, and its salts8335Not exempt at any concentrationChemical mixtures containing any amount of 4-anilinopiperidine are not exempt.

Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers12250.6% by WeightConcentration based on any combination of phenylpropanolamine, norpseudoephedrine and their salts, optical isomers and salts of optical isomers.
Piperidine, and its salts270420% by Weight or VolumeConcentration based on any combination of piperidine and its salts. Concentration based on weight if a solid, weight or volume if a liquid.
Piperonal875020% by Weight or Volume
Propionic anhydride832820% by Weight or Volume
Pseudoephedrine, its salts, optical isomers, and salts of optical isomers8112Not exempt at any concentrationChemical mixtures containing any amount of ephedrine and/or pseudoephedrine, and their salts, optical isomers and salts of optical isomers are not exempt due to concentration, unless otherwise exempted.
Red Phosphorus679580% by weight.
Safrole832320% by VolumeConcentration in a mixture cannot exceed 20% if taken alone or in any combination with isosafrole.
White phosphorus6796Not exempt at any concentrationChemical mixtures containing any amount of white phosphorus are not exempt due to concentration, unless otherwise exempted.
List II Chemicals
Acetic Anhydride851920% by Weight or Volume
Acetone653235% by Weight or VolumeExports only; Limit applies to acetone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.
Benzyl chloride856820% by Weight or Volume
2-butanone671435% by Weight or VolumeExports only; Limit applies to 2-butanone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.
Ethyl ether658435% by Weight or VolumeExports only; Limit applies to ethyl ether or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.
Hydrochloric acid654520% by Weight or VolumeHydrogen chloride in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on hydrogen chloride in the mixture and not the combined weight of the carrier solvent, if any.
Methyl isobutyl ketone671535% by Weight or VolumeExports only pursuant to § 1310.08; Limit applies to methyl isobutyl ketone or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.
Potassium permanganate657915% by Weight
Sodium Permanganate658815% by Weight
Sulfuric acid655220% by Weight or VolumeSulfuric acid in an inert carrier solvent, such as aqueous or alcoholic solutions, is not considered a mixture. Weight is based on sulfuric acid in the mixture and not the combined weight of the carrier solvent, if any.
Toluene59435% by Weight or VolumeExports only; Limit applies to toluene or any combination of acetone, ethyl ether, 2-butanone, methyl isobutyl ketone, and toluene if present in the mixture by summing the concentrations for each chemical.

(d) The following categories of chemical mixtures are automatically exempt from the provisions of the Controlled Substances Act as described in paragraph (a) of this section:


(1) Chemical mixtures that are distributed directly to an incinerator for destruction or directly to an authorized waste recycler or reprocessor where such distributions are documented on United States Environmental Protection Agency Form 8700-22; persons distributing the mixture to the incinerator or recycler must maintain and make available to agents of the Administration, upon request, such documentation for a period of no less than two years.


(2) Completely formulated paints and coatings: Completely formulated paints and coatings are only those formulations that contain all of the components of the paint or coating for use in the final application without the need to add any additional substances except a thinner if needed in certain cases. A completely formulated paint or coating is defined as any clear or pigmented liquid, liquefiable or mastic composition designed for application to a substrate in a thin layer that is converted to a clear or opaque solid protective, decorative, or functional adherent film after application. Included in this category are clear coats, top-coats, primers, varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, temporary protective coatings and film-forming agents.


(3) Iodine products classified as iodophors that exist as an iodine complex to include poloxamer-iodine complex, polyvinyl pyrrolidone-iodine complex (i.e., povidone-iodine), undecoylium chloride iodine, nonylphenoxypoly (ethyleneoxy) ethanol-iodine complex, iodine complex with phosphate ester of alkylaryloxy polyethylene glycol, and iodine complex with ammonium ether sulfate/polyoxyethylene sorbitan monolaurate.


(4) Iodine products that consist of organically bound iodine (a non-ionic complex) (e.g., iopamidol, iohexol, and amiodarone.)


(e) The Administrator may, at any time, terminate or modify the exemption for any chemical mixture which has been granted an exemption pursuant to the concentration limits as specified in paragraph (c) of this section or pursuant to the category exemption as specified in paragraph (d) of this section. In terminating or modifying an exemption, the Administrator shall issue, and publish in the Federal Register, notification of the removal of an exemption for a product or group of products for which evidence of diversion has been found, as well as the date on which the termination of exemption shall take effect. The Administrator shall permit any interested party to file written comments on or objections to the order within 60 days of the date of publication of the order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the order in light of comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as determined appropriate.


(f) The Administrator may modify any part of the criteria for exemption as specified in paragraphs (c) and (d) of this section upon evidence of diversion or attempted diversion. In doing so, the Administrator shall issue and publish a Notice of Proposed Rulemaking in the Federal Register. The Administrator shall permit any interested persons to file written comments on or objections to the proposal. After considering any comments or objections filed, the Administrator shall publish in the Federal Register a final order.


[68 FR 23204, May 1, 2003, as amended at 69 FR 74971, Dec. 15, 2004; 71 FR 60826, Oct. 17, 2006; 72 FR 20047, Apr. 23, 2007; 72 FR 35931, July 2, 2007; 72 FR 40745, July 25, 2007; 75 FR 37306, June 29, 2010; 76 FR 17781, Mar. 31, 2011; 76 FR 31830, June 2, 2011; 82 FR 32460, July 14, 2017; 85 FR 20828, Apr. 15, 2020; 86 FR 24708, May 10, 2021; 86 FR 64366, Nov. 18, 2021]


§ 1310.13 Exemption of chemical mixtures; application.

(a) The Administrator may, by publication of a Final Rule in the Federal Register, exempt from the application of all or any part of the Act a chemical mixture consisting of two or more chemical components, at least one of which is not a List I or List II chemical, if:


(1) The mixture is formulated in such a way that it cannot be easily used in the illicit production of a controlled substance; and


(2) The listed chemical or chemicals contained in the chemical mixture cannot be readily recovered.


(b) Any manufacturer seeking an exemption for a chemical mixture, not exempt under § 1310.12, from the application of all or any part of the Act, may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.


(c) An application for exemption under this section shall contain the following information:


(1) The name, address, and registration number, if any, of the applicant;


(2) The date of the application;


(3) The exact trade name(s) of the applicant’s chemical mixture and:


(i) If the applicant formulates or manufactures the chemical mixture for other entities, the exact trade names of the chemical mixtures and the names of the entities for which the chemical mixtures were prepared; and


(ii) If a group of mixtures (e.g. formulations having identical function and containing the same listed chemical(s)), the information required in paragraph (c)(3)(i) of this section and a brief narrative of their use.


(4) (i) The complete qualitative and quantitative composition of the chemical mixture (including all listed and all non-listed chemicals); or


(ii) If a group of mixtures, the concentration range for the listed chemical and a listing of all non-listed chemicals with respective concentration ranges.


(5) (i) The chemical and physical properties of the mixture and how they differ from the properties of the listed chemical or chemicals; and


(ii) If a group of mixtures, how the group’s properties differ from the properties of the listed chemical.


(6) A statement that the applicant believes justifies an exemption for the chemical mixture or group of mixtures. The statement must explain how the chemical mixture(s) meets the exemption criteria set forth in paragraph (a) of this section.


(7) A statement that the applicant accepts the right of the Administrator to terminate exemption from regulation for the chemical mixture(s) granted exemption under this section.


(8) The identification of any information on the application that is considered by the applicant to be a trade secret or confidential and entitled to protection under U.S. laws restricting the public disclosure of such information.


(d) The Administrator may require the applicant to submit such additional documents or written statements of fact relevant to the application that he deems necessary for determining if the application should be granted.


(e) Within a reasonable period of time after the receipt of an application for an exemption under this section, the Administrator will notify the applicant in writing of the acceptance or rejection of the application for filing. If the application is not accepted for filing, an explanation will be provided. The Administrator is not required to accept an application if any information required pursuant to paragraph (c) of this section or requested pursuant to paragraph (d) of this section is lacking or not readily understood. The applicant may, however, amend the application to meet the requirements of paragraphs (c) and (d) of this section. If the exemption is subsequently granted, the applicant shall again be notified in writing and the Administrator shall issue, and publish in the Federal Register, an order on the application. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order. If any comments or objections raise significant issues regarding any findings of fact or conclusions of law upon which the order is based, the Administrator may suspend the effectiveness of the order until he has reconsidered the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as deemed appropriate.


(f) The Administrator may, at any time, terminate or modify an exemption for any product pursuant to paragraph (e) of this section. In terminating or modifying an exemption, the Administrator shall issue, and publish in the Federal Register, notification of the removal of an exempt product or group of exempt products for which evidence of diversion has been found. This order shall specify the date on which the termination of exemption shall take effect. The Administrator shall permit any interested party to file written comments on or objections to the order within 60 days of the date of publication of the order in the Federal Register. If any such comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which the order is based, the Administrator may suspend the effectiveness of the order until he has reconsidered the order in light of comments and objections filed. Thereafter, the Administrator shall reinstate, terminate, or amend the original order as determined appropriate.


(g) A manufacturer of an exempted chemical mixture shall notify DEA in writing, of any change in the quantitative or qualitative composition of a chemical mixture that has been granted an exemption by application. Changes include those greater than the range of concentration given in the application or that remove non-listed chemical(s) given in the application as part of the formulation. A new application will be required only if reformulation results in a new product having a different commercial application or can no longer be defined as part of a group of exempted chemicals. DEA must be notified of reformulation at least 30 days in advance of marketing the reformulated mixture. For a change in name or other designation, code, or any identifier, a written notification is required. DEA must be notified of any changes at least 60 days in advance of the effective date for the change.


(h) Each manufacturer seeking exemption must apply for such an exemption. A formulation granted exemption by publication in the Federal Register will not be exempted for all manufacturers.


(i) The following chemical mixtures, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as exempt chemical mixtures for the purposes set forth in this section and are exempted by the Administrator from application of Sections 302, 303, 310, 1007, 1008, and 1018 of the Act (21 U.S.C. 822, 823, 830, 957, 958, and 971):


Table 1 to Paragraph (i) – Exempt Chemical Mixtures

Manufacturer
Product name
1
Form
Date
Cerilliant Corporation1R,2S(-)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant Corporation1S,2R(+)-Ephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant Corporation1S,2R(+)-Ephedrine-D3 hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant Corporation1S,2R(+)-Ephedrine hydrochloride 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant CorporationPseudoephedrine-D3 hydrochloride 0.1 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant CorporationR,R(-)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20) methylene chloride, or tetrahydrofuranLiquid8/2/2007
Cerilliant CorporationS,S(+)-Pseudoephedrine 1.0 mg/ml as free base in one of: 1,2-dimethoxyethane, acetonitrile, acetonitrile: water (≥50% acetonitrile), dimethylformamide, ethylene glycol, isopropanol, methanol, methanol/water (50:50), methanol/dimethyl sulfoxide (80:20), methylene chloride, or tetrahydrofuranLiquid8/2/2007
E.I. DuPont deNemours & CoRC-5156Liquid4/22/2005
E.I. DuPont deNemours & CoVH-6037Liquid4/22/2005
GFS ChemicalsWaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 5 mg/mlLiquid11/26/2018
GFS ChemicalsWaterMark® Karl-Fisher Reagent, 5 mg/ml Single Solution NON-HAZLiquid11/26/2018
GFS ChemicalsWaterMark® Karl-Fisher Reagent, Pyridine-Free Single Solution, 2 mg/mlLiquid11/26/2018
GFS ChemicalsWaterMark® Karl-Fisher Reagent, 2 mg/ml Single Solution NON-HAZLiquid11/26/2018
GFS ChemicalsWaterMark® Karl-Fisher Reagent, 5 mg/ml, Stabilized, Pyridine-BasedLiquid11/26/2018
Hawthorne Products, IncSole Pack Hoof DressingPaste8/14/2007
Hawthorne Products, IncSole Pack Hoof PackingPaste8/14/2007
Lord CorporationChemlok TS701-52Liquid05/03/2018
Lord CorporationChemlok TS701-53Liquid05/03/2018
Quality Assurance Service Corporation10 to 1000 nanograms per milliliter of ephedrine in blood, serum, or urineLiquid9/26/2007
Quality Assurance Service Corporation10 to 1000 nanograms per milliliter of pseudoephedrine in blood, serum, or urineLiquid9/26/2007
Quality Assurance Service Corporation10 to 1000 nanograms per milliliter of phenylpropanolamine in blood, serum, or urineLiquid9/26/2007
Reichhold, IncBeckosol® 12021-00 AA-200, IA-441, P531-TLiquid5/05/2005
Reichhold, IncUrotuf® L06-30S, F78-50TLiquid5/05/2005
Reichhold, IncBeckosol AA-220Liquid6/14/2005
Sigma-AldrichHydranal®-Composite 1Liquid5/29/2013
Sigma-AldrichHydranal®-Composite 2Liquid5/29/2013
Sigma-AldrichHydranal®-Composite 5KLiquid5/29/2013
Sigma-AldrichHydranal®-Composite 5Liquid5/29/2013
Standard Homeopathic CoBaby Cough SyrupLiquid9/28/2012
Standard Homeopathic CoDefend Cough & Cold NightLiquid9/28/2012
Standard Homeopathic CoDefend Cough & ColdLiquid9/28/2012
Standard Homeopathic CoDiarrexLiquid9/28/2012
Waterbury Companies, IncWaterbury 332500Liquid4/11/2005
Waterbury Companies, IncWaterbury 332762Liquid4/11/2005
Waterbury Companies, IncWaterbury 332400Liquid4/11/2005
Waterbury Companies, IncWaterbury 346201Liquid4/11/2005


1 Designate product line if a group.


[68 FR 23204, May 1, 2003, as amended at 75 FR 10681, Mar. 9, 2010; 75 FR 53869, Sept. 2, 2010; 76 FR 31830, June 2, 2011; 81 FR 97025, Dec. 30, 2016; 85 FR 4586, Jan. 27, 2020]


§ 1310.14 Removal of exemption from definition of regulated transaction.

The Administrator finds that the following drugs or groups of drugs are being diverted to obtain a listed chemical for use in the illicit production of a controlled substance and removes the drugs or groups of drugs from exemption under paragraph (1)(iv) of the definition of regulated transaction in § 1300.02 of this chapter pursuant to the criteria listed in § 1310.10 of this part:


(a) Nonprescription drugs containing ephedrine, its salts, optical isomers, and salts of optical isomers.


(b) Nonprescription drugs containing phenylpropanolamine, its salts, optical isomers, and salts of optical isomers.


(c) Nonprescription drugs containing pseudoephedrine, its salts, optical isomers, and salts of optical isomers.


[75 FR 38922, July 7, 2010, as amended at 77 FR 4237, Jan. 27, 2012]


§ 1310.16 Exemptions for certain scheduled listed chemical products.

(a) Upon the application of a manufacturer of a scheduled listed chemical product, the Administrator may by regulation provide that the product is exempt from part 1314 of this chapter if the Administrator determines that the product cannot be used in the illicit manufacture of a controlled substance.


(b) An application for an exemption under this section must contain all of the following information:


(1) The name and address of the applicant.


(2) The exact trade name of the scheduled listed chemical product for which exemption is sought.


(3) The complete quantitative and qualitative composition of the drug product.


(4) A brief statement of the facts that the applicant believes justify the granting of an exemption under this section.


(5) Certification by the applicant that the product may be lawfully marketed or distributed under the Federal, Food, Drug, and Cosmetic Act.


(6) The identification of any information on the application that is considered by the applicant to be a trade secret or confidential and entitled to protection under U.S. laws restricting the public disclosure of such information by government employees.


(c) The Administrator may require the applicant to submit additional documents or written statements of fact relevant to the application that he deems necessary for determining if the application should be granted.


(d) Within a reasonable period of time after the receipt of a completed application for an exemption under this section, the Administrator shall notify the applicant of acceptance or non-acceptance of the application. If the application is not accepted, an explanation will be provided. The Administrator is not required to accept an application if any of the information required in paragraph (b) of this section or requested under paragraph (c) of this section is lacking or not readily understood. The applicant may, however, amend the application to meet the requirements of paragraphs (b) and (c) of this section.


(e) If the application is accepted for filing, the Administrator shall issue and publish in the Federal Register an order on the application, which shall include a reference to the legal authority under which the order is based. This order shall specify the date on which it shall take effect.


(f) The Administrator shall permit any interested person to file written comments on or objections to the order. If any comments or objections raise significant issues regarding any findings of fact or conclusions of law upon which the order is based, the Administrator shall immediately suspend the effectiveness of the order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Administrator shall reinstate, revoke, or amend the original order as deemed appropriate.


[71 FR 56024, Sept. 26, 2006]


§ 1310.21 Sale by Federal departments or agencies of chemicals which could be used to manufacture controlled substances.

(a) A Federal department or agency may not sell from the stocks of the department or agency any chemical which, as determined by the Administrator of the Drug Enforcement Administration, could be used in the manufacture of a controlled substance, unless the Administrator certifies in writing to the head of the department or agency that there is no reasonable cause to believe that the sale of the specific chemical to a specific person would result in the illegal manufacture of a controlled substance. For purposes of this requirement, reasonable cause to believe means that the Administration has knowledge of facts which would cause a reasonable person to reasonably conclude that a chemical would be diverted to the illegal manufacture of a controlled substance.


(b) A Federal department or agency must request certification by submitting a written request to the Administrator, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address. A request for certification may be transmitted directly to the Office of Diversion Control, Drug Enforcement Administration, through electronic facsimile media. A request for certification must be submitted no later than fifteen calendar days before the proposed sale is to take place. In order to facilitate the sale of chemicals from Federal departments’ or agencies’ stocks, Federal departments or agencies may wish to submit requests as far in advance of the fifteen calendar days as possible. The written notification of the proposed sale must include:


(1) The name and amount of the chemical to be sold;


(2) The name and address of the prospective bidder;


(3) The name and address of the prospective end-user, in cases where a sale is being brokered;


(4) Point(s) of contact for the prospective bidder and, where appropriate, prospective end-user; and


(5) The end use of the chemical.


(c) Within fifteen calendar days of receipt of a request for certification, the Administrator will certify in writing to the head of the Federal department or agency that there is, or is not, reasonable cause to believe that the sale of the specific chemical to the specific bidder and end-user would result in the illegal manufacture of a controlled substance. In making this determination, the following factors must be considered:


(1) Past experience of the prospective bidder or end-user in the maintenance of effective controls against diversion of listed chemicals into other than legitimate medical, scientific, and industrial channels;


(2) Compliance of the prospective bidder or end-user with applicable Federal, state and local law;


(3) Prior conviction record of the prospective bidder or end-user relating to listed chemicals or controlled substances under Federal or state laws; and


(4) Such other factors as may be relevant to and consistent with the public health and safety.


(d) If the Administrator certifies to the head of a Federal department or agency that there is no reasonable cause to believe that the sale of a specific chemical to a prospective bidder and end-user will result in the illegal manufacture of a controlled substance, that certification will be effective for one year from the date of issuance with respect to further sales of the same chemical to the same prospective bidder and end-user, unless the Administrator notifies the head of the Federal department or agency in writing that the certification is withdrawn. If the certification is withdrawn, DEA will also provide written notice to the bidder and end-user, which will contain a statement of the legal and factual basis for this determination.


(e) If the Administrator determines there is reasonable cause to believe the sale of the specific chemical to a specific bidder and end-user would result in the illegal manufacture of a controlled substance, DEA will provide written notice to the head of a Federal department or agency refusing to certify the proposed sale under the authority of 21 U.S.C. 890. DEA also will provide, within fifteen calendar days of receiving a request for certification from a Federal department or agency, the same written notice to the prospective bidder and end-user, and this notice also will contain a statement of the legal and factual basis for the refusal of certification. The prospective bidder and end-user may, within thirty calendar days of receipt of notification of the refusal, submit written comments or written objections to the Administrator’s refusal. At the same time, the prospective bidder and end-user also may provide supporting documentation to contest the Administrator’s refusal. If such written comments or written objections raise issues regarding any finding of fact or conclusion of law upon which the refusal is based, the Administrator will reconsider the refusal of the proposed sale in light of the written comments or written objections filed. Thereafter, within a reasonable time, the Administrator will withdraw or affirm the original refusal of certification as he determines appropriate. The Administrator will provide written reasons for any affirmation of the original refusal. Such affirmation of the original refusal will constitute a final decision for purposes of judicial review under 21 U.S.C. 877.


(f) If the Administrator determines there is reasonable cause to believe that an existing certification should be withdrawn, DEA will provide written notice to the head of a Federal department or agency of such withdrawal under the authority of 21 U.S.C. 890. DEA also will provide, within fifteen calendar days of withdrawal of an existing certification, the same written notice to the bidder and end-user, and this notice also will contain a statement of the legal and factual basis for the withdrawal. The bidder and end-user may, within thirty calendar days of receipt of notification of the withdrawal of the existing certification, submit written comments or written objections to the Administrator’s withdrawal. At the same time, the bidder and end-user also may provide supporting documentation to contest the Administrator’s withdrawal. If such written comments or written objections raise issues regarding any finding of fact or conclusion of law upon which the withdrawal of the existing certification is based, the Administrator will reconsider the withdrawal of the existing certification in light of the written comments or written objections filed. Thereafter, within a reasonable time, the Administrator will withdraw or affirm the original withdrawal of the existing certification as he determines appropriate. The Administrator will provide written reasons for any affirmation of the original withdrawal of the existing certification. Such affirmation of the original withdrawal of the existing certification will constitute a final decision for purposes of judicial review under 21 U.S.C. 877.


[68 FR 62737, Nov. 6, 2003, as amended at 75 FR 10681, Mar. 9, 2010]


PART 1311 – REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS


Authority:21 U.S.C. 821, 828, 829, 871(b), 958(e), 965, unless otherwise noted.


Source:70 FR 16915, Apr. 1, 2005, unless otherwise noted.

Subpart A – General

§ 1311.01 Scope.

This part sets forth the rules governing the creation, transmission, and storage of electronic orders and prescriptions.


[75 FR 16310, Mar. 31, 2010]


§ 1311.02 Definitions.

Any term contained in this part shall have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


[75 FR 16310, Mar. 31, 2010]


§ 1311.05 Standards for technologies for electronic transmission of orders.

(a) A registrant or a person with power of attorney to sign orders for Schedule I and II controlled substances may use any technology to sign and electronically transmit orders if the technology provides all of the following:


(1) Authentication: The system must enable a recipient to positively verify the signer without direct communication with the signer and subsequently demonstrate to a third party, if needed, that the sender’s identity was properly verified.


(2) Nonrepudiation: The system must ensure that strong and substantial evidence is available to the recipient of the sender’s identity, sufficient to prevent the sender from successfully denying having sent the data. This criterion includes the ability of a third party to verify the origin of the document.


(3) Message integrity: The system must ensure that the recipient, or a third party, can determine whether the contents of the document have been altered during transmission or after receipt.


(b) DEA has identified the following means of electronically signing and transmitting order forms as meeting all of the standards set forth in paragraph (a) of this section.


(1) Digital signatures using Public Key Infrastructure (PKI) technology.


(2) [Reserved]


§ 1311.08 Incorporation by reference.

(a) These incorporations by reference were approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be inspected at the Drug Enforcement Administration, 600 Army Navy Drive, Arlington, VA 22202 or at the National Archives and Records Administration (NARA). For information on the availability of this material at the Drug Enforcement Administration, call (202) 307-1000. For information on the availability of this material at NARA, call (202) 741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.


(b) These standards are available from the National Institute of Standards and Technology, Computer Security Division, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899-8930, (301) 975-6478 or TTY (301) 975-8295, [email protected], and are available at http://csrc.nist.gov/. The following standards are incorporated by reference:


(1) Federal Information Processing Standard Publication (FIPS PUB) 140-2, Change Notices (12-03-2002), Security Requirements for Cryptographic Modules, May 25, 2001 (FIPS 140-2) including Annexes A through D; incorporation by reference approved for §§ 1311.30(b), 1311.55(b), 1311.115(b), 1311.120(b), 1311.205(b).


(i) Annex A: Approved Security Functions for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, September 23, 2004.


(ii) Annex B: Approved Protection Profiles for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, November 4, 2004.


(iii) Annex C: Approved Random Number Generators for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, January 31, 2005.


(iv) Annex D: Approved Key Establishment Techniques for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, February 23, 2004.


(2) Federal Information Processing Standard Publication (FIPS PUB) 180-2, Secure Hash Standard, August 1, 2002, as amended by change notice 1, February 25, 2004 (FIPS 180-2); incorporation by reference approved for §§ 1311.30(b) and 1311.55(b).


(3) Federal Information Processing Standard Publication (FIPS PUB) 180-3, Secure Hash Standard (SHS), October 2008 (FIPS 180-3); incorporation by reference approved for §§ 1311.120(b) and 1311.205(b).


(4) Federal Information Processing Standard Publication (FIPS PUB) 186-2, Digital Signature Standard, January 27, 2000, as amended by Change Notice 1, October 5, 2001 (FIPS 186-2); incorporation by reference approved for §§ 1311.30(b) and 1311.55(b).


(5) Federal Information Processing Standard Publication (FIPS PUB) 186-3, Digital Signature Standard (DSS), June 2009 (FIPS 186-3); incorporation by reference approved for §§ 1311.120(b), 1311.205(b), and 1311.210(c).


(6) Draft NIST Special Publication 800-63-1, Electronic Authentication Guideline, December 8, 2008 (NIST SP 800-63-1); Burr, W. et al.; incorporation by reference approved for § 1311.105(a).


(7) NIST Special Publication 800-76-1, Biometric Data Specification for Personal Identity Verification, January 2007 (NIST SP 800-76-1); Wilson, C. et al.; incorporation by reference approved for § 1311.116(d).


[75 FR 16310, Mar. 31, 2010]


Subpart B – Obtaining and Using Digital Certificates for Electronic Orders

§ 1311.10 Eligibility to obtain a CSOS digital certificate.

The following persons are eligible to obtain a CSOS digital certificate from the DEA Certification Authority to sign electronic orders for controlled substances.


(a) The person who signed the most recent DEA registration application or renewal application and a person authorized to sign a registration application.


(b) A person granted power of attorney by a DEA registrant to sign orders for one or more schedules of controlled substances.


§ 1311.15 Limitations on CSOS digital certificates.

(a) A CSOS digital certificate issued by the DEA Certification Authority will authorize the certificate holder to sign orders for only those schedules of controlled substances covered by the registration under which the certificate is issued.


(b) When a registrant, in a power of attorney letter, limits a certificate applicant to a subset of the registrant’s authorized schedules, the registrant is responsible for ensuring that the certificate holder signs orders only for that subset of schedules.


§ 1311.20 Coordinators for CSOS digital certificate holders.

(a) Each registrant, regardless of number of digital certificates issued, must designate one or more responsible persons to serve as that registrant’s CSOS coordinator regarding issues pertaining to issuance of, revocation of, and changes to digital certificates issued under that registrant’s DEA registration. While the coordinator will be the main point of contact between one or more DEA registered locations and the CSOS Certification Authority, all digital certificate activities are the responsibility of the registrant with whom the digital certificate is associated. Even when an individual registrant, i.e., an individual practitioner, is applying for a digital certificate to order controlled substances a CSOS Coordinator must be designated; though in such a case, the individual practitioner may also serve as the coordinator.


(b) Once designated, coordinators must identify themselves, on a one-time basis, to the Certification Authority. If a designated coordinator changes, the Certification Authority must be notified of the change and the new responsibilities assumed by each of the registrant’s coordinators, if applicable. Coordinators must complete the application that the DEA Certification Authority provides and submit the following:


(1) Two copies of identification, one of which must be a government-issued photographic identification.


(2) A copy of each current DEA Certificate of Registration (DEA form 223) for each registered location for which the coordinator will be responsible or, if the applicant (or their employer) has not been issued a DEA registration, a copy of each application for registration of the applicant or the applicant’s employer.


(3) The applicant must have the completed application notarized and forward the completed application and accompanying documentation to the DEA Certification Authority.


(c) Coordinators will communicate with the Certification Authority regarding digital certificate applications, renewals and revocations. For applicants applying for a digital certificate from the DEA Certification Authority, and for applicants applying for a power of attorney digital certificate for a DEA registrant, the registrant’s Coordinator must verify the applicant’s identity, review the application package, and submit the completed package to the Certification Authority.


§ 1311.25 Requirements for obtaining a CSOS digital certificate.

(a) To obtain a certificate to use for signing electronic orders for controlled substances, a registrant or person with power of attorney for a registrant must complete the application that the DEA Certification Authority provides and submit the following:


(1) Two copies of identification, one of which must be a government-issued photographic identification.


(2) A current listing of DEA registrations for which the individual has authority to sign controlled substances orders.


(3) A copy of the power of attorney from the registrant, if applicable.


(4) An acknowledgment that the applicant has read and understands the Subscriber Agreement and agrees to the statement of subscriber obligations that DEA provides.


(b) The applicant must provide the completed application to the registrant’s coordinator for CSOS digital certificate holders who will review the application and submit the completed application and accompanying documentation to the DEA Certification Authority.


(c) When the Certification Authority approves the application, it will send the applicant a one-time use reference number and access code, via separate channels, and information on how to use them. Using this information, the applicant must then electronically submit a request for certification of the public digital signature key. After the request is approved, the Certification Authority will provide the applicant with the signed public key certificate.


(d) Once the applicant has generated the key pair, the Certification Authority must prove that the user has possession of the key. For public keys, the corresponding private key must be used to sign the certificate request. Verification of the signature using the public key in the request will serve as proof of possession of the private key.


§ 1311.30 Requirements for storing and using a private key for digitally signing orders.

(a) Only the certificate holder may access or use his or her digital certificate and private key.


(b) The certificate holder must provide FIPS-approved secure storage for the private key, as discussed by FIPS 140-2, 180-2, 186-2, and accompanying change notices and annexes, as incorporated by reference in § 1311.08.


(c) A certificate holder must ensure that no one else uses the private key. While the private key is activated, the certificate holder must prevent unauthorized use of that private key.


(d) A certificate holder must not make back-up copies of the private key.


(e) The certificate holder must report the loss, theft, or compromise of the private key or the password, via a revocation request, to the Certification Authority within 24 hours of substantiation of the loss, theft, or compromise. Upon receipt and verification of a signed revocation request, the Certification Authority will revoke the certificate. The certificate holder must apply for a new certificate under the requirements of § 1311.25.


§ 1311.35 Number of CSOS digital certificates needed.

A purchaser of Schedule I and II controlled substances must obtain a separate CSOS certificate for each registered location for which the purchaser will order these controlled substances.


§ 1311.40 Renewal of CSOS digital certificates.

(a) A CSOS certificate holder must generate a new key pair and obtain a new CSOS digital certificate when the registrant’s DEA registration expires or whenever the information on which the certificate is based changes. This information includes the registered name and address, the subscriber’s name, and the schedules the registrant is authorized to handle. A CSOS certificate will expire on the date on which the DEA registration on which the certificate is based expires.


(b) The Certification Authority will notify each CSOS certificate holder 45 days in advance of the expiration of the certificate holder’s CSOS digital certificate.


(c) If a CSOS certificate holder applies for a renewal before the certificate expires, the certificate holder may renew electronically twice. For every third renewal, the CSOS certificate holder must submit a new application and documentation, as provided in § 1311.25.


(d) If a CSOS certificate expires before the holder applies for a renewal, the certificate holder must submit a new application and documentation, as provided in § 1311.25.


§ 1311.45 Requirements for registrants that allow powers of attorney to obtain CSOS digital certificates under their DEA registration.

(a) A registrant that grants power of attorney must report to the DEA Certification Authority within 6 hours of either of the following (advance notice may be provided, where applicable):


(1) The person with power of attorney has left the employ of the institution.


(2) The person with power of attorney has had his or her privileges revoked.


(b) A registrant must maintain a record that lists each person granted power of attorney to sign controlled substances orders.


§ 1311.50 Requirements for recipients of digitally signed orders.

(a) The recipient of a digitally signed order must do the following before filling the order:


(1) Verify the integrity of the signature and the order by having the system validate the order.


(2) Verify that the certificate holder’s CSOS digital certificate has not expired by checking the expiration date against the date the order was signed.


(3) Check the validity of the certificate holder’s certificate by checking the Certificate Revocation List.


(4) Check the certificate extension data to determine whether the sender has the authority to order the controlled substance.


(b) A recipient may cache Certificate Revocation Lists for use until they expire.


§ 1311.55 Requirements for systems used to process digitally signed orders.

(a) A CSOS certificate holder and recipient of an electronic order may use any system to write, track, or maintain orders provided that the system has been enabled to process digitally signed documents and that it meets the requirements of paragraph (b) or (c) of this section.


(b) A system used to digitally sign Schedule I or II orders must meet the following requirements:


(1) The cryptographic module must be FIPS 140-2, Level 1 validated, as incorporated by reference in § 1311.08.


(2) The digital signature system and hash function must be compliant with FIPS 186-2 and FIPS 180-2, as incorporated by reference in § 1311.08.


(3) The private key must be stored on a FIPS 140-2 Level 1 validated cryptographic module using a FIPS-approved encryption algorithm, as incorporated by reference in § 1311.08.


(4) The system must use either a user identification and password combination or biometric authentication to access the private key. Activation data must not be displayed as they are entered.


(5) The system must set a 10-minute inactivity time period after which the certificate holder must reauthenticate the password to access the private key.


(6) For software implementations, when the signing module is deactivated, the system must clear the plain text private key from the system memory to prevent the unauthorized access to, or use of, the private key.


(7) The system must be able to digitally sign and transmit an order.


(8) The system must have a time system that is within five minutes of the official National Institute of Standards and Technology time source.


(9) The system must archive the digitally signed orders and any other records required in part 1305 of this chapter, including any linked data.


(10) The system must create an order that includes all data fields listed under § 1305.21(b) of this chapter.


(c) A system used to receive, verify, and create linked records for orders signed with a CSOS digital certificate must meet the following requirements:


(1) The cryptographic module must be FIPS 140-2, Level 1 validated, as incorporated by reference in § 1311.08.


(2) The digital signature system and hash function must be compliant with FIPS 186-2 and FIPS 180-2, as incorporated by reference in § 1311.08.


(3) The system must determine that an order has not been altered during transmission. The system must invalidate any order that has been altered.


(4) The system must validate the digital signature using the signer’s public key. The system must invalidate any order in which the digital signature cannot be validated.


(5) The system must validate that the DEA registration number contained in the body of the order corresponds to the registration number associated with the specific certificate by separately generating the hash value of the registration number and certificate subject distinguished name serial number and comparing that hash value to the hash value contained in the certificate extension for the DEA registration number. If the hash values are not equal the system must invalidate the order.


(6) The system must check the Certificate Revocation List automatically and invalidate any order with a certificate listed on the Certificate Revocation List.


(7) The system must check the validity of the certificate and the Certification Authority certificate and invalidate any order that fails these validity checks.


(8) The system must have a time system that is within five minutes of the official National Institute of Standards and Technology time source.


(9) The system must check the substances ordered against the schedules that the registrant is allowed to order and invalidate any order that includes substances the registrant is not allowed to order.


(10) The system must ensure that an invalid finding cannot be bypassed or ignored and the order filled.


(11) The system must archive the order and associate with it the digital certificate received with the order.


(12) If a registrant sends reports on orders to DEA, the system must create a report in the format DEA specifies, as provided in § 1305.29 of this chapter.


(d) For systems used to process CSOS orders, the system developer or vendor must have an initial independent third-party audit of the system and an additional independent third-party audit whenever the signing or verifying functionality is changed to determine whether it correctly performs the functions listed under paragraphs (b) and (c) of this section. The system developer must retain the most recent audit results and retain the results of any other audits of the software completed within the previous two years.


§ 1311.60 Recordkeeping.

(a) A supplier and purchaser must maintain records of CSOS electronic orders and any linked records for two years. Records may be maintained electronically. Records regarding controlled substances that are maintained electronically must be readily retrievable from all other records.


(b) Electronic records must be easily readable or easily rendered into a format that a person can read. They must be made available to the Administration upon request.


(c) CSOS certificate holders must maintain a copy of the subscriber agreement that the Certification Authority provides for the life of the certificate.


Subpart C – Electronic Prescriptions


Source:75 FR 16310, Mar. 31, 2010, unless otherwise noted.

§ 1311.100 General.

(a) This subpart addresses the requirements that must be met to issue and process Schedule II, III, IV, and V controlled substance prescriptions electronically.


(b) A practitioner may issue a prescription for a Schedule II, III, IV, or V controlled substance electronically if all of the following conditions are met:


(1) The practitioner is registered as an individual practitioner or exempt from the requirement of registration under part 1301 of this chapter and is authorized under the registration or exemption to dispense the controlled substance;


(2) The practitioner uses an electronic prescription application that meets all of the applicable requirements of this subpart; and


(3) The prescription is otherwise in conformity with the requirements of the Act and this chapter.


(c) An electronic prescription for a Schedule II, III, IV, or V controlled substance created using an electronic prescription application that does not meet the requirements of this subpart is not a valid prescription, as that term is defined in § 1300.03 of this chapter.


(d) A controlled substance prescription created using an electronic prescription application that meets the requirements of this subpart is not a valid prescription if any of the functions required under this subpart were disabled when the prescription was indicated as ready for signature and signed.


(e) A registered pharmacy may process electronic prescriptions for controlled substances only if all of the following conditions are met:


(1) The pharmacy uses a pharmacy application that meets all of the applicable requirements of this subpart; and


(2) The prescription is otherwise in conformity with the requirements of the Act and this chapter.


(f) Nothing in this part alters the responsibilities of the practitioner and pharmacy, specified in part 1306 of this chapter, to ensure the validity of a controlled substance prescription.


§ 1311.102 Practitioner responsibilities.

(a) The practitioner must retain sole possession of the hard token, where applicable, and must not share the password or other knowledge factor, or biometric information, with any other person. The practitioner must not allow any other person to use the token or enter the knowledge factor or other identification means to sign prescriptions for controlled substances. Failure by the practitioner to secure the hard token, knowledge factor, or biometric information may provide a basis for revocation or suspension of registration pursuant to section 304(a)(4) of the Act (21 U.S.C. 824(a)(4)).


(b) The practitioner must notify the individuals designated under § 1311.125 or § 1311.130 within one business day of discovery that the hard token has been lost, stolen, or compromised or the authentication protocol has been otherwise compromised. A practitioner who fails to comply with this provision may be held responsible for any controlled substance prescriptions written using his two-factor authentication credential.


(c) If the practitioner is notified by an intermediary or pharmacy that an electronic prescription was not successfully delivered, as provided in § 1311.170, he must ensure that any paper or oral prescription (where permitted) issued as a replacement of the original electronic prescription indicates that the prescription was originally transmitted electronically to a particular pharmacy and that the transmission failed.


(d) Before initially using an electronic prescription application to sign and transmit controlled substance prescriptions, the practitioner must determine that the third-party auditor or certification organization has found that the electronic prescription application records, stores, and transmits the following accurately