CODE OF FEDERAL REGULATIONS PARTS 1300-1308
TABLE OF CONTENTS CHAPTER II DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1300 • DEFINITIONS
PART 1301 • REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES • REGISTRATION • EXCEPTIONS TO REGISTRATION AND FEES • ACTION ON APPLICATION FOR REGISTRATION: REVOCATION OR SUSPENSION OF REGISTRATION • HEARINGS • MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION • EMPLOYEE SCREENING-NON- PRACTITIONERS
PART 1302 • LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
PART 1303 • QUOTAS • AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS • INDIVIDUAL MANUFACTURING QUOTAS • HEARINGS
PART 1304 • RECORDS AND REPORTS OF REGISTRANTS • INVENTORY REQUIREMENTS • CONTINUING RECORDS • REPORTS
PART 1305 • ORDER FORMS
PART 1306 • PRESCRIPTIONS • CONTROLLED SUBSTANCES LISTED IN SCHEDULE II • CONTROLLED SUBSTANCES LISTED IN SECHEDULES III, IV AND V
PART 1307 • MISCELLANEOUS • SPECIAL EXCEPTIONS FOR MANUFACTURE AND DISTRIBUTION OF CONTROLLED SUBSTANCES • DISPOSAL OF CONTROLLED SUBSTANCES • SPECIAL EXEMPT PERSONS
PART 1308 • SCHEDULE OF CONTROLLED SUBSTANCES PART 1300—DEFINITIONS (xiii) Methandriol; (xiv) Methandrostenolone; Sec. (xv) Methenolone; 1300.01 Definitions relating to controlled (xvi) Methyltestosterone; substances. (xvii) Mibolerone; 1300.02 Definitions relating to listed chemi- (xviii) Nandrolone; cals. (xix) Norethandrolone; AUTHORITY: 21 U.S.C. 802, 871(b), 951, 958(f) (xx) Oxandrolone; SOURCE: 62 FR 13941, Mar. 24, 1997, unless (xxi) Oxymesterone; otherwise noted. (xxii) Oxymetholone; (xxiii) Stanolone; § 1300.01 Definitions relating to con- trolled substances. (xxiv) Stanozolol; (xxv) Testolactone; (a) Any term not defined in this part (xxvi) Testosterone; shall have the definition set forth in (xxvii) Trenbolone; and section 102 of the Act (21 U.S.C. 802), except that certain terms used in part (xxviii) Any salt, ester, or isomer of a 1316 of this chapter are defined at the drug or substance described or listed in beginning of each subpart of that part. this paragraph, if that salt, ester, or (b) As used in parts 1301 through 1308 isomer promotes muscle growth. Ex- and part 1312 of this chapter, the fol- cept such term does not include an an- lowing terms shall have the meanings abolic steroid which is expressly in- specified: tended for administration through im- (1) The term Act means the Con- plants to cattle or other nonhuman trolled Substances Act, as amended (84 species and which has been approved by Stat. 1242; 21 U.S.C. 801) and/or the Con- the Secretary of Health and Human trolled Substances Import and Export Services for such administration. If Act, as amended (84 Stat. 1285; 21 U.S.C. any person prescribes, dispenses, or dis- 951). tributes such steroid for human use, (2) The term Administration means such person shall be considered to have the Drug Enforcement Administration. prescribed, dispensed, or distributed an (3) The term Administrator means the anabolic steroid within the meaning of Administrator of the Drug Enforce- this paragraph. ment Administration. The Adminis- (5) The term basic class means, as to trator has been delegated authority controlled substances listed in Sched- under the Act by the Attorney General ules I and II: (28 CFR 0.100). (i) Each of the opiates, including its (4) The term anabolic steroid means isomers, esters, ethers, salts, and salts any drug or hormonal substance, of isomers, esters, and ethers whenever chemically and pharmacologically re- the existence of such isomers, esters, lated to testosterone (other than estro- ethers, and salts is possible within the gens, progestins, and corticosteroids) specific chemical designation, listed in that promotes muscle growth, and in- § 1308.11(b) of this chapter; cludes: (ii) Each of the opium derivatives, in- (i) Boldenone; cluding its salts, isomers, and salts of (ii) Chlorotestosterone (4- isomers whenever the existence of such chlortestosterone); salts, isomers, and salts of isomers is (iii) Clostebol; possible within the specific chemical (iv) designation, listed in § 1308.11(c) of this Dehydrochlormethyltestosterone; chapter; (v) Dihydrotestosterone (4- (iii) Each of the hallucinogenic sub- dihydrotestosterone); stances, including its salts, isomers, (vi) Drostanolone; and salts of isomers whenever the ex- (vii) Ethylestrenol; istence of such salts, isomers, and salts (viii) Fluoxymesterone; of isomers is possible within the spe- (ix) Formebulone (formebolone); cific chemical designation, listed in (x) Mesterolone; § 1308.11(d) of this chapter; (xi) Methandienone; (iv) Each of the following substances, (xii) Methandranone; whether produced directly or indirectly
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by extraction from substances of vege- containers are stored or are used for table origin, or independently by shipment of controlled substances. means of chemical synthesis, or by a (7) The term compounder means any combination of extraction and chem- person engaging in maintenance or de- ical synthesis: toxification treatment who also mixes, (A) Opium, including raw opium, prepares, packages or changes the dos- opium extracts, opium fluid extracts, age form of a narcotic drug listed in powdered opium, granulated opium, de- Schedules II, III, IV or V for use in odorized opium and tincture of opium; maintenance or detoxification treat- (B) Apomorphine; ment by another narcotic treatment (C) Codeine; program. (D) Etorphine hydrochloride; (8) The term controlled substance has (E) Ethylmorphine; the meaning given in section 802(6) of (F) Hydrocodone; Title 21, United States Code (U.S.C.). (G) Hydromorphone; (9) The term customs territory of the (H) Metopon; United States means the several (I) Morphine; States, the District of Columbia, and (J) Oxycodone; Puerto Rico. (K) Oxymorphone; (10) The term detoxification treatment (L) Thebaine; means the dispensing, for a period of (M) Mixed alkaloids of opium listed time as specified below, of a narcotic in Section 1308.12(b)(2) of this chapter; drug or narcotic drugs in decreasing (N) Cocaine; and doses to an individual to alleviate ad- (O) Ecgonine; verse physiological or psychological ef- (v) Each of the opiates, including its fects incident to withdrawal from the isomers, esters, ethers, salts, and salts continuous or sustained use of a nar- of isomers, esters, and ethers whenever cotic drug and as a method of bringing the existence of such isomers, esters, the individual to a narcotic drug-free ethers, and salts is possible within the state within such period of time. There specific chemical designation, listed in are two types of detoxification treat- § 1308.12(c) of this chapter; and ment: Short-term detoxification treat- (vi) Methamphetamine, its salts, iso- ment and long-term detoxification mers, and salts of its isomers; treatment. (vii) Amphetamine, its salts, optical (i) Short-term detoxification treat- isomers, and salts of its optical iso- ment is for a period not in excess of 30 mers; days. (viii) Phenmetrazine and its salts; (ii) Long-term detoxification treat- (ix) Methylphenidate; ment is for a period more than 30 days (x) Each of the substances having a but not in excess of 180 days. depressant effect on the central nerv- (11) The term dispenser means an in- ous system, including its salts, iso- dividual practitioner, institutional mers, and salts of isomers whenever practitioner, pharmacy or pharmacist the existence of such salts, isomers, who dispenses a controlled substance. and salts of isomers is possible within (12) The term export means, with re- the specific chemical designation, list- spect to any article, any taking out or ed in § 1308.12(e) of this chapter. removal of such article from the juris- (6) The term commercial container diction of the United States (whether means any bottle, jar, tube, ampule, or or not such taking out or removal con- other receptacle in which a substance stitutes an exportation within the is held for distribution or dispensing to meaning of the customs and related an ultimate user, and in addition, any laws of the United States). box or package in which the receptacle (13) The term exporter includes every is held for distribution or dispensing to person who exports, or who acts as an an ultimate user. The term commercial export broker for exportation of, con- container does not include any package trolled substances listed in any sched- liner, package insert or other material ule. kept with or within a commercial con- (14) The term hearing means: tainer, nor any carton, crate, drum, or (i) In part 1301 of this chapter, any other package in which commercial hearing held for the granting, denial,
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revocation, or suspension of a registra- manufactured or otherwise acquired by tion pursuant to sections 303, 304, and a registrant, whether in bulk, commer- 1008 of the Act (21 U.S.C. 823, 824 and cial containers, or contained in phar- 958). maceutical preparations in the posses- (ii) In part 1303 of this chapter, any sion of the registrant (including stocks hearing held regarding the determina- held by the registrant under separate tion of aggregate production quota or registration as a manufacturer, im- the issuance, adjustment, suspension, porter, exporter, or distributor). or denial of a procurement quota or an (21) The term isomer means the opti- individual manufacturing quota. cal isomer, except as used in § 1308.11(d) (iii) In part 1308 of this chapter, any and § 1308.12(b)(4) of this chapter. As hearing held for the issuance, amend- used in § 1308.11(d) of this chapter, the ment, or repeal of any rule issuable term isomer means the optical, posi- pursuant to section 201 of the Act (21 tional, or geometric isomer. As used in U.S.C. 811). § 1308.12(b)(4) of this chapter, the term (15) The term import means, with re- isomer means the optical or geometric spect to any article, any bringing in or isomer. introduction of such article into either (22) The term jurisdiction of the United the jurisdiction of the United States or States means the customs territory of the customs territory of the United the United States, the Virgin Islands, States, and from the jurisdiction of the the Canal Zone, Guam, American United States into the customs terri- Samoa, and the Trust Territories of tory of the United States (whether or the Pacific Islands. not such bringing in or introduction (23) The term label means any display constitutes an importation within the of written, printed, or graphic matter meaning of the tariff laws of the placed upon the commercial container United States). of any controlled substance by any (16) The term importer includes every manufacturer of such substance. person who imports, or who acts as an import broker for importation of, con- (24) The term labeling means all la- trolled substances listed in any sched- bels and other written, printed, or ule. graphic matter: (17) The term individual practitioner (i) Upon any controlled substance or means a physician, dentist, veteri- any of its commercial containers or narian, or other individual licensed, wrappers, or registered, or otherwise permitted, by (ii) Accompanying such controlled the United States or the jurisdiction in substance. which he/she practices, to dispense a (25) The term Long Term Care Facility controlled substance in the course of (LTCF) means a nursing home, retire- professional practice, but does not in- ment care, mental care or other facil- clude a pharmacist, a pharmacy, or an ity or institution which provides ex- institutional practitioner. tended health care to resident patients. (18) The term institutional practitioner (26) The term maintenance treatment means a hospital or other person (other means the dispensing for a period in ex- than an individual) licensed, reg- cess of twenty-one days, of a narcotic istered, or otherwise permitted, by the drug or narcotic drugs in the treat- United States or the jurisdiction in ment of an individual for dependence which it practices, to dispense a con- upon heroin or other morphine-like trolled substance in the course of pro- drug. fessional practice, but does not include (27) The term manufacture means the a pharmacy. producing, preparation, propagation, (19) The term interested person means compounding, or processing of a drug any person adversely affected or ag- or other substance or the packaging or grieved by any rule or proposed rule repackaging of such substance, or the issuable pursuant to section 201 of the labeling or relabeling of the commer- Act (21 U.S.C. 811). cial container of such substance, but (20) The term inventory means all fac- does not include the activities of a tory and branch stocks in finished form practitioner who, as an incident to his/ of a basic class of controlled substance her administration or dispensing such
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substance in the course of his/her pro- (vi) Any compound, mixture, or prep- fessional practice, prepares, com- aration which contains any quantity of pounds, packages or labels such sub- any of the substances referred to in stance. The term manufacturer means a paragraphs (b)(31)(i) through (v) of this person who manufactures a drug or section. other substance, whether under a reg- (31) The term narcotic treatment pro- istration as a manufacturer or under gram means a program engaged in authority of registration as a re- maintenance and/or detoxification searcher or chemical analyst. treatment with narcotic drugs. (28) The term mid-level practitioner (32) The term net disposal means, for means an individual practitioner, other a stated period, the quantity of a basic than a physician, dentist, veterinarian, class of controlled substance distrib- or podiatrist, who is licensed, reg- uted by the registrant to another per- istered, or otherwise permitted by the son, plus the quantity of that basic United States or the jurisdiction in class used by the registrant in the pro- which he/she practices, to dispense a duction of (or converted by the reg- controlled substance in the course of istrant into) another basic class of con- professional practice. Examples of mid- trolled substance or a noncontrolled level practitioners include, but are not substance, plus the quantity of that limited to, health care providers such basic class otherwise disposed of by the as nurse practitioners, nurse midwives, registrant, less the quantity of that nurse anesthetists, clinical nurse spe- basic class returned to the registrant cialists and physician assistants who by any purchaser, and less the quantity are authorized to dispense controlled of that basic class distributed by the substances by the state in which they registrant to another registered manu- practice. facturer of that basic class for purposes other than use in the production of, or (29) The term name means the official conversion into, another basic class of name, common or usual name, chem- controlled substance or a noncon- ical name, or brand name of a sub- trolled substance or in the manufac- stance. ture of dosage forms of that basic class. (30) The term narcotic drug means any (33) The term pharmacist means any of the following whether produced di- pharmacist licensed by a State to dis- rectly or indirectly by extraction from pense controlled substances, and shall substances of vegetable origin or inde- include any other person (e.g., phar- pendently by means of chemical syn- macist intern) authorized by a State to thesis or by a combination of extrac- dispense controlled substances under tion and chemical synthesis: the supervision of a pharmacist li- (i) Opium, opiates, derivatives of censed by such State. opium and opiates, including their iso- (34) The term person includes any in- mers, esters, ethers, salts, and salts of dividual, corporation, government or isomers, esters, and ethers whenever governmental subdivision or agency, the existence of such isomers, esters, business trust, partnership, associa- ethers and salts is possible within the tion, or other legal entity. specific chemical designation. Such (35) The term prescription means an term does not include the isoquinoline order for medication which is dispensed alkaloids of opium. to or for an ultimate user but does not (ii) Poppy straw and concentrate of include an order for medication which poppy straw. is dispensed for immediate administra- (iii) Coca leaves, except coca leaves tion to the ultimate user. (e.g., an and extracts of coca leaves from which order to dispense a drug to a bed pa- cocaine, ecgonine and derivatives of ec- tient for immediate administration in gonine or their salts have been re- a hospital is not a prescription.) moved. (36) The term proceeding means all ac- (iv) Cocaine, its salts, optical and tions taken for the issuance, amend- geometric isomers, and salts of iso- ment, or repeal of any rule issued pur- mers. suant to section 201 of the Act (21 (v) Ecgonine, its derivatives, their U.S.C. 811), commencing with the pub- salts, isomers and salts of isomers. lication by the Administrator of the
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proposed rule, amended rule, or repeal § 1300.02 Definitions relating to listed in the FEDERAL REGISTER. chemicals. (37) The term purchaser means any (a) Any term not defined in this part registered person entitled to obtain shall have the definition set forth in and execute order forms pursuant to section 102 of the Act (21 U.S.C. 802), §§ 1305.04 and 1305.06. except that certain terms used in part (38) The term readily retrievable 1316 of this chapter are defined at the means that certain records are kept by beginning of each subpart of that part. automatic data processing systems or other electronic or mechanized record- (b) As used in parts 1309, 1310, and keeping systems in such a manner that 1313 of this chapter, the following they can be separated out from all terms shall have the meaning specified: other records in a reasonable time and/ (1) The term Act means the Con- or records are kept on which certain trolled Substances Act, as amended (84 items are asterisked, redlined, or in Stat. 1242; 21 U.S.C. 801) and/or the Con- some other manner visually identifi- trolled Substances Import and Export able apart from other items appearing Act, as amended (84 Stat. 1285; 21 U.S.C. on the records. 951) as amended. (39) The terms register and registration (2) The term Administration means refer only to registration required and the Drug Enforcement Administration. permitted by sections 303 or 1007 of the (3) The term Administrator means the Act (21 U.S.C. 823 or 957). Administrator of the Drug Enforce- (40) The term registrant means any ment Administration. The Adminis- person who is registered pursuant to ei- trator has been delegated authority ther section 303 or section 1008 of the under the Act by the Attorney General Act (21 U.S.C. 823 or 958). (28 CFR 0.100). (41) The term supplier means any reg- (4) The terms broker and trader mean istered person entitled to fill order any individual, corporation, corporate forms pursuant to § 1305.08 of this chap- division, partnership, association, or ter. other legal entity which assists in ar- (42) The term freight forwarding facil- ranging an international transaction in ity means a separate facility operated a listed chemical by— by a distributing registrant through (i) Negotiating contracts; which sealed, packaged controlled sub- (ii) Serving as an agent or inter- stances in unmarked shipping con- mediary; or tainers (i.e., the containers do not indi- (iii) Fulfilling a formal obligation to cate that the contents include con- complete the transaction by bringing trolled substances) are, in the course of together a buyer and seller, a buyer delivery to, or return from, customers, and transporter, or a seller and trans- transferred in less than 24 hours. A dis- porter, or by receiving any form of tributing registrant who operates a compensation for so doing. freight forwarding facility may use the (5) The term chemical export means facility to transfer controlled sub- transferring ownership or control, or stances from any location the distrib- the sending or taking of threshold uting registrant operates that is reg- quantities of listed chemicals out of istered with the Administration to the United States (whether or not such manufacture, distribute, or import con- sending or taking out constitutes an trolled substances, or, with respect to exportation within the meaning of the returns, registered to dispense con- Customs and related laws of the United trolled substances, provided that the States). notice required by § 1301.12(b)(4) of Part (6) The term chemical exporter is a 1301 of this chapter has been submitted regulated person who, as the principal and approved. For purposes of this defi- party in interest in the export trans- nition, a distributing registrant is a action, has the power and responsi- person who is registered with the Ad- bility for determining and controlling ministration as a manufacturer, dis- the sending of the listed chemical out tributor, and/or importer. of the United States. [62 FR 13941, Mar. 24, 1997, as amended at 65 (7) The term chemical import means FR 44678, July 19, 2000] with respect to a listed chemical, any
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bringing in or introduction of such list- chemical exporter and for each regular ed chemical into either the jurisdiction customer; of the United States or into the Cus- (iii) The nature of the regular cus- toms territory of the United States tomer’s business (i.e., importer, ex- (whether or not such bringing in or in- porter, distributor, manufacturer, troduction constitutes an importation etc.), and if known, the use to which within the meaning of the tariff laws of the listed chemical or chemicals will the United States). be applied; (8) The term chemical importer is a (iv) The duration of the business rela- regulated person who, as the principal tionship; party in interest in the import trans- (v) The frequency and number of action, has the power and responsi- transactions occurring during the pre- bility for determining and controlling ceding 12-month period; the bringing in or introduction of the (vi) the amounts and the listed chem- listed chemical into the United States. ical or chemicals involved in regulated (9) The term chemical mixture means a transactions between the chemical ex- combination of two or more chemical porter and regular customer; substances, at least one of which is not (vii) The method of delivery (direct a listed chemical, except that such shipment or through a broker or for- term does not include any combination warding agent); and of a listed chemical with another chemical that is present solely as an (viii) Other information that the impurity or which has been created to chemical exporter considers relevant evade the requirements of the Act. for determining whether a customer is a regular customer. (10) The term customs territory of the United States means the several States, (13) The term established record as an the District of Columbia, and Puerto importer means that the regulated per- Rico. son has imported a listed chemical at (11) The term encapsulating machine least once within the past six months, means any manual, semi-automatic, or or twice within the past twelve months fully automatic equipment which may from a foreign supplier. The term also be used to fill shells or capsules with means that the regulated person has any powdered, granular, semi-solid, or provided the Administration with the liquid material. following information in accordance (12) The term established business rela- with the waiver of the 15-day advance tionship with a foreign customer means notice requirements of § 1313.15 of this the regulated person has exported a chapter: listed chemical at least once within (i) The name, DEA registration num- the past six months, or twice within ber (where applicable), street address, the past twelve months to a foreign telephone number, telex number, and, manufacturer, distributor, or end user where available, the facsimile number of the chemical that has an established of the regulated person and of each for- business in the foreign country with a eign supplier; and fixed street address. A person or busi- (ii) The frequency and number of ness which functions as a broker or transactions occurring during the pre- intermediary is not a customer for pur- ceding 12 month period. poses of this definition. The term also (14) The term hearing means any means that the regulated person has hearing held for the granting, denial, provided the Administration with the revocation, or suspension of a registra- following information in accordance tion pursuant to sections 303, 304, and with the waiver of 15-day advance no- 1008 of the Act (21 U.S.C. 823, 824 and tice requirements of § 1313.24 of this 958). chapter: (15) The term international transaction (i) The name and street address of means a transaction involving the the chemical exporter and of each reg- shipment of a listed chemical across an ular customer; international border (other than a (ii) The telephone number, telex United States border) in which a number, contact person, and where broker or trader located in the United available, the facsimile number for the States participates.
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(16) The term jurisdiction of the United (26) The term regular importer means, States means the customs territory of with respect to a listed chemical, a the United States, the Virgin Islands, person that has an established record the Canal Zone, Guam, American as an importer of that listed chemical Samoa, and the Trust Territories of that is reported to the Administrator. the Pacific Islands. (27) The term regulated person means (17) The term listed chemical means any individual, corporation, partner- any List I chemical or List II chemical. ship, association, or other legal entity (18) The term List I chemical means a who manufactures, distributes, im- chemical specifically designated by the ports, or exports a listed chemical, a Administrator in § 1310.02(a) of this tableting machine, or an encapsulating chapter that, in addition to legitimate machine, or who acts as a broker or uses, is used in manufacturing a con- trader for an international transaction trolled substance in violation of the involving a listed chemical, tableting Act and is important to the manufac- machine, or encapsulating machine. ture of a controlled substance. (28) The term regulated transaction (19) The term List II chemical means a means: chemical, other than a List I chemical, (i) A distribution, receipt, sale, im- specifically designated by the Adminis- portation, or exportation of a listed trator in § 1310.02(b) of this chapter chemical, or an international trans- that, in addition to legitimate uses, is action involving shipment of a listed used in manufacturing a controlled chemical, or if the Administrator es- substance in violation of the Act. tablishes a threshold amount for a spe- (20) The term name means the official cific listed chemical, a threshold name, common or usual name, chem- amount as determined by the Adminis- ical name, or brand name of a sub- trator, which includes a cumulative stance. threshold amount for multiple trans- (21) The term person includes any in- actions, of a listed chemical, except dividual, corporation, government or that such term does not include: governmental subdivision or agency, business trust, partnership, associa- (A) A domestic lawful distribution in tion, or other legal entity. the usual course of business between (22) The term readily retrievable agents or employees of a single regu- means that certain records are kept by lated person; in this context, agents or automatic data processing systems or employees means individuals under the other electronic or mechanized record- direct management and control of the keeping systems in such a manner that regulated person; they can be separated out from all (B) A delivery of a listed chemical to other records in a reasonable time and/ or by a common or contract carrier for or records are kept on which certain carriage in the lawful and usual course items are asterisked, redlined, or in of the business of the common or con- some other manner visually identifi- tract carrier, or to or by a warehouse- able apart from other items appearing man for storage in the lawful and usual on the records. course of the business of the ware- (23) The terms register and registration houseman, except that if the carriage refer only to registration required and or storage is in connection with the permitted by sections 303 or 1007 of the distribution, importation, or expor- Act (21 U.S.C. 823 or 957). tation of a listed chemical to a third (24) The term registrant means any person, this paragraph does not relieve person who is registered pursuant to ei- a distributor, importer, or exporter ther section 303 or section 1008 of the from compliance with parts 1309, 1310, Act (21 U.S.C. 823 or 958). and 1313 of this chapter; (25) The term regular customer means (C) Any category of transaction or a person with whom the regulated per- any category of transaction for a spe- son has an established business rela- cific listed chemical or chemicals spec- tionship for a specified listed chemical ified by regulation of the Adminis- or chemicals that has been reported to trator as excluded from this definition the Administration subject to the cri- as unnecessary for enforcement of the teria established in § 1300.02(b)(12). Act;
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(D) Any transaction in a listed chem- automatic equipment which may be ical that is contained in a drug that used for the compaction or molding of may be marketed or distributed law- powdered or granular solids, or semi- fully in the United States under the solid material, to produce coherent Federal Food, Drug, and Cosmetic Act solid tablets. unless— [62 FR 13941, Mar. 24, 1997; 62 FR 15392, Apr. (1)(i) The drug contains ephedrine or 1, 1997] its salts, optical isomers, or salts of op- tical isomers; or (ii) The Administrator has deter- PART 1301—REGISTRATION OF mined pursuant to the criteria in MANUFACTURERS, DISTRIBUTORS, 1310.10 that the drug or group of drugs AND DISPENSERS OF CON- is being diverted to obtain the listed TROLLED SUBSTANCES chemical for use in the illicit produc- tion of a controlled substance; and GENERAL INFORMATION (2) The quantity of ephedrine or Sec. other listed chemical contained in the 1301.01 Scope of this part 1301. drug included in the transaction or 1301.02 Definitions. multiple transactions equals or exceeds 1301.03 Information; special instructions. the threshold established for that REGISTRATION chemical. (E) Any transaction in a chemical 1301.11 Persons required to register. 1301.12 Separate registrations for separate mixture listed in § 1310.13 of this chap- locations. ter. 1301.13 Application for registration; time (ii) A distribution, importation, or for application; expiration date; registra- exportation of a tableting machine or tion for independent activities; applica- encapsulating machine except that tion forms, fees, contents and signature; such term does not include a domestic coincident activities. lawful distribution in the usual course 1301.14 Filing of application; acceptance for filing; defective applications. of business between agents and employ- 1301.15 Additional information. ees of a single regulated person; in this 1301.16 Amendments to and withdrawal of context, agents or employees means in- applications. dividuals under the direct management 1301.17 Special procedures for certain appli- and control of the regulated person. cations. (29) The term retail distributor means 1301.18 Research protocols. a grocery store, general merchandise EXCEPTIONS TO REGISTRATION AND FEES store, drug store, or other entity or person whose activities as a distributor 1301.21 Exception from fees. 1301.22 Exemption of agents and employees; relating to drug products containing affiliated practitioners. pseudoephedrine, phenylpropanola- 1301.23 Exemption of certain military and mine, or ephedrine are limited almost other personnel. exclusively to sales for personal use, 1301.24 Exemption of law enforcement offi- both in number of sales and volume of cials. sales, either directly to walk-in cus- 1301.25 Registration regarding ocean ves- tomers or in face-to-face transactions sels, aircraft, and other entities. by direct sales. For the purposes of this 1301.26 Exemptions from import or export requirements for personal medical use. paragraph, sale for personal use means the distribution of below-threshold ACTION ON APPLICATION FOR REGISTRATION: quantities in a single transaction to an REVOCATION OR SUSPENSION OF REGISTRATION individual for legitimate medical use. 1301.31 Administrative review generally. Also for the purposes of this paragraph, 1301.32 Action on applications for research a grocery store is an entity within in Schedule I substances. Standard Industrial Classification 1301.33 Application for bulk manufacture of (SIC) code 5411, a general merchandise Schedule I and II substances. store is an entity within SIC codes 5300 1301.34 Application for importation of Schedule I and II substances. through 5399 and 5499, and a drug store 1301.35 Certificate of registration; denial of is an entity within SIC code 5912. registration. (30) The term tableting machine means 1301.36 Suspension or revocation of registra- any manual, semi-automatic, or fully tion; suspension of registration pending
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final order; extension of registration generally by those sections and specifi- pending final order. cally by the sections of this part. 1301.37 Order to show cause. [62 FR 13945, Mar. 24, 1997] HEARINGS 1301.41 Hearings generally. § 1301.02 Definitions. 1301.42 Purpose of hearing. Any term used in this part shall have 1301.43 Request for hearing or appearance; the definition set forth in section 102 of waiver. the Act (21 U.S.C. 802) or part 1300 of 1301.44 Burden of proof. this chapter. 1301.45 Time and place of hearing. 1301.46 Final order. [62 FR 13945, Mar. 24, 1997]
MODIFICATION, TRANSFER, AND TERMINATION § 1301.03 Information; special instruc- OF REGISTRATION tions. 1301.51 Modification in registration. Information regarding procedures 1301.52 Termination of registration; transfer of registration; distribution upon dis- under these rules and instructions continuance of business. supplementing these rules will be fur- nished upon request by writing to the SECURITY REQUIREMENTS Registration Unit, Drug Enforcement 1301.71 Security requirements generally. Administration, Department of Jus- 1301.72 Physical security controls for non- tice, Post Office Box 28083, Central Sta- practitioners; narcotic treatment pro- tion, Washington, DC 20005. grams and compounders for narcotic treatment programs; storage areas. [36 FR 7778, Apr. 24, 1971. Redesignated at 38 1301.73 Physical security controls for non- FR 26609, Sept. 23, 1973, and amended at 51 practitioners; compounders for narcotic FR 5319, Feb. 13, 1986] treatment programs; manufacturing and compounding areas. REGISTRATION 1301.74 Other security controls for non- practitioners; narcotic treatment pro- § 1301.11 Persons required to register. grams and compounders for narcotic (a) Every person who manufactures, treatment programs. distributes, dispenses, imports, or ex- 1301.75 Physical security controls for prac- ports any controlled substance or who titioners. 1301.76 Other security controls for practi- proposes to engage in the manufacture, tioners. distribution, dispensing, importation 1301.77 Security controls for freight for- or exportation of any controlled sub- warding facilities. stance shall obtain a registration un- less exempted by law or pursuant to EMPLOYEE SCREENING—NON-PRACTITIONERS §§ 1301.22–1301.26. Only persons actually 1301.90 Employee screening procedures. engaged in such activities are required 1301.91 Employee responsibility to report to obtain a registration; related or af- drug diversion. filiated persons who are not engaged in 1301.92 Illicit activities by employees. such activities are not required to be 1301.93 Sources of information for employee checks. registered. (For example, a stockholder or parent corporation of a corporation AUTHORITY: 21 U.S.C. 821, 822, 823, 824, manufacturing controlled substances is 871(b), 875, 877. not required to obtain a registration.) SOURCE: 36 FR 7778, Apr. 24, 1971, unless (b) [Reserved] otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. [62 FR 13945, Mar. 24, 1997]
GENERAL INFORMATION § 1301.12 Separate registrations for separate locations. § 1301.01 Scope of this part 1301. (a) A separate registration is re- Procedures governing the registra- quired for each principal place of busi- tion of manufacturers, distributors, ness or professional practice at one dispensers, importers, and exporters of general physical location where con- controlled substances pursuant to sec- trolled substances are manufactured, tions 301–304 and 1007–1008 of the Act (21 distributed, imported, exported, or dis- U.S.C. 821–824 and 957–958) are set forth pensed by a person.
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(b) The following locations shall be also detail what state licensing re- deemed not to be places where con- quirements apply to the facility and trolled substances are manufactured, the registrant’s actions to comply with distributed, or dispensed: any such requirements. The Special (1) A warehouse where controlled Agent in Charge of the DEA Office in substances are stored by or on behalf of the area where the freight forwarding a registered person, unless such sub- facility will be operated will provide stances are distributed directly from written notice of approval or dis- such warehouse to registered locations approval to the person within thirty other than the registered location from days after confirmed receipt of the no- which the substances were delivered or tice. Registrants that are currently op- to persons not required to register by erating freight forwarding facilities virtue of subsection 302(c)(2) or sub- under a memorandum of understanding section 1007(b)(1)(B) of the Act (21 with the Administration must provide U.S.C. 822(c)(2) or 957(b)(1)(B)); notice as required by this section no (2) An office used by agents of a reg- later than September 18, 2000 and re- istrant where sales of controlled sub- ceive written approval from the Spe- stances are solicited, made, or super- cial Agent in Charge of the DEA Office vised but which neither contains such in the area in which the freight for- substances (other than substances for warding facility is operated in order to display purposes or lawful distribution continue operation of the facility. as samples only) nor serves as a dis- [62 FR 13945, Mar. 24, 1997, as amended at 65 tribution point for filling sales orders; FR 44678, July 19, 2000; 65 FR 45829, July 25, and 2000] (3) An office used by a practitioner (who is registered at another location) § 1301.13 Application for registration; where controlled substances are pre- time for application; expiration scribed but neither administered nor date; registration for independent otherwise dispensed as a regular part of activities; application forms, fees, the professional practice of the practi- contents and signature; coincident tioner at such office, and where no sup- activities. plies of controlled substances are (a) Any person who is required to be maintained. registered and who is not so registered (4) A freight forwarding facility, as may apply for registration at any time. defined in § 1300.01 of this part, provided No person required to be registered that the distributing registrant oper- shall engage in any activity for which ating the facility has submitted writ- registration is required until the appli- ten notice of intent to operate the fa- cation for registration is granted and a cility by registered mail, return re- Certificate of Registration is issued by ceipt requested (or other suitable the Administrator to such person. means of documented delivery) and (b) Any person who is registered may such notice has been approved. The no- apply to be reregistered not more than tice shall be submitted to the Special 60 days before the expiration date of Agent in Charge of the Administra- his/her registration, except that a bulk tion’s offices in both the area in which manufacturer of Schedule I or II con- the facility is located and each area in trolled substances or an importer of which the distributing registrant main- Schedule I or II controlled substances tains a registered location that will may apply to be reregistered no more transfer controlled substances through than 120 days before the expiration the facility. The notice shall detail the date of their registration. registered locations that will utilize (c) At the time a manufacturer, dis- the facility, the location of the facil- tributor, researcher, analytical lab, im- ity, the hours of operation, the indi- porter, exporter or narcotic treatment vidual(s) responsible for the controlled program is first registered, that busi- substances, the security and record- ness activity shall be assigned to one of keeping procedures that will be em- twelve groups, which shall correspond ployed, and whether controlled sub- to the months of the year. The expira- stances returns will be processed tion date of the registrations of all reg- through the facility. The notice must istrants within any group will be the
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last date of the month designated for trolled substances activities, which are that group. In assigning any of the deemed to be independent of each above business activities to a group, other. Application for each registration the Administration may select a group shall be made on the indicated form, the expiration date of which is less and shall be accompanied by the indi- than one year from the date such busi- cated fee. Fee payments shall be made ness activity was registered. If the in the form of a personal, certified, or business activity is assigned to a group cashier’s check or money order made which has an expiration date less than payable to the ‘‘Drug Enforcement Ad- three months from the date of which ministration’’. The application fees are the business activity is registered, the not refundable. Any person, when reg- registration shall not expire until one istered to engage in the activities de- year from that expiration date; in all scribed in each subparagraph in this other cases, the registration shall ex- paragraph, shall be authorized to en- pire on the expiration date following gage in the coincident activities de- the date on which the business activity scribed without obtaining a registra- is registered. tion to engage in such coincident ac- (d) At the time a retail pharmacy, tivities, provided that, unless specifi- hospital/clinic, practitioner or teach- cally exempted, he/she complies with ing institution is first registered, that all requirements and duties prescribed business activity shall be assigned to by law for persons registered to engage one of twelve groups, which shall cor- in such coincident activities. Any per- respond to the months of the year. The son who engages in more than one expiration date of the registrations of group of independent activities shall all registrants within any group will be obtain a separate registration for each the last day of the month designated group of activities, except as provided for that group. In assigning any of the in this paragraph under coincident ac- above business activities to a group, tivities. A single registration to engage the Administration may select a group in any group of independent activities the expiration date of which is not less listed below may include one or more than 28 months nor more than 39 controlled substances listed in the months from the date such business ac- schedules authorized in that group of tivity was registered. After the initial independent activities. A person reg- registration period, the registration istered to conduct research with con- shall expire 36 months from the initial trolled substances listed in Schedule I expiration date. may conduct research with any sub- (e) Any person who is required to be stances listed in Schedule I for which registered and who is not so registered, he/she has filed and had approved a re- shall make application for registration search protocol. for one of the following groups of con- (1)
Reg- Applica- istra- Business activity Controlled substances DEA application tion fee tion pe- Coincident activities allowed forms (dollars) riod (years)
(i) Manufacturing Schedules I through V New—225 875 1 Schedules I through V: May distribute Renewal—225a 875 that substance or class for which registration was issued; may not distribute any substance or class for which not registered. Schedules II through V: May conduct chemical analysis and preclinical research (including quality control analysis) with substances listed in those schedules for which authorization as a manufacturer was issued. (ii) Distributing Schedules I through V New—225 438 1 Renewal—225a 438
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Reg- Applica- istra- Business activity Controlled substances DEA application tion fee tion pe- Coincident activities allowed forms (dollars) riod (years)
(iii) Dispensing or Schedules II through V New—224 210 3 May conduct research and instruc- Instructing (In- Renewal—224a 210 tional activities with those sub- cludes Practitioner stances for which registration was Hospital/Clinic, granted, except that a mid-level Retail Pharmacy, practitioner may conduct such re- Teaching Institu- search only to the extent expressly tion) authorized under state statute. A pharmacist may manufacture an aqueous or oleaginous solution or solid dosage form containing a nar- cotic controlled substance in Schedule II through V in a propor- tion not exceeding 20 percent of the complete solution, compound, or mixture. (iv) Research Schedule I New—225 70 1 A researcher may manufacture or im- Renewal—225a 70 port 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 Section 1301.18 and to distribute such class to persons registered or au- thorized to conduct research with such class of substance or reg- istered or authorized to conduct chemical analysis with controlled substances. (v) Research Schedules II through V New—225 70 1 May conduct chemical analysis with Renewal—225a 70 controlled substances in those schedules for which registration was issued; manufacture such sub- stances 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 per- sons registered or authorized to conduct chemical analysis, instruc- tional activities, or research with such substances, and to persons exempted from registration pursu- ant to Section 1301.24; and con- duct instructional activities with con- trolled substances. (vi) Narcotic Treat- Narcotic Drugs in New—363 70 1 ment Program (in- Schedules II through Renewal—363a 70 cluding V compounder) (vii) Importing Schedules I through V New—225 438 1 May distribute that substance or class Renewal—225a 438 for which registration was issued; may not distribute any substance or class for which not registered. (viii) Exporting Schedules I through V New—225 438 1 Renewal—225a 438
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Reg- Applica- istra- Business activity Controlled substances DEA application tion fee tion pe- Coincident activities allowed forms (dollars) riod (years)
(ix) Chemical Anal- Schedules I through V New—225 70 1 May manufacture and import con- ysis Renewal—225a 70 trolled substances for analytical or instructional activities; may dis- tribute such substances to persons registered or authorized to conduct chemical analysis, instructional ac- tivities, or research with such sub- stances and to persons exempted from registration pursuant to Sec- tion 1301.24; may export such sub- stances to persons in other coun- tries performing chemical analysis or enforcing laws relating to con- trolled substances or drugs in those countries; and may conduct instruc- tional activities with controlled sub- stances.
(2) DEA Forms 224, 225, and 363 may Registration as an importer or ex- be obtained at any area office of the porter shall not entitle a registrant to Administration or by writing to the import or export any controlled sub- Registration Unit, Drug Enforcement stance not specified in such registra- Administration, Department of Jus- tion. tice, Post Office Box 28083, Central Sta- (h) Each application for registration tion, Washington, DC 20005. to conduct research with any basic (3) DEA Forms 224a, 225a, and 363a class of controlled substance listed in will be mailed, as applicable, to each Schedule II shall include the Adminis- registered person approximately 60 tration Controlled Substances Code days before the expiration date of his/ Number, as set forth in part 1308 of this her registration; if any registered per- chapter, for each such basic class to be son does not receive such forms within manufactured or imported as a coinci- 45 days before the expiration date of dent activity of that registration. A his/her registration, he/she must statement listing the quantity of each promptly give notice of such fact and such basic class of controlled substance request such forms by writing to the to be imported or manufactured during Registration Unit of the Administra- the registration period for which appli- tion at the foregoing address. cation is being made shall be included (f) Each application for registration with each such application. For pur- to handle any basic class of controlled poses of this paragraph only, manufac- substance listed in Schedule I (except turing is defined as the production of a to conduct chemical analysis with such controlled substance by synthesis, ex- classes), and each application for reg- traction or by agricultural/horti- istration to manufacture a basic class cultural means. of controlled substance listed in Sched- (i) Each application shall include all ule II shall include the Administration information called for in the form, un- Controlled Substances Code Number, as less the item is not applicable, in set forth in part 1308 of this chapter, which case this fact shall be indicated. for each basic class to be covered by (j) Each application, attachment, or such registration. other document filed as part of an ap- (g) Each application for registration plication, shall be signed by the appli- to import or export controlled sub- cant, if an individual; by a partner of stances shall include the Administra- the applicant, if a partnership; or by an tion Controlled Substances Code Num- officer of the applicant, if a corpora- ber, as set forth in part 1308 of this tion, corporate division, association, chapter, for each controlled substance trust or other entity. An applicant may whose importation or exportation is to authorize one or more individuals, who be authorized by such registration. would not otherwise be authorized to
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do so, to sign applications for the ap- whether the application will be grant- plicant by filing with the Registration ed. Unit of the Administration a power of [62 FR 13948, Mar. 24, 1997] attorney for each such individual. The power of attorney shall be signed by a § 1301.15 Additional information. person who is authorized to sign appli- cations under this paragraph and shall The Administrator may require an contain the signature of the individual applicant to submit such documents or being authorized to sign applications. written statements of fact relevant to The power of attorney shall be valid the application as he/she deems nec- until revoked by the applicant. essary to determine whether the appli- cation should be granted. The failure of [62 FR 13946, Mar. 24, 1997] the applicant to provide such docu- ments or statements within a reason- § 1301.14 Filing of application; accept- able time after being requested to do so ance for filing; defective applica- shall be deemed to be a waiver by the tions. applicant of an opportunity to present (a) All applications for registration such documents or facts for consider- shall be submitted for filing to the ation by the Administrator in granting Registration Unit, Drug Enforcement or denying the application. Administration, Department of Jus- tice, Post Office Box 28083, Central Sta- [62 FR 13948, Mar. 24, 1997] tion, Washington, DC 20005. The appro- § 1301.16 Amendments to and with- priate registration fee and any required drawal of applications. attachments must accompany the ap- plication. (a) An application may be amended (b) Any person required to obtain or withdrawn without permission of more than one registration may submit the Administrator at any time before all applications in one package. Each the date on which the applicant re- application must be complete and ceives an order to show cause pursuant should not refer to any accompanying to § 1301.37. An application may be application for required information. amended or withdrawn with permission (c) Applications submitted for filing of the Administrator at any time are dated upon receipt. If found to be where good cause is shown by the ap- complete, the application will be ac- plicant or where the amendment or cepted for filing. Applications failing withdrawal is in the public interest. to comply with the requirements of (b) After an application has been ac- this part will not generally be accepted cepted for filing, the request by the ap- for filing. In the case of minor defects plicant that it be returned or the fail- as to completeness, the Administrator ure of the applicant to respond to offi- may accept the application for filing cial correspondence regarding the ap- with a request to the applicant for ad- plication, when sent by registered or ditional information. A defective appli- certified mail, return receipt re- cation will be returned to the applicant quested, shall be deemed to be a with- within 10 days following its receipt drawal of the application. with a statement of the reason for not [62 FR 13949, Mar. 24, 1997] accepting the application for filing. A defective application may be corrected § 1301.17 Special procedures for cer- and resubmitted for filing at any time; tain applications. the Administrator shall accept for fil- (a) If, at the time of application for ing any application upon resubmission registration of a new pharmacy, the by the applicant, whether complete or pharmacy has been issued a license not. from the appropriate State licensing (d) Accepting an application for fil- agency, the applicant may include with ing does not preclude any subsequent his/her application an affidavit as to request for additional information pur- the existence of the State license in suant to § 1301.15 and has no bearing on the following form:
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Affidavit for New Pharmacy llllllllll (Store name) hereby cer- tify: I, llllllllll, the (1) That said company was issued a phar- llllllllll (Title of officer, official, macy permit No. by the partner, or other position) of llllll (Board of Pharmacy of llllllllll (Corporation, partner- llllllllll ship, or sole proprietor), doing business as Licensing Agency) of the State of and a DEA Registration Number llllllllll (Store name) at llllll llllllllll (Number and Street), llllllllll for a pharmacy located at llllllllll (City) llllll (State) llllllllll (Number and Street) llllll (Zip code), hereby certify that llllll (City) llllll (State) said store was issued a pharmacy permit No. llllll (Zip Code); and llll by the llllllll (Board of (2) That said company is acquiring the Pharmacy or Licensing Agency) of the State pharmacy business of llllllllll of llllll on llllll (Date). (Name of Seller) doing business This statement is submitted in order to ob- asllllllllllwith DEA Registration tain a Drug Enforcement Administration Number llllll on or about llllll registration number. I understand that if (Date of Transfer) and that said company has any information is false, the Administration applied (or will apply on llllll (Date) may immediately suspend the registration for a pharmacy permit from the board of for this store and commence proceedings to pharmacy (or licensing agency) of the State revoke under 21 U.S.C. 824(a) because of the of llllll to do business as danger to public health and safety. I further llllllllll (Store name) at understand that any false information con- llllllllll (Number and Street) tained in this affidavit may subject me per- llllllllll (City) llllll (State) sonally and the above-named corporation/ llllll (Zip Code). partnership/business to prosecution under 21 This statement is submitted in order U.S.C. 843, the penalties for conviction of which include imprisonment for up to 4 to obtain a Drug Enforcement Admin- years, a fine of not more than $30,000 or both. istration registration number. llllllllllllllllllllllll I understand that if a DEA registration Signature (Person who signs Application for number is issued, the pharmacy may acquire Registration) controlled substances but may not dispense State of lllllllllllllllllll them until a pharmacy permit or license is County of llllllllllllllllll issued by the State board of pharmacy or li- Subscribed to and sworn before me this censing agency. llll day of llll, 19lll. I understand that if any information is llllllllllllllllllllllll false, the Administration may immediately Notary Public suspend the registration for this store and (b) Whenever the ownership of a commence proceedings to revoke under 21 pharmacy is being transferred from one U.S.C. 824(a) because of the danger to public person to another, if the transferee health and safety. I further understand that owns at least one other pharmacy li- any false information contained in this affi- davit may subject me personally to prosecu- censed in the same State as the one the tion under 21 U.S.C. 843, the penalties for ownership of which is being trans- conviction of which include imprisonment ferred, the transferee may apply for for up to 4 years, a fine of not more than registration prior to the date of trans- $30,000 or both. fer. The Administrator may register llllllllllllllllllllllll the applicant and authorize him to ob- Signature (Person who signs Application for tain controlled substances at the time Registration) of transfer. Such registration shall not State of lllllllllllllllllll authorize the transferee to dispense County of llllllllllllllllll controlled substances until the phar- Subscribed to and sworn before me macy has been issued a valid State li- thisllday ofllllll, 19ll. llllllllllllllllllllllll cense. The transferee shall include Notary Public with his/her application the following affidavit: (c) The Administrator shall follow the normal procedures for approving an Affidavit for Transfer of Pharmacy application to verify the statements in the affidavit. If the statements prove I, llllllllll, the llllllllll (Title of officer, official, to be false, the Administrator may re- partner or other position) of voke the registration on the basis of llllllllll (Corporation, partner- section 304(a)(1) of the Act (21 U.S.C. ship, or sole proprietor), doing business as 824(a)(1)) and suspend the registration
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immediately by pending revocation on to be used or the substance to be im- the basis of section 304(d) of the Act (21 ported. U.S.C. 824(d)). At the same time, the (3) Authority: Administrator may seize and place (i) Institutional approval. under seal all controlled substances (ii) Approval of a Human Research possessed by the applicant under sec- Committee for human studies. tion 304(f) of the Act (21 U.S.C. 824(f)). (iii) Indication of an approved active Intentional misuse of the affidavit pro- Notice of Claimed Investigational Ex- cedure may subject the applicant to emption for a New Drug (number). prosecution for fraud under section (iv) Indication of an approved funded 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), grant (number), if any. and obtaining controlled substances (b) In the case of a clinical investiga- through registration by fraudulent tion with controlled substances listed means may subject the applicant to in Schedule I, the applicant shall sub- prosecution under section 403(a)(3) of mit three copies of a Notice of Claimed the Act (21 U.S.C. 843(a)(3)). The pen- Investigational Exemption for a New alties for conviction of either offense Drug (IND) together with a statement include imprisonment for up to 4 years, of the security provisions (as pro- a fine not exceeding $30,000 or both. scribed in paragraph (a)(2)(vi) of this section for a research protocol) to, and [62 FR 13949, Mar. 24, 1997] have such submission approved by, the § 1301.18 Research protocols. Food and Drug Administration as re- quired in 21 U.S.C. 355(i) and § 130.3 of (a) A protocol to conduct research this title. Submission of this Notice with controlled substances listed in and statement to the Food and Drug Schedule I shall be in the following Administration shall be in lieu of a re- form and contain the following infor- search protocol to the Administration mation where applicable: as required in paragraph (a) of this sec- (1) Investigator: tion. The applicant, when applying for (i) Name, address, and DEA registra- registration with the Administration, tion number; if any. shall indicate that such notice has (ii) Institutional affiliation. been submitted to the Food and Drug (iii) Qualifications, including a cur- Administration by submitting to the riculum vitae and an appropriate bibli- Administration with his/her DEA Form ography (list of publications). 225 three copies of the following certifi- (2) Research project: cate: (i) Title of project. (ii) Statement of the purpose. I hereby certify that on llllllllll (iii) Name of the controlled sub- (Date), pursuant to 21 U.S.C. 355(i) and 21 stances or substances involved and the CFR 130.3, I, llllllllll (Name and amount of each needed. Address of IND Sponsor) submitted a Notice (iv) Description of the research to be of Claimed Investigational Exemption for a New Drug (IND) to the Food and Drug Ad- conducted, including the number and ministration for: species of research subjects, the dosage llllllllllllllllllllllll to be administered, the route and (Name of Investigational Drug). method of administration, and the du- ration of the project. llllllllllllllllllllllll (Date) (v) Location where the research will be conducted. llllllllllllllllllllllll (vi) Statement of the security provi- (Signature of Applicant). sions for storing the controlled sub- (c) In the event that the registrant stances (in accordance with § 1301.75) desires to increase the quantity of a and for dispensing the controlled sub- controlled substance used for an ap- stances in order to prevent diversion. proved research project, he/she shall (vii) If the investigator desires to submit a request to the Registration manufacture or import any controlled Unit, Drug Enforcement Administra- substance listed in paragraph (a)(2)(iii) tion, Post Office Box 28083, Central of this section, a statement of the Station, Washington, DC 20005, by reg- quantity to be manufactured or im- istered mail, return receipt requested. ported and the sources of the chemicals The request shall contain the following
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information: DEA registration number; and Coast Guard), of any State, or any name of the controlled substance or political subdivision or agency thereof. substances and the quantity of each (b) In order to claim exemption from authorized in the approved protocol; payment of a registration or rereg- and the additional quantity of each de- istration application fee, the registrant sired. Upon return of the receipt, the shall have completed the certification registrant shall be authorized to pur- on the appropriate application form, chase the additional quantity of the wherein the registrant’s superior (if controlled substance or substances the registrant is an individual) or offi- specified in the request. The Adminis- cer (if the registrant is an agency) cer- tration shall review the letter and for- tifies to the status and address of the ward it to the Food and Drug Adminis- registrant and to the authority of the tration together with the Administra- registrant to acquire, possess, or han- tion comments. The Food and Drug Ad- dle controlled substances. ministration shall approve or deny the (c) Exemption from payment of a reg- request as an amendment to the pro- istration or reregistration application tocol and so notify the registrant. Ap- fee does not relieve the registrant of proval of the letter by the Food and any other requirements or duties pre- Drug Administration shall authorize scribed by law. the registrant to use the additional quantity of the controlled substance in [62 FR 13950, Mar. 24, 1997] the research project. (d) In the event the registrant desires § 1301.22 Exemption of agents and em- to conduct research beyond the vari- ployees; affiliated practitioners. ations provided in the registrant’s ap- (a) The requirement of registration is proved protocol (excluding any in- waived for any agent or employee of a crease in the quantity of the controlled person who is registered to engage in substance requested for his/her re- any group of independent activities, if search project as outlined in paragraph such agent or employee is acting in the (c) of this section), he/she shall submit usual course of his/her business or em- three copies of a supplemental protocol ployment. in accordance with paragraph (a) of (b) An individual practitioner who is this section describing the new re- an agent or employee of another prac- search and omitting information in the titioner (other than a mid-level practi- supplemental protocol which has been tioner) registered to dispense con- stated in the original protocol. Supple- trolled substances may, when acting in mental protocols shall be processed and the normal course of business or em- approved or denied in the same manner ployment, administer or dispense as original research protocols. (other than by issuance of prescription) [62 FR 13949, Mar. 24, 1997] controlled substances if and to the ex- tent that such individual practitioner EXCEPTIONS TO REGISTRATION AND FEES is authorized or permitted to do so by the jurisdiction in which he or she § 1301.21 Exemption from fees. practices, under the registration of the (a) The Administrator shall exempt employer or principal practitioner in from payment of an application fee for lieu of being registered him/herself. registration or reregistration: (c) An individual practitioner who is (1) Any hospital or other institution an agent or employee of a hospital or which is operated by an agency of the other institution may, when acting in United States (including the U.S. the normal course of business or em- Army, Navy, Marine Corps., Air Force, ployment, administer, dispense, or pre- and Coast Guard), of any State, or any scribe controlled substances under the political subdivision or agency thereof. registration of the hospital or other in- (2) Any individual practitioner who is stitution which is registered in lieu of required to obtain an individual reg- being registered him/herself, provided istration in order to carry out his or that: her duties as an official of an agency of (1) Such dispensing, administering or the United States (including the U.S. prescribing is done in the usual course Army, Navy, Marine Corps, Air Force, of his/her professional practice;
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(2) Such individual practitioner is au- Health Service employee is his/her So- thorized or permitted to do so by the cial Security identification number. jurisdiction in which he/she is prac- (b) The requirement of registration is ticing; waived for any official or agency of the (3) The hospital or other institution U.S. Army, Navy, Marine Corps, Air by whom he/she is employed has Force, Coast Guard, or Public Health verified that the individual practi- Service who or which is authorized to tioner is so permitted to dispense, ad- import or export controlled substances minister, or prescribe drugs within the in the course of his/her official duties. jurisdiction; (c) If any official exempted by this (4) Such individual practitioner is section also engages as a private indi- acting only within the scope of his/her vidual in any activity or group of ac- employment in the hospital or institu- tivities for which registration is re- tion; quired, such official shall obtain a reg- (5) The hospital or other institution istration for such private activities. authorizes the individual practitioner [62 FR 13951, Mar. 24, 1997] to administer, dispense or prescribe under the hospital registration and § 1301.24 Exemption of law enforce- designates a specific internal code ment officials. number for each individual practi- (a) The requirement of registration is tioner so authorized. The code number waived for the following persons in the shall consist of numbers, letters, or a circumstances described in this sec- combination thereof and shall be a suf- tion: fix to the institution’s DEA registra- (1) Any officer or employee of the Ad- tion number, preceded by a hyphen ministration, any officer of the U.S. (e.g., APO123456–10 or APO123456–A12); Customs Service, any officer or em- and ployee of the United States Food and (6) A current list of internal codes Drug Administration, and any other and the corresponding individual prac- Federal officer who is lawfully engaged titioners is kept by the hospital or in the enforcement of any Federal law other institution and is made available relating to controlled substances, at all times to other registrants and drugs or customs, and is duly author- law enforcement agencies upon request ized to possess or to import or export for the purpose of verifying the author- controlled substances in the course of ity of the prescribing individual practi- his/her official duties; and tioner. (2) Any officer or employee of any State, or any political subdivision or [62 FR 13950, Mar. 24, 1997] agency thereof, who is engaged in the enforcement of any State or local law § 1301.23 Exemption of certain mili- relating to controlled substances and is tary and other personnel. duly authorized to possess controlled (a) The requirement of registration is substances in the course of his/her offi- waived for any official of the U.S. cial duties. Army, Navy, Marine Corps, Air Force, (b) Any official exempted by this sec- Coast Guard, Public Health Service, or tion may, when acting in the course of Bureau of Prisons who is authorized to his/her official duties, procure any con- prescribe, dispense, or administer, but trolled substance in the course of an not to procure or purchase, controlled inspection, in accordance with substances in the course of his/her offi- § 1316.03(d) of this chapter, or in the cial duties. Such officials shall follow course of any criminal investigation procedures set forth in part 1306 of this involving the person from whom the chapter regarding prescriptions, but substance was procured, and may pos- shall state the branch of service or sess any controlled substance and dis- agency (e.g., ‘‘U.S. Army’’ or ‘‘Public tribute any such substance to any Health Service’’) and the service iden- other official who is also exempted by tification number of the issuing official this section and acting in the course of in lieu of the registration number re- his/her official duties. quired on prescription forms. The serv- (c) In order to enable law enforce- ice identification number for a Public ment agency laboratories, including
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laboratories of the Administration, to ministrator as appropriate for applica- obtain and transfer controlled sub- tion of this section (e.g., emergency stances for use as standards in chem- kits at field sites of an industrial firm). ical analysis, such laboratories shall (b) A medical officer shall be: obtain annually a registration to con- (1) Licensed in a state as a physician; duct chemical analysis. Such labora- (2) Employed by the owner or oper- tories shall be exempted from payment ator of the vessel, aircraft or other en- of a fee for registration. Laboratory tity; and personnel, when acting in the scope of (3) Registered under the Act at either their official duties, are deemed to be of the following locations: officials exempted by this section and (i) The principal office of the owner within the activity described in section or operator of the vessel, aircraft or 515(d) of the Act (21 U.S.C. 885(d)). For other entity or purposes of this paragraph, laboratory (ii) At any other location provided activities shall not include field or that the name, address, registration other preliminary chemical tests by of- number and expiration date as they ap- ficials exempted by this section. pear on his/her Certificate of Registra- (d) In addition to the activities au- tion (DEA Form 223) for this location thorized under a registration to con- are maintained for inspection at said duct chemical analysis pursuant to principal office in a readily retrievable § 1301.13(e)(1)(ix), laboratories of the manner. Administration shall be authorized to (c) A registered medical officer may manufacture or import controlled sub- serve as medical officer for more than stances for any lawful purpose, to dis- one vessel, aircraft, or other entity tribute or export such substances to under a single registration, unless he/ any person, and to import and export she serves as medical officer for more such substances in emergencies with- than one owner or operator, in which out regard to the requirements of part case he/she shall either maintain a sep- 1312 of this chapter if a report con- arate registration at the location of cerning the importation or exportation the principal office of each such owner is made to the Drug Operations Section or operator or utilize one or more reg- of the Administration within 30 days of istrations pursuant to paragraph such importation or exportation. (b)(3)(ii) of this section. [62 FR 13951, Mar. 24, 1997] (d) If no medical officer is employed by the owner or operator of a vessel, or § 1301.25 Registration regarding ocean in the event such medical officer is not vessels, aircraft, and other entities. accessible and the acquisition of con- (a) If acquired by and dispensed under trolled substances is required, the mas- the general supervision of a medical of- ter or first officer of the vessel, who ficer described in paragraph (b) of this shall not be registered under the Act, section, or the master or first officer of may purchase controlled substances the vessel under the circumstances de- from a registered manufacturer or dis- scribed in paragraph (d) of this section, tributor, or from an authorized phar- controlled substances may be held for macy as described in paragraph (f) of stocking, be maintained in, and dis- this section, by following the procedure pensed from medicine chests, first aid outlined below: packets, or dispensaries: (1) The master or first officer of the (1) On board any vessel engaged in vessel must personally appear at the international trade or in trade between vendor’s place of business, present ports of the United States and any proper identification (e.g., Seaman’s merchant vessel belonging to the U.S. photographic identification card) and a Government; written requisition for the controlled (2) On board any aircraft operated by substances. an air carrier under a certificate of per- (2) The written requisition must be mit issued pursuant to the Federal on the vessel’s official stationery or Aviation Act of 1958 (49 U.S.C. 1301); purchase order form and must include and the name and address of the vendor, (3) In any other entity of fixed or the name of the controlled substance, transient location approved by the Ad- description of the controlled substance
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(dosage form, strength and number or sale and filed with the controlled sub- volume per container) number of con- stances records of the vendor, copy 2 of tainers ordered, the name of the vessel, the record of sale shall be furnished to the vessel’s official number and coun- the officer of the vessel and retained try of registry, the owner or operator aboard the vessel, copy 3 of the record of the vessel, the port at which the ves- of sale shall be forwarded to the near- sel is located, signature of the vessel’s est DEA Division Office within 15 days officer who is ordering the controlled after the end of the month in which the substances and the date of the requisi- sale is made. tion. (4) The vendor’s record of sale should (3) The vendor may, after verifying be similar to, and must include all the the identification of the vessel’s officer information contained in, the below requisitioning the controlled sub- listed format. stances, deliver the control substances to that officer. The transaction shall SALE OF CONTROLLED SUBSTANCES TO be documented, in triplicate, on a VESSELS record of sale in a format similar to that outlined in paragraph (d)(4) of this (Name of registrant) llllllllllll section. The vessel’s requisition shall (Address of registrant) lllllllllll be attached to copy 1 of the record of (DEA registration number) lllllllll
Number of pack- Packages distrib- Line No. ages ordered Size of packages Name of product uted Date distributed
1 ...... 2 ...... 3 ......
FOOTNOTE: Line numbers may be continued according to needs of the vendor.
Number of lines completed lllllllll responsible to the medical officer to Name of vessel lllllllllllllll justify his/her actions. Vessel’s official number lllllllllll (f) Any registered pharmacy that Vessel’s country of registry lllllllll wishes to distribute controlled sub- Owner or operator of the vessel lllllll stances pursuant to this section shall Name and title of vessel’s officer who pre- be authorized to do so, provided: sented the requisition llll (1) The registered pharmacy notifies Signature of vessel’s officer who presented the nearest Division Office of the Ad- the requisition llll ministration of its intention to so dis- (e) Any medical officer described in tribute controlled substances prior to paragraph (b) of this section shall, in the initiation of such activity. This no- addition to complying with all require- tification shall be by registered mail ments and duties prescribed for reg- and shall contain the name, address, istrants generally, prepare an annual and registration number of the phar- report as of the date on which his/her macy as well as the date upon which registration expires, which shall give such activity will commence; and in detail an accounting for each vessel, (2) Such activity is authorized by aircraft, or other entity, and a sum- state law; and mary accounting for all vessels, air- (3) The total number of dosage units craft, or other entities under his/her of all controlled substances distributed supervision for all controlled sub- by the pharmacy during any calendar stances purchased, dispensed or dis- year in which the pharmacy is reg- posed of during the year. The medical istered to dispense does not exceed the officer shall maintain this report with limitations imposed upon such dis- other records required to be kept under tribution by § 1307.11(a)(4) and (b) of the Act and, upon request, deliver a this chapter. copy of the report to the Administra- (g) Owners or operators of vessels, tion. The medical officer need not be aircraft, or other entities described in present when controlled substances are this section shall not be deemed to pos- dispensed, if the person who actually sess or dispense any controlled sub- dispensed the controlled substances is stance acquired, stored and dispensed
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in accordance with this section. Addi- (2) The trade or chemical name and tionally, owners or operators of ves- the symbol designating the schedule of sels, aircraft, or other entities de- the controlled substance if it appears scribed in this section or in Article 32 on the container label, or, if such name of the Single Convention on Narcotic does not appear on the label, the name Drugs, 1961, or in Article 14 of the Con- and address of the pharmacy or practi- vention on Psychotropic Substances, tioner who dispensed the substance and 1971, shall not be deemed to import or the prescription number, if any; and export any controlled substances pur- (c) The importation of the controlled chased and stored in accordance with substance for personal medical use is that section or applicable article. authorized or permitted under other (h) The Master of a vessel shall pre- Federal laws and state law. pare a report for each calendar year [62 FR 13952, Mar. 24, 1997] which shall give in detail an account- ing for all controlled substances pur- ACTION ON APPLICATION FOR REGISTRA- chased, dispensed, or disposed of during TION: REVOCATION OR SUSPENSION OF the year. The Master shall file this re- REGISTRATION port with the medical officer employed by the owner or operator of his/her ves- § 1301.31 Administrative review gen- sel, if any, or, if not, he/she shall main- erally. tain this report with other records re- The Administrator may inspect, or quired to be kept under the Act and, cause to be inspected, the establish- upon request, deliver a copy of the re- ment of an applicant or registrant, pur- port to the Administration. suant to subpart A of part 1316 of this (i) Controlled substances acquired chapter. The Administrator shall re- and possessed in accordance with this view the application for registration section shall not be distributed to per- and other information gathered by the sons not under the general supervision Administrator regarding an applicant of the medical officer employed by the in order to determine whether the ap- owner or operator of the vessel, air- plicable standards of section 303 (21 craft, or other entity, except in accord- U.S.C. 823) or section 1008 (21 U.S.C. 958) ance with § 1307.21 of this chapter. of the Act have been met by the appli- [62 FR 13951, Mar. 24, 1997] cant. [62 FR 13953, Mar. 24, 1997] § 1301.26 Exemptions from import or export requirements for personal § 1301.32 Action on applications for re- medical use. search in Schedule I substances. Any individual who has in his/her (a) In the case of an application for possession a controlled substance listed registration to conduct research with in schedules II, III, IV, or V, which he/ controlled substances listed in Sched- she has lawfully obtained for his/her ule I, the Administrator shall process personal medical use, or for adminis- the application and protocol and for- tration to an animal accompanying ward a copy of each to the Secretary of him/her, may enter or depart the Health and Human Services (Secretary) United States with such substance not- within 7 days after receipt. The Sec- withstanding sections 1002–1005 of the retary shall determine the qualifica- Act (21 U.S.C. 952–955), providing the tions and competency of the applicant, following conditions are met: as well as the merits of the protocol (a) The controlled substance is in the (and shall notify the Administrator of original container in which it was dis- his/her determination) within 21 days pensed to the individual; and after receipt of the application and (b) The individual makes a declara- complete protocol, except that in the tion to an appropriate official of the case of a clinical investigation, the U.S. Customs Service stating: Secretary shall have 30 days to make (1) That the controlled substance is such determination and notify the Ad- possessed for his/her personal use, or ministrator. The Secretary, in deter- for an animal accompanying him/her; mining the merits of the protocol, shall and consult with the Administrator as to
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effective procedures to safeguard ade- § 1301.33 Application for bulk manu- quately against diversion of such con- facture of Schedule I and II sub- trolled substances from legitimate stances. medical or scientific use. (a) In the case of an application for (b) An applicant whose protocol is de- registration or reregistration to manu- fective shall be notified by the Sec- facture in bulk a basic class of con- retary within 21 days after receipt of trolled substance listed in Schedule I such protocol from the Administrator or II, the Administrator shall, upon the (or in the case of a clinical investiga- filing of such application, publish in tion within 30 days), and he/she shall be the FEDERAL REGISTER a notice naming requested to correct the existing de- the applicant and stating that such ap- fects before consideration shall be plicant has applied to be registered as a bulk manufacturer of a basic class of given to his/her submission. narcotic or nonnarcotic controlled sub- (c) If the Secretary determines the stance, which class shall be identified. applicant qualified and competent and A copy of said notice shall be mailed the research protocol meritorious, he/ simultaneously to each person reg- she shall notify the Administrator in istered as a bulk manufacturer of that writing of such determination. The Ad- basic class and to any other applicant ministrator shall issue a certificate of therefor. Any such person may, within registration within 10 days after re- 60 days from the date of publication of ceipt of this notice, unless he/she deter- the notice in the FEDERAL REGISTER, mines that the certificate of registra- file with the Administrator written tion should be denied on a ground spec- comments on or objections to the ified in section 304(a) of the Act (21 issuance of the proposed registration. U.S.C. 824(a)). In the case of a supple- (b) In order to provide adequate com- mental protocol, a replacement certifi- petition, the Administrator shall not cate of registration shall be issued by be required to limit the number of the Administrator. manufacturers in any basic class to a number less than that consistent with (d) If the Secretary determines that maintenance of effective controls the protocol is not meritorious and/or against diversion solely because a the applicant is not qualified or com- smaller number is capable of producing petent, he/she shall notify the Adminis- an adequate and uninterrupted supply. trator in writing setting forth the rea- (c) This section shall not apply to the sons for such determination. If the Ad- manufacture of basic classes of con- ministrator determines that grounds trolled substances listed in Schedules I exist for the denial of the application, or II as an incident to research or he/she shall within 10 days issue an chemical analysis as authorized in order to show cause pursuant to § 1301.13(e)(1). § 1301.37 and, if requested by the appli- [62 FR 13953, Mar. 24, 1997] cant, hold a hearing on the application pursuant to § 1301.41. If the grounds for § 1301.34 Application for importation denial of the application include a de- of Schedule I and II substances. termination by the Secretary, the Sec- (a) In the case of an application for retary or his duly authorized agent registration or reregistration to import shall furnish testimony and documents a controlled substance listed in Sched- pertaining to his determination at such ule I or II, under the authority of sec- hearing. tion 1002(a)(2)(B) of the Act (21 U.S.C. (e) Supplemental protocols will be 952(a)(2)(B)), the Administrator shall, processed in the same manner as origi- upon the filing of such application, nal research protocols. If the proc- publish in the FEDERAL REGISTER a no- essing of an application or research tice naming the applicant and stating protocol is delayed beyond the time that such applicant has applied to be registered as an importer of a Schedule limits imposed by this section, the ap- I or II controlled substance, which sub- plicant shall be so notified in writing. stance shall be identified. A copy of [62 FR 13953, Mar. 24, 1997] said notice shall be mailed simulta- neously to each person registered as a
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bulk manufacturer of that controlled (3) Promotion of technical advances substance and to any other applicant in the art of manufacturing these sub- therefor. Any such person may, within stances and the development of new 30 days from the date of publication of substances; the notice in the FEDERAL REGISTER, (4) Prior conviction record of appli- file written comments on or objections cant under Federal and State laws re- to the issuance of the proposed reg- lating to the manufacture, distribu- istration, and may, at the same time, tion, or dispensing of such substances; file a written request for a hearing on (5) Past experience in the manufac- the application pursuant to § 1301.43. If ture of controlled substances, and the a hearing is requested, the Adminis- existence in the establishment of effec- trator shall hold a hearing on the ap- tive control against diversion; plication in accordance with § 1301.41. (6) That the applicant will be per- Notice of the hearing shall be published mitted to import only: in the FEDERAL REGISTER, and shall be (i) Such amounts of crude opium, mailed simultaneously to the applicant poppy straw, concentrate of poppy and to all persons to whom notice of straw, and coca leaves as the Adminis- the application was mailed. Any such trator finds to be necessary to provide person may participate in the hearing for medical, scientific, or other legiti- by filing a notice of appearance in ac- mate purposes; or cordance with § 1301.43 of this chapter. (ii) Such amounts of any controlled Notice of the hearing shall contain a substances listed in Schedule I or II as summary of all comments and objec- the Administrator shall find to be nec- tions filed regarding the application essary to provide for the medical, sci- and shall state the time and place for entific, or other legitimate needs of the the hearing, which shall not be less United States during an emergency in than 30 days after the date of publica- which domestic supplies of such sub- tion of such notice in the FEDERAL stances are found by the Administrator REGISTER. A hearing pursuant to this to be inadequate; or section may be consolidated with a (iii) Such amounts of any controlled hearing held pursuant to § 1301.35 or substance listed in Schedule I or II as § 1301.36 of this part. the Administrator shall find to be nec- (b) The Administrator shall register essary to provide for the medical, sci- an applicant to import a controlled entific, or other legitimate needs of the substance listed in Schedule I or II if United States in any case in which the he/she determines that such registra- Administrator finds that competition tion is consistent with the public inter- among domestic manufacturers of the est and with U.S. obligations under controlled substance is inadequate and international treaties, conventions, or will not be rendered adequate by the protocols in effect on May 1, 1971. In registration of additional manufactur- determining the public interest, the ers under section 303 of the Act (21 following factors shall be considered: U.S.C. 823); or (1) Maintenance of effective controls (iv) Such limited quantities of any against diversion of particular con- controlled substance listed in Schedule trolled substances and any controlled I or II as the Administrator shall find substance in Schedule I or II com- to be necessary for scientific, analyt- pounded therefrom into other than le- ical or research uses; and gitimate medical, scientific research, (7) Such other factors as may be rel- or industrial channels, by limiting the evant to and consistent with the public importation and bulk manufacture of health and safety. such controlled substances to a number (c) In determining whether the appli- of establishments which can produce cant can and will maintain effective an adequate and uninterrupted supply controls against diversion within the of these substances under adequately meaning of paragraph (b) of this sec- competitive conditions for legitimate tion, the Administrator shall consider medical, scientific, research, and in- among other factors: dustrial purposes; (1) Compliance with the security re- (2) Compliance with applicable State quirements set forth in §§ 1301.71– and local law; 1301.76; and
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(2) Employment of security proce- demonstrate, in and of itself, that ade- dures to guard against in-transit losses quate competition among them does within and without the jurisdiction of not exist. the United States. [62 FR 13953, Mar. 24, 1997] (d) In determining whether competi- tion among the domestic manufactur- § 1301.35 Certificate of registration; ers of a controlled substance is ade- denial of registration. quate within the meaning of para- (a) The Administrator shall issue a graphs (b)(1) and (b)(6)(iii) of this sec- Certificate of Registration (DEA Form tion, as well as section 1002(a)(2)(B) of 223) to an applicant if the issuance of the Act (21 U.S.C. 952(a)(2)(B)), the Ad- registration or reregistration is re- ministrator shall consider: quired under the applicable provisions (1) The extent of price rigidity in the of sections 303 or 1008 of the Act (21 light of changes in: U.S.C. 823 and 958). In the event that (i) raw materials and other costs and the issuance of registration or rereg- (ii) conditions of supply and demand; istration is not required, the Adminis- (2) The extent of service and quality trator shall deny the application. Be- competition among the domestic man- fore denying any application, the Ad- ufacturers for shares of the domestic ministrator shall issue an order to market including: show cause pursuant to § 1301.37 and, if (i) Shifts in market shares and requested by the applicant, shall hold a (ii) Shifts in individual customers hearing on the application pursuant to among domestic manufacturers; § 1301.41. (3) The existence of substantial dif- (b) If in response to a show cause ferentials between domestic prices and order a hearing is requested by an ap- the higher of prices generally pre- plicant for registration or reregistra- vailing in foreign markets or the prices tion to manufacture in bulk a basic at which the applicant for registration class of controlled substance listed in to import is committed to undertake Schedule I or II, notice that a hearing to provide such products in the domes- has been requested shall be published tic market in conformity with the Act. in the FEDERAL REGISTER and shall be In determining the existence of sub- mailed simultaneously to the applicant stantial differentials hereunder, appro- and to all persons to whom notice of priate consideration should be given to the application was mailed. Any person any additional costs imposed on domes- entitled to file comments or objections tic manufacturers by the requirements to the issuance of the proposed reg- of the Act and such other cost-related istration pursuant to § 1301.33(a) may and other factors as the Administrator participate in the hearing by filing no- may deem relevant. In no event shall tice of appearance in accordance with an importer’s offering prices in the § 1301.43. Such persons shall have 30 United States be considered if they are days to file a notice of appearance after lower than those prevailing in the for- the date of publication of the notice of eign market or markets from which a request for a hearing in the FEDERAL the importer is obtaining his/her sup- REGISTER. ply; (c) The Certificate of Registration (4) The existence of competitive re- (DEA Form 223) shall contain the straints imposed upon domestic manu- name, address, and registration num- facturers by governmental regulations; ber of the registrant, the activity au- and thorized by the registration, the sched- (5) Such other factors as may be rel- ules and/or Administration Controlled evant to the determinations required Substances Code Number (as set forth under this paragraph. in part 1308 of this chapter) of the con- (e) In considering the scope of the do- trolled substances which the registrant mestic market, consideration shall be is authorized to handle, the amount of given to substitute products which are fee paid (or exemption), and the expira- reasonably interchangeable in terms of tion date of the registration. The reg- price, quality and use. istrant shall maintain the certificate (f) The fact that the number of exist- of registration at the registered loca- ing manufacturers is small shall not tion in a readily retrievable manner
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and shall permit inspection of the cer- § 1301.37 an order of immediate suspen- tificate by any official, agent or em- sion which shall contain a statement of ployee of the Administration or of any his findings regarding the danger to Federal, State, or local agency engaged public health or safety. in enforcement of laws relating to con- (f) Upon service of the order of the trolled substances. Administrator suspending or revoking [62 FR 13954, Mar. 24, 1997] registration, the registrant shall im- mediately deliver his/her Certificate of § 1301.36 Suspension or revocation of Registration, any order forms, and any registration; suspension of registra- import or export permits in his/her pos- tion pending final order; extension session to the nearest office of the Ad- of registration pending final order. ministration. The suspension or rev- (a) For any registration issued under ocation of a registration shall suspend section 303 of the Act (21 U.S.C. 823), or revoke any individual manufac- the Administrator may: turing or procurement quota fixed for (1) Suspend the registration pursuant the registrant pursuant to part 1303 of to section 304(a) of the Act (21 U.S.C. this chapter and any import or export 824(a)) for any period of time. permits issued to the registrant pursu- (2) Revoke the registration pursuant ant to part 1312 of this chapter. Also, to section 304(a) of the Act (21 U.S.C. upon service of the order of the Admin- 824(a)). istrator revoking or suspending reg- (b) For any registration issued under istration, the registrant shall, as in- section 1008 of the Act (21 U.S.C. 958), structed by the Administrator: the Administrator may: (1) Deliver all controlled substances (1) Suspend the registration pursuant in his/her possession to the nearest of- to section 1008(d) of the Act (21 U.S.C. fice of the Administration or to au- 958(d)) for any period of time. thorized agents of the Administration; (2) Revoke the registration pursuant or to section 1008(d) of the Act (21 U.S.C. 958(d)) if he/she determines that such (2) Place all controlled substances in registration is inconsistent with the his/her possession under seal as de- public interest as defined in section scribed in sections 304(f) or 1008(d)(6) of 1008 or with the United States obliga- the Act (21 U.S.C. 824(f) or 958(d)(6)). tions under international treaties, con- (g) In the event that revocation or ventions, or protocols in effect on Oc- suspension is limited to a particular tober 12, 1984. controlled substance or substances, the (c) The Administrator may limit the registrant shall be given a new Certifi- revocation or suspension of a registra- cate of Registration for all substances tion to the particular controlled sub- not affected by such revocation or sus- stance, or substances, with respect to pension; no fee shall be required to be which grounds for revocation or sus- paid for the new Certificate of Reg- pension exist. istration. The registrant shall deliver (d) Before revoking or suspending the old Certificate of Registration and, any registration, the Administrator if appropriate, any order forms in his/ shall issue an order to show cause pur- her possession to the nearest office of suant to § 1301.37 and, if requested by the Administration. The suspension or the registrant, shall hold a hearing revocation of a registration, when lim- pursuant to § 1301.41. ited to a particular basic class or class- (e) The Administrator may suspend es of controlled substances, shall sus- any registration simultaneously with pend or revoke any individual manu- or at any time subsequent to the serv- facturing or procurement quota fixed ice upon the registrant of an order to for the registrant for such class or show cause why such registration classes pursuant to part 1303 of this should not be revoked or suspended, in chapter and any import or export per- any case where he/she finds that there mits issued to the registrant for such is an imminent danger to the public class or classes pursuant to part 1312 of health or safety. If the Administrator this chapter. Also, upon service of the so suspends, he/she shall serve with the order of the Administrator revoking or order to show cause pursuant to suspending registration, the registrant
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shall, as instructed by the Adminis- § 1301.37 Order to show cause. trator: (a) If, upon examination of the appli- (1) Deliver to the nearest office of the cation for registration from any appli- Administration or to authorized agents cant and other information gathered of the Administration all of the par- by the Administration regarding the ticular controlled substance or sub- applicant, the Administrator is unable stances affected by the revocation or to make the determinations required suspension which are in his/her posses- by the applicable provisions of section sion; or 303 and/or section 1008 of the Act (21 (2) Place all of such substances under U.S.C. 823 and 958) to register the appli- seal as described in sections 304(f) or cant, the Administrator shall serve 958(d)(6) of the Act (21 U.S.C. 824(f) or upon the applicant an order to show 958(d)(6)). cause why the registration should not (h) Any suspension shall continue in be denied. effect until the conclusion of all pro- (b) If, upon information gathered by ceedings upon the revocation or sus- the Administration regarding any reg- pension, including any judicial review istrant, the Administrator determines thereof, unless sooner withdrawn by that the registration of such registrant the Administrator or dissolved by a is subject to suspension or revocation pursuant to section 304 or section 1008 court of competent jurisdiction. Any of the Act (21 U.S.C. 824 and 958), the registrant whose registration is sus- Administrator shall serve upon the reg- pended under paragraph (e) of this sec- istrant an order to show cause why the tion may request a hearing on the rev- registration should not be revoked or ocation or suspension of his/her reg- suspended. istration at a time earlier than speci- (c) The order to show cause shall call fied in the order to show cause pursu- upon the applicant or registrant to ap- ant to § 1301.37. This request shall be pear before the Administrator at a granted by the Administrator, who time and place stated in the order, shall fix a date for such hearing as which shall not be less than 30 days early as reasonably possible. after the date of receipt of the order. (i) In the event that an applicant for The order to show cause shall also con- reregistration (who is doing business tain a statement of the legal basis for under a registration previously granted such hearing and for the denial, revoca- and not revoked or suspended) has ap- tion, or suspension of registration and plied for reregistration at least 45 days a summary of the matters of fact and before the date on which the existing law asserted. registration is due to expire, and the (d) Upon receipt of an order to show Administrator has issued no order on cause, the applicant or registrant the application on the date on which must, if he/she desires a hearing, file a the existing registration is due to ex- request for a hearing pursuant to pire, the existing registration of the § 1301.43. If a hearing is requested, the applicant shall automatically be ex- Administrator shall hold a hearing at the time and place stated in the order, tended and continue in effect until the pursuant to § 1301.41. date on which the Administrator so (e) When authorized by the Adminis- issues his/her order. The Administrator trator, any agent of the Administra- may extend any other existing reg- tion may serve the order to show istration under the circumstances con- cause. templated in this section even though the registrant failed to apply for rereg- [62 FR 13955, Mar. 24, 1997] istration at least 45 days before expira- HEARINGS tion of the existing registration, with or without request by the registrant, if § 1301.41 Hearings generally. the Administrator finds that such ex- tension is not inconsistent with the (a) In any case where the Adminis- trator shall hold a hearing on any reg- public health and safety. istration or application therefor, the [62 FR 13955, Mar. 24, 1997] procedures for such hearing shall be
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governed generally by the adjudication a hearing need not also file a notice of procedures set forth in the Administra- appearance. tive Procedure Act (5 U.S.C. 551–559) (c) Any person entitled to a hearing and specifically by sections 303, 304, or to participate in a hearing pursuant and 1008 of the Act (21 U.S.C. 823–824 to § 1301.32 or §§ 1301.34–1301.36 may, and 958), by §§ 1301.42–1301.46 of this within the period permitted for filing a part, and by the procedures for admin- request for a hearing or a notice of ap- istrative hearings under the Act set pearance, file with the Administrator a forth in §§ 1316.41–1316.67 of this chap- waiver of an opportunity for a hearing ter. or to participate in a hearing, together (b) Any hearing under this part shall with a written statement regarding be independent of, and not in lieu of, such person’s position on the matters criminal prosecutions or other pro- of fact and law involved in such hear- ceedings under the Act or any other ing. Such statement, if admissible, law of the United States. shall be made a part of the record and [62 FR 13956, Mar. 24, 1997] shall be considered in light of the lack of opportunity for cross-examination in § 1301.42 Purpose of hearing. determining the weight to be attached to matters of fact asserted therein. If requested by a person entitled to a hearing, the Administrator shall hold a (d) If any person entitled to a hearing hearing for the purpose of receiving or to participate in a hearing pursuant factual evidence regarding the issues to § 1301.32 or §§ 1301.34–1301.36 fails to involved in the denial, revocation, or file a request for a hearing or a notice suspension of any registration, and the of appearance, or if such person so files granting of any application for reg- and fails to appear at the hearing, such istration to import or to manufacture person shall be deemed to have waived in bulk a basic class of controlled sub- the opportunity for a hearing or to par- stance listed in Schedule I or II. Exten- ticipate in the hearing, unless such sive argument should not be offered person shows good cause for such fail- into evidence but rather presented in ure. opening or closing statements of coun- (e) If all persons entitled to a hearing sel or in memoranda or proposed find- or to participate in a hearing waive or ings of fact and conclusions of law. are deemed to waive their opportunity for the hearing or to participate in the [62 FR 13956, Mar. 24, 1997] hearing, the Administrator may cancel the hearing, if scheduled, and issue his/ § 1301.43 Request for hearing or ap- her final order pursuant to § 1301.46 pearance; waiver. without a hearing. (a) Any person entitled to a hearing pursuant to § 1301.32 or §§ 1301.34–1301.36 [62 FR 13956, Mar. 24, 1997] and desiring a hearing shall, within 30 days after the date of receipt of the § 1301.44 Burden of proof. order to show cause (or the date of pub- (a) At any hearing on an application lication of notice of the application for to manufacture any controlled sub- registration in the FEDERAL REGISTER stance listed in Schedule I or II, the ap- in the case of § 1301.34), file with the plicant shall have the burden of prov- Administrator a written request for a ing that the requirements for such reg- hearing in the form prescribed in istration pursuant to section 303(a) of § 1316.47 of this chapter. the Act (21 U.S.C. 823(a)) are satisfied. (b) Any person entitled to participate Any other person participating in the in a hearing pursuant to § 1301.34 or hearing pursuant to § 1301.35(b) shall § 1301.35(b) and desiring to do so shall, have the burden of proving any propo- within 30 days of the date of publica- sitions of fact or law asserted by such tion of notice of the request for a hear- person in the hearing. ing in the FEDERAL REGISTER, file with (b) At any hearing on the granting or the Administrator a written notice of denial of an applicant to be registered intent to participate in such hearing in to conduct a narcotic treatment pro- the form prescribed in § 1316.48 of this gram or as a compounder, the appli- chapter. Any person filing a request for cant shall have the burden of proving
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that the requirements for each reg- in Schedule I or II is granted, or any istration pursuant to section 303(g) of application for registration is denied, the Act (21 U.S.C. 823(g)) are satisfied. or any registration is revoked or sus- (c) At any hearing on the granting or pended, the order shall include the denial of an application to be reg- findings of fact and conclusions of law istered to import or export any con- upon which the order is based. The trolled substance listed in Schedule I order shall specify the date on which it or II, the applicant shall have the bur- shall take effect. The Administrator den of proving that the requirements shall serve one copy of his/her order for such registration pursuant to sec- upon each party in the hearing. tions 1008(a) and (d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any [62 FR 13956, Mar. 24, 1997] other person participating in the hear- ing pursuant to § 1301.34 shall have the MODIFICATION, TRANSFER AND burden of proving any propositions of TERMINATION OF REGISTRATION fact or law asserted by him/her in the hearings. § 1301.51 Modification in registration. (d) At any other hearing for the de- Any registrant may apply to modify nial of a registration, the Administra- his/her registration to authorize the tion shall have the burden of proving handling of additional controlled sub- that the requirements for such reg- stances or to change his/her name or istration pursuant to section 303 or sec- address, by submitting a letter of re- tion 1008(c) and (d) of the Act (21 U.S.C. quest to the Registration Unit, Drug 823 or 958(c) and (d)) are not satisfied. Enforcement Administration, Depart- (e) At any hearing for the revocation ment of Justice, Post Office Box 28083, or suspension of a registration, the Ad- Central Station, Washington, DC 20005. ministration shall have the burden of proving that the requirements for such The letter shall contain the reg- revocation or suspension pursuant to istrant’s name, address, and registra- section 304(a) or section 1008(d) of the tion number as printed on the certifi- Act (21 U.S.C. 824(a) or 958(d)) are satis- cate of registration, and the substances fied. and/or schedules to be added to his/her registration or the new name or ad- [62 FR 13956, Mar. 24, 1997] dress and shall be signed in accordance § 1301.45 Time and place of hearing. with § 1301.13(j). If the registrant is seeking to handle additional controlled The hearing will commence at the substances listed in Schedule I for the place and time designated in the order purpose of research or instructional ac- to show cause or notice of hearing pub- tivities, he/she shall attach three cop- lished in the FEDERAL REGISTER (unless expedited pursuant to § 1301.36(h)) but ies of a research protocol describing thereafter it may be moved to a dif- each research project involving the ad- ferent place and may be continued ditional substances, or two copies of a from day to day or recessed to a later statement describing the nature, ex- day without notice other than an- tent, and duration of such instruc- nouncement thereof by the presiding tional activities, as appropriate. No fee officer at the hearing. shall be required to be paid for the modification. The request for modifica- [62 FR 13956, Mar. 24, 1997] tion shall be handled in the same man- § 1301.46 Final order. ner as an application for registration. If the modification in registration is As soon as practicable after the pre- approved, the Administrator shall issue siding officer has certified the record to the Administrator, the Adminis- a new certificate of registration (DEA trator shall issue his/her order on the Form 223) to the registrant, who shall granting, denial, revocation, or suspen- maintain it with the old certificate of sion of registration. In the event that registration until expiration. an application for registration to im- [62 FR 13956, Mar. 24, 1997] port or to manufacture in bulk a basic class of any controlled substance listed
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§ 1301.52 Termination of registration; (2) The name, address, registration transfer of registration; distribution number, and authorized business activ- upon discontinuance of business. ity of the person acquiring the business (a) Except as provided in paragraph (registrant-transferee); (b) of this section, the registration of (3) Whether the business activities any person shall terminate if and when will be continued at the location reg- such person dies, ceases legal exist- istered by the person discontinuing ence, or discontinues business or pro- business, or moved to another location fessional practice. Any registrant who (if the latter, the address of the new lo- ceases legal existence or discontinues cation should be listed); business or professional practice shall (4) Whether the registrant-transferor notify the Administrator promptly of has a quota to manufacture or procure such fact. any controlled substance listed in (b) No registration or any authority Schedule I or II (if so, the basic class or conferred thereby shall be assigned or class of the substance should be indi- otherwise transferred except upon such cated); and conditions as the Administration may (5) The date on which the transfer of specifically designate and then only controlled substances will occur. pursuant to written consent. Any per- (e) Unless the registrant-transferor is son seeking authority to transfer a reg- informed by the Special Agent in istration shall submit a written re- Charge, before the date on which the quest, providing full details regarding transfer was stated to occur, that the the proposed transfer of registration, transfer may not occur, the registrant- to the Deputy Assistant Administrator, transferor may distribute (without Office of Diversion Control, Drug En- being registered to distribute) con- forcement Administration, Department trolled substances in his/her possession of Justice, Washington, DC 20537. (c) Any registrant desiring to dis- to the registrant-transferee in accord- continue business activities altogether ance with the following: or with respect to controlled sub- (1) On the date of transfer of the con- stances (without transferring such trolled substances, a complete inven- business activities to another person) tory of all controlled substances being shall return for cancellation his/her transferred shall be taken in accord- certificate of registration, and any ance with § 1304.11 of this chapter. This unexecuted order forms in his/her pos- inventory shall serve as the final in- session, to the Registration Unit, Drug ventory of the registrant-transferor Enforcement Administration, Depart- and the initial inventory of the reg- ment of Justice, Post Office Box 28083, istrant-transferee, and a copy of the in- Central Station, Washington, DC 20005. ventory shall be included in the records Any controlled substances in his/her of each person. It shall not be nec- possession may be disposed of in ac- essary to file a copy of the inventory cordance with § 1307.21 of this chapter. with the Administration unless re- (d) Any registrant desiring to dis- quested by the Special Agent in continue business activities altogether Charge. Transfers of any substances or with respect to controlled substance listed in Schedule I or II shall require (by transferring such business activi- the use of order forms in accordance ties to another person) shall submit in with part 1305 of this chapter. person or by registered or certified (2) On the date of transfer of the con- mail, return receipt requested, to the trolled substances, all records required Special Agent in Charge in his/her to be kept by the registrant-transferor area, at least 14 days in advance of the with reference to the controlled sub- date of the proposed transfer (unless stances being transferred, under part the Special Agent in Charge waives 1304 of this chapter, shall be trans- this time limitation in individual in- ferred to the registrant-transferee. Re- stances), the following information: sponsibility for the accuracy of records (1) The name, address, registration prior to the date of transfer remains number, and authorized business activ- with the transferor, but responsibility ity of the registrant discontinuing the for custody and maintenance shall be business (registrant-transferor); upon the transferee.
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(3) In the case of registrants required (2) The type and form of controlled to make reports pursuant to part 1304 substances handled (e.g., bulk liquids of this chapter, a report marked or dosage units, usable powders or non- ‘‘Final’’ will be prepared and submitted usable powders); by the registrant-transferor showing (3) The quantity of controlled sub- the disposition of all the controlled stances handled; substances for which a report is re- (4) The location of the premises and quired; no additional report will be re- the relationship such location bears on quired from him, if no further trans- security needs; actions involving controlled substances (5) The type of building construction are consummated by him. The initial comprising the facility and the general report of the registrant-transferee characteristics of the building or build- shall account for transactions begin- ings; ning with the day next succeeding the (6) The type of vault, safe, and secure date of discontinuance or transfer of enclosures or other storage system business by the transferor-registrant (e.g., automatic storage and retrieval and the substances transferred to him system) used; shall be reported as receipts in his/her (7) The type of closures on vaults, initial report. safes, and secure enclosures; [62 FR 13957, Mar. 24, 1997] (8) The adequacy of key control sys- tems and/or combination lock control SECURITY REQUIREMENTS systems; (9) The adequacy of electric detection § 1301.71 Security requirements gen- and alarm systems, if any including erally. use of supervised transmittal lines and (a) All applicants and registrants standby power sources; shall provide effective controls and (10) The extent of unsupervised public procedures to guard against theft and access to the facility, including the diversion of controlled substances. In presence and characteristics of perim- order to determine whether a reg- eter fencing, if any; istrant has provided effective controls (11) The adequacy of supervision over against diversion, the Administrator employees having access to manufac- shall use the security requirements set turing and storage areas; forth in §§ 1301.72–1301.76 as standards (12) The procedures for handling busi- for the physical security controls and ness guests, visitors, maintenance per- operating procedures necessary to pre- sonnel, and nonemployee service per- vent diversion. Materials and construc- sonnel; tion which will provide a structural (13) The availability of local police equivalent to the physical security protection or of the registrant’s or ap- controls set forth in §§ 1301.72, 1301.73 plicant’s security personnel, and; and 1301.75 may be used in lieu of the (14) The adequacy of the registrant’s materials and construction described or applicant’s system for monitoring in those sections. the receipt, manufacture, distribution, (b) Substantial compliance with the and disposition of controlled sub- standards set forth in §§ 1301.72–1301.76 stances in its operations. may be deemed sufficient by the Ad- (c) When physical security controls ministrator after evaluation of the become inadequate as a result of a con- overall security system and needs of trolled substance being transferred to a the applicant or registrant. In evalu- different schedule, or as a result of a ating the overall security system of a noncontrolled substance being listed on registrant or applicant, the Adminis- any schedule, or as a result of a signifi- trator may consider any of the fol- cant increase in the quantity of con- lowing factors as he may deem relevant trolled substances in the possession of to the need for strict compliance with the registrant during normal business security requirements: operations, the physical security con- (1) The type of activity conducted trols shall be expanded and extended (e.g., processing of bulk chemicals, pre- accordingly. A registrant may adjust paring dosage forms, packaging, label- physical security controls within the ing, cooperative buying, etc.); requirements set forth in §§ 1301.72–
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1301.76 when the need for such controls factured or distributed in accordance decreases as a result of a controlled with an exemption under section 505(i) substance being transferred to a dif- of the FFDCA which shall be subject to ferent schedule, or a result of a con- the requirements of paragraph (b) of trolled substance being removed from this section) shall be stored in one of control, or as a result of a significant the following secured areas: decrease in the quantity of controlled (1) Where small quantities permit, a substances in the possession of the reg- safe or steel cabinet; istrant during normal business oper- (i) Which safe or steel cabinet shall ations. have the following specifications or the (d) Any registrant or applicant desir- equivalent: 30 man-minutes against ing to determine whether a proposed surreptitious entry, 10 man-minutes security system substantially complies against forced entry, 20 man-hours with, or is the structural equivalent of, against lock manipulation, and 20 man- the requirements set forth in §§ 1301.72– hours against radiological techniques; 1301.76 may submit any plans, blue- (ii) Which safe or steel cabinet, if it prints, sketches or other materials re- weighs less than 750 pounds, is bolted garding the proposed security system or cemented to the floor or wall in such either to the Special Agent in Charge a way that it cannot be readily re- in the region in which the system will moved; and be used, or to the Diversion Operations (iii) Which safe or steel cabinet, if Section, Drug Enforcement Adminis- necessary, depending upon the quan- tration, Department of Justice, Wash- tities and type of controlled substances ington, DC 20537. stored, is equipped with an alarm sys- (e) Physical security controls of loca- tem which, upon attempted unauthor- tions registered under the Harrison ized entry, shall transmit a signal di- Narcotic Act or the Narcotics Manufac- rectly to a central protection company turing Act of 1960 on April 30, 1971, or a local or State police agency which shall be deemed to comply substan- has a legal duty to respond, or a 24- tially with the standards set forth in hour control station operated by the §§ 1301.72, 1301.73 and 1301.75. Any new registrant, or such other protection as facilities or work or storage areas con- the Administrator may approve. structed or utilized for controlled sub- (2) A vault constructed before, or stances, which facilities or work or under construction on, September 1, storage areas have not been previously 1971, which is of substantial construc- approved by the Administration, shall tion with a steel door, combination or not necessarily be deemed to comply key lock, and an alarm system; or substantially with the standards set (3) A vault constructed after Sep- forth in §§ 1301.72, 1301.73 and 1301.75, tember 1, 1971: notwithstanding that such facilities or (i) The walls, floors, and ceilings of work or storage areas have physical se- which vault are constructed of at least curity controls similar to those pre- 8 inches of reinforced concrete or other viously approved by the Administra- substantial masonry, reinforced tion. vertically and horizontally with 1⁄2-inch steel rods tied 6 inches on center, or [36 FR 18729, Sept. 21, 1971. Redesignated at the structural equivalent to such rein- 38 FR 26609, Sept. 24, l973, and amended at 46 FR 28841, May 29, 1981; 47 FR 41735, Sept. 22, forced walls, floors, and ceilings; 1982; 51 FR 5319, Feb. 13, 1986] (ii) The door and frame unit of which vault shall conform to the following § 1301.72 Physical security controls for specifications or the equivalent: 30 non-practitioners; narcotic treat- man-minutes against surreptitious ment programs and compounders entry, 10 man-minutes against forced for narcotic treatment programs; entry, 20 man-hours against lock ma- storage areas. nipulation, and 20 man-hours against (a) Schedules I and II. Raw material, radiological techniques; bulk materials awaiting further proc- (iii) Which vault, if operations re- essing, and finished products which are quire it to remain open for frequent ac- controlled substances listed in Sched- cess, is equipped with a ‘‘day-gate’’ ule I or II (except GHB that is manu- which is self-closing and self-locking,
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or the equivalent, for use during the observation of a responsible employee hours of operation in which the vault or agent of the registrant is permitted door is open; in lieu of a self-closing, self-locking (iv) The walls or perimeter of which door. Doors may be sliding or hinged. vault are equipped with an alarm, Regarding hinged doors, where hinges which upon unauthorized entry shall are mounted on the outside, such transmit a signal directly to a central hinges shall be sealed, welded or other- station protection company, or a local wise constructed to inhibit removal. or State police agency which has a Locking devices for such doors shall be legal duty to respond, or a 24-hour con- either of the multiple-position com- trol station operated by the registrant, bination or key lock type and: or such other protection as the Admin- (a) In the case of key locks, shall re- istrator may approve, and, if nec- quire key control which limits access essary, holdup buttons at strategic to a limited number of employees, or; points of entry to the perimeter area of (b) In the case of combination locks, the vault; the combination shall be limited to a (v) The door of which vault is minimum number of employees and equipped with contact switches; and can be changed upon termination of (vi) Which vault has one of the fol- employment of an employee having lowing: Complete electrical lacing of the walls, floor and ceilings; sensitive knowledge of the combination; ultrasonic equipment within the vault; (4) A cage, located within a building a sensitive sound accumulator system; on the premises, meeting the following or such other device designed to detect specifications: illegal entry as may be approved by the (i) Having walls constructed of not Administration. less than No. 10 gauge steel fabric (b) Schedules III, IV and V. Raw mate- mounted on steel posts, which posts rial, bulk materials awaiting further are: processing, and finished products which (a) At least one inch in diameter; are controlled substances listed in (b) Set in concrete or installed with Schedules III, IV, and V, and GHB when lag bolts that are pinned or brazed; and it is manufactured or distributed in ac- (c) Which are placed no more than cordance with an exemption under sec- ten feet apart with horizontal one and tion 505(i) of the FFDCA, shall be one-half inch reinforcements every stored in the following secure storage sixty inches; areas: (ii) Having a mesh construction with (1) A safe or steel cabinet as de- openings of not more than two and one- scribed in paragraph (a)(1) of this sec- half inches across the square, tion; (iii) Having a ceiling constructed of (2) A vault as described in paragraph the same material, or in the alter- (a)(2) or (3) of this section equipped native, a cage shall be erected which with an alarm system as described in reaches and is securely attached to the paragraph (b)(4)(v) of this section; structural ceiling of the building. A (3) A building used for storage of lighter gauge mesh may be used for the Schedules III through V controlled sub- stances with perimeter security which ceilings of large enclosed areas if walls limits access during working hours and are at least 14 feet in height, provides security after working hours (iv) Is equipped with a door con- and meets the following specifications: structed of No. 10 gauge steel fabric on (i) Has an electronic alarm system as a metal door frame in a metal door described in paragraph (b)(4)(v) of this flange, and in all other respects con- section, forms to all the requirements of 21 CFR (ii) Is equipped with self-closing, self- 1301.72(b)(3)(ii), and locking doors constructed of substan- (v) Is equipped with an alarm system tial material commensurate with the which upon unauthorized entry shall type of building construction, provided, transmit a signal directly to a central however, a door which is kept closed station protection agency or a local or and locked at all times when not in use state police agency, each having a and when in use is kept under direct legal duty to respond, or to a 24-hour
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control station operated by the reg- thorized employees. When it is nec- istrant, or to such other source of pro- essary for employee maintenance per- tection as the Administrator may ap- sonnel, nonemployee maintenance per- prove; sonnel, business guests, or visitors to (5) An enclosure of masonry or other be present in or pass through con- material, approved in writing by the trolled substances storage areas, the Administrator as providing security registrant shall provide for adequate comparable to a cage; observation of the area by an employee (6) A building or enclosure within a specifically authorized in writing. building which has been inspected and [36 FR 18730, Sept. 21, 1971, as amended at 37 approved by DEA or its predecessor FR 15919, Aug. 8, 1972. Redesignated at 38 FR agency, BND, and continues to provide 26609, Sept. 24, l973] adequate security against the diversion of Schedule III through V controlled EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1301.72, see the List of CFR substances, of which fact written ac- Sections Affected, which appears in the knowledgment has been made by the Finding Aids section of the printed volume Special Agent in Charge of DEA for the and on GPO Access. area in which such building or enclo- sure is situated; § 1301.73 Physical security controls for (7) Such other secure storage areas as non-practitioners; compounders for may be approved by the Administrator narcotic treatment programs; man- after considering the factors listed in ufacturing and compounding areas. § 1301.71(b), (1) through (14); All manufacturing activities (includ- (8)(i) Schedule III through V con- ing processing, packaging and labeling) trolled substances may be stored with involving controlled substances listed Schedules I and II controlled sub- in any schedule and all activities of stances under security measures pro- compounders shall be conducted in ac- vided by 21 CFR 1301.72(a); cordance with the following: (ii) Non-controlled drugs, substances (a) All in-process substances shall be and other materials may be stored with returned to the controlled substances Schedule III through V controlled sub- storage area at the termination of the stances in any of the secure storage process. If the process is not termi- areas required by 21 CFR 1301.72(b), nated at the end of a workday (except provided that permission for such stor- where a continuous process or other age of non-controlled items is obtained normal manufacturing operation in advance, in writing, from the Spe- should not be interrupted), the proc- cial Agent in Charge of DEA for the essing area or tanks, vessels, bins or area in which such storage area is situ- bulk containers containing such sub- ated. Any such permission tendered stances shall be securely locked, with must be upon the Special Agent in adequate security for the area or build- Charge’s written determination that ing. If such security requires an alarm, such non-segregated storage does not such alarm, upon unauthorized entry, diminish security effectiveness for shall transmit a signal directly to a Schedules III through V controlled sub- central station protection company, or stances. local or state police agency which has (c) Multiple storage areas. Where sev- a legal duty to respond, or a 24-hour eral types or classes of controlled sub- control station operated by the reg- stances are handled separately by the istrant. registrant or applicant for different (b) Manufacturing activities with purposes (e.g., returned goods, or goods controlled substances shall be con- in process), the controlled substances ducted in an area or areas of clearly de- may be stored separately, provided fined limited access which is under sur- that each storage area complies with veillance by an employee or employees the requirements set forth in this sec- designated in writing as responsible for tion. the area. ‘‘Limited access’’ may be pro- (d) Accessibility to storage areas. The vided, in the absence of physical divid- controlled substances storage areas ers such as walls or partitions, by traf- shall be accessible only to an absolute fic control lines or restricted space des- minimum number of specifically au- ignation. The employee designated as
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responsible for the area may be en- contract carrier selected pursuant to gaged in the particular manufacturing § 1301.74(e), upon discovery of such theft operation being conducted: Provided, or loss. The registrant shall also com- That he is able to provide continuous plete DEA Form 106 regarding such surveillance of the area in order that theft or loss. Thefts must be reported unauthorized persons may not enter or whether or not the controlled sub- leave the area without his knowledge. stances are subsequently recovered (c) During the production of con- and/or the responsible parties are iden- trolled substances, the manufacturing tified and action taken against them. areas shall be accessible to only those (d) The registrant shall not dis- employees required for efficient oper- tribute any controlled substance listed ation. When it is necessary for em- in Schedules II through V as a com- ployee maintenance personnel, non- plimentary sample to any potential or employee maintenance personnel, busi- current customer (1) without the prior ness guests, or visitors to be present in written request of the customer, (2) to or pass through manufacturing areas be used only for satisfying the legiti- during production of controlled sub- mate medical needs of patients of the stances, the registrant shall provide for customer, and (3) only in reasonable adequate observation of the area by an quantities. Such request must contain employee specifically authorized in the name, address, and registration writing. number of the customer and the name and quantity of the specific controlled [36 FR 18731, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, l973 and amended at 39 substance desired. The request shall be FR 37984, Oct. 25, 1974] preserved by the registrant with other records of distribution of controlled § 1301.74 Other security controls for substances. In addition, the require- non-practitioners; narcotic treat- ments of part 1305 of the chapter shall ment programs and compounders be complied with for any distribution for narcotic treatment programs. of a controlled substance listed in (a) Before distributing a controlled Schedule II. For purposes of this para- substance to any person who the reg- graph, the term ‘‘customer’’ includes a istrant does not know to be registered person to whom a complimentary sam- to possess the controlled substance, the ple of a substance is given in order to registrant shall make a good faith in- encourage the prescribing or recom- quiry either with the Administration mending of the substance by the per- or with the appropriate State con- son. trolled substances registration agency, (e) When shipping controlled sub- if any, to determine that the person is stances, a registrant is responsible for registered to possess the controlled selecting common or contract carriers substance. which provide adequate security to (b) The registrant shall design and guard against in-transit losses. When operate a system to disclose to the reg- storing controlled substances in a pub- istrant suspicious orders of controlled lic warehouse, a registrant is respon- substances. The registrant shall inform sible for selecting a warehouseman the Field Division Office of the Admin- which will provide adequate security to istration in his area of suspicious or- guard against storage losses; wherever ders when discovered by the registrant. possible, the registrant shall store con- Suspicious orders include orders of un- trolled substances in a public ware- usual size, orders deviating substan- house which complies with the require- tially from a normal pattern, and or- ments set forth in § 1301.72. In addition, ders of unusual frequency. the registrant shall employ pre- (c) The registrant shall notify the cautions (e.g., assuring that shipping Field Division Office of the Adminis- containers do not indicate that con- tration in his area of any theft or sig- tents are controlled substances) to nificant loss of any controlled sub- guard against storage or in-transit stances upon discovery of such theft or losses. loss. The supplier shall be responsible (f) When distributing controlled sub- for reporting in-transit losses of con- stances through agents (e.g., trolled substances by the common or detailmen), a registrant is responsible
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for providing and requiring adequate cians, staff members and security security to guard against theft and di- guards. Similarly, such factors will be version while the substances are being taken into consideration when evalu- stored or handled by the agent or ating existing security or requiring agents. new security at a narcotic treatment (g) Before the initial distribution of program. carfentanil etorphine hydrochloride [36 FR 7778, Apr. 24, 1971; 36 FR 13386, July 21, and/or diprenorphine to any person, the 1971, as amended at 36 FR 18731, Sept. 21, registrant must verify that the person 1971. Redesignated at 38 FR 26609, Sept. 24, is authorized to handle the sub- l973] stances(s) by contacting the Drug En- EDITORIAL NOTE: For FEDERAL REGISTER ci- forcement Administration. tations affecting § 1301.74, see the List of CFR (h) The acceptance of delivery of nar- Sections Affected, which appears in the cotic substances by a narcotic treat- Finding Aids section of the printed volume ment program shall be made only by a and on GPO Access. licensed practitioner employed at the facility or other authorized individuals § 1301.75 Physical security controls for designated in writing. At the time of practitioners. delivery, the licensed practitioner or (a) Controlled substances listed in other authorized individual designated Schedule I shall be stored in a securely in writing (excluding persons currently locked, substantially constructed cabi- or previously dependent on narcotic net. drugs), shall sign for the narcotics and (b) Controlled substances listed in place his specific title (if any) on any Schedules II, III, IV, and V shall be invoice. Copies of these signed invoices stored in a securely locked, substan- shall be kept by the distributor. tially constructed cabinet. However, (i) Narcotics dispensed or adminis- pharmacies and institutional practi- tered at a narcotic treatment program tioners may disperse such substances will be dispensed or administered di- throughout the stock of noncontrolled rectly to the patient by either (1) the substances in such a manner as to ob- licensed practitioner, (2) a registered struct the theft or diversion of the con- nurse under the direction of the li- trolled substances. censed practitioner, (3) a licensed prac- (c) This section shall also apply to tical nurse under the direction of the nonpractitioners authorized to conduct licensed practitioner, or (4) a phar- research or chemical analysis under macist under the direction of the li- another registration. censed practitioner. (d) Carfentanil etorphine hydro- (j) Persons enrolled in a narcotic chloride and diprenorphine shall be treatment program will be required to stored in a safe or steel cabinet equiva- wait in an area physically separated lent to a U.S. Government Class V se- from the narcotic storage and dis- curity container. pensing area. This requirement will be [39 FR 3674, Jan. 29, 1974, as amended at 39 enforced by the program physician and FR 17838, May 21, 1974; 54 FR 33674, Aug. 16, employees. 1989; 62 FR 13957, Mar. 24, 1997] (k) All narcotic treatment programs must comply with standards estab- § 1301.76 Other security controls for lished by the Secretary of Health and practitioners. Human Services (after consultation (a) The registrant shall not employ, with the Administration) respecting as an agent or employee who has access the quantities of narcotic drugs which to controlled substances, any person may be provided to persons enrolled in who has been convicted of a felony of- a narcotic treatment program for unsu- fense relating to controlled substances pervised use. or who, at any time, had an application (l) DEA may exercise discretion re- for registration with the DEA denied, garding the degree of security required had a DEA registration revoked or has in narcotic treatment programs based surrendered a DEA registration for on such factors as the location of a pro- cause. For purposes of this subsection, gram, the number of patients enrolled the term ‘‘for cause’’ means a sur- in a program and the number of physi- render in lieu of, or as a consequence
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of, any federal or state administrative, cility must be packed in sealed, un- civil or criminal action resulting from marked shipping containers. an investigation of the individual’s handling of controlled substances. [65 FR 44678, July 19, 2000; 65 FR 45829, July 25, 2000] (b) The registrant shall notify the Field Division Office of the Adminis- EMPLOYEE SCREENING—NON- tration in his area of the theft or sig- PRACTITIONERS nificant loss of any controlled sub- stances upon discovery of such loss or § 1301.90 Employee screening proce- theft. The registrant shall also com- dures. plete DEA (or BND) Form 106 regarding It is the position of DEA that the ob- such loss or theft. taining of certain information by non- (c) Whenever the registrant distrib- practitioners is vital to fairly assess utes a controlled substance (without the likelihood of an employee commit- being registered as a distributor, as ting a drug security breach. The need permitted in § 1301.13(e)(1) and/or to know this information is a matter of §§ 1307.11–1307.12) he/she shall comply business necessity, essential to overall with the requirements imposed on non- controlled substances security. In this practitioners in § 1301.74 (a), (b), and (e). regard, it is believed that conviction of [36 FR 7778, Apr. 24, 1971, as amended at 36 crimes and unauthorized use of con- FR 18731, Sept. 21, 1971; 37 FR 15919, Aug. 8, trolled substances are activities that 1972. Redesignated at 38 FR 26609, Sept. 24, are proper subjects for inquiry. It is, l973; 47 FR 41735, Sept. 22, 1982; 56 FR 36728, therefore, assumed that the following Aug. 1, 1991; 62 FR 13957, Mar. 24, 1997] questions will become a part of an em- ployer’s comprehensive employee § 1301.77 Security controls for freight forwarding facilities. screening program: (a) All Schedule II–V controlled sub- Question. Within the past five years, have stances that will be temporarily stored you been convicted of a felony, or within the at the freight forwarding facility must past two years, of any misdemeanor or are you presently formally charged with com- be either: mitting a criminal offense? (Do not include (1) stored in a segregated area under any traffic violations, juvenile offenses or constant observation by designated re- military convictions, except by general sponsible individual(s); or court-martial.) If the answer is yes, furnish (2) stored in a secured area that details of conviction, offense, location, date meets the requirements of Section and sentence. 1301.72(b) of this Part. For purposes of Question. In the past three years, have you this requirement, a facility that may ever knowingly used any narcotics, amphet- be locked down (i.e., secured against amines or barbiturates, other than those pre- physical entry in a manner consistent scribed to you by a physician? If the answer with requirements of Section is yes, furnish details. 1301.72(b)(3)(ii) of this part) and has a Advice. An authorization, in writing, that monitored alarm system or is subject allows inquiries to be made of courts and law to continuous monitoring by security enforcement agencies for possible pending personnel will be deemed to meet the charges or convictions must be executed by a requirements of Section 1301.72(b)(3) of person who is allowed to work in an area where access to controlled substances clear- this Part. ly exists. A person must be advised that any (b) Access to controlled substances false information or omission of information must be kept to an absolute minimum will jeopardize his or her position with re- number of specifically authorized indi- spect to employment. The application for viduals. Non-authorized individuals employment should inform a person that in- may not be present in or pass through formation furnished or recovered as a result controlled substances storage areas of any inquiry will not necessarily preclude without adequate observation provided employment, but will be considered as part of an overall evaluation of the person’s by an individual authorized in writing qualifications. The maintaining of fair em- by the registrant. ployment practices, the protection of the (c) Controlled substances being trans- person’s right of privacy, and the assurance ferred through a freight forwarding fa- that the results of such inquiries will be
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treated by the employer in confidence will be pending charges and convictions. Local prac- explained to the employee. tice may require such inquiries to be made in person, rather than by mail, and a copy of an [40 FR 17143, Apr. 17, 1975] authorization from the employee may be re- quired by certain law enforcement agencies. § 1301.91 Employee responsibility to DEA inquiries. Inquiries supplying identi- report drug diversion. fying information should also be furnished to Reports of drug diversion by fellow DEA Field Division Offices along with writ- employees is not only a necessary part ten consent from the concerned individual of an overall employee security pro- for a check of DEA files for records of con- gram but also serves the public inter- victions. The Regional check will result in a national check being made by the Field Divi- est at large. It is, therefore, the posi- sion Office. tion of DEA that an employee who has knowledge of drug diversion from his [40 FR 17143, Apr. 17, 1975, as amended at 47 employer by a fellow employee has an FR 41735, Sept. 22, 1982] obligation to report such information to a responsible security official of the PART 1302—LABELING AND PACK- employer. The employer shall treat AGING REQUIREMENTS FOR such information as confidential and CONTROLLED SUBSTANCES shall take all reasonable steps to pro- tect the confidentiality of the informa- Sec. tion and the identity of the employee 1302.01 Scope of part 1302. furnishing information. A failure to re- 1302.02 Definitions. port information of drug diversion will 1302.03 Symbol required; exceptions. 1302.04 Location and size of symbol on label be considered in determining the feasi- and labeling. bility of continuing to allow an em- 1302.05 Effective dates of labeling require- ployee to work in a drug security area. ments. The employer shall inform all employ- 1302.06 Sealing of controlled substances. ees concerning this policy. 1302.07 Labeling and packaging require- ments for imported and exported sub- [40 FR 17143, Apr. 17, 1975] stances. § 1301.92 Illicit activities by employ- AUTHORITY: 21 U.S.C. 821, 825, 871(b), 958(e). ees. SOURCE: 36 FR 7785, Apr. 24, 1971, unless It is the position of DEA that em- otherwise noted. Redesignated at 38 FR 26609, ployees who possess, sell, use or divert Sept. 24, 1973. controlled substances will subject § 1302.01 Scope of part 1302. themselves not only to State or Fed- eral prosecution for any illicit activ- Requirements governing the labeling ity, but shall also immediately become and packaging of controlled substances the subject of independent action re- pursuant to sections 1305 and 1008(d) of garding their continued employment. the Act (21 U.S.C. 825 and 958(d)) are set The employer will assess the serious- forth generally by those sections and ness of the employee’s violation, the specifically by the sections of this part. position of responsibility held by the [36 FR 13386, July 21, 1971. Redesignated at 38 employee, past record of employment, FR 26609, Sept. 24, l973] etc., in determining whether to sus- pend, transfer, terminate or take other § 1302.02 Definitions. action against the employee. Any term contained in this part shall have the definition set forth in section [40 FR 17143, Apr. 17, 1975] 102 of the Act (21 U.S.C. 802) or part § 1301.93 Sources of information for 1300 of this chapter. employee checks. [62 FR 13958, Mar. 24, 1997] DEA recommends that inquiries con- cerning employees’ criminal records be § 1302.03 Symbol required; exceptions. made as follows: (a) Each commercial container of a Local inquiries. Inquiries should be made by controlled substance (except for a con- name, date and place of birth, and other trolled substance excepted by the Ad- identifying information, to local courts and ministrator pursuant to § 1308.31 of this law enforcement agencies for records of chapter) shall have printed on the label
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the symbol designating the schedule in labeling shall be clear and large which such controlled substance is list- enough to afford prompt identification ed. Each such commercial container, if of the controlled substance upon in- it otherwise has no label, must bear a spection of the labeling. label complying with the requirement of this part. [62 FR 13958, Mar. 24, 1997] (b) Each manufacturer shall print § 1302.05 Effective dates of labeling re- upon the labeling of each controlled quirements. substance distributed by him the sym- bol designating the schedule in which All labels on commercial containers such controlled substance is listed. of, and all labeling of, a controlled sub- (c) The following symbols shall des- stance which either is transferred to ignate the schedule corresponding another schedule or is added to any thereto: schedule shall comply with the require- ments of § 1302.03, on or before the ef- Schedule fective date established in the final Schedule I ...... CI or C–I. order for the transfer or addition. Schedule II ...... CII or C–II. Schedule III ...... CIII or C–III. [62 FR 13958, Mar. 24, 1997] Schedule IV ...... CIV or C–IV. Schedule V ...... CV or C–V. § 1302.06 Sealing of controlled sub- stances. The word ‘‘schedule’’ need not be used. No distinction need be made between On each bottle, multiple dose vial, or narcotic and nonnarcotic substances. other commercial container of any (d) The symbol is not required on a controlled substance, there shall be se- carton or wrapper in which a commer- curely affixed to the stopper, cap, lid, cial container is held if the symbol is covering, or wrapper or such container easily legible through such carton or a seal to disclose upon inspection any wrapper. tampering or opening of the container. (e) The symbol is not required on a [62 FR 13958, Mar. 24, 1997] commercial container too small or oth- erwise unable to accommodate a label, § 1302.07 Labeling and packaging re- if the symbol is printed on the box or quirements for imported and ex- package from which the commercial ported substances. container is removed upon dispensing (a) The symbol requirements of to an ultimate user. §§ 1302.03–1302.05 apply to every com- (f) The symbol is not required on a mercial container containing, and to commercial container containing, or all labeling of, controlled substances on the labeling of, a controlled sub- imported into the jurisdiction of and/or stance being utilized in clinical re- the customs territory of the United search involving blind and double blind States. studies. (b) The symbol requirements of [36 FR 7785, Apr. 24, 1971, as amended at 36 §§ 1302.03–1302.05 do not apply to any FR 18731, Sept. 21, 1971. Redesignated at 38 commercial containers containing, or FR 26609, Sept. 24, 1973] any labeling of, a controlled substance intended for export from the jurisdic- § 1302.04 Location and size of symbol on label and labeling. tion of the United States. (c) The sealing requirements of The symbol shall be prominently lo- § 1302.06 apply to every bottle, multiple cated on the label or the labeling of the dose vial, or other commercial con- commercial container and/or the panel tainer of any controlled substance list- of the commercial container normally ed in schedule I or II, or any narcotic displayed to dispensers of any con- controlled substance listed in schedule trolled substance. The symbol on labels III or IV, imported into, exported from, shall be clear and large enough to af- or intended for export from, the juris- ford easy identification of the schedule diction of and/or the customs territory of the controlled substance upon in- of the United States. spection without removal from the dis- penser’s shelf. The symbol on all other [62 FR 13958, Mar. 24, 1997]
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PART 1303—QUOTAS AGGREGATE PRODUCTION AND PROCUREMENT QUOTAS GENERAL INFORMATION § 1303.11 Aggregate production quotas. Sec. (a) The Administrator shall deter- 1303.01 Scope of part 1303. mine the total quantity of each basic 1303.02 Definitions. class of controlled substance listed in AGGREGATE PRODUCTION AND PROCUREMENT Schedule I or II necessary to be manu- QUOTAS factured during the following calendar year to provide for the estimated med- 1303.11 Aggregate production quotas. ical, scientific, research and industrial 1303.12 Procurement quotas. needs of the United States, for lawful 1303.13 Adjustments of aggregate produc- tion quotas. export requirements, and for the estab- lishment and maintenance of reserve INDIVIDUAL MANUFACTURING QUOTAS stocks. 1303.21 Individual manufacturing quotas. (b) In making his determinations, the 1303.22 Procedure for applying for individual Administrator shall consider the fol- manufacturing quotas. lowing factors: 1303.23 Procedure for fixing individual man- (1) Total net disposal of the class by ufacturing quotas. all manufacturers during the current 1303.24 Inventory allowance. and 2 preceding years; 1303.25 Increase in individual manufac- (2) Trends in the national rate of net turing quotas. disposal of the class; 1303.26 Reduction in individual manufac- (3) Total actual (or estimated) inven- turing quotas. tories of the class and of all substances 1303.27 Abandonment of quota. manufactured from the class, and HEARINGS trends in inventory accumulation; (4) Projected demand for such class 1303.31 Hearings generally. as indicated by procurement quotas re- 1303.32 Purpose of hearing. quested pursuant to § 1303.12; and 1303.33 Waiver or modification of rules. (5) Other factors affecting medical, 1303.34 Request for hearing or appearance; scientific, research, and industrial waiver. needs in the United States and lawful 1303.35 Burden of proof. 1303.36 Time and place of hearing. export requirements, as the Adminis- 1303.37 Final order. trator finds relevant, including changes in the currently accepted med- AUTHORITY: 21 U.S.C. 821, 826, 871(b). ical use in treatment with the class or the substances which are manufactured GENERAL INFORMATION from it, the economic and physical availability of raw materials for use in § 1303.01 Scope of part 1303. manufacturing and for inventory pur- Procedures governing the establish- poses, yield and stability problems, po- ment of production and manufacturing tential disruptions to production (in- quotas on basic classes of controlled cluding possible labor strikes), and re- substances listed in schedules I and II cent unforeseen emergencies such as pursuant to section 306 of the Act (21 floods and fires. U.S.C. 826) are governed generally by (c) The Administrator shall, on or be- that section and specifically by the fore May 1 of each year, publish in the sections of this part. FEDERAL REGISTER, general notice of [36 FR 7786, Apr. 24, 1971. Redesignated at 38 an aggregate production quota for any FR 26609, Sept. 24, 1973] basic class determined by him under this section. A copy of said notice shall § 1303.02 Definitions. be mailed simultaneously to each per- son registered as a bulk manufacturer Any term contained in this part shall of the basic class. The Administrator have the definition set forth in section shall permit any interested person to 102 of the Act (21 U.S.C. 802) or part file written comments on or objections 1300 of this chapter. to the proposal and shall designate in [62 FR 13958, Mar. 24, 1997] the notice the time during which such
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filings may be made. The Adminis- plicant shall state whether he intends trator may, but shall not be required to manufacture the basic class himself to, hold a public hearing on one or or purchase it from another manufac- more issues raised by the comments turer. The applicant shall state sepa- and objections filed with him. In the rately each purpose for which the basic event the Administrator decides to class is desired, the quantity desired hold such a hearing, he shall publish for that purpose during the next cal- notice of the hearing in the FEDERAL endar year, and the quantities used and REGISTER, which notice shall summa- estimated to be used, if any, for that rize the issues to be heard and shall set purpose during the current and pre- the time for the hearing which shall ceding 2 calendar years. If the purpose nnt be less than 30 days after the date is to manufacture the basic class into of publication of the notice. After con- dosage form, the applicant shall state sideration of any comments or objec- the official name, common or usual tions, or after a hearing if one is or- name, chemical name, or brand name dered by the Administrator, the Ad- of that form. If the purpose is to manu- ministrator shall issue and publish in facture another substance, the appli- the FEDERAL REGISTER his final order cant shall state the official name, com- determining the aggregate production mon or usual name, chemical name, or quota for the basic class of controlled brand name of the substance, and, if a substance. The order shall include the controlled substance listed in any findings of fact and conclusions of law schedule, the schedule number and Ad- upon which the order is based. The ministration Controlled Substances order shall specify the date on which it Code Number, as set forth in part 1308 shall take effect. A copy of said order of this chapter, of the substance. If the shall be mailed simultaneously to each purpose is to manufacture another person registered as a bulk manufac- basic class of controlled substance list- turer of the basic class. ed in Schedule I or II, the applicant [36 FR 7786, Apr. 24, 1971, as amended at 37 shall also state the quantity of the FR 15919, Aug. 8, 1972. Redesignated at 38 FR other basic class which the applicant 26609, Sept. 24, 1973] has applied to manufacture pursuant to § 1303.22 and the quantity of the first § 1303.12 Procurement quotas. basic class necessary to manufacture a (a) In order to determine the esti- specified unit of the second basic class. mated needs for, and to insure an ade- DEA Form 250 shall be filed on or be- quate and uninterrupted supply of, fore April 1 of the year preceding the basic classes of controlled substances calendar year for which the procure- listed in Schedules I and II (except raw ment quota is being applied. Copies of opium being imported by the registrant DEA Form 250 may be obtained from, pursuant to an import permit) the Ad- and shall be filed with, the Drug & ministrator shall issue procurement Chemical Evaluation Section, Drug En- quotas authorizing persons to procure forcement Administration, Department and use quantities of each basic class of Justice, Washington, DC 20537. of such substances for the purpose of (c) The Administrator shall, on or be- manufacturing such class into dosage fore July 1 of the year preceding the forms or into other substances. calendar year during which the quota (b) Any person who is registered to shall be effective, issue to each quali- manufacture controlled substances fied applicant a procurement quota au- listed in any schedule and who desires thorizing him to procure and use: to use during the next calendar year (1) All quantities of such class nec- any basic class of controlled substances essary to manufacture all quantities of listed in Schedule I or II (except raw other basic classes of controlled sub- opium being imported by the registrant stances listed in Schedules I and II pursuant to an import permit) for pur- which the applicant is authorized to poses of manufacturing, shall apply on manufacture pursuant to § 1303.23; and DEA Form 250 for a procurement quota (2) Such other quantities of such for such basic class. A separate applica- class as the applicant has applied to tion must be made for each basic class procure and use and are consistent desired to be procured or used. The ap- with his past use, his estimated needs,
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and the total quantity of such class ment quota under paragraph (b) of this that will be produced. section unless the order is accompanied (d) Any person to whom a procure- by a certification as required under ment quota has been issued may at any this section. The certification required time request an adjustment in the by this section shall contain the fol- quota by applying to the Adminis- lowing: The date of the certification; trator with a statement showing the the name and address of the bulk man- need for the adjustment. Such applica- ufacturer to whom the certification is tion shall be filed with the Drug & directed; a reference to the number of Chemical Evaluation Section, Drug En- the DEA Form 222 to which the certifi- forcement Administration, Department cation applies; the name of the person of Justice, Washington, DC 20537. The giving the order to which the certifi- Administrator shall increase or de- cation applies; the name of the basic crease the procurement quota of such class specified in the DEA Form 222 to person if and to the extent that he which the certification applies; the ap- finds, after considering the factors enu- propriate schedule within which is list- merated in paragraph (c) of this section ed the basic class specified in the DEA and any occurrences since the issuance of the procurement quota, that the Form 222 to which the certification ap- need justifies an adjustment. plies; a statement that the quantity (e) The following persons need not (expressed in grams) of the basic class obtain a procurement quota: specified in the DEA Form 222 to which (1) Any person who is registered to the certification applies does not ex- manufacture a basic class of controlled ceed the unused and available procure- substance listed in Schedule I or II and ment quota of such basic class, issued who uses all of the quantity he manu- to the person giving the order, for the factures in the manufacture of a sub- current calendar year; and the signa- stance not controlled under the Act; ture of the individual who signed the (2) Any person who is registered or DEA Form 222 to which the certifi- authorized to conduct chemical anal- cation applies. ysis with controlled substances (for [36 FR 7786, Apr. 24, 1971, as amended at 36 controlled substances to be used in FR 13386, July 21, 1971; 36 FR 18731, Sept. 21, such analysis only); and 1971; 37 FR 15919, Aug. 8, 1972. Redesignated (3) Any person who is registered to at 38 FR 26609, Sept. 24, 1973] conduct research with a basic class of controlled substance listed in Schedule EDITORIAL NOTE: For FEDERAL REGISTER ci- I or II and who is authorized to manu- tations affecting § 1303.12, see the List of CFR Sections Affected, which appears in the facture a quantity of such class pursu- Finding Aids section of the printed volume ant to § 1301.13 of this chapter. and on GPO Access. (f) Any person to whom a procure- ment quota has been issued, author- § 1303.13 Adjustments of aggregate izing that person to procure and use a production quotas. quantity of a basic class of controlled (a) The Administrator may at any substances listed in Schedules I or II time increase or reduce the aggregate during the current calendar year, shall, at or before the time of giving an order production quota for a basic class of to another manufacturer requiring the controlled substance listed in Schedule distribution of a quantity of such basic I or II which he has previously fixed class, certify in writing to such other pursuant to § 1303.11. manufacturer that the quantity of such (b) In determining to adjust the ag- basic class ordered does not exceed the gregate production quota, the Adminis- person’s unused and available procure- trator shall consider the following fac- ment quota of such basic class for the tors: current calendar year. The written cer- (1) Changes in the demand for that tification shall be executed by the class, changes in the national rate of same individual who signed the DEA net disposal of the class, and changes Form 222 transmitting the order. Man- in the rate of net disposal of the class ufacturers shall not fill an order from by registrants holding individual man- persons required to apply for a procure- ufacturing quotas for that class;
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(2) Whether any increased demand for a public hearing on one or more issues that class, the national and/or indi- raised by the comments and objections vidual rates of net disposal of that filed with him. In the event the Admin- class are temporary, short term, or istrator decides to hold such a hearing, long term; he shall publish notice of the hearing (3) Whether any increased demand for in the FEDERAL REGISTER, which notice that class can be met through existing shall summarize the issues to be heard inventories, increased individual man- and shall set the time for the hearing, ufacturing quotas, or increased impor- which shall not be less than 10 days tation, without increasing the aggre- after the date of publication of the no- gate production quota, taking into ac- tice. After consideration of any com- count production delays and the prob- ments or objections, or after a hearing ability that other individual manufac- if one is ordered by the Administrator, turing quotas may be suspended pursu- ant to § 1303.24(b); the Administrator shall issue and pub- (4) Whether any decreased demand lish in the FEDERAL REGISTER his final for that class will result in excessive order determining the aggregate pro- inventory accumulation by all persons duction for the basic class of controlled registered to handle that class (includ- substance. The order shall include the ing manufacturers, distributors, practi- findings of fact and conclusions of law tioners, importers, and exporters), not- upon which the order is based. The withstanding the possibility that indi- order shall specify the date on which it vidual manufacturing quotas may be shall take effect. A copy of said order suspended pursuant to § 1303.24(b) or shall be mailed simultaneously to each abandoned pursuant to § 1303.27; person registered as a bulk manufac- (5) Other factors affecting medical, turer of the basic class. scientific, research, and industrial needs in the United States and lawful [37 FR 15919, Aug. 8, 1972. Redesignated at 38 export requirements, as the Adminis- FR 26609, Sept. 24, 1973] trator finds relevant, including INDIVIDUAL MANUFACTURING QUOTAS changes in the currently accepted med- ical use in treatment with the class or § 1303.21 Individual manufacturing the substances which are manufactured quotas. from it, the economic and physical availability of raw materials for use in (a) The Administrator shall, on or be- manufacturing and for inventory pur- fore July 1 of each year, fix for and poses, yield and stability problems, po- issue to each person who is registered tential disruptions to production (in- to manufacture a basic class of con- cluding possible labor strikes), and re- trolled substance listed in Schedule I cent unforeseen emergencies such as or II, and who applies for a manufac- floods and fires. turing quota, an individual manufac- (c) The Administrator in the event he turing quota authorizing that person to determines to increase or reduce the manufacture during the next calendar aggregate production quota for a basic year a quantity of that basic class. Any class of controlled substance, shall manufacturing quota fixed and issued publish in the FEDERAL REGISTER gen- by the Administrator shall be subject eral notice of an adjustment in the ag- to his authority to reduce or limit it at gregate production quota for that class a later date pursuant to § 1303.26 and to determined by him under this section. his authority to revoke or suspend it at A copy of said notice shall be mailed any time pursuant to §§ 1301.36 of this simultaneously to each person reg- chapter. istered as a bulk manufacturer of the (b) No individual manufacturing basic class. The Administrator shall quota shall be required for registrants permit any interested person to file listed in § 1303.12(e). written comments on or objections to the proposal and shall designate in the [36 FR 7786, Apr. 24, 1971. Redesignated at 38 notice the time during which such fil- FR 26609, Sept. 24, 1973, as amended at 62 FR ings may be made. The Administrator 13958, Mar. 24, 1997] may, but shall not be required to, hold
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§ 1303.22 Procedure for applying for labor strikes) and recent unforeseen individual manufacturing quotas. emergencies such as floods and fires. Any person who is registered to man- [36 FR 7786, Apr. 24, 1971, as amended at 36 ufacture any basic class of controlled FR 13386, July 21, 1971; 37 FR 15920, Aug. 8, substance listed in Schedule I or II and 1972. Redesignated at 38 FR 26609, Sept. 24, who desires to manufacture a quantity 1973, and amended at 46 FR 28841, May 29, of such class shall apply on DEA Form 1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958, 189 for a manufacturing quota for such Mar. 24, 1997] quantity of such class. Copies of DEA § 1303.23 Procedure for fixing indi- Form 189 may be obtained from, and vidual manufacturing quotas. shall be filed (on or before May 1 of the year preceding the calendar year for (a) In fixing individual manufac- which the manufacturing quota is turing quotas for a basic class of con- being applied) with, the Drug & Chem- trolled substance listed in Schedule I ical Evaluation Section, Drug Enforce- or II, the Administrator shall allocate ment Administration, Department of to each applicant who is currently Justice, Washington, D.C. 20537. A sep- manufacturing such class a quota equal arate application must be made for to 100 percent of the estimated net dis- each basic class desired to be manufac- posal of that applicant for the next cal- tured. The applicant shall state: endar year, adjusted— (a) The name and Administration (1) By the amount necessary to in- Controlled Substances Code Number, as crease or reduce the estimated inven- set forth in part 1308 of this chapter, of tory of the applicant on December 31 of the basic class. the current year to his estimated in- (b) For the basic class in each of the ventory allowance for the next cal- current and preceding 2 calendar years, endar year, pursuant to § 1303.24, and (1) The authorized individual manu- (2) By any other factors which the facturing quota, if any; Administrator deems relevant to the fixing of the individual manufacturing (2) The actual or estimated quantity quota of the applicant, including the manufactured; trend of (and recent changes in) his and (3) The actual or estimated net dis- the national rates of net disposal, his posal; production cycle and current inventory (4) The actual or estimated inventory position, the economic and physical allowance pursuant to § 1303.24; and availability of raw materials for use in (5) The actual or estimated inventory manufacturing and for inventory pur- as of December 31; poses, yield and stability problems, po- (c) For the basic class in the next cal- tential disruptions to production (in- endar year, cluding possible labor strikes), and re- (1) The desired individual manufac- cent unforeseen emergencies such as turing quota; and floods and fires. (2) Any additional factors which the (b) In fixing individual manufac- applicant finds relevant to the fixing of turing quotas for a basic class of con- his individual manufacturing quota, in- trolled substance listed in Schedule I cluding the trend of (and recent or II, the Administrator shall allocate changes in) his and the national rates to each applicant who is not currently of net disposal, his production cycle manufacturing such class a quota equal and current inventory position, the to 100 percent of the reasonably esti- econolic and physical availability of mated net disposal of that applicant raw materials for use in manufacturing for the next calendar year, as deter- and for inventory purposes, yield and mined by the Administrator, ad- stability problems, potential disrup- justed— tions to production (including possible
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(1) By the amount necessary to pro- disposal, his quota for that class is vide the applicant his estimated inven- automatically suspended and shall re- tory allowance for the next calendar main suspended until his inventory is year, pursuant to § 1303.24, and less than 60 percent of his estimated (2) By any other factors which the net disposal. The Administrator may, Administrator deems relevant to the upon application and for good cause fixing of the individual manufacturing shown, permit a manufacturer whose quota of the applicant, including the quota is, or is likely to be, suspended trend of (and recent changes in) the na- pursuant to this paragraph to continue tional rate of net disposal, his produc- manufacturing and to accumulate an tion cycle and current inventory posi- inventory in excess of 65 percent of his tion, the economic and physical avail- estimated net disposal, upon such con- ability of raw materials for use in man- ditions and within such limitations as ufacturing and for inventory purposes, the Administrator may find necessary yield and stability problems, potential or desirable. disruptions to production (including (c) If, during a calendar year, a reg- possible labor strikes), and recent un- istrant has manufactured the entire foreseen emergencies such as floods quantity of a basic class allocated to and fires. him under an individual manufacturing (c) The Administrator shall, on or be- quota, and his inventory of that class fore March 1 of each year, adjust the is less than 40 percent of his estimated individual manufacturing quota allo- net disposal of that class for that year, cated for that year to each applicant in the Administrator may, upon applica- paragraph (a) of this section by the tion pursuant to § 1303.25, increase the amount necessary to increase or reduce quota of such registrant sufficiently to the actual inventory of the applicant allow restoration of the inventory to 50 to December 31 of the preceding year to percent of the estimated net disposal his estimated inventory allowance for for that year. the current calendar year, pursuant to [36 FR 7786, Apr. 24, 1971, as amended at 36 § 1303.24. FR 13386, July 21, 1971. Redesignated at 38 FR [36 FR 7786, Apr. 24, 1971, as amended at 37 26609, Sept. 24, 1973] FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973] § 1303.25 Increase in individual manu- facturing quotas. § 1303.24 Inventory allowance. (a) Any registrant who holds an indi- (a) For the purpose of determining vidual manufacturing quota for a basic individual manufacturing quotas pur- class of controlled substance listed in suant to § 1303.23, each registered man- Schedule I or II may file with the Ad- ufacturer shall be allowed as a part of ministrator an application on Adminis- such quota an amount sufficient to tration Form 189 for an increase in maintain an inventory equal to, such quota in order for him to meet his (1) For current manufacturers, 50 per- estimated net disposal, inventory and cent of his average estimated net dis- other requirements during the remain- posal for the current calendar year and der of such calendar year. the last preceding calendar year; or (b) The Administrator, in passing (2) For new manufacturers, 50 percent upon a registrant’s application for an of his reasonably estimated net dis- increase in his individual manufac- posal for the next calendar year as de- turing quota, shall take into consider- termined by the Administrator. ation any occurrences since the filing (b) During each calendar year each of such registrant’s initial quota appli- registered manufacturer shall be al- cation that may require an increased lowed to maintain an inventory of a manufacturing rate by such registrant basic class not exceeding 65 percent of during the balance of the calendar his estimated net disposal of that class year. In passing upon such application for that year, as determined at the the Administrator may also take into time his quota for that year was deter- consideration the amount, if any, by mined. At any time the inventory of a which his determination of the total basic class held by a manufacturer ex- quantity for the basic class of con- ceeds 65 percent of his estimated net trolled substance to be manufactured
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under § 1303.11 exceeds the aggregate of filing with the Drug & Chemical Eval- all the individual manufacturing uation Section a written notice of such quotas for the basic class of controlled abandonment, stating the name and substance, and the equitable distribu- Administration Controlled Substances tion of such excess among other reg- Code Number, as set forth in part 1308 istrants. of this chapter, of the substance and [36 FR 7786, Apr. 24, 1971, as amended at 36 the amount which he has chosen not to FR 13386, July 21, 1971. Redesignated at 38 FR manufacture. The Administrator may, 26609, Sept. 24, 1973] in his discretion, allocate such amount among the other manufacturers in pro- § 1303.26 Reduction in individual man- ufacturing quotas. portion to their respective quotas. The Administrator may at any time [36 FR 7786, Apr. 24, 1971, as amended at 36 reduce an individual manufacturing FR 13386, July 21, 1971. Redesignated at 38 FR quota for a basic class of controlled 26609, Sept. 24, 1973, and amended at 46 FR substance listed in Schedule I or II 28841, May 29, 1981; 51 FR 5319, Feb. 13, 1986; which he has previously fixed in order 62 FR 13958, Mar. 24, 1997] to prevent the aggregate of the indi- vidual manufacturing quotas and im- HEARINGS port permits outstanding or to be § 1303.31 Hearings generally. granted from exceeding the aggregate production quota which has been estab- (a) In any case where the Adminis- lished for that class pursuant of trator shall hold a hearing regarding § 1303.11, as adjusted pursuant to the determination of an aggregate pro- § 1303.13. If a quota assigned to a new duction quota pursuant to § 1303.11(c), manufacturer pursuant to § 1303.23(b), or regarding the adjustment of an ag- or if a quota assigned to any manufac- gregate production quota pursuant to turer is increased pursuant to § 1303.13(c), the procedures for such § 1303.24(c), or if an import permit hearing shall be governed generally by issued to an importer pursuant to part the rule making procedures set forth in 1312 of this chapter, causes the total the Administrative Procedure Act (5 quantity of a basic class to be manu- U.S.C. 551–559) and specifically by sec- factured and imported during the year tion 306 of the Act (21 U.S.C. 826), by to exceed the aggregate production quota which has been established for §§ 1303.32–1303.37, and by the procedures that class pursuant to § 1303.11, as ad- for administrative hearings under the justed pursuant to § 1303.13, the Admin- Act set forth in §§ 1316.41–1316.67 of this istrator may proportionately reduce chapter. the individual manufacturing quotas (b) In any case where the Adminis- and import permits of all other reg- trator shall hold a hearing regarding istrants to keep the aggregate produc- the issuance, adjustment, suspension, tion quota within the limits originally or denial of a procurement quota pur- established, or, alternatively, the Ad- suant to § 1303.12, or the issuance, ad- ministrator may reduce the individual justment, suspension, or denial of an manufacturing quota of any registrant individual manufacturing quota pursu- whose quota is suspended pursuant to ant to §§ 1303.21–1303.27, the procedures § 1303.24(b) or § 1301.36 of this chapter, or for such hearing shall be governed gen- is abandoned pursuant to § 1303.27. erally by the adjudication procedures [36 FR 7786, Apr. 24, 1971, as amended at 37 set forth in the Administrative Proce- FR 15920, Aug. 8, 1972. Redesignated at 38 FR dures Act (5 U.S.C. 551–559) and specifi- 26609, Sept. 24, 1973, as amended at 62 FR cally by section 306 of the Act (21 13958, Mar. 24, 1997] U.S.C. 826), by §§ 1303.32–1303.37, and by the procedures for administrative hear- § 1303.27 Abandonment of quota. ings under the Act set forth in Any manufacturer assigned an indi- §§ 1316.41–1316.67 of this chapter. vidual manufacturing quota for any basic class pursuant to § 1303.23 may at [36 FR 7786, Apr. 24, 1971, as amended at 37 any time abandon his right to manu- FR 15920, Aug. 8, 1972. Redesignated at 38 FR facture all or any part of such quota by 26609, Sept. 24, 1973]
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§ 1303.32 Purpose of hearing. ministrator a written request for a (a) The Administrator may, in his hearing in the form prescribed in sole discretion, hold a hearing for the § 1316.47 of this chapter. Any interested purpose of receiving factual evidence person who desires a hearing on the de- regarding any one or more issues (to be termination of an aggregate production specified by him) involved in the deter- quota shall, within the time prescribed mination or adjustment of any aggre- in § 1303.11(c), file with the Adminis- gate production quota. trator a written request for a hearing (b) If requested by a person applying in the form prescribed in § 1316.47 of for or holding a procurement quota or this chapter, including in the request a an individual manufacturing quota, the statement of the grounds for a hearing. Administrator shall hold a hearing for (b) Any interested person who desires the purpose of receiving factual evi- to participate in a hearing on the de- dence regarding the issues involved in termination or adjustment of an aggre- the issuance, adjustment, suspension, gate production quota, which hearing or denial of such quota to such person, is ordered by the Administrator pursu- but the Administrator need not hold a ant to § 1303.11(c) or § 1303.13(c) may do hearing on the suspension of a quota so by filing with the Administrator, pursuant to § 1301.36 of this chapter sep- within 30 days of the date of publica- arate from a hearing on the suspension tion of notice of the hearing in the of registration pursuant to those sec- FEDERAL REGISTER, a written notice of tions. his intention to participate in such (c) Extensive argument should not be hearing in the form prescribed in offered into evidence but rather pre- § 1316.48 of this chapter. sented in opening or closing state- (c) Any person entitled to a hearing ments of counsel or in memoranda or or to participate in a hearing pursuant proposed findings of fact and conclu- to paragraph (b) of this section, may, sions of law. within the period permitted for filing a [36 FR 7786, Apr. 24, 1971, as amended at 37 request for a hearing of notice of ap- FR 15920, Aug. 8, 1972. Redesignated at 38 FR pearance, file with the Administrator a 26609, Sept. 24, 1973, as amended at 62 FR waiver of an opportunity for a hearing 13958, Mar. 24, 1997] or to participate in a hearing, together § 1303.33 Waiver or modification of with a written statement regarding his rules. position on the matters of fact and law The Administrator or the presiding involved in such hearing. Such state- officer (with respect to matters pend- ment, if admissible, shall be made a ing before him) may modify or waive part of the record and shall be consid- any rule in this part by notice in ad- ered in light of the lack of opportunity vance of the hearing, if he determines for cross-examination in determining that no party in the hearing will be un- the weight to be attached to matters of duly prejudiced and the ends of justice fact asserted therein. will thereby be served. Such notice of (d) If any person entitled to a hearing modification or waiver shall be made a or to participate in a hearing pursuant part of the record of the hearing. to paragraph (b) of this section, fails to file a request for a hearing or notice of [36 FR 7786, Apr. 24,1971. Redesignated at 38 FR 26609, Sept. 24, 1973] appearance, or if he so files and fails to appear at the hearing, he shall be § 1303.34 Request for hearing or ap- deemed to have waived his opportunity pearance; waiver. for the hearing or to participate in the (a) Any applicant or registrant who hearing, unless he shows good cause for desires a hearing on the issuance, ad- such failure. justment, suspension, or denial of his (e) If all persons entitled to a hearing procurement and/or individual manu- or to participate in a hearing waive or facturing quota shall, within 30 days are deemed to waive their opportunity after the date of receipt of the for the hearing or to participate in the issuance, adjustment, suspension, or hearing, the Administrator may cancel denial of such quota, file with the Ad- the hearing, if scheduled, and issue his
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final order pursuant to § 1303.37 without § 1303.37 Final order. a hearing. As soon as practicable after the pre- [36 FR 7786, Apr. 24, 1971, as amended at 36 siding officer has certified the record FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, to the Administrator, the Adminis- 1972. Redesignated at 38 FR 26609, Sept. 24, trator shall issue his order on the de- 1973] termination or adjustment of the ag- § 1303.35 Burden of proof. gregate production quota or on the issuance, adjustment, suspension, or (a) At any hearing regarding the de- denial of the procurement quota or in- termination or adjustment of an aggre- dividual manufacturing quota, as case gate production quota, each interested person participating in the hearing may be. The order shall include the shall have the burden of proving any findings of fact and conclusions of law propositions of fact or law asserted by upon which the order is based. The him in the hearing. order shall specify the date on which it (b) At any hearing regarding the shall take effect. The Administrator issuance, adjustment, suspension, or shall serve one copy of his order upon denial of a procurement or individual each party in the hearing. manufacturing quota, the Administra- [36 FR 7786, Apr. 24, 1971, as amended at 37 tion shall have the burden of proving FR 15920, Aug. 8, 1972. Redesignated at 38 FR that the requirements of this part for 26609, Sept. 24, 1973] such issuance, adjustment, suspension, or denial are satisfied. PART 1304—RECORDS AND [36 FR 7786, Apr. 24, 1971, as amended at 37 REPORTS OF REGISTRANTS FR 15920, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR GENERAL INFORMATION 13958, Mar. 24, 1997] Sec. § 1303.36 Time and place of hearing. 1304.01 Scope of part 1304. (a) If any applicant or registrant re- 1304.02 Definitions. quests a hearing on the issuance, ad- 1304.03 Persons required to keep records and justment, suspension, or denial of his file reports. procurement and/or individual manu- 1304.04 Maintenance of records and inven- facturing quota pursuant to § 1303.34, tories. the Administrator shall hold such INVENTORY REQUIREMENTS hearing. Notice of the hearing shall be given to the applicant or registrant of 1304.11 Inventory requirements. the time and place at least 30 days CONTINUING RECORDS prior to the hearing, unless the appli- cant or registrant waives such notice 1304.21 General requirements for continuing and requests the hearing be held at an records. earlier time, in which case the Admin- 1304.22 Records for manufacturers, distribu- istrator shall fix a date for such hear- tors, dispensers, researchers, importers, and exporters. ing as early as reasonably possible. 1304.23 Records for chemical analysts. (b) The hearing will commence at the 1304.24 Records for maintenance treatment place and time designated in the notice programs and detoxification treatment given pursuant to paragraph (a) of this programs. section or in the notice of hearing pub- 1304.25 Records for treatment programs lished in the FEDERAL REGISTER pursu- which compound narcotics for treatment ant to § 1303.11(c) or § 1303.13 (c), but programs and other locations. thereafter it may be moved to a dif- ferent place and may be continued REPORTS from day to day or recessed to a later 1304.31 Reports from manufacturers import- day without notice other than an- ing narcotic raw material. nouncement thereof by the presiding 1304.32 Reports of manufacturers importing officer at the hearing. coca leaves. 1304.33 Reports to ARCOS. [36 FR 7786, Apr. 24, 1971, as amended at 37 FR 15920, Aug. 8, 1972. Redesignated at 38 FR AUTHORITY: 21 U.S.C. 821, 827, 871(b), 958(e), 26609, Sept. 24, 1973] 965, unless otherwise noted.
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GENERAL INFORMATION ment the transfer; when he imports a substance, he keeps as part of his § 1304.01 Scope of part 1304. records the documentation required of Inventory and other records and re- an importer; and when substances are ports required under section 307 or sec- used in chemical analysis, he need not tion 1008(d) of the Act (21 U.S.C. 827 and keep a record of this because such a 958(d)) shall be in accordance with, and record would not be required of him contain the information required by, under a registration to do chemical those sections and by the sections of analysis. All of these records may be this part. maintained in one consolidated record system. Similarly, the researcher may [36 FR 7789, Apr. 24, 1971. Redesignated at 38 store all of his controlled items in one FR 26609, Sept. 24, 1973] place, and every two years take inven- § 1304.02 Definitions. tory of all items on hand, regardless of whether the substances were manufac- Any term contained in this part shall tured by him, imported by him, or pur- have the definition set forth in section chased domestically by him, of whether 102 of the Act (21 U.S.C. 802) or part the substances will be administered to 1300 of this chapter. subjects, distributed to other research- [62 FR 13958, Mar. 24, 1997] ers, or destroyed during chemical anal- ysis. § 1304.03 Persons required to keep (b) A registered individual practi- records and file reports. tioner is required to keep records, as (a) Each registrant shall maintain described in § 1304.04, of controlled sub- the records and inventories and shall stances in Schedules II, III, IV, and V file the reports required by this part, which are dispensed, other than by pre- except as exempted by this section. scribing or administering in the lawful Any registrant who is authorized to course of professional practice. conduct other activities without being (c) A registered individual practi- registered to conduct those activities, tioner is not required to keep records either pursuant to § 1301.22(b) of this of controlled substances in Schedules chapter or pursuant to §§ 1307.11–1307.15 II, III, IV, and V which are prescribed of this chapter, shall maintain the in the lawful course of professional records and inventories and shall file practice, unless such substances are the reports required by this part for prescribed in the course of mainte- persons registered to conduct such ac- nance or detoxification treatment of an tivities. This latter requirement should individual. not be construed as requiring stocks of (d) A registered individual practi- controlled substances being used in tioner is not required to keep records various activities under one registra- of controlled substances listed in tion to be stored separately, nor that Schedules II, III, IV and V which are separate records are required for each administered in the lawful course of activity. The intent of the Administra- professional practice unless the practi- tion is to permit the registrant to keep tioner regularly engages in the dis- one set of records which are adapted by pensing or administering of controlled the registrant to account for controlled substances and charges patients, either substances used in any activity. Also, separately or together with charges for the Administration does not wish to other professional services, for sub- acquire separate stocks of the same stances so dispensed or administered. substance to be purchased and stored Records are required to be kept for for separate activities. Otherwise, controlled substances administered in there is no advantage gained by per- the course of maintenance or detoxi- mitting several activities under one fication treatment of an individual. registration. Thus, when a researcher (e) Each registered mid-level practi- manufactures a controlled item, he tioner shall maintain in a readily re- must keep a record of the quantity trievable manner those documents re- manufactured; when he distributes a quired by the state in which he/she quantity of the item, he must use and practices which describe the conditions keep invoices or order forms to docu- and extent of his/her authorization to
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dispense controlled substances and must be maintained for a period of two shall make such documents available years. for inspection and copying by author- [36 FR 7790, Apr. 24, 1971, as amended at 36 ized employees of the Administration. FR 18731, Sept. 21, 1971; 37 FR 15920, Aug. 8, Examples of such documentation in- 1972. Redesignated at 38 FR 26609, Sept. 24, clude protocols, practice guidelines or 1973, and amended at 50 FR 40523, Oct. 4, 1985; practice agreements. 51 FR 5320, Feb. 13, 1986; 51 FR 26154, July 21, (f) Registered persons using any con- 1986; 58 FR 31175, June 1, 1993; 62 FR 13958, trolled substances while conducting Mar. 24, 1997; 65 FR 44679, July 19, 2000] preclinical research, in teaching at a § 1304.04 Maintenance of records and registered establishment which main- inventories. tains records with respect to such sub- stances or conducting research in con- (a) Every inventory and other records formity with an exemption granted required to be kept under this part under section 505(i) or 512(j) of the Fed- shall be kept by the registrant and be eral Food, Drug, and Cosmetic Act (21 available, for at least 2 years from the U.S.C. 355(i) or 360b(j)) at a registered date of such inventory or records, for inspection and copying by authorized establishment which maintains records employees of the Administration, ex- in accordance with either of those sec- cept that financial and shipping tions, are not required to keep records records (such as invoices and packing if he/she notifies the Administration of slips but not executed order forms sub- the name, address, and registration ject to § 1305.13 of this chapter) may be number of the establishment maintain- kept at a central location, rather than ing such records. This notification at the registered location, if the reg- shall be given at the time the person istrant has notified the Administration applies for registration or reregistra- of his intention to keep central tion and shall be made in the form of records. Written notification must be an attachment to the application, submitted by registered or certified which shall be filed with the applica- mail, return receipt requested, in trip- tion. licate, to the Special Agent in Charge (g) A distributing registrant who uti- of the Administration in the area in lizes a freight forwarding facility shall which the registrant is located. Unless maintain records to reflect transfer of the registrant is informed by the Spe- controlled substances through the fa- cial Agent in Charge that permission cility. These records must contain the to keep central records is denied, the date, time of transfer, number of car- registrant may maintain central tons, crates, drums or other packages records commencing 14 days after re- in which commercial containers of con- ceipt of his notification by the Special trolled substances are shipped and au- Agent in Charge. thorized signatures for each transfer. A All notifications must include: distributing registrant may, as part of (1) The nature of the records to be the initial request to operate a freight kept centrally. forwarding facility, request permission (2) The exact location where the to store records at a central location. records will be kept. Approval of the request to maintain (3) The name, address, DEA registra- central records would be implicit in tion number and type of DEA registra- the approval of the request to operate tion of the registrant whose records are the facility. Otherwise, a request to being maintained centrally. maintain records at a central location (4) Whether central records will be must be submitted in accordance with maintained in a manual, or computer § 1304.04 of this part. These records readable form.
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(b) All registrants that are author- ARCOS Unit, P.O. Box 28293, Central ized to maintain a central record- Station, Washington, DC 20005. keeping system shall be subject to the (e) All central recordkeeping permits following conditions: previously issued by the Administra- (1) The records to be maintained at tion expired September 30, 1980. the central record location shall not (f) Each registered manufacturer, dis- include executed order forms, prescrip- tributor, importer, exporter, narcotic tions and/or inventories which shall be treatment program and compounder maintained at each registered location. for narcotic treatment program shall (2) If the records are kept on micro- maintain inventories and records of film, computer media or in any form controlled substances as follows: requiring special equipment to render (1) Inventories and records of con- the records easily readable, the reg- trolled substances listed in Schedules I istrant shall provide access to such and II shall be maintained separately equipment with the records. If any from all of the records of the reg- code system is used (other than pricing istrant; and information), a key to the code shall be (2) Inventories and records of con- provided to make the records under- trolled substances listed in Schedules standable. III, IV, and V shall be maintained ei- (3) The registrant agrees to deliver ther separately from all other records of the registrant or in such form that all or any part of such records to the the information required is readily re- registered location within two business trievable from the ordinary business days upon receipt of a written request records of the registrant. from the Administration for such (g) Each registered individual practi- records, and if the Administration tioner required to keep records and in- chooses to do so in lieu of requiring de- stitutional practitioner shall maintain livery of such records to the registered inventories and records of controlled location, to allow authorized employ- substances in the manner prescribed in ees of the Administration to inspect paragraph (f) of this section. such records at the central location (h) Each registered pharmacy shall upon request by such employees with- maintain the inventories and records of out a warrant of any kind. controlled substances as follows: (4) In the event that a registrant fails (1) Inventories and records of all con- to comply with these conditions, the trolled substances listed in Schedules I Special Agent in Charge may cancel and II shall be maintained separately such central recordkeeping authoriza- from all other records of the pharmacy, tion, and all other central record- and prescriptions for such substances keeping authorizations held by the reg- shall be maintained in a separate pre- istrant without a hearing or other pro- scription file; and cedures. In the event of a cancellation (2) Inventories and records of con- of central recordkeeping authoriza- trolled substances listed in Schedules tions under this paragraph the reg- III, IV, and V shall be maintained ei- istrant shall, within the time specified ther separately from all other records by the Special Agent in Charge, comply of the pharmacy or in such form that with the requirements of this section the information required is readily re- that all records be kept at the reg- trievable from ordinary business istered location. records of the pharmacy, and prescrip- (c) Registrants need not notify the tions for such substances shall be Special Agent in Charge or obtain cen- maintained either in a separate pre- tral recordkeeping approval in order to scription file for controlled substances maintain records on an in-house com- listed in Schedules III, IV, and V only puter system. or in such form that they are readily (d) ARCOS participants who desire retrievable from the other prescription authorization to report from other records of the pharmacy. Prescriptions than their registered locations must will be deemed readily retrievable if, at obtain a separate central reporting the time they are initially filed, the identifier. Request for central report- face of the prescription is stamped in ing identifiers will be submitted to: red ink in the lower right corner with
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the letter ‘‘C’’ no less than 1 inch high possessing the substance is responsible. and filed either in the prescription file The inventory may be taken either as for controlled substances listed in of opening of business or as of the close Schedules I and II or in the usual con- of business on the inventory date and secutively numbered prescription file it shall be indicated on the inventory. for non-controlled substances. How- (b) Initial inventory date. Every person ever, if a pharmacy employs an ADP required to keep records shall take an system or other electronic record- inventory of all stocks of controlled keeping system for prescriptions which substances on hand on the date he/she permits identification by prescription first engages in the manufacture, dis- number and retrieval of original docu- tribution, or dispensing of controlled ments by prescriber’s name, patient’s substances, in accordance with para- name, drug dispensed, and date filled, graph (e) of this section as applicable. then the requirement to mark the hard In the event a person commences busi- copy prescription with a red ‘‘C’’ is ness with no controlled substances on waived. hand, he/she shall record this fact as the initial inventory. (Authority: 21 U.S.C. 821 and 871(b); 28 CFR 0.100) (c) Biennial inventory date. After the initial inventory is taken, the reg- [36 FR 7790, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971. Redesignated at 38 FR istrant shall take a new inventory of 26609, Sept. 24, l973, and amended at 39 FR all stocks of controlled substances on 37985, Oct. 25, 1974; 45 FR 44266, July 1, 1980; hand at least every two years. The bi- 47 FR 41735, Sept. 22, 1982; 51 FR 5320, Feb. 13, ennial inventory may be taken on any 1986; 62 FR 13959, Mar. 24, 1997] date which is within two years of the previous biennial inventory date. INVENTORY REQUIREMENTS (d) Inventory date for newly controlled § 1304.11 Inventory requirements. substances. On the effective date of a rule by the Administrator pursuant to (a) Each inven- General requirements. §§ 1308.45, 1308.46, or 1308.47 of this chap- tory shall contain a complete and accu- ter adding a substance to any schedule rate record of all controlled substances of controlled substances, which sub- on hand on the date the inventory is stance was, immediately prior to that taken, and shall be maintained in writ- date, not listed on any such schedule, ten, typewritten, or printed form at the registered location. An inventory every registrant required to keep taken by use of an oral recording de- records who possesses that substance vice must be promptly transcribed. shall take an inventory of all stocks of Controlled substances shall be deemed the substance on hand. Thereafter, to be ‘‘on hand’’ if they are in the pos- such substance shall be included in session of or under the control of the each inventory made by the registrant registrant, including substances re- pursuant to paragraph (c) of this sec- turned by a customer, ordered by a cus- tion. tomer but not yet invoiced, stored in a (e) Inventories of manufacturers, dis- warehouse on behalf of the registrant, tributors, dispensers, researchers, import- and substances in the possession of em- ers, exporters and chemical analysts. ployees of the registrant and intended Each person registered or authorized for distribution as complimentary sam- (by § 1301.13 or §§ 1307.11–1307.13 of this ples. A separate inventory shall be chapter) to manufacture, distribute, made for each registered location and dispense, import, export, conduct re- each independent activity registered, search or chemical analysis with con- except as provided in paragraph (e)(4) trolled substances and required to keep of this section. In the event controlled records pursuant to § 1304.03 shall in- substances in the possession or under clude in the inventory the information the control of the registrant are stored listed below. at a location for which he/she is not (1) Inventories of manufacturers. Each registered, the substances shall be in- person registered or authorized to man- cluded in the inventory of the reg- ufacture controlled substances shall in- istered location to which they are sub- clude the following information in the ject to control or to which the person inventory:
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(i) For each controlled substance in weight or the total number of units of bulk form to be used in (or capable of finished form; and use in) the manufacture of the same or (C) The reason for the substance other controlled or non-controlled sub- being maintained by the registrant and stances in finished form, the inventory whether such substance is capable of shall include: use in the manufacture of any con- (A) The name of the substance and trolled substance in finished form. (B) The total quantity of the sub- (2) Inventories of distributors. Each stance to the nearest metric unit person registered or authorized to dis- weight consistent with unit size. tribute controlled substances shall in- (ii) For each controlled substance in clude in the inventory the same infor- the process of manufacture on the in- mation required of manufacturers pur- ventory date, the inventory shall in- suant to paragraphs (e)(1) (iii) and (iv) clude: of this section. (A) The name of the substance; (3) Inventories of dispensers and re- (B) The quantity of the substance in searchers. Each person registered or au- each batch and/or stage of manufac- thorized to dispense or conduct re- ture, identified by the batch number or search with controlled substances shall other appropriate identifying number; include in the inventory the same in- and formation required of manufacturers (C) The physical form which the sub- pursuant to paragraphs (e)(1) (iii) and stance is to take upon completion of (iv) of this section. In determining the the manufacturing process (e.g., granu- number of units of each finished form lations, tablets, capsules, or solutions), of a controlled substance in a commer- identified by the batch number or cial container which has been opened, other appropriate identifying number, the dispenser shall do as follows: and if possible the finished form of the (i) If the substance is listed in Sched- substance (e.g., 10-milligram tablet or ule I or II, make an exact count or 10-milligram concentration per fluid measure of the contents, or ounce or milliliter) and the number or (ii) If the substance is listed in volume thereof. Schedule III, IV or V, make an esti- (iii) For each controlled substance in mated count or measure of the con- finished form the inventory shall in- tents, unless the container holds more clude: than 1,000 tablets or capsules in which (A) The name of the substance; case he/she must make an exact count (B) Each finished form of the sub- of the contents. stance (e.g., 10-milligram tablet or 10- (4) Inventories of importers and export- milligram concentration per fluid ers. Each person registered or author- ounce or milliliter); ized to import or export controlled sub- (C) The number of units or volume of stances shall include in the inventory each finished form in each commercial the same information required of man- container (e.g., 100-tablet bottle or 3- ufacturers pursuant to paragraphs milliliter vial); and (e)(1) (iii) and (iv) of this section. Each (D) The number of commercial con- such person who is also registered as a tainers of each such finished form (e.g. manufacturer or as a distributor shall four 100-tablet bottles or six 3-milli- include in his/her inventory as an im- liter vials). porter or exporter only those stocks of (iv) For each controlled substance controlled substances that are actually not included in paragraphs (e)(1) (i), (ii) separated from his stocks as a manu- or (iii) of this section (e.g., damaged, facturer or as a distributor (e.g., in defective or impure substances await- transit or in storage for shipment). ing disposal, substances held for qual- (5) Inventories of chemical analysts. ity control purposes, or substances Each person registered or authorized to maintained for extemporaneous conduct chemical analysis with con- compoundings) the inventories shall trolled substances shall include in his include: inventory the same information re- (A) The name of the substance; quired of manufacturers pursuant to (B) The total quantity of the sub- paragraphs (e)(1) (iii) and (iv) of this stance to the nearest metric unit section as to substances which have
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been manufactured, imported, or re- any documents of transfer (e.g., in- ceived by such person. If less than 1 voices or packing slips). kilogram of any controlled substance [36 FR 7792, Apr. 24, 1971, as amended at 36 (other than a hallucinogenic controlled FR 13386, July 21, 1971. Redesignated at 38 FR substance listed in Schedule I), or less 26609, Sept. 24, 1973, as amended at 62 FR than 20 grams of a hallucinogenic sub- 13960, Mar. 24, 1997] stance listed in Schedule I (other than lysergic acid diethylamide), or less § 1304.22 Records for manufacturers, than 0.5 gram of lysergic acid distributors, dispensers, research- diethylamide, is on hand at the time of ers, importers and exporters. inventory, that substance need not be Each person registered or authorized included in the inventory. Laboratories (by § 1301.13(e) or §§ 1307.11–1307.13 of of the Administration may possess up this chapter) to manufacture, dis- to 150 grams of any hallucinogenic sub- tribute, dispense, import, export or stance in Schedule I without regard to conduct research with controlled sub- a need for an inventory of those sub- stances shall maintain records with the stances. No inventory is required of information listed below. known or suspected controlled sub- (a) Records for manufacturers. Each stances received as evidentiary mate- person registered or authorized to man- rials for analysis. ufacture controlled substances shall [62 FR 13959, Mar. 24, 1997] maintain records with the following in- formation: CONTINUING RECORDS (1) For each controlled substance in bulk form to be used in, or capable of § 1304.21 General requirements for use in, or being used in, the manufac- continuing records. ture of the same or other controlled or (a) Every registrant required to keep noncontrolled substances in finished records pursuant to § 1304.03 shall main- form, tain on a current basis a complete and (i) The name of the substance; accurate record of each such substance (ii) The quantity manufactured in manufactured, imported, received, bulk form by the registrant, including sold, delivered, exported, or otherwise the date, quantity and batch or other disposed of by him/her, except that no identifying number of each batch man- registrant shall be required to main- ufactured; tain a perpetual inventory. (iii) The quantity received from (b) Separate records shall be main- other persons, including the date and tained by a registrant for each reg- quantity of each receipt and the name, istered location except as provided in address, and registration number of the § 1304.04 (a). In the event controlled other person from whom the substance substances are in the possession or was received; under the control of a registrant at a (iv) The quantity imported directly location for which he is not registered, by the registrant (under a registration the substances shall be included in the as an importer) for use in manufacture records of the registered location to by him/her, including the date, quan- which they are subject to control or to tity, and import permit or declaration which the person possessing the sub- number for each importation; stance is responsible. (v) The quantity used to manufacture (c) Separate records shall be main- the same substance in finished form, tained by a registrant for each inde- including: pendent activity for which he/she is (A) The date and batch or other iden- registered, except as provided in tifying number of each manufacture; § 1304.22(d). (B) The quantity used in the manu- (d) In recording dates of receipt, im- facture; portation, distribution, exportation, or (C) The finished form (e.g., 10-milli- other transfers, the date on which the gram tablets or 10-milligram con- controlled substances are actually re- centration per fluid ounce or milli- ceived, imported, distributed, exported, liter); or otherwise transferred shall be used (D) The number of units of finished as the date of receipt or distribution of form manufactured;
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(E) The quantity used in quality con- manufactured from bulk form by the trol; registrant, including the information (F) The quantity lost during manu- required pursuant to paragraph facturing and the causes therefore, if (a)(1)(v) of this section; known; (iv) The number of units of finished (G) The total quantity of the sub- forms and/or commercial containers stance contained in the finished form; acquired from other persons, including (H) The theoretical and actual yields; the date of and number of units and/or and commercial containers in each acquisi- (I) Such other information as is nec- tion to inventory and the name, ad- essary to account for all controlled dress, and registration number of the substances used in the manufacturing person from whom the units were ac- process; quired; (vi) The quantity used to manufac- (v) The number of units of finished ture other controlled and noncon- forms and/or commercial containers trolled substances, including the name imported directly by the person (under of each substance manufactured and a registration or authorization to im- the information required in paragraph port), including the date of, the num- (a)(1)(v) of this section; ber of units and/or commercial con- (vii) The quantity distributed in bulk tainers in, and the import permit or form to other persons, including the declaration number for, each importa- date and quantity of each distribution tion; and the name, address, and registration (vi) The number of units and/or com- number of each person to whom a dis- mercial containers manufactured by tribution was made; the registrant from units in finished (viii) The quantity exported directly form received from others or imported, by the registrant (under a registration including: as an exporter), including the date, (A) The date and batch or other iden- quantity, and export permit or declara- tifying number of each manufacture; tion number of each exportation; (B) The operation performed (e.g., re- (ix) The quantity distributed or dis- packaging or relabeling); posed of in any other manner by the (C) The number of units of finished registrant (e.g., by distribution of com- form used in the manufacture, the plimentary samples or by destruction), number manufactured and the number including the date and manner of dis- lost during manufacture, with the tribution or disposal, the name, ad- causes for such losses, if known; and dress, and registration number of the (D) Such other information as is nec- person to whom distributed, and the essary to account for all controlled quantity distributed or disposed; and substances used in the manufacturing (x) The originals of all written cer- process; tifications of available procurement (vii) The number of commercial con- quotas submitted by other persons (as tainers distributed to other persons, in- required by § 1303.12(f) of this chapter) cluding the date of and number of con- relating to each order requiring the tainers in each reduction from inven- distribution of a basic class of con- tory, and the name, address, and reg- trolled substance listed in Schedule I istration number of the person to or II. whom the containers were distributed; (2) For each controlled substance in (viii) The number of commercial con- finished form, tainers exported directly by the reg- (i) The name of the substance; istrant (under a registration as an ex- (ii) Each finished form (e.g., 10-milli- porter), including the date, number of gram tablet or 10-milligram concentra- containers and export permit or dec- tion per fluid ounce or milliliter) and laration number for each exportation; the number of units or volume of fin- and ished form in each commercial con- (ix) The number of units of finished tainer (e.g., 100-tablet bottle or 3-milli- forms and/or commercial containers liter vial); distributed or disposed of in any other (iii) The number of containers of manner by the registrant (e.g., by dis- each such commercial finished form tribution of complimentary samples or
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by destruction), including the date and § 1304.23 Records for chemical ana- manner of distribution or disposal, the lysts. name, address, and registration num- (a) Each person registered or author- ber of the person to whom distributed, ized (by § 1301.22(b) of this chapter) to and the quantity in finished form dis- conduct chemical analysis with con- tributed or disposed. trolled substances shall maintain (b) Records for distributors. Each per- records with the following information son registered or authorized to dis- (to the extent known and reasonably tribute controlled substances shall ascertainable by him) for each con- maintain records with the same infor- trolled substance: mation required of manufacturers pur- (1) The name of the substance; suant to paragraphs (a)(2) (i), (ii), (iv), (2) The form or forms in which the (v), (vii), (viii) and (ix) of this section. substance is received, imported, or (c) Records for dispensers and research- manufactured by the registrant (e.g., Each person registered or author- ers. powder, granulation, tablet, capsule, or ized to dispense or conduct research solution) and the concentration of the with controlled substances shall main- substance in such form (e.g., C.P., tain records with the same information U.S.P., N.F., 10-milligram tablet or 10- required of manufacturers pursuant to milligram concentration per milli- paragraph (a)(2) (i), (ii), (iv), (vii), and liter); (ix) of this section. In addition, records (3) The total number of the forms re- shall be maintained of the number of ceived, imported or manufactured (e.g., units or volume of such finished form 100 tablets, thirty 1-milliliter vials, or dispensed, including the name and ad- 10 grams of powder), including the date dress of the person to whom it was dis- and quantity of each receipt, importa- pensed, the date of dispensing, the number of units or volume dispensed, tion, or manufacture and the name, ad- and the written or typewritten name or dress, and registration number, if any, initials of the individual who dispensed of the person from whom the substance or administered the substance on be- was received; half of the dispenser. (4) The quantity distributed, ex- (d) Records for importers and exporters. ported, or destroyed in any manner by Each person registered or authorized to the registrant (except quantities used import or export controlled substances in chemical analysis or other labora- shall maintain records with the same tory work), including the date and information required of manufacturers manner of distribution, exportation, or pursuant to paragraphs (a)(2) (i), (iv), destruction, and the name, address, (v) and (vii) of this section. In addition, and registration number, if any, of the quantity disposed of in any other each person to whom the substance was manner by the registrant (except quan- distributed or exported. tities used in manufacturing by an im- (b) Records of controlled substances porter under a registration as a manu- used in chemical analysis or other lab- facturer), which quantities are to be re- oratory work are not required. corded pursuant to paragraphs (a)(1) (c) Records relating to known or sus- (iv) and (v) of this section; and the pected controlled substances received quantity (or number of units or volume as evidentiary material for analysis are in finished form) exported, including not required under paragraph (a) of the date, quantity (or number of units this section. or volume), and the export permit or [36 FR 7793, Apr. 24, 1971, as amended at 36 declaration number for each expor- FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, tation, but excluding all quantities 1971. Redesignated at 38 FR 26609, Sept. 24, (and number of units and volumes) 1973, and further redesignated at 62 FR 13961, manufactured by an exporter under a Mar. 24, 1997] registration as a manufacturer, which § 1304.24 Records for maintenance quantities (and numbers of units and treatment programs and detoxifica- volumes) are to be recorded pursuant tion treatment programs. to paragraphs (a)(1)(xiii) or (a)(2)(xiii) (a) Each person registered or author- of this section. ized (by § 1301.22 of this chapter) to [62 FR 13960, Mar. 24, 1997] maintain and/or detoxify controlled
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substance users in a narcotic treat- (3) The quantity received from other ment program shall maintain records persons, including the date and quan- with the following information for each tity of each receipt and the name, ad- narcotic controlled substance: dress and registration number of the (1) Name of substance; other person from whom the substance (2) Strength of substance; was received; (3) Dosage form; (4) The quantity imported directly by (4) Date dispensed; the registrant (under a registration as (5) Adequate identification of patient an importer) for use in compounding by (consumer); him, including the date, quantity and (6) Amount consumed; import permit or declaration number (7) Amount and dosage form taken of each importation; home by patient; and (5) The quantity used to compound (8) Dispenser’s initials. the same substance in finished form, (b) The records required by paragraph including: (a) of this section will be maintained in (i) The date and batch or other iden- a dispensing log at the narcotic treat- tifying number of each compounding; ment program site and will be main- (ii) The quantity used in the com- tained in compliance with § 1304.22 pound; without reference to § 1304.03. (iii) The finished form (e.g., 10-milli- (c) All sites which compound a bulk gram tablets or 10-milligram con- narcotic solution from bulk narcotic centration per fluid ounce or milliliter; powder to liquid for on-site use must (iv) The number of units of finished keep a separate batch record of the form compounded; compounding. (v) The quantity used in quality con- (d) Records of identity, diagnosis, trol; prognosis, or treatment of any patients (vi) The quantity lost during which are maintained in connection compounding and the causes therefore, with the performance of a narcotic if known; treatment program shall be confiden- (vii) The total quantity of the sub- tial, except that such records may be stance contained in the finished form; disclosed for purposes and under the (viii) The theoretical and actual circumstances authorized by part 310 yields; and and 42 CFR part 2. (ix) Such other information as is nec- [39 FR 37985, Oct. 25, 1974. Redesignated and essary to account for all controlled amended at 62 FR 13961, Mar. 24, 1997] substances used in the compounding process; § 1304.25 Records for treatment pro- (6) The quantity used to manufacture grams which compound narcotics other controlled and non-controlled for treatment programs and other substances; including the name of each locations. substance manufactured and the infor- Each person registered or authorized mation required in paragraph (a)(5) of by § 1301.22 of this chapter to compound this section; narcotic drugs for off-site use in a nar- (7) The quantity distributed in bulk cotic treatment program shall main- form to other programs, including the tain records which include the fol- date and quantity of each distribution lowing information for each narcotic and the name, address and registration drug: number of each program to whom a dis- (a) For each narcotic controlled sub- tribution was made; stance in bulk form to be used in, or (8) The quantity exported directly by capable of use in, or being used in, the the registrant (under a registration as compounding of the same or other non- an exporter), including the date, quan- controlled substances in finished form: tity, and export permit or declaration (1) The name of the substance; number of each exploration; and (2) The quantity compounded in bulk (9) The quantity disposed of by de- form by the registrant, including the struction, including the reason, date date, quantity and batch or other iden- and manner of destruction. All other tifying number of each batch com- destruction of narcotic controlled sub- pounded; stances will comply with § 1307.22.
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(b) For each narcotic controlled sub- istrant (under a registration as an ex- stance in finished form: porter), including the date, number of (1) The name of the substance; containers and export permit or dec- (2) Each finished form (e.g., 10-milli- laration number for each exportation; gram tablet or 10 milligram concentra- and tion per fluid ounce or milliliter) and (9) The number of units of finished the number of units or volume or fin- forms and/or commercial containers ished form in each commercial con- destroyed in any manner by the reg- tainer (e.g., 100-tablet bottle or 3-milli- istrant, including the reason, the date liter vial); and manner of destruction. All other (3) The number of containers of each destruction of narcotic controlled sub- such commercial finished form com- stances will comply with § 1307.22. pounded from bulk form by the reg- istrant, including the information re- [39 FR 37985, Oct. 25, 1974. Redesignated at 62 FR 13961, Mar. 24, 1997] quired pursuant to paragraph (a)(5) of this section; REPORTS (4) The number of units of finished forms and/or commercial containers re- § 1304.31 Reports from manufacturers ceived from other persons, including importing narcotic raw material. the date of and number of units and/or (a) Every manufacturer which im- commercial containers in each receipt ports or manufactures from narcotic and the name, address and registration raw material (opium, poppy straw, and number of the person from whom the concentrate of poppy straw) shall sub- units were received; mit information which accounts for the (5) The number of units of finished importation and for all manufacturing forms and/or commercial containers operations performed between importa- imported directly by the person (under tion and the production in bulk or fin- a registration or authorization to im- ished marketable products, standard- port), including the date of, the num- ized in accordance with the U.S. Phar- ber of units and/or commercial con- macopeia, National Formulary or other tainers in, and the import permit or recognized medical standards. Reports declaration number for, each importa- shall be signed by the authorized offi- tion; cial and submitted quarterly on com- (6) The number of units and/or com- pany letterhead to the Drug Enforce- mercial containers compounded by the ment Administration, Drug and Chem- registrant from units in finished form ical Evaluation Section, Washington, received from others or imported, in- D.C. 20537, on or before the 15th day of cluding: the month immediately following the (i) The date and batch or other iden- period for which it is submitted. tifying number of each compounding; (b) The following information shall (ii) The operation performed (e.g., re- be submitted for each type of narcotic packaging or relabeling); raw material (quantities are expressed (iii) The number of units of finished as grams of anhydrous morphine alka- form used in the compound, the num- loid): ber compounded and the number lost during compounding, with the causes (1) Beginning inventory; for such losses, if known; and (2) Gains on reweighing; (iv) Such other information as is nec- (3) Imports; essary to account for all controlled (4) Other receipts; substances used in the compounding (5) Quantity put into process; process; (6) Losses on reweighing; (7) The number of containers distrib- (7) Other dispositions and uted to other programs, including the (8) Ending inventory. date, the number of containers in each (c) The following information shall distribution, and the name, address and be submitted for each narcotic raw ma- registration number of the program to terial derivative including morphine, whom the containers were distributed; codeine, thebaine, oxycodone, (8) The number of commercial con- hydrocodone, medicinal opium, manu- tainers exported directly by the reg- facturing opium, crude alkaloids and
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other derivatives (quantities are ex- rather as end-product in-process inven- pressed as grams of anhydrous base or tories. anhydrous morphine alkaloid for man- [62 FR 13961, Mar. 24, 1997] ufacturing opium and medicinal opium): § 1304.32 Reports of manufacturers im- (1) Beginning inventory; porting coca leaves. (2) Gains on reweighing; (a) Every manufacturer importing or (3) Quantity extracted from narcotic manufacturing from raw coca leaves raw material; shall submit information accounting (4) Quantity produced/manufactured/ for the importation and for all manu- synthesized; facturing operations performed be- (5) Quantity sold; tween the importation and the manu- (6) Quantity returned to conversion facture of bulk or finished products processes for reworking; standardized in accordance with U.S. (7) Quantity used for conversion; Pharmacopoeia, National Formulary, (8) Quantity placed in process; or other recognized standards. The re- (9) Other dispositions; ports shall be submitted quarterly on (10) Losses on reweighing and company letterhead to the Drug En- forcement Administration, Drug and (11) Ending inventory. Chemical Evaluation Section, Wash- (d) The following information shall ington, DC 20537, on or before the 15th be submitted for importation of each day of the month immediately fol- narcotic raw material: lowing the period for which it is sub- (1) Import permit number; mitted. (2) Date shipment arrived at the (b) The following information shall United States port of entry; be submitted for raw coca leaf, ecgo- (3) Actual quantity shipped; nine, ecgonine for conversion or fur- (4) Assay (percent) of morphine, co- ther manufacture, benzoylecgonine, deine and thebaine and manufacturing coca extracts (list for (5) Quantity shipped, expressed as an- tinctures and extracts; and others sep- hydrous morphine alkaloid. arately), other crude alkaloids and (e) Upon importation of crude opium, other derivatives (quantities should be samples will be selected and assays reported as grams of actual quantity made by the importing manufacturer involved and the cocaine alkaloid con- in the manner and according to the tent or equivalency): method specified in the U.S. Pharma- (1) Beginning inventory; copoeia. Where final assay data is not (2) Imports; determined at the time of rendering re- (3) Gains on reweighing; port, the report shall be made on the (4) Quantity purchased; basis of the best data available, subject (5) Quantity produced; to adjustment, and the necessary ad- (6) Other receipts; justing entries shall be made on the (7) Quantity returned to processes for next report. reworking; (f) Where factory procedure is such (8) Material used in purification for that partial withdrawals of opium are sale; made from individual containers, there (9) Material used for manufacture or shall be attached to each container a production; stock record card on which shall be (10) Losses on reweighing; kept a complete record of all with- (11) Material used for conversion; drawals therefrom. (12) Other dispositions and (g) All in-process inventories should (13) Ending inventory. be expressed in terms of end-products (c) The following information shall and not precursors. Once precursor ma- be submitted for importation of coca terial has been changed or placed into leaves: process for the manufacture of a speci- (1) Import permit number; fied end-product, it must no longer be (2) Date the shipment arrived at the accounted for as precursor stocks United States port of entry; available for conversion or use, but (3) Actual quantity shipped;
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(4) Assay (percent) of cocaine alka- trolled substance on hand as of the loid and close of business on December 31 of (5) Total cocaine alkaloid content. each year, indicating whether the sub- (d) Upon importation of coca leaves, stance is in storage or in process of samples will be selected and assays manufacturing. These reports shall be made by the importing manufacturer filed not later than January 15 of the in accordance with recognized chem- following year. Manufacturing trans- ical procedures. These assays shall action reports shall be filed annually form the basis of accounting for such for each calendar year not later than coca leaves, which shall be accounted January 15 of the following year, ex- for in terms of their cocaine alkaloid cept that a registrant may be given content or equivalency or their total permission to file more frequently (but anhydrous coca alkaloid content. not more frequently than quarterly). Where final assay data is not deter- (c) Persons reporting. For controlled mined at the time of submission, the substances in Schedules I, II or nar- report shall be made on the basis of the cotic controlled substances in Schedule best data available, subject to adjust- III, each person who is registered to ment, and the necessary adjusting en- manufacture in bulk or dosage form, or tries shall be made on the next report. to package, repackage, label or relabel, (e) Where factory procedure is such and each person who is registered to that partial withdrawals of medicinal distribute shall report acquisition/dis- coca leaves are made from individual tribution transactions. In addition to containers, there shall be attached to reporting acquisition/distribution the container a stock record card on transactions, each person who is reg- which shall be kept a complete record istered to manufacture controlled sub- of withdrawals therefrom. stances in bulk or dosage form shall re- (f) All in-process inventories should port manufacturing transactions on be expressed in terms of end-products controlled substances in Schedules I and not precursors. Once precursor ma- and II, each narcotic controlled sub- terial has been changed or placed into stance listed in Schedules III, IV, and process for the manufacture of a speci- V, and on each psychotropic controlled fied end-product, it must no longer be substance listed in Schedules III and IV accounted for as precursor stocks as identified in paragraph (d) of this available for conversion or use, but section. rather as end-product in-process inven- (d) Substances covered. (1) Manufac- tories. turing and acquisition/distribution [62 FR 13962, Mar. 24, 1997] transaction reports shall include data on each controlled substance listed in § 1304.33 Reports to ARCOS. Schedules I and II and on each narcotic (a) Reports generally. All reports re- controlled substance listed in Schedule quired by this section shall be filed III (but not on any material, com- with the ARCOS Unit, PO 28293, Cen- pound, mixture or preparation con- tral Station, Washington, DC 20005 on taining a quantity of a substance hav- DEA Form 333, or on media which con- ing a stimulant effect on the central tains the data required by DEA Form nervous system, which material, com- 333 and which is acceptable to the pound, mixture or preparation is listed ARCOS Unit. in Schedule III or on any narcotic con- (b) Frequency of reports. Acquisition/ trolled substance listed in Schedule V). Distribution transaction reports shall Additionally, reports on manufacturing be filed every quarter not later than transactions shall include the fol- the 15th day of the month succeeding lowing psychotropic controlled sub- the quarter for which it is submitted; stances listed in Schedules III and IV: except that a registrant may be given (i) Schedule III permission to file more frequently (but (A) Benzphetamine; not more frequently than monthly), de- (B) Cyclobarbital; pending on the number of transactions (C) Methyprylon; and being reported each time by that reg- (D) Phendimetrazine. istrant. Inventories shall provide data (ii) Schedule IV on the stocks of each reported con- (A) Barbital;
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(B) Diethylpropion (Amfepramone); 1305.06 Procedure for executing order forms. (C) Ethchlorvynol; 1305.07 Power of attorney. (D) Ethinamate; 1305.08 Persons entitled to fill order forms. (E) Lefetamine (SPA); 1305.09 Procedure for filling order forms. (F) Mazindol; 1305.10 Procedure for endorsing order forms. 1305.11 Unaccepted and defective order (G) Meprobamate; forms. (H) Methylphenobarbital; 1305.12 Lost and stolen order forms. (I) Phenobarbital; 1305.13 Preservation of order forms. (J) Phentermine; and 1305.14 Return of unused order forms. (K) Pipradrol. 1305.15 Cancellation and voiding of order (2) Data shall be presented in such a forms. manner as to identify the particular 1305.16 Special procedure for filling certain form, strength, and trade name, if any, order forms. of the product containing the con- AUTHORITY: 21 U.S.C. 821, 828, 871(b), unless trolled substance for which the report otherwise noted. is being made. For this purpose, per- SOURCE: 36 FR 7796, Apr. 24, 1971, unless sons filing reports shall utilize the Na- otherwise noted. Redesignated at 38 FR 26609, tional Drug Code Number assigned to Sept. 24, 1973. the product under the National Drug Code System of the Food and Drug Ad- § 1305.01 Scope of part 1305. ministration. Procedures governing the issuance, (e) Transactions reported. Acquisition/ use, and preservation of order forms distribution transaction reports shall pursuant to section 1308 of the Act (21 provide data on each acquisition to in- U.S.C. 828) are set forth generally by ventory (identifying whether it is, e.g., that section and specifically by the by purchase or transfer, return from a sections of this part. customer, or supply by the Federal Government) and each reduction from § 1305.02 Definitions. inventory (identifying whether it is, Any term contained in this part shall e.g., by sale or transfer, theft, destruc- have the definition set forth in section tion or seizure by Government agen- 102 of the Act (21 U.S.C. 802) or part cies). Manufacturing reports shall pro- 1300 of this chapter. vide data on material manufactured, manufacture from other material, use [62 FR 13963, Mar. 24, 1997] in manufacturing other material and use in producing dosage forms. § 1305.03 Distributions requiring order (f) Exceptions. A registered institu- forms. tional practitioner who repackages or An order form (DEA Form 222) is re- relabels exclusively for distribution or quired for each distribution of a Sched- who distributes exclusively to (for dis- ule I or II controlled substance except pensing by) agents, employees, or af- to persons exempted from registration filiated institutional practitioners of under part 1301 of this chapter; which the registrant may be exempted from are exported from the United States in filing reports under this section by ap- conformity with the Act; or for deliv- plying to the ARCOS Unit of the Ad- ery to a registered analytical labora- ministration. tory, or its agent approved by DEA. (Approved by the Office of Management and [62 FR 13963, Mar. 24, 1997] Budget under control number 1117–0003) § 1305.04 Persons entitled to obtain [62 FR 13962, Mar. 24, 1997] and execute order forms. (a) Order forms may be obtained only PART 1305—ORDER FORMS by persons who are registered under section 303 of the Act (21 U.S.C. 823) to Sec. handle controlled substances listed in 1305.01 Scope of part 1305. Schedules I and II, and by persons who 1305.02 Definitions. 1305.03 Distributions requiring order forms. are registered under section 1008 of the 1305.04 Persons entitled to obtain and exe- Act (21 U.S.C. 958) to export such sub- cute order forms. stances. Persons not registered to han- 1305.05 Procedure for obtaining order forms. dle controlled substances listed in
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Schedule I or II and persons registered the same person who signed the most only to import controlled substances recent application for registration or listed in any schedule are not entitled for reregistration, or by any person au- to obtain order forms. thorized to obtain and execute order (b) An order form may be executed forms by a power of attorney pursuant only on behalf of the registrant named to § 1305.07. thereon and only if his/her registration (d) Order forms will be serially num- as to the substances being purchased bered and issued with the name, ad- has not expired or been revoked or sus- dress and registration number of the pended. registrant, the authorized activity and [36 FR 7796, Apr. 24, 1971. Redesignated at 38 schedules of the registrant. This infor- FR 26609, Sept. 24, 1973, as amended at 62 FR mation cannot be altered or changed 13964, Mar. 24, 1997] by the registrant; any errors must be corrected by the Registration Unit of § 1305.05 Procedure for obtaining the Administration by returning the order forms. forms with notification of the error. (a) Order Forms are issued in mailing [36 FR 7796, Apr. 24, 1971, as amended at 36 envelopes containing either seven or FR 18732, Sept. 21, 1971. Redesignated at 38 fourteen forms, each form containing FR 26609, Sept. 24, 1973, and amended at 51 an original duplicate and triplicate FR 5319, Feb. 13, 1986; 53 FR 4963, Feb. 19, copy (respectively, Copy 1, Copy 2, and 1988; 62 FR 13964, Mar. 24, 1997] Copy 3). A limit, which is based on the business activity of the registrant, will § 1305.06 Procedure for executing be imposed on the number of order order forms. forms which will be furnished on any (a) Order forms shall be prepared and requisition unless additional forms are executed by the purchaser simulta- specifically requested and a reasonable neously in triplicate by means of need for such additional forms is interleaved carbon sheets which are shown. part of the DEA Form 222. Order forms (b) Any person applying for a reg- shall be prepared by use of a type- istration which would entitle him/her writer, pen, or indelible pencil. to obtain order forms may requisition (b) Only one item shall be entered on such forms by so indicating on the ap- each numbered line. An item shall con- plication form; order forms will be sup- sist of one or more commercial or bulk plied upon the registration of the appli- containers of the same finished or bulk cant. Any person holding a registration form and quantity of the same sub- entitling him/her to obtain order forms stance. The number of lines completed may requisition such forms for the shall be noted on that form at the bot- first time by contacting any Division tom of the form, in the space provided. Office or the Registration Unit of the Order forms for carfentanil, etorphine Administration. Any person already hydrochloride, and diprenorphine shall holding order forms may requisition contain only these substances. additional forms on DEA Form 222a (c) The name and address of the sup- which is mailed to a registrant ap- plier from whom the controlled sub- proximately 30 days after each ship- stances are being ordered shall be en- ment of order forms to that registrant tered on the form. Only one supplier or by contacting any Division Office or may be listed on any form. the Registration Unit of the Adminis- (d) Each order form shall be signed tration. All requisition forms (DEA and dated by a person authorized to Form 222a) shall be submitted to the sign an application for registration. Registration Unit, Drug Enforcement The name of the purchaser, if different Administration, Department of Jus- from the individual signing the order tice, Post Office Box 28083, Central Sta- form, shall also be inserted in the sig- tion, Washington, DC 20005. nature space. Unexecuted order forms (c) Each requisition shall show the may be kept and may be executed at a name, address, and registration num- location other than the registered loca- ber of the registrant and the number of tion printed on the form, provided that books of order forms desired. Each req- all unexecuted forms are delivered uisition shall be signed and dated by promptly to the registered location
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upon an inspection of such location by said attorney shall lawfully do or cause to be any officer authorized to make inspec- done by virtue hereof. tions, or to enforce, any Federal, State, llllllllllllllllllllllll or local law regarding controlled sub- (Signature of person granting power) stances. I, lllll (name of attorney-in-fact), [62 FR 13963, Mar. 24, 1997] hereby affirm that I am the person named herein as attorney-in-fact and that the sig- § 1305.07 Power of attorney. nature affixed hereto is my signature. Any purchaser may authorize one or llllllllllllllllllllllll more individuals, whether or not lo- (Signature of attorney-in-fact) cated at the registered location of the Witnesses: purchaser, to obtain and execute order 1. lllll. forms on his/her behalf by executing a 2. lllll. power of attorney for each such indi- Signed and dated on the lll day of vidual. The power of attorney shall be lllll, (year), at lllll. signed by the same person who signed Notice of Revocation the most recent application for reg- istration or reregistration and by the The foregoing power of attorney is hereby individual being authorized to obtain revoked by the undersigned, who is author- and execute order forms. The power of ized to sign the current application for reg- attorney shall be filed with the exe- istration of the above-named registrant cuted order forms of the purchaser, and under the Controlled Substances Act of the shall be retained for the same period as Controlled Substances Import and Export Act. Written notice of this revocation has any order form bearing the signature of been given to the attorney-in-fact lllll the attorney. The power of attorney this same day. shall be available for inspection to- gether with other order form records. llllllllllllllllllllllll Any power of attorney may be revoked (Signature of person revoking power) at any time by executing a notice of Witnesses: revocation, signed by the person who 1. lllll. signed (or was authorized to sign) the 2. lllll. Signed and dated on the day of power of attorney or by a successor, lll lllll, (year), at lllll. whoever signed the most recent appli- cation for registration or reregistra- [62 FR 13963, Mar. 24, 1997] tion, and filing it with the power of at- torney being revoked. The form for the § 1305.08 Persons entitled to fill order power of attorney and notice of revoca- forms. tion shall be similar to the following: An order form may be filled only by a person registered as a manufacturer Power of Attorney for DEA Order Forms or distributor of controlled substances lllll (Name of registrant) listed in Schedule I or II under section lllll (Address of registrant) 303 of the Act (21 U.S.C. 823) or as an lllll (DEA registration number) importer of such substances under sec- I, lllll (name of person granting power), the undersigned, who is authorized tion 1008 of the Act (21 U.S.C. 958), ex- to sign the current application for registra- cept for the following: tion of the above-named registrant under the (a) A person registered to dispense Controlled Substances Act or Controlled such substances under section 303 of Substances Import and Export Act, have the Act, or to export such substances made, constituted, and appointed, and by under section 1008 of the Act, if he/she these presents, do make, constitute, and ap- point lllll (name of attorney-in-fact), is discontinuing business or if his/her my true and lawful attorney for me in my registration is expiring without rereg- name, place, and stead, to execute applica- istration, may dispose of any con- tions for books of official order forms and to trolled substances listed in Schedule I sign such order forms in requisition for or II in his/her possession pursuant to Schedule I and II controlled substances, in order forms in accordance with § 1307.14 accordance with section 308 of the Controlled Substances Act (21 U.S.C. 828) and part 1305 of this chapter; of Title 21 of the Code of Federal Regula- (b) A person who has obtained any tions. I hereby ratify and confirm all that controlled substance in Schedule I or II
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by order form may return such sub- part and the balance supplied by addi- stance, or portion thereof, to the per- tional shipments within 60 days fol- son from whom he obtained the sub- lowing the date of the order form. No stance or the manufacturer of the sub- order form shall be valid more than 60 stance pursuant to the order form of days after its execution by the pur- the latter person; chaser, except as specified in paragraph (c) A person registered to dispense (f) of this section. such substances may distribute such (c) The controlled substances shall substances to another dispenser pursu- only be shipped to the purchaser and at ant to, and only in the circumstances the location printed by the Adminis- described in, § 1307.11 of this chapter; tration on the order form, except as and specified in paragraph (f) of this sec- (d) A person registered or authorized tion. to conduct chemical analysis or re- (d) The supplier shall retain Copy 1 of search with controlled substances may the order form for his/her own files and distribute a controlled substance listed forward Copy 2 to the Special Agent in in Schedule I or II to another person Charge of the Drug Enforcement Ad- registered or authorized to conduct ministration in the area in which the chemical analysis, instructional activi- supplier is located. Copy 2 shall be for- ties, or research with such substances warded at the close of the month dur- pursuant to the order form of the lat- ing which the order is filled; if an order ter person, if such distribution is for is filled by partial shipments, Copy 2 the purpose of furthering such chem- shall be forwarded at the close of the ical analysis, instructional activities, month during which the final shipment or research. is made or during which the 60-day va- (e) A person registered as a lidity period expires. compounder of narcotic substances for (e) The purchaser shall record on use at off-site locations in conjunction Copy 3 of the order form the number of with a narcotic treatment program at commercial or bulk containers fur- the compounding location, who is au- nished on each item and the dates on thorized to handle Schedule II nar- which such containers are received by cotics, is authorized to fill order forms the purchaser. for distribution of narcotic drugs to (f) Order forms submitted by reg- off-site narcotic treatment programs istered procurement officers of the De- only. fense Personnel Support Center of De- fense Supply Agency for delivery to [36 FR 7796, Apr. 24, 1971, as amended at 36 FR 13386, July 21, 1971; 36 FR 18732, Sept. 21, armed services establishments within 1971; 37 FR 15921, Aug. 8, 1972. Redesignated the United States may be shipped to lo- at 38 FR 26609, Sept. 24, 1973] cations other than the location printed on the order form, and in partial ship- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1305.08, see the List of CFR ments at different times not to exceed Sections Affected, which appears in the six months from the date of the order, Finding Aids section of the printed volume as designated by the procurement offi- and on GPO Access. cer when submitting the order.
§ 1305.09 Procedure for filling order [36 FR 7796, Apr. 24, 1971, as amended at 36 forms. FR 18732, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 47 (a) The purchaser shall submit Copy 1 FR 41735, Sept. 22, 1982; 62 FR 13964, Mar. 24, and Copy 2 of the order form to the 1997] supplier, and retain Copy 3 in his own files. § 1305.10 Procedure for endorsing (b) The supplier shall fill the order, if order forms. possible and if he/she desires to do so, (a) An order form made out to any and record on Copies 1 and 2 the num- supplier who cannot fill all or a part of ber of commercial or bulk containers the order within the time limitation furnished on each item and the date on set forth in § 1305.09 may be endorsed to which such containers are shipped to another supplier for filling. The en- the purchaser. If an order cannot be dorsement shall be made only by the filled in its entirety, it may be filled in supplier to whom the order form was
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first made, shall state (in the spaces a statement containing the serial num- provided on the reverse sides of Copies ber and date of the lost form, and stat- 1 and 2 of the order form) the name and ing that the goods covered by the first address of the second supplier, and order form were not received through shall be signed by a person authorized loss of that order form. Copy 3 of the to obtain and execute order forms on second form and a copy of the state- behalf of the first supplier. The first ment shall be retained with Copy 3 of supplier may not fill any part of an the order form first executed. A copy of order on an endorsed form. The second the statement shall be attached to Cop- supplier shall fill the order, if possible ies 1 and 2 of the second order form and if he/she desires to do so, in accord- sent to the supplier. If the first order ance with § 1305.09 (b), (c), and (d), in- form is subsequently received by the cluding shipping all substances di- supplier to whom it was directed, the rectly to the purchaser. supplier shall mark upon the face (b) Distributions made on endorsed thereof ‘‘Not accepted’’ and return Cop- order forms shall be reported by the ies 1 and 2 to the purchaser, who shall second supplier in the same manner as attach it to Copy 3 and the statement. all other distributions except that (b) Whenever any used or unused where the name of the supplier is re- order forms are stolen or lost (other- quested on the reporting form, the sec- wise than in the course of trans- ond supplier shall record the name, ad- mission) by any purchaser or supplier, dress and registration number of the he/she shall immediately upon dis- first supplier. covery of such theft or loss, report the same to the Special Agent in Charge of [36 FR 7796, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR the Drug Enforcement Administration 13964, Mar. 24, 1997] in the Divisional Office responsible for the area in which the registrant is lo- § 1305.11 Unaccepted and defective cated, stating the serial number of order forms. each form stolen or lost. If the theft or (a) No order form shall be filled if it: loss includes any original order forms (1) Is not complete, legible, or prop- received from purchasers and the sup- erly prepared, executed, or endorsed; or plier is unable to state the serial num- (2) Shows any alteration, erasure, or bers of such order forms, he/she shall change of any description. report the date or approximate date of (b) If an order form cannot be filled receipt thereof and the names and ad- for any reason under this section, the dresses of the purchasers. If an entire supplier shall return Copies 1 and 2 to book of order forms is lost or stolen, the purchaser with a statement as to and the purchaser is unable to state the reason (e.g., illegible or altered). A the serial numbers of the order forms supplier may for any reason refuse to contained therein, he/she shall report, accept any order and if a supplier re- in lieu of the numbers of the forms con- fuses to accept the order, a statement tained in such book, the date or ap- that the order is not accepted shall be proximate date of issuance thereof. If sufficient for purposes of this para- any unused order form reported stolen graph. or lost is subsequently recovered or (c) When received by the purchaser, found, the Special Agent in Charge of Copies 1 and 2 of the order form and the the Drug Enforcement Administration statement shall be attached to Copy 3 in the Divisional Office responsible for and retained in the files of the pur- the area in which the registrant is lo- chaser in accordance with § 1305.13. A cated shall immediately be notified. defective order form may not be cor- [36 FR 7796, Apr. 24, 1971, as amended at 36 rected; it must be replaced by a new FR 13386, July 21, 1971. Redesignated at 38 FR order form in order for the order to be 26609, Sept. 24, 1973, and amended at 51 FR filled. 5319, Feb. 13, 1986; 62 FR 13964, Mar. 24, 1997]
§ 1305.12 Lost and stolen order forms. § 1305.13 Preservation of order forms. (a) If a purchaser ascertains that an (a) The purchaser shall retain Copy 3 unfilled order form has been lost, he of each order form which has been shall execute another in triplicate and filled. He/She shall also retain in his
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files all copies of each unaccepted or ing ‘‘canceled’’ in the space provided defective order form and each state- for number of items shipped. ment attached thereto. (b) A supplier may void part or all of (b) The supplier shall retain Copy 1 of an order on an order form by notifying each order form which he/she has filled. the purchaser in writing of such void- (c) Order forms must be maintained ing. The supplier shall indicate the separately from all other records of the voiding in the manner prescribed for registrant. Order forms are required to cancellation in paragraph (a) of this be kept available for inspection for a section. period of 2 years. If a purchaser has (c) No cancellation or voiding per- several registered locations, he/she mitted by this section shall affect in must retain Copy 3 of the executed any way contract rights of either the order forms and any attached state- purchaser or the supplier. ments or other related documents (not [36 FR 7796, Apr. 24, 1971, as amended at 36 including unexecuted order forms FR 13386, July 21, 1971. Redesignated at 38 FR which may be kept elsewhere pursuant 26609, Sept. 24, 1973] to § 1305.06(d)) at the registered loca- tion printed on the order form. § 1305.16 Special procedure for filling (d) The supplier of carfentanil certain order forms. etorphine hydrochloride and (a) The purchaser of carfentanil diprenorphine shall maintain order etorphine hydrochloride or forms for these substances separately diprenorphine shall submit copy 1 and 2 from all other order forms and records of the order form to the supplier and required to be maintained by the reg- retain copy 3 in his own files. istrant. (b) The supplier, if he/she determines [36 FR 7796, Apr. 24, 1971. Redesignated at 38 that the purchaser is a veterinarian en- FR 26609, Sept. 24, 1973, and amended at 39 gaged in zoo and exotic animal prac- FR 17839, May 21, 1974; 54 FR 33674, Aug. 16, tice, wildlife management programs 1989; 62 FR 13964, Mar. 24, 1997] and/or research and authorized by the Administrator to handle these sub- § 1305.14 Return of unused order stances shall fill the order in accord- forms. ance with the procedures set forth in If the registration of any purchaser § 1305.09 except that: terminates (because the purchaser dies, (1) Order forms for carfentanil ceases legal existence, discontinues etorphine hydrochloride and business or professional practice, or diprenorphine shall only contain these changes his name or address as shown substances in reasonable quantities on his registration) or is suspended or and revoked pursuant to § 1301.36 of this (2) The substances shall only be chapter as to all controlled substances shipped to the purchaser at the loca- listed in Schedules I and II for which tion printed by the Administration he/she is registered, he/she shall return upon the order form under secure con- all unused order forms for such sub- ditions using substantial packaging stance to the nearest office of the Ad- material with no markings on the out- ministration. side which would indicate the content. [36 FR 7796, Apr. 24, 1971, as amended at 36 [39 FR 17839, May 21, 1974, as amended at 54 FR 18732, Sept. 21, 1971. Redesignated at 38 FR 33674, Aug. 16, 1989; 62 FR 13964, Mar. 24, FR 26609, Sept. 24, 1973, as amended at 62 FR 1997] 13964, Mar. 24, 1997]
§ 1305.15 Cancellation and voiding of PART 1306—PRESCRIPTIONS order forms. GENERAL INFORMATION (a) A purchaser may cancel part or all of an order on an order form by no- Sec. tifying the supplier in writing of such 1306.01 Scope of part 1306. 1306.02 Definitions. cancellation. The supplier shall indi- 1306.03 Persons entitled to issue prescrip- cate the cancellation on Copies 1 and 2 tions. of the order form by drawing a line 1306.04 Purpose of issue of prescription. through the canceled items and print- 1306.05 Manner of issuance of prescriptions.
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1306.06 Persons entitled to fill prescriptions. ployee or agent of the individual prac- 1306.07 Administering or dispensing of nar- titioner. cotic drugs. [36 FR 7799, Apr. 24, 1971, as amended at 36 CONTROLLED SUBSTANCES LISTED IN SCHEDULE FR 18732, Sept. 21, 1971. Redesignated at 38 II FR 26609, Sept. 24, 1973, as amended at 62 FR 1306.11 Requirement of prescription. 13966, Mar. 24, 1997] 1306.12 Refilling prescriptions. 1306.13 Partial filling of prescriptions. § 1306.04 Purpose of issue of prescrip- 1306.14 Labeling of substances and filling of tion. prescriptions. (a) A prescription for a controlled CONTROLLED SUBSTANCES LISTED IN substance to be effective must be SCHEDULES III, IV, AND V issued for a legitimate medical purpose 1306.21 Requirement of prescription. by an individual practitioner acting in 1306.22 Refilling of prescriptions. the usual course of his professional 1306.23 Partial filling of prescriptions. practice. The responsibility for the 1306.24 Labeling of substances and filling of proper prescribing and dispensing of prescriptions. 1306.25 Transfer between pharmacies of controlled substances is upon the pre- presription information for Schedules III, scribing practitioner, but a cor- IV, and V controlled substances for refill responding responsibility rests with purposes. the pharmacist who fills the prescrip- 1306.26 Dispensing without prescription. tion. An order purporting to be a pre- AUTHORITY: 21 U.S.C. 821, 829, 871(b), unless scription issued not in the usual course otherwise noted. of professional treatment or in legiti- SOURCE: 36 FR 7799, Apr. 24, 1971; 36 FR mate and authorized research is not a 13386, July 21, 1971, unless otherwise noted. prescription within the meaning and Redesignated at 38 FR 26609, Sept. 24, 1973. intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly GENERAL INFORMATION filling such a purported prescription, as § 1306.01 Scope of part 1306. well as the person issuing it, shall be subject to the penalties provided for Rules governing the issuance, filling violations of the provisions of law re- and filing of prescriptions pursuant to lating to controlled substances. section 309 of the Act (21 U.S.C. 829) are (b) A prescription may not be issued set forth generally in that section and in order for an individual practitioner specifically by the sections of this part. to obtain controlled substances for sup- § 1306.02 Definitions. plying the individual practitioner for the purpose of general dispensing to pa- Any term contained in this part shall tients. have the definition set forth in section 102 of the Act (21 U.S.C. 802) or part (c) A prescription may not be issued 1300 of this chapter. for the dispensing of narcotic drugs listed in any schedule for ‘‘detoxifica- [62 FR 13964, Mar. 24, 1997] tion treatment’’ or ‘‘maintenance treatment’’ as defined in Section 102 of § 1306.03 Persons entitled to issue pre- scriptions. the Act (21 U.S.C. 802). (a) A prescription for a controlled [36 FR 7799, Apr. 24, 1971. Redesignated at 38 substance may be issued only by an in- FR 26609, Sept. 24, 1973, and amended at 39 dividual practitioner who is: FR 37986, Oct. 25, 1974] (1) authorized to prescribe controlled substances by the jurisdiction in which § 1306.05 Manner of issuance of pre- scriptions. he is licensed to practice his profession and (a) All prescriptions for controlled (2) either registered or exempted substances shall be dated as of, and from registration pursuant to signed on, the day when issued and §§ 1301.22(c) and 1301.23 of this chapter. shall bear the full name and address of (b) A prescription issued by an indi- the patient, the drug name, strength, vidual practitioner may be commu- dosage form, quantity prescribed, di- nicated to a pharmacist by an em- rections for use and the name, address
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and registration number of the practi- § 1306.06 Persons entitled to fill pre- tioner. A practitioner may sign a pre- scriptions. scription in the same manner as he A prescription for controlled sub- would sign a check or legal document stances may only be filled by a phar- (e.g., J.H. Smith or John H. Smith). macist acting in the usual course of his Where an oral order is not permitted, professional practice and either reg- prescriptions shall be written with ink istered individually or employed in a or indelible pencil or typewriter and registered pharmacy or registered in- shall be manually signed by the practi- stitutional practitioner. tioner. The prescriptions may be pre- pared by the secretary or agent for the § 1306.07 Administering or dispensing signature of a practitioner, but the pre- of narcotic drugs. scribing practitioner is responsible in (a) The administering or dispensing case the prescription does not conform directly (but not prescribing) of nar- in all essential respects to the law and cotic drugs listed in any schedule to a regulations. A corresponding liability narcotic drug dependent person for rests upon the pharmacist who fills a ‘‘detoxification treatment’’ or ‘‘main- prescription not prepared in the form tenance treatment’’ as defined in sec- prescribed by these regulations. tion 102 of the Act (21 U.S.C. 802) shall (b) An individual practitioner ex- be deemed to be within the meaning of the term ‘‘in the course of his profes- empted from registration under sional practice or research’’ in section § 1301.22(c) of this chapter shall include 308(e) and section 102(20) of the Act (21 on all prescriptions issued by him or U.S.C. 828 (e)): Provided, That the prac- her the registration number of the hos- titioner is separately registered with pital or other institution and the spe- the Attorney General as required by cial internal code number assigned to section 303(g) of the Act (21 U.S.C. him or her by the hospital or other in- 823(g)) and then thereafter complies stitution as provided in § 1301.22(c) of with the regulatory standards imposed this chapter, in lieu of the registration relative to treatment qualification, se- number of the practitioner required by curity, records and unsupervised use of this section. Each written prescription drugs pursuant to such Act. shall have the name of the physician (b) Nothing in this section shall pro- stamped, typed, or handprinted on it, hibit a physician who is not specifi- as well as the signature of the physi- cally registered to conduct a narcotic cian. treatment program from administering (c) An official exempted from reg- (but not prescribing) narcotic drugs to istration under § 1301.22(c) shall include a person for the purpose of relieving on all prescriptions issued by him his acute withdrawal symptoms when nec- branch of service or agency (e.g., ‘‘U.S. essary while arrangements are being Army’’ or ‘‘Public Health Service’’) and made for referral for treatment. Not his service identification number, in more than one day’s medication may lieu of the registration number of the be administered to the person or for the person’s use at one time. Such practitioner required by this section. emergency treatment may be carried The service identification number for a out for not more than three days and Public Health Service employee is his may not be renewed or extended. Social Security identification number. (c) This section is not intended to im- Each prescription shall have the name pose any limitations on a physician or of the officer stamped, typed, or authorized hospital staff to administer handprinted on it, as well as the signa- or dispense narcotic drugs in a hospital ture of the officer. to maintain or detoxify a person as an [36 FR 7799, Apr. 24, 1971, as amended at 36 incidental adjunct to medical or sur- FR 18733, Sept. 21, 1971. Redesignated at 38 gical treatment of conditions other FR 26609, Sept. 24, 1973, and amended at 56 than addiction, or to administer or dis- FR 25026, June 3, 1991; 60 FR 36641, July 18, pense narcotic drugs to persons with 1995; 62 FR 13966, Mar. 24, 1997] intractable pain in which no relief or
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cure is possible or none has been found (2) The prescription shall be imme- after reasonable efforts. diately reduced to writing by the phar- macist and shall contain all informa- [39 FR 37986, Oct. 25, 1974] tion required in § 1306.05, except for the CONTROLLED SUBSTANCES LISTED IN signature of the prescribing individual SCHEDULE II practitioner; (3) If the prescribing individual prac- § 1306.11 Requirement of prescription. titioner is not known to the phar- (a) A pharmacist may dispense di- macist, he must make a reasonable ef- rectly a controlled substance listed in fort to determine that the oral author- Schedule II, which is a prescription ization came from a registered indi- drug as determined under the Federal vidual practitioner, which may include Food, Drug, and Cosmetic Act, only a callback to the prescribing individual pursuant to a written prescription practitioner using his phone number as signed by the practitioner, except as listed in the telephone directory and/or provided in paragraph (d) of this sec- other good faith efforts to insure his tion. A prescription for a Schedule II identity; and controlled substance may be trans- (4) Within 7 days after authorizing an mitted by the practitioner or the prac- emergency oral prescription, the pre- titioner’s agent to a pharmacy via fac- scribing individual practitioner shall simile equipment, provided that the cause a written prescription for the original written, signed prescription is emergency quantity prescribed to be presented to the pharmacist for review delivered to the dispensing pharmacist. prior to the actual dispensing of the In addition to conforming to the re- controlled substance, except as noted quirements of § 1306.05, the prescription in paragraph (e), (f), or (g) of this sec- shall have written on its face ‘‘Author- tion. The original prescription shall be ization for Emergency Dispensing,’’ maintained in accordance with and the date of the oral order. The § 1304.04(h) of this chapter. written prescription may be delivered (b) An individual practitioner may to the pharmacist in person or by mail, administer or dispense directly a con- but if delivered by mail it must be trolled substance listed in Schedule II postmarked within the 7 day period. in the course of his professional prac- Upon receipt, the dispensing phar- tice without a prescription, subject to macist shall attach this prescription to § 1306.07. the oral emergency prescription which (c) An institutional practitioner may had earlier been reduced to writing. administer or dispense directly (but The pharmacist shall notify the near- not prescribe) a controlled substance est office of the Administration if the listed in Schedule II only pursuant to a prescribing individual practitioner written prescription signed by the pre- fails to deliver a written prescription scribing individual practitioner or to to him; failure of the pharmacist to do an order for medication made by an in- so shall void the authority conferred dividual practitioner which is dis- by this paragraph to dispense without pensed for immediate administration a written prescription of a prescribing to the ultimate user. individual practitioner. (d) In the case of an emergency situa- (e) A prescription prepared in accord- tion, as defined by the Secretary in ance with § 1306.05 written for a Sched- § 290.10 of this title, a pharmacist may ule II narcotic substance to be com- dispense a controlled substance listed pounded for the direct administration in Schedule II upon receiving oral au- to a patient by parenteral, intra- thorization of a prescribing individual venous, intramuscular, subcutaneous practitioner, provided that: or intraspinal infusion may be trans- (1) The quantity prescribed and dis- mitted by the practitioner or the prac- pensed is limited to the amount ade- titioner’s agent to the pharmacy by quate to treat the patient during the facsimile. The facsimile serves as the emergency period (dispensing beyond original written prescription for pur- the emergency period must be pursuant poses of this paragraph (e) and it shall to a written prescription signed by the be maintained in accordance with prescribing individual practitioner); § 1304.04(h) of this chapter.
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(f) A prescription prepared in accord- further quantity may be supplied be- ance with § 1306.05 written for Schedule yond 72 hours without a new prescrip- II substance for a resident of a Long tion. Term Care Facility may be trans- (b) A prescription for a Schedule II mitted by the practitioner or the prac- controlled substance written for a pa- titioner’s agent to the dispensing phar- tient in a Long Term Care Facility macy by facsimile. The facsimile (LTCF) or for a patient with a medical serves as the original written prescrip- diagnosis documenting a terminal ill- tion for purposes of this paragraph (f) ness may be filled in partial quantities and it shall be maintained in accord- to include individual dosage units. If ance with § 1304.04(h). there is any question whether a patient (g) A prescription prepared in accord- may be classified as having a terminal ance with § 1306.05 written for a Sched- illness, the pharmacist must contact ule II narcotic substance for a patient the practitioner prior to partially fill- enrolled in a hospice care program cer- ing the prescription. Both the phar- tified and/or paid for by Medicare under Title XVIII or a hospice program which macist and the prescribing practitioner is licensed by the state may be trans- have a corresponding responsibility to mitted by the practitioner or the prac- assure that the controlled substance is titioner’s agent to the dispensing phar- for a terminally ill patient. The phar- macy by facsimile. The practitioner or macist must record on the prescription the practitioner’s agent will note on whether the patient is ‘‘terminally ill’’ the prescription that the patient is a or an ‘‘LTCF patient.’’ A prescription hospice patient. The facsimile serves as that is partially filled and does not the original written prescription for contain the notation ‘‘terminally ill’’ purposes of this paragraph (g) and it or ‘‘LTCF patient’’ shall be deemed to shall be maintained in accordance with have been filled in violation of the Act. § 1304.04(h). For each partial filling, the dispensing pharmacist shall record on the back of [36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 the prescription (or on another appro- FR 26609, Sept. 24, 1973 and amended at 53 FR priate record, uniformly maintained, 4964, Feb. 19, 1988; 59 FR 26111, May 19, 1994; and readily retrievable) the date of the 59 FR 30832, June 15, 1994; 62 FR 13964, Mar. partial filling, quantity dispensed, re- 24, 1997; 65 FR 45713, July 25, 2000] maining quantity authorized to be dis- pensed, and the identification of the § 1306.12 Refilling prescriptions. dispensing pharmacist. The total quan- The refilling of a prescription for a tity of Schedule II controlled sub- controlled substance listed in Schedule stances dispensed in all partial fillings II is prohibited. must not exceed the total quantity pre- scribed. Schedule II prescriptions for § 1306.13 Partial filling of prescrip- tions. patients in a LTCF or patients with a medical diagnosis documenting a ter- (a) The partial filling of a prescrip- minal illness shall be valid for a period tion for a controlled substance listed in not to exceed 60 days from the issue Schedule II is permissible, if the phar- date unless sooner terminated by the macist is unable to supply the full discontinuance of medication. quantity called for in a written or emergency oral prescription and he (c) Information pertaining to current makes a notation of the quantity sup- Schedule II prescriptions for patients plied on the face of the written pre- in a LTCF or for patients with a med- scription (or written record of the ical diagnosis documenting a terminal emergency oral prescription). The re- illness may be maintained in a comput- maining portion of the prescription erized system if this system has the ca- may be filled within 72 hours of the pability to permit: first partial filling; however, if the re- (1) Output (display or printout) of the maining portion is not or cannot be original prescription number, date of filled within the 72-hour period, the issue, identification of prescribing indi- pharmacist shall so notify the pre- vidual practitioner, identification of scribing individual practitioner. No patient, address of the LTCF or address
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of the hospital or residence of the pa- forth the directions for use and cau- tient, identification of medication au- tionary statements, if any, contained thorized (to include dosage, form, in the prescription or required by law. strength and quantity), listing of the (c) All written prescriptions and partial fillings that have been dis- written records of emergency oral pre- pensed under each prescription and the scriptions shall be kept in accordance information required in § 1306.13(b). with requirements of § 1304.04(h) of this (2) Immediate (real time) updating of chapter. the prescription record each time a partial filling of the prescription is [36 FR 13368, July 21, 1971, as amended at 37 conducted. FR 15921, Aug. 8, 1972. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 62 FR (3) Retrieval of partially filled Sched- 13965, Mar. 24, 1997] ule II prescription information is the same as required by § 1306.22(b) (4) and CONTROLLED SUBSTANCES LISTED IN (5) for Schedule III and IV prescription SCHEDULES III, IV, AND V refill information. § 1306.21 Requirement of prescription. (Authority: 21 U.S.C. 801, et seq.) (a) A pharmacist may dispense di- [36 FR 7799, Apr. 24, 1971. Redesignated at 38 rectly a controlled substance listed in FR 26609, Sept. 24, 1973, and amended at 45 Schedule III, IV, or V which is a pre- FR 54330, July 15, 1980; 56 FR 25027, June 3, 1991; 62 FR 13965, Mar. 24, 1997] scription drug as determined under the Federal Food, Drug, and Cosmetic Act, § 1306.14 Labeling of substances and only pursuant to either a written pre- filling of prescriptions. scription signed by a practitioner or a (a) The pharmacist filling a written facsimile of a written, signed prescrip- or emergency oral prescription for a tion transmitted by the practitioner or controlled substance listed in Schedule the practitioner’s agent to the phar- II shall affix to the package a label macy or pursuant to an oral prescrip- showing date of filling, the pharmacy tion made by an individual practitioner name and address, the serial number of and promptly reduced to writing by the the prescription, the name of the pa- pharmacist containing all information tient, the name of the prescribing prac- required in § 1306.05, except for the sig- titioner, and directions for use and nature of the practitioner. cautionary statements, if any, con- (b) An individual practitioner may tained in such prescription or required administer or dispense directly a con- by law. trolled substance listed in Schedule III, (b) The requirements of paragraph (a) IV, or V in the course of his/her profes- of this section do not apply when a sional practice without a prescription, controlled substance listed in Schedule subject to § 1306.07. II is prescribed for administration to (c) An institutional practitioner may an ultimate user who is institutional- administer or dispense directly (but ized: Provided, That: not prescribe) a controlled substance (1) Not more than 7-day supply of the listed in Schedule III, IV, or V only controlled substance listed in Schedule pursuant to a written prescription II is dispensed at one time; signed by an individual practitioner, or (2) The controlled substance listed in pursuant to a facsimile of a written Schedule II is not in the possession of prescription or order for medication the ultimate user prior to the adminis- transmitted by the practitioner or the tration; practitioner’s agent to the institu- (3) The institution maintains appro- tional practitioner-pharmacist, or pur- priate safeguards and records regarding suant to an oral prescription made by the proper administration, control, dis- an individual practitioner and prompt- pensing, and storage of the controlled ly reduced to writing by the phar- substance listed in Schedule II; and macist (containing all information re- (4) The system employed by the phar- quired in Section 1306.05 except for the macist in filling a prescription is ade- signature of the individual practi- quate to identify the supplier, the tioner), or pursuant to an order for product, and the patient, and to set medication made by an individual
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practitioner which is dispensed for im- tion for any additional quantities be- mediate administration to the ulti- yond the five refill, six-month limita- mate user, subject to § 1306.07. tion. [62 FR 13965, Mar. 24, 1997] (b) As an alternative to the proce- dures provided by subsection (a), an § 1306.22 Refilling of prescriptions. automated data processing system may (a) No prescription for a controlled be used for the storage and retrieval of substance listed in Schedule III or IV refill information for prescription or- shall be filled or refilled more than six ders for controlled substances in months after the date on which such Schedule III and IV, subject to the fol- prescription was issued and no such lowing conditions: prescription authorized to be refilled (1) Any such proposed computerized may be refilled more than five times. system must provide on-line retrieval Each refilling of a prescription shall be (via CRT display or hard-copy print- entered on the back of the prescription out) of original prescription order in- or on another appropriate document. If formation for those prescription orders entered on another document, such as which are currently authorized for re- a medication record, the document filling. This shall include, but is not must be uniformly maintained and limited to, data such as the original readily retrievable. The following in- prescription number, date of issuance formation must be retrievable by the of the original prescription order by prescription number consisting of the the practitioner, full name and address name and dosage form of the controlled of the patient, name, address, and DEA substance, the date filled or refilled, registration number of the practi- the quantity dispensed, initials of the tioner, and the name, strength, dosage dispensing pharmacist for each refill, form, quantity of the controlled sub- and the total number of refills for that stance prescribed (and quantity dis- prescription. If the pharmacist merely pensed if different from the quantity initials and dates the back of the pre- prescribed), and the total number of re- scription it shall be deemed that the fills authorized by the prescribing prac- full face amount of the prescription has titioner. been dispensed. The prescribing practi- (2) Any such proposed computerized tioner may authorize additional refills system must also provide on-line re- of Schedule III or IV controlled sub- trieval (via CRT display or hard-copy stances on the original prescription printout) of the current refill history through an oral refill authorization for Schedule III or IV controlled sub- transmitted to the pharmacist pro- vided the following conditions are met: stance prescription orders (those au- (1) The total quantity authorized, in- thorized for refill during the past six cluding the amount of the original pre- months.) This refill history shall in- scription, does not exceed five refills clude, but is not limited to, the name nor extend beyond six months from the of the controlled substance, the date of date of issue of the original prescrip- refill, the quantity dispensed, the iden- tion. tification code, or name or initials of (2) The pharmacist obtaining the oral the dispensing pharmacist for each re- authorization records on the reverse of fill and the total number of refills dis- the original prescription the date, pensed to date for that prescription quantity of refill, number of additional order. refills authorized, and initials the pre- (3) Documentation of the fact that scription showing who received the au- the refill information entered into the thorization from the prescribing prac- computer each time a pharmacist re- titioner who issued the original pre- fills an original prescription order for a scription. Schedule III or IV controlled substance (3) The quantity of each additional is correct must be provided by the indi- refill authorized is equal to or less than vidual pharmacist who makes use of the quantity authorized for the initial such a system. If such a system pro- filling of the original prescription. vides a hard-copy printout of each (4) The prescribing practitioner must day’s controlled substance prescription execute a new and separate prescrip- order refill data, that printout shall be
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verified, dated, and signed by the indi- user pharmacy, it must, if requested to vidual pharmacist who refilled such a do so by the Agent or Investigator, prescription order. The individual verify the printout transmittal capa- pharmacist must verify that the data bility of its system by documentation indicated is correct and then sign this (e.g., postmark). document in the same manner as he (5) In the event that a pharmacy would sign a check or legal document which employs such a computerized (e.g., J. H. Smith, or John H. Smith). system experiences system down-time, This document shall be maintained in a the pharmacy must have an auxiliary separate file at that pharmacy for a pe- procedure which will be used for docu- riod of two years from the dispensing mentation of refills os Schedule III and date. This printout of the day’s con- IV controlled substance prescription trolled substance prescription order re- orders. This auxiliary procedure must fill data must be provided to each phar- insure that refills are authorized by macy using such a computerized sys- the original prescription order, that tem within 72 hours of the date on the maximum number of refills has not which the refill was dispensed. It must been exceeded, and that all of the ap- be verified and signed by each phar- propriate data is retained for on-line macist who is involved with such dis- data entry as soon as the computer sys- pensing. In lieu of such a printout, the tem is available for use again. pharmacy shall maintain a bound log (c) When filing refill information for book, or separate file, in which each in- original prescription orders for Sched- dividual pharmacist involved in such ule III or IV controlled substances, a dispensing shall sign a statement (in pharmacy may use only one of the two the manner previously described) each systems described in paragraphs (a) or day, attesting to the fact that the refill (b) of this section. information entered into the computer [36 FR 7799, Apr. 24, 1971; 36 FR 13386, July 21, that day has been reviewed by him and 1971. Redesignated at 38 FR 26609, Sept. 24, is correct as shown. Such a book or file 1973, and amended at 42 FR 28878, June 6, must be maintained at the pharmacy 1977; 45 FR 44266, July 1, 1980; 52 FR 3605, Feb. employing such a system for a period 5, 1987; 62 FR 13966, Mar. 24, 1997] of two years after the date of dis- pensing the appropriately authorized § 1306.23 Partial filling of prescrip- refill. tions. (4) Any such computerized system The partial filling of a prescription shall have the capability of producing a for a controlled substance listed in printout of any refill data which the Schedule III, IV, or V is permissible, user pharmacy is responsible for main- provided that: taining under the Act and its imple- (a) Each partial filling is recorded in menting regulations. For example, this the same manner as a refilling, would include a refill-by-refill audit (b) The total quantity dispensed in trail for any specified strength and dos- all partial fillings does not exceed the age form of any controlled substance total quantity prescribed, and (by either brand or generic name or (c) No dispensing occurs after 6 both). Such a printout must include months after the date on which the name of the prescribing practitioner, prescription was issued. name and address of the patient, quan- [36 FR 18733, Sept. 21, 1971. Redesignated at tity dispensed on each refill, date of 38 FR 26609, Sept. 24, 1973, and amended at 51 dispensing for each refill, name or FR 5320, Feb. 13, 1986; 62 FR 13965, Mar. 24, identification code of the dispensing 1997] pharmacist, and the number of the original prescription order. In any § 1306.24 Labeling of substances and computerized system employed by a filing of prescriptions. user pharmacy the central record- (a) The pharmacist filling a prescrip- keeping location must be capable of tion for a controlled substance listed in sending the printout to the pharmacy Schedule III, IV, or V shall affix to the within 48 hours, and if a DEA Special package a label showing the pharmacy Agent or Diversion Investigator re- name and address, the serial number quests a copy of such printout from the and date of initial filling, the name of
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the patient, the name of the practi- (i) Write the word ‘‘VOID’’ on the tioner issuing the prescription, and di- face of the invalidated prescription. rections for use and cautionary state- (ii) Record on the reverse of the in- ments, if any, contained in such pre- validated prescription the name, ad- scription as required by law. dress and DEA registration number of (b) The requirements of paragraph (a) the pharmacy to which it was trans- of this section do not apply when a ferred and the name of the pharmacist controlled substance listed in Schedule receiving the prescription information. III, IV, or V is prescribed for adminis- (iii) Record the date of the transfer tration to an ultimate user who is in- and the name of the pharmacist trans- stitutionalized: Provided, That: ferring the information. (1) Not more than a 34-day supply or (b) The pharmacist receiving the 100 dosage units, whichever is less, of transferred prescription information the controlled substance listed in shall reduce to writing the following: Schedule III, IV, or V is dispensed at (1) Write the word ‘‘transfer’’ on the one time; face of the transferred prescription. (2) The controlled substance listed in (2) Provide all information required Schedule III, IV, or V is not in the pos- to be on a prescription pursuant to 21 session of the ultimate user prior to CFR 1306.05 and include: administration; (i) Date of issuance of original pre- (3) The institution maintains appro- scription; priate safeguards and records the prop- (ii) Original number of refills author- er administration, control, dispensing, ized on original prescription; and storage of the controlled substance (iii) Date of original dispensing; listed in Schedule III, IV, or V; and (iv) Number of valid refills remaining (4) The system employed by the phar- and date(s) and locations of previous macist in filling a prescription is ade- refill(s); quate to identify the supplier, the (v) Pharmacy’s name, address, DEA product and the patient, and to set registration number and prescription forth the directions for use and cau- number from which the prescription in- tionary statements, if any, contained formation was transferred; in the prescription or required by law. (vi) Name of pharmacist who trans- (c) All prescriptions for controlled ferred the prescription. substances listed in Schedules III, IV, (vii) Pharmacy’s name, address, DEA and V shall be kept in accordance with registration number and prescription § 1304.04(h) of this chapter. number from which the prescription was originally filled; [62 FR 13965, Mar. 24, 1997] (3) The original and transferred pre- § 1306.25 Transfer between pharmacies scription(s) must be maintained for a of prescription information for period of two years from the date of Schedules III, IV, and V controlled last refill. substances for refill purposes. (c) Pharmacies electronically access- (a) The transfer of original prescrip- ing the same prescription record must tion information for a controlled sub- satisfy all information requirements of stance listed in Schedules III, IV or V a manual mode for prescription for the purpose of refill dispensing is transferral. permissible between pharmacies on a (d) The procedure allowing the trans- one time basis only. However, phar- fer of prescription information for re- macies electronically sharing a real- fill purposes is permissible only if al- time, on-line database may transfer up lowable under existing state or other to the maximum refills permitted by applicable law. law and the prescriber’s authorization. [46 FR 48919, Oct. 5, 1981. Redesignated and Transfers are subject to the following amended at 62 FR 13966, Mar. 24, 1997] requirements: (1) The transfer is communicated di- § 1306.26 Dispensing without prescrip- rectly between two licensed phar- tion. macists and the transferring phar- A controlled substance listed in macist records the following informa- Schedules II, III, IV, or V which is not tion: a prescription drug as determined
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under the Federal Food, Drug, and Cos- PART 1307—MISCELLANEOUS metic Act, may be dispensed by a phar- macist without a prescription to a pur- GENERAL INFORMATION chaser at retail, provided that: Sec. (a) Such dispensing is made only by a 1307.01 Definitions. pharmacist (as defined in part 1300 of 1307.02 Application of State law and other this chapter), and not by a nonphar- Federal law. macist employee even if under the su- 1307.03 Exceptions to regulations. pervision of a pharmacist (although after the pharmacist has fulfilled his SPECIAL EXCEPTIONS FOR MANUFACTURE AND professional and legal responsibilities DISTRIBUTION OF CONTROLLED SUBSTANCES set forth in this section, the actual 1307.11 Distribution by dispenser to another cash, credit transaction, or delivery, practitioner. may be completed by a nonphar- 1307.12 Distribution to supplier. macist); 1307.13 Incidental manufacture of controlled substances. (b) Not more than 240 cc. (8 ounces) of any such controlled substance con- DISPOSAL OF CONTROLLED SUBSTANCES taining opium, nor more than 120 cc. (4 1307.21 Procedure for disposing of controlled ounces) of any other such controlled substances. substance nor more than 48 dosage 1307.22 Disposal of controlled substances by units of any such controlled substance the Administration. containing opium, nor more than 24 SPECIAL EXEMPT PERSONS dosage units of any other such con- trolled substance may be dispensed at 1307.31 Native American Church. retail to the same purchaser in any AUTHORITY: 21 U.S.C. 821, 822(d), 871(b), un- given 48-hour period; less otherwise noted. (c) The purchaser is at least 18 years SOURCE: 36 FR 7801, Apr. 24, 1971, unless of age; otherwise noted. Redesignated at 38 FR 26609, (d) The pharmacist requires every Sept. 24, 1973. purchaser of a controlled substance under this section not known to him to GENERAL INFORMATION furnish suitable identification (includ- ing proof of age where appropriate); § 1307.01 Definitions. (e) A bound record book for dis- Any term contained in this part shall pensing of controlled substances under have the definition set forth in section this section is maintained by the phar- 102 of the Act (21 U.S.C. 802) or part macist, which book shall contain the 1300 of this chapter. name and address of the purchaser, the [62 FR 13966, Mar. 24, 1997] name and quantity of controlled sub- stance purchased, the date of each pur- § 1307.02 Application of State law and chase, and the name or initials of the other Federal law. pharmacist who dispensed the sub- Nothing in this chapter shall be con- stance to the purchaser (the book shall strued as authorizing or permitting be maintained in accordance with the any person to do any act which such recordkeeping requirement of § 1304.04 person is not authorized or permitted of this chapter); and to do under other Federal laws or obli- (f) A prescription is not required for gations under international treaties, distribution or dispensing of the sub- conventions or protocols, or under the stance pursuant to any other Federal, law of the State in which he/she desires State or local law. to do such act nor shall compliance with such parts be construed as compli- [36 FR 7799, Apr. 24, 1971, as amended at 36 ance with other Federal or State laws FR 18733, Sept. 21, 1971. Redesignated at 38 unless expressly provided in such other FR 26609, Sept. 24, 1973, and further laws. redesigated and amended at 62 FR 13966, Mar. 24, 1997] [62 FR 13966, Mar. 24, 1997]
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§ 1307.03 Exceptions to regulations. units of all controlled substances Any person may apply for an excep- which will be distributed by him pursu- tion to the application of any provision ant to this section and § 1301.25 of this of this chapter by filing a written re- chapter will exceed 5 percent of the quest stating the reasons for such ex- total number of dosage units of all con- ception. Requests shall be filed with trolled substances distributed and dis- the Administrator, Drug Enforcement pensed by him during that calendar Administration, Department of Jus- year, the practitioner shall obtain a tice, Washington, DC 20537. The Admin- registration to distribute controlled istrator may grant an exception in his substances. discretion, but in no case shall he/she be required to grant an exception to [36 FR 18733, Sept. 21, 1971. Redesignated at any person which is otherwise required 38 FR 26609, Sept. 24, 1973, and amended at 50 FR 31590, Aug. 5, 1985; 62 FR 13967, Mar. 24, by law or the regulations cited in this 1997] section. [62 FR 13966, Mar. 24, 1997] § 1307.12 Distribution to supplier. (a) Any person lawfully in possession SPECIAL EXCEPTIONS FOR MANUFACTURE of a controlled substance listed in any AND DISTRIBUTION OF CONTROLLED SUBSTANCES schedule may distribute (without being registered to distribute) that substance § 1307.11 Distribution by dispenser to to the person from whom he obtained it another practitioner. or to the manufacturer of the sub- (a) A practitioner who is registered stance, provided that a written record to dispense a controlled substance may is maintained which indicates the date distribute (without being registered to of the transaction, the name, form, and distribute) a quantity of such sub- quantity of the substance, the name, stance to another practitioner for the address, and registration number, if purpose of general dispensing by the any, of the person making the distribu- practitioner to his or its patients: Pro- tion, and the name, address, and reg- vided, That: istration number, if known, of the sup- (1) The practitioner to whom the con- plier or manufacturer. In the case of trolled substance is to be distributed is returning a controlled substance in registered under the Act to dispense Schedule I or II, an order form shall be that controlled substance; (2) The distribution is recorded by used in the manner prescribed in part the distributing practitioner in accord- 1305 of this chapter and be maintained ance with § 1304.22(c) of this chapter as the written record of the trans- and by the receiving practitioner in ac- action. Any person not required to reg- cordance with § 1304.22(c) of this chap- ister pursuant to sections 302(c) or ter; 1007(b)(1) of the Act (21 U.S.C. 822(c) or (3) If the substance is listed in Sched- 957(b)(1)) shall be exempt from main- ule I or II, an order form is used as re- taining the records required by this quired in part 1305 of this chapter; section. (4) The total number of dosage units (b) Distributions referred to in para- of all controlled substances distributed graph (a) may be made through a by the practitioner pursuant to this freight forwarding facility operated by section and § 1301.25 of this chapter dur- the person to whom the controlled sub- ing each calendar year in which the stance is being returned provided that practitioner is registered to dispense prior arrangement has been made for does not exceed 5 percent of the total the return and the person making the number of dosage units of all con- distribution delivers the controlled trolled substances distributed and dis- pensed by the practitioner during the substance directly to an agent or em- same calendar year. ployee of the person to whom the con- (b) If, during any calendar year in trolled substance is being returned. which the practitioner is registered to [65 FR 44679, July 19, 2000; 65 FR 45829, July dispense, the practitioner has reason to 25, 2000] believe that the total number of dosage
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§ 1307.13 Incidental manufacture of (b) The Special Agent in Charge shall controlled substances. authorize and instruct the applicant to Any registered manufacturer who, in- dispose of the controlled substance in cidentally but necessarily, manufac- one of the following manners: tures a controlled substance as a result (1) By transfer to person registered of the manufacture of a controlled sub- under the Act and authorized to pos- stance or basic class of controlled sub- sess the substance; stance for which he is registered and (2) By delivery to an agent of the Ad- has been issued an individual manufac- ministration or to the nearest office of turing quota pursuant to part 1303 of the Administration; this chapter (if such substance or class (3) By destruction in the presence of is listed in Schedule I or II) shall be ex- an agent of the Administration or empt from the requirement of registra- other authorized person; or tion pursuant to part 1301 of this (4) By such other means as the Spe- chapter and, if such incidentally manu- cial Agent in Charge may determine to factured substance is listed in Schedule assure that the substance does not be- I or II, shall be exempt from the re- come available to unauthorized per- quirement of an individual manufac- sons. turing quota pursuant to part 1303 of (c) In the event that a registrant is this chapter, if such substances are dis- required regularly to dispose of con- posed of in accordance with § 1307.21. trolled substances, the Special Agent [36 FR 7801, Apr. 24, 1971. Redesignated at 38 in Charge may authorize the registrant FR 26609, Sept. 24, 1973, and further redesig- to dispose of such substances, in ac- nated at 62 FR 13967, Mar. 24, 1997] cordance with paragraph (b) of this sec- tion, without prior approval of the Ad- DISPOSAL OF CONTROLLED SUBSTANCES ministration in each instance, on the condition that the registrant keep § 1307.21 Procedure for disposing of records of such disposals and file peri- controlled substances. odic reports with the Special Agent in (a) Any person in possession of any Charge summarizing the disposals controlled substance and desiring or re- made by the registrant. In granting quired to dispose of such substance such authority, the Special Agent in may request assistance from the Spe- Charge may place such conditions as he cial Agent in Charge of the Adminis- deems proper on the disposal of con- tration in the area in which the person trolled substances, including the meth- is located for authority and instruc- od of disposal and the frequency and tions to dispose of such substance. The detail of reports. request should be made as follows: (d) This section shall not be con- (1) If the person is a registrant, he/ strued as affecting or altering in any she shall list the controlled substance way the disposal of controlled sub- or substances which he/she desires to stances through procedures provided in dispose of on DEA Form 41, and submit laws and regulations adopted by any three copies of that form to the Special State. Agent in Charge in his/her area; or [36 FR 7801, Apr. 24, 1971, as amended at 37 (2) If the person is not a registrant, FR 15922, Aug. 8, 1972. Redesignated at 38 FR he/she shall submit to the Special 26609, Sept. 24, 1973, and amended at 47 FR Agent in Charge a letter stating: 41735, Sept. 22, 1982; 62 FR 13967, Mar. 24, 1997] (i) The name and address of the per- son; § 1307.22 Disposal of controlled sub- (ii) The name and quantity of each stances by the Administration. controlled substance to be disposed of; Any controlled substance delivered (iii) How the applicant obtained the to the Administration under § 1307.21 or substance, if known; and forfeited pursuant to section 511 of the (iv) The name, address, and registra- Act (21 U.S.C. 881) may be delivered to tion number, if known, of the person any department, bureau, or other agen- who possessed the controlled sub- cy of the United States or of any State stances prior to the applicant, if upon proper application addressed to known. the Administrator, Drug Enforcement
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Administration, Department of Jus- EXCLUDED VETERINARY ANABOLIC STEROID tice, Washington, DC 20537 The applica- IMPLANT PRODUCTS tion shall show the name, address, and 1308.25 Exclusion of a veterinary anabolic official title of the person or agency to steroid implant product; application. whom the controlled drugs are to be 1308.26 Excluded veterinary anabolic steroid delivered, including the name and implant products. quantity of the substances desired and EXEMPTED PRESCRIPTION PRODUCTS the purpose for which intended. The de- livery of such controlled drugs shall be 1308.31 Application for exemption of a non- narcotic prescription product. ordered by the Administrator, if, in his 1308.32 Exempted prescription products. opinion, there exists a medical or sci- entific need therefor. EXEMPT ANABOLIC STEROID PRODUCTS [38 FR 7801, Apr. 24, 1971. Redesignated at 38 1308.33 Exemption of certain anabolic ster- FR 26609, Sept. 24, 1973, as amended at 62 FR oid products; application. 1308.34 Exempt anabolic steroid products. 13967, Mar. 24, 1997] HEARINGS SPECIAL EXEMPT PERSONS 1308.41 Hearings generally. § 1307.31 Native American Church. 1308.42 Purpose of hearing. 1308.43 Initiation of proceedings for rule- The listing of peyote as a controlled making. substance in Schedule I does not apply 1308.44 Request for hearing or appearance; to the nondrug use of peyote in bona waiver. fide religious ceremonies of the Native 1308.45 Final order. American Church, and members of the 1308.46 Control required under international treaty. Native American Church so using pe- 1308.47 Control of immediate precursors. yote are exempt from registration. Any 1308.49 Emergency scheduling. person who manufactures peyote for or AUTHORITY: 21 U.S.C. 811, 812, 871(b), unless distributes peyote to the Native Amer- otherwise noted. ican Church, however, is required to obtain registration annually and to SOURCE: 38 FR 8254, Mar. 30, 1973, unless comply with all other requirements of otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973. law. GENERAL INFORMATION PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES § 1308.01 Scope of part 1308. Schedules of controlled substances GENERAL INFORMATION established by section 202 of the Act (21 U.S.C. 812), as they are changed, up- Sec. dated, and republished from time to 1308.01 Scope of part 1308. 1308.02 Definitions. time, are set forth in this part. 1308.03 Administration Controlled Sub- § 1308.02 Definitions. stances Code Number. Any term contained in this part shall SCHEDULES have the definition set forth in section 1308.11 Schedule I. 102 of the Act (21 U.S.C. 802) or part 1308.12 Schedule II. 1300 of this chapter. 1308.13 Schedule III. [62 FR 13967, Mar. 24, 1997] 1308.14 Schedule IV. 1308.15 Schedule V. § 1308.03 Administration Controlled EXCLUDED NONNARCOTIC SUBSTANCES Substances Code Number. (a) Each controlled substance, or 1308.21 Application for exclusion of a non- narcotic substance. basic class thereof, has been assigned 1308.22 Excluded substances. an ‘‘Administration Controlled Sub- stances Code Number’’ for purposes of EXEMPT CHEMICAL PREPARATIONS identification of the substances or 1308.23 Exemption of certain chemical prep- class on certain Certificates of Reg- arations; application. istration issued by the Administration 1308.24 Exemption chemical preparations. pursuant to §§ 1301.35 of this chapter
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and on certain order forms issued by (4) Alphacetylmethadol (except levo- the Administration pursuant to alphacetylmethadol also known as levo-alpha- acetylmethadol, levomethadyl acetate, or LAAM) ..... 9603 § 1305.05(d) of this chapter. Applicants (5) Alphameprodine ...... 9604 for procurement and/or individual man- (6) Alphamethadol ...... 9605 ufacturing quotas must include the ap- (7) Alpha-methylfentanyl (N-[1-(alpha-methyl-beta- propriate code number on the applica- phenyl)ethyl-4-piperidyl] propionanilide; 1-(1-methyl- 2-phenylethyl)-4-(N-propanilido) piperidine) ...... 9814 tion as required in §§ 1303.12(b) and (8) Alpha-methylthiofentanyl (N-[1-methyl-2-(2- 1303.22(a) of this chapter. Applicants thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9832 for import and export permits must in- (9) Benzethidine ...... 9606 (10) Betacetylmethadol ...... 9607 clude the appropriate code number on (11) Beta-hydroxyfentanyl (N-[1-(2-hydroxy-2- the application as required in phenethyl)-4-piperidinyl]-N-phenylpropanamide) ...... 9830 §§ 1312.12(a) and 1312.22(a) of this chap- (12) Beta-hydroxy-3-methylfentanyl (other name: N-[1- ter. Authorized registrants who desire (2-hydroxy-2-phenethyl)-3-methyl-4-piperidinyl]-N- phenylpropanamide ...... 9831 to import or export a controlled sub- (13) Betameprodine ...... 9608 stance for which an import or export (14) Betamethadol ...... 9609 permit is not required must include the (15) Betaprodine ...... 9611 appropriate Administration Controlled (16) Clonitazene ...... 9612 (17) Dextromoramide ...... 9613 Substances Code Number beneath or (18) Diampromide ...... 9615 beside the name of each controlled sub- (19) Diethylthiambutene ...... 9616 stance listed on the DEA Form 236 (20) Difenoxin ...... 9168 (Controlled Substance Import/Export (21) Dimenoxadol ...... 9617 (22) Dimepheptanol ...... 9618 Declaration) which is executed for such (23) Dimethylthiambutene ...... 9619 importation or exportation as required (24) Dioxaphetyl butyrate ...... 9621 in §§ 1312.18(c) and 1312.27(b) of this (25) Dipipanone ...... 9622 (26) Ethylmethylthiambutene ...... 9623 chapter. (27) Etonitazene ...... 9624 (b) Except as stated in paragraph (a) (28) Etoxeridine ...... 9625 of this section, no applicant or reg- (29) Furethidine ...... 9626 istrant is required to use the Adminis- (30) Hydroxypethidine ...... 9627 (31) Ketobemidone ...... 9628 tration Controlled Substances Code (32) Levomoramide ...... 9629 Number for any purpose. (33) Levophenacylmorphan ...... 9631 (34) 3-Methylfentanyl (N-[3-methyl-1-(2-phenylethyl)-4- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 piperidyl]-N-phenylpropanamide) ...... 9813 FR 26609, Sept. 24, 1973 and amended at 51 FR (35) 3-methylthiofentanyl (N-[(3-methyl-1-(2- 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] thienyl)ethyl-4-piperidinyl]-N-phenylpropanamide) ..... 9833 (36) Morpheridine ...... 9632 SCHEDULES (37) MPPP (1-methyl-4-phenyl-4-propionoxypiperidine) 9661 (38) Noracymethadol ...... 9633 (39) Norlevorphanol ...... 9634 § 1308.11 Schedule I. (40) Normethadone ...... 9635 (a) Schedule I shall consist of the (41) Norpipanone ...... 9636 (42) Para-fluorofentanyl (N-(4-fluorophenyl)-N-[1-(2- drugs and other substances, by what- phenethyl)-4-piperidinyl] propanamide ...... 9812 ever official name, common or usual (43) PEPAP (1-(-2-phenethyl)-4-phenyl-4- name, chemical name, or brand name acetoxypiperidine ...... 9663 designated, listed in this section. Each (44) Phenadoxone ...... 9637 (45) Phenampromide ...... 9638 drug or substance has been assigned (46) Phenomorphan ...... 9647 the DEA Controlled Substances Code (47) Phenoperidine ...... 9641 Number set forth opposite it. (48) Piritramide ...... 9642 (49) Proheptazine ...... 9643 (b) Opiates. Unless specifically ex- (50) Properidine ...... 9644 cepted or unless listed in another (51) Propiram ...... 9649 schedule, any of the following opiates, (52) Racemoramide ...... 9645 including their isomers, esters, ethers, (53) Thiofentanyl (N-phenyl-N-[1-(2-thienyl)ethyl-4- piperidinyl]-propanamide ...... 9835 salts, and salts of isomers, esters and (54) Tilidine ...... 9750 ethers, whenever the existence of such (55) Trimeperidine ...... 9646 isomers, esters, ethers and salts is pos- (c) Opium derivatives. Unless specifi- sible within the specific chemical des- cally excepted or unless listed in an- ignation (for purposes of paragraph other schedule, any of the following (b)(34) only, the term isomer includes opium derivatives, its salts, isomers, the optical and geometric isomers): and salts of isomers whenever the ex- (1) Acetyl-alpha-methylfentanyl (N-[1-(1-methyl-2- istence of such salts, isomers, and salts phenethyl)-4-piperidinyl]-N-phenylacetamide) ...... 9815 (2) Acetylmethadol ...... 9601 of isomers is possible within the spe- (3) Allylprodine ...... 9602 cific chemical designation: 82
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(1) Acetorphine ...... 9319 (12) N-hydroxy-3,4-methylenedioxyamphetamine (also (2) Acetyldihydrocodeine ...... 9051 known as N-hydroxy-alpha-methyl- (3) Benzylmorphine ...... 9052 3,4(methylenedioxy)phenethylamine, and N-hydroxy (4) Codeine methylbromide ...... 9070 MDA ...... 7402 (13) 3,4,5-trimethoxy amphetamine ...... 7390 (5) Codeine-N-Oxide ...... 9053 (14) Bufotenine ...... 7433 (6) Cyprenorphine ...... 9054 Some trade and other names: 3-(β (7) Desomorphine ...... 9055 -Dimethylaminoethyl)-5-hydroxyindole; 3-(2- (8) Dihydromorphine ...... 9145 dimethylaminoethyl)-5-indolol; N, N- (9) Drotebanol ...... 9335 dimethylserotonin; 5-hydroxy-N,N- (10) Etorphine (except hydrochloride salt) ...... 9056 dimethyltryptamine; mappine (11) Heroin ...... 9200 (15) Diethyltryptamine ...... 7434 (12) Hydromorphinol ...... 9301 Some trade and other names: N,N- (13) Methyldesorphine ...... 9302 Diethyltryptamine; DET (14) Methyldihydromorphine ...... 9304 (16) Dimethyltryptamine ...... 7435 (15) Morphine methylbromide ...... 9305 Some trade or other names: DMT (16) Morphine methylsulfonate ...... 9306 (17) Ibogaine ...... 7260 (17) Morphine-N-Oxide ...... 9307 Some trade and other names: 7-Ethyl- (18) Myrophine ...... 9308 6,6β,7,8,9,10,12,13-octahydro-2-methoxy-6,9- (19) Nicocodeine ...... 9309 methano-5H-pyrido [1′, 2′:1,2] azepino [5,4-b] (20) Nicomorphine ...... 9312 indole; Tabernanthe iboga (21) Normorphine ...... 9313 (18) Lysergic acid diethylamide ...... 7315 (22) Pholcodine ...... 9314 (19) Marihuana ...... 7360 (23) Thebacon ...... 9315 (20) Mescaline ...... 7381 (21) Parahexyl—7374; some trade or other names: 3- (d) Hallucinogenic substances. Unless Hexyl-1-hydroxy-7,8,9,10-tetrahydro-6,6,9-trimethyl- specifically excepted or unless listed in 6H-dibenzo[b,d]pyran; Synhexyl. another schedule, any material, com- (22) Peyote ...... 7415 Meaning all parts of the plant presently classified pound, mixture, or preparation, which botanically as Lophophora williamsii Lemaire, contains any quantity of the following whether growing or not, the seeds thereof, any hallucinogenic substances, or which extract from any part of such plant, and every compound, manufacture, salts, derivative, mixture, contains any of its salts, isomers, and or preparation of such plant, its seeds or extracts salts of isomers whenever the existence (Interprets 21 USC 812(c), Schedule I(c) (12)) of such salts, isomers, and salts of iso- (23) N-ethyl-3-piperidyl benzilate ...... 7482 mers is possible within the specific (24) N-methyl-3-piperidyl benzilate ...... 7484 (25) Psilocybin ...... 7437 chemical designation (for purposes of (26) Psilocyn ...... 7438 this paragraph only, the term ‘‘isomer’’ (27) Tetrahydrocannabinols ...... 7370 includes the optical, position and geo- Synthetic equivalents of the substances contained in the plant, or in the resinous extractives of Can- metric isomers): nabis, sp. and/or synthetic substances, deriva- (1) Alpha-ethyltryptamine ...... 7249 tives, and their isomers with similar chemical Some trade or other names: etryptamine; Monase; structure and pharmacological activity such as the α-ethyl-1H-indole-3-ethanamine; 3-(2-aminobutyl) following: indole; α-ET; and AET. ∆1 cis or trans tetrahydrocannabinol, and their opti- (2) 4-bromo-2,5-dimethoxy-amphetamine ...... 7391 cal isomers Some trade or other names: 4-bromo-2,5- ∆6 cis or trans tetrahydrocannabinol, and their opti- dimethoxy-α-methylphenethylamine; 4-bromo-2,5- cal isomers DMA ∆3,4 cis or trans tetrahydrocannabinol, and its opti- (3) 4-Bromo-2,5-dimethoxyphenethylamine ...... 7392 cal isomers Some trade or other names: 2-(4-bromo-2,5- (Since nomenclature of these substances is not dimethoxyphenyl)-1-aminoethane; alpha- internationally standardized, compounds of these desmethyl DOB; 2C-B, Nexus. structures, regardless of numerical designation of (4) 2,5-dimethoxyamphetamine ...... 7396 atomic positions covered.) Some trade or other names: 2,5-dimethoxy-α- (28) Ethylamine analog of phencyclidine ...... 7455 methylphenethylamine; 2,5-DMA Some trade or other names: N-ethyl-1- (5) 2,5-dimethoxy-4-ethylamphet-amine ...... 7399 phenylcyclohexylamine, (1- Some trade or other names: DOET phenylcyclohexyl)ethylamine, N-(1- (6) 4-methoxyamphetamine ...... 7411 phenylcyclohexyl)ethylamine, cyclohexamine, PCE Some trade or other names: 4-methoxy-α- (29) Pyrrolidine analog of phencyclidine ...... 7458 methylphenethylamine; Some trade or other names: 1-(1-phenylcyclohexyl)- paramethoxyamphetamine, PMA pyrrolidine, PCPy, PHP (7) 5-methoxy-3,4-mdthylenedioxy-amphetamine ...... 7401 (30) Thiophene analog of phencyclidine ...... 7470 Some trade or other names: 1-[1-(2-thienyl)- (8) 4-methyl-2,5-dimethoxy-amphetamine ...... 7395 cyclohexyl]-piperidine, 2-thienylanalog of Some trade and other names: 4-methyl-2,5- phencyclidine, TPCP, TCP dimethoxy-α-methylphenethylamine; ‘‘DOM’’; and (31) 1-[1-(2-thienyl)cyclohexyl]pyrrolidine ...... 7473 ‘‘STP’’ Some other names: TCPy (9) 3,4-methylenedioxy amphetamine ...... 7400 (10) 3,4-methylenedioxymethamphetamine (MDMA) .... 7405 (e) Depressants. Unless specifically (11) 3,4-methylenedioxy-N-ethylamphetamine (also excepted or unless listed in another known as N-ethyl-alpha-methyl- 3,4(methylenedioxy)phenethylamine, N-ethyl MDA, schedule, any material, compound, MDE, MDEA ...... 7404 mixture, or preparation which contains 83
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any quantity of the following sub- § 1308.12 Schedule II. stances having a depressant effect on (a) Schedule II shall consist of the the central nervous system, including drugs and other substances, by what- its salts, isomers, and salts of isomers ever official name, common or usual whenever the existence of such salts, name, chemical name, or brand name isomers, and salts of isomers is possible designated, listed in this section. Each within the specific chemical designa- drug or substance has been assigned tion: the Controlled Substances Code Num- (1) gamma-hydroxybutyric acid (some other names in- ber set forth opposite it. clude GHB; gamma-hydroxybutyrate; 4- (b) Substances, vegetable origin or hydroxybutyrate; 4-hydroxybutanoic acid; sodium oxybate; sodium oxybutyrate) ...... 2010 chemical synthesis. Unless specifically (2) Mecloqualone ...... 2572 excepted or unless listed in another (3) Methaqualone ...... 2565 schedule, any of the following sub- stances whether produced directly or (f) Stimulants. Unless specifically ex- indirectly by extraction from sub- cepted or unless listed in another stances of vegetable origin, or inde- schedule, any material, compound, pendently by means of chemical syn- mixture, or preparation which contains thesis, or by a combination of extrac- any quantity of the following sub- tion and chemical synthesis: stances having a stimulant effect on (1) Opium and opiate, and any salt, the central nervous system, including compound, derivative, or preparation its salts, isomers, and salts of isomers: of opium or opiate excluding (1) Aminorex (Some other names: aminoxaphen; 2- apomorphine, thebaine-derived amino-5-phenyl-2-oxazoline; or 4,5-dihydro-5- butorphanol, dextrorphan, nalbuphine, phenly-2-oxazolamine) ...... 1585 nalmefene, naloxone, and naltrexone, (2) Cathinone ...... 1235 Some trade or other names: 2-amino-1-phenyl-1- and their respective salts, but includ- propanone, alpha-aminopropiophenone, 2- ing the following: aminopropiophenone, and norephedrone (1) Raw opium ...... 9600 (3) Fenethylline ...... 1503 (2) Opium extracts ...... 9610 (4) Methcathinone (Some other names: 2- (3) Opium fluid ...... 9620 (methylamino)-propiophenone; alpha- (4) Powdered opium ...... 9639 (methylamino)propiophenone; 2-(methylamino)-1- (5) Granulated opium ...... 9640 phenylpropan-1-one; alpha-N- (6) Tincture of opium ...... 9630 methylaminopropiophenone; monomethylpropion; (7) Codeine ...... 9050 ephedrone; N-methylcathinone; methylcathinone; (8) Dihydroetorphine ...... 9334 AL–464; AL–422; AL–463 and UR1432), its salts, (9) Ethylmorphine ...... 9190 optical isomers and salts of optical isomers ...... 1237 (10) Etorphine hydrochloride ...... 9059 (5) (±)cis-4-methylaminorex ((±)cis-4,5-dihydro-4-meth- (11) Hydrocodone ...... 9193 yl-5-phenyl-2-oxazolamine) ...... 1590 (12) Hydromorphone ...... 9150 (13) Metopon ...... 9260 (6) N-ethylamphetamine ...... 1475 (14) Morphine ...... 9300 (7) N,N-dimethylamphetamine (also known as N,N- (15) Oxycodone ...... 9143 alpha-trimethyl-benzeneethanamine; N,N-alpha- (16) Oxymorphone ...... 9652 trimethylphenethylamine) ...... 1480 (17) Thebaine ...... 9333 (g) Temporary listing of substances sub- (2) Any salt, compound, derivative, or ject to emergency scheduling. Any mate- preparation thereof which is chemi- rial, compound, mixture or preparation cally equivalent or identical with any which contains any quantity of the fol- of the substances referred to in para- lowing substances: graph (b) (1) of this section, except that (1) N-[1-benzyl-4-piperidyl]-N-phenylpropanamide these substances shall not include the (benzylfentanyl), its optical isomers, salts and salts isoquinoline alkaloids of opium. of isomers ...... 9818 (3) Opium poppy and poppy straw. (2) N-[1-(2-thienyl)methyl-4-piperidyl]-N- phenylpropanamide (thenylfentanyl), its optical (4) Coca leaves (9040) and any salt, isolers, salts and salts of isomers ...... 9834 compound, derivative or preparation of coca leaves (including cocaine (9041) [39 FR 22141, June 20, 1974] and ecgonine (9180) and their salts, iso- mers, derivatives and salts of isomers EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1308.11, see the List of CFR and derivatives), and any salt, com- Sections Affected, which appears in the pound, derivative, or preparation Finding Aids section of the printed volume thereof which is chemically equivalent and on GPO Access. or identical with any of these sub- stances, except that the substances
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shall not include decocainized coca (e) Depressants. Unless specifically leaves or extraction of coca leaves, excepted or unless listed in another whhch extractions do not contain co- schedule, any material, compound, caine or ecgonine. mixture, or preparation which contains (5) Concentrate of poppy straw (the any quantity of the following sub- crude extract of poppy straw in either stances having a depressant effect on liquid, solid or powder form which con- the central nervous system, including tains the phenanthrene alkaloids of the its salts, isomers, and salts of isomers opium poppy), 9670. whenever the existence of such salts, (c) Opiates. Unless specifically ex- isomers, and salts of isomers is possible cepted or unless in another schedule within the specific chemical designa- any of the following opiates, including tion: its isomers, esters, ethers, salts and (1) Amobarbital ...... 2125 (2) Glutethimide ...... 2550 salts of isomers, esters and ethers (3) Pentobarbital ...... 2270 whenever the existence of such iso- (4) Phencyclidine ...... 7471 mers, esters, ethers, and salts is pos- (5) Secobarbital ...... 2315 sible within the specific chemical des- (f) Hallucinogenic substances. ignation, dextrorphan and (1) Nabilone ...... 7379 levopropoxyphene excepted: [Another name for nabilone: (±)-trans-3-(1,1- (1) Alfentanil ...... 9737 dimethylheptyl)-6,6a,7,8,10,10a-hexahydro-1-hy- droxy-6,6-dimethyl-9H-dibenzo[b,d]pyran-9-one] (2) Alphaprodine ...... 9010 (3) Anileridine ...... 9020 (g) Immediate precursors. Unless spe- (4) Bezitramide ...... 9800 cifically excepted or unless listed in (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 (6) Carfentanil ...... 9743 another schedule, any material, com- (7) Dihydrocodeine ...... 9120 pound, mixture, or preparation which (8) Diphenoxylate ...... 9170 contains any quantity of the following (9) Fentanyl ...... 9801 substances: (10) Isomethadone ...... 9226 (11) Levo-alphacetylmethadol ...... 9648 (1) Immediate precursor to amphet- [Some other names: levo-alpha-acetylmethadol, amine and methamphetamine: levomethadyl acetate, LAAM] (i) Phenylacetone ...... 8501 (12) Levomethorphan ...... 9210 Some trade or other names: phenyl-2-propanone; (13) Levorphanol ...... 9220 P2P; benzyl methyl ketone; methyl benzyl ke- (14) Metazocine ...... 9240 tone; (15) Methadone ...... 9250 (16) Methadone-Intermediate, 4-cyano-2- (2) Immediate precursors to dimethylamino-4,4-diphenyl butane ...... 9254 phencyclidine (PCP): (17) Moramide-Intermediate, 2-methyl-3-morpholino-1, (i) 1-phenylcyclohexylamine ...... 7460 1-diphenylpropane-carboxylic acid ...... 9802 (ii) 1-piperidinocyclohexanecarbonitrile (PCC) ...... 8603 (18) Pethidine (meperidine) ...... 9230 (19) Pethidine-Intermediate-A, 4-cyano-1-methyl-4- [39 FR 22142, June 20, 1974] phenylpiperidine ...... 9232 (20) Pethidine-Intermediate-B, ethyl-4- EDITORIAL NOTE: For FEDERAL REGISTER ci- phenylpiperidine-4-carboxylate ...... 9233 tations affecting § 1308.12, see the List of CFR (21) Pethidine-Intermediate-C, 1-methyl-4- Sections Affected, which appears in the phenylpiperidine-4-carboxylic acid ...... 9234 Finding Aids section of the printed volume (22) Phenazocine ...... 9715 and on GPO Access. (23) Piminodine ...... 9730 (24) Racemethorphan ...... 9732 (25) Racemorphan ...... 9733 § 1308.13 Schedule III. (26) Remifentanil ...... 9739 (a) Schedule III shall consist of the (27) Sufentanil ...... 9740 drugs and other substances, by what- (d) Stimulants. Unless specifically ex- ever official name, common or usual cepted or unless listed in another name, chemical name, or brand name schedule, any material, compound, designated, listed in this section. Each mixture, or preparation which contains drug or substance has been assigned any quantity of the following sub- the DEA Controlled Substances Code stances having a stimulant effect on Number set forth opposite it. the central nervous system: (b) Stimulants. Unless specifically ex- (1) Amphetamine, its salts, optical isomers, and salts cepted or unless listed in another of its optical isomers ...... 1100 schedule, any material, compound, (2) Methamphetamine, its salts, isomers, and salts of mixture, or preparation which contains its isomers ...... 1105 (3) Phenmetrazine and its salts ...... 1631 any quantity of the following sub- (4) Methylphenidate ...... 1724 stances having a stimulant effect on
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the central nervous sxstem, including (e) Narcotic Drugs. Unless specifically its salts, isomers (whether optical, po- excepted or unless listed in another sition, or geometric), and salts of such schedule, any material, compound, isomers whenever the existence of such mixture, or preparation containing any salts, isomers, and salts of isomers is of the following narcotic drugs, or possible within the specific chemical their salts calculated as the free anhy- designation: drous base or alkaloid, in limited quan- (1) Those compounds, mixtures, or preparations in tities as set forth below: dosage unit form containing any stimulant sub- stances listed in schedule II which compounds, mix- (1) Not more than 1.8 grams of codeine per 100 milli- tures, or preparations were listed on August 25, liters or not more than 90 milligrams per dosage 1971, as excepted compounds under § 1308.32, and unit, with an equal or greater quantity of an any other drug of the quantitative composition isoquinoline alkaloid of opium ...... 9803 shown in that list for those drugs or which is the (2) Not more than 1.8 grams of codeine per 100 milli- same except that it contains a lesser quantity of liters or not more than 90 milligrams per dosage controlled substances ...... 1405 unit, with one or more active, nonnarcotic ingredi- (2) Benzphetamine ...... 1228 ents in recognized therapeutic amounts ...... 9804 (3) Chlorphentermine ...... 1645 (3) Not more than 300 milligrams of dihydrocodeinone (4) Clortermine ...... 1647 (hydrocodone) per 100 milliliters or not more than (5) Phendimetrazine ...... 1615 15 milligrams per dosage unit, with a fourfold or greater quantity of an isoquinoline alkaloid of opium 9805 (c) Depressants. Unless specifically (4) Not more than 300 milligrams of dihydrocodeinone excepted or unless listed in another (hydrocodone) per 100 milliliters or not more than schedule, any material, compound, 15 milligrams per dosage unit, with one or more ac- tive nonnarcotic ingredients in recognized thera- mixture, or preparation which contains peutic amounts ...... 9806 any quantity of the following sub- (5) Not more than 1.8 grams of dihydrocodeine per stances having a depressant effect on 100 milliliters or not more than 90 milligrams per the central nervous system: dosage unit, with one or more active nonnarcotic in- gredients in recognized therapeutic amounts ...... 9807 (1) Any compound, mixture or preparation containing: (6) Not more than 300 milligrams of ethylmorphine per (i) Amobarbital ...... 2126 100 milliliters or not more than 15 milligrams per (ii) Secobarbital ...... 2316 dosage unit, with one or more active, nonnarcotic in- (iii) Pentobarbital ...... 2271 gredients in recognized therapeutic amounts ...... 9808 or any salt thereof and one or more other active (7) Not more than 500 milligrams of opium per 100 medicinal ingredients which are not listed in any milliliters or per 100 grams or not more than 25 milli- schedule. grams per dosage unit, with one or more active, (2) Any suppository dosage form containing: nonnarcotic ingredients in recognized therapeutic (i) Amobarbital ...... 2126 amounts ...... 9809 (ii) Secobarbital ...... 2316 (8) Not more than 50 milligrams of morphine per 100 (iii) Pentobarbital ...... 2271 milliliters or per 100 grams, with one or more active, or any salt of any of these drugs and approved by nonnarcotic ingredients in recognized therapeutic the Food and Drug Administration for marketing amounts ...... 9810 only as a suppository. (3) Any substance which contains any quantity of a (f) Anabolic steroids. Unless specifi- derivative of barbituric acid or any salt thereof ...... 2100 cally excepted or unless listed in an- (4) Chlorhexadol ...... 2510 (5) Any drug product containing gamma hydroxybutyric other schedule, any material, com- acid, including its salts, isomers, and salts of iso- pound, mixture, or preparation con- mers, for which an application is approved under taining any quantity of the following section 505 of the Federal Food, Drug, and Cos- metic Act ...... 2012 substances, including its salts, isomers, (6) Ketamine, its salts, isomers, and salts of isomers .. 7285 and salts of isomers whenever the ex- ± [Some other names for ketamine: ( )-2-(2- istence of such salts of isomers is pos- chlorophenyl)-2-(methylamino)-cyclohexanone] (7) Lysergic acid ...... 7300 sible within the specific chemical des- (8) Lysergic acid amide ...... 7310 ignation: (9) Methyprylon ...... 2575 (10) Sulfondiethylmethane ...... 2600 (1) Anabolic Steroids ...... 4000 (11) Sulfonethylmethane ...... 2605 (12) Sulfonmethane ...... 2610 (g) Hallucinogenic substances. (13) Tiletamine and zolazepam or any salt thereof ...... 7295 Some trade or other names for a tiletamine- (1) Dronabinol (synthetic) in sesame oil zolazepam combination product: and encapsulated in a soft gelatin capsule in Telazol.. a U.S. Food and Drug Administration ap- Some trade or other names for tiletamine: proved product—7369. 2-(ethylamino)-2-(2-thienyl)-cyclohexanone.. Some trade or other names for zolazepam: [Some other names for dronabinol: (6aR- 4-(2-fluorophenyl)-6,8-dihydro-1,3,8- trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- trimethylpyrazolo-[3,4-e] [1,4]-diazepin- 7(1H)-one, flupyrazapon.. pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- delta-9-(trans)-tetrahydrocannabinol] (d) Nalorphine 9400.
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(2) [Reserved] (23) Haloxazolam ...... 2771 (24) Ketazolam ...... 2772 [39 FR 22142, June 20, 1974, as amended at 41 (25) Loprazolam ...... 2773 FR 43401, Oct. 1, 1976; 43 FR 3359, Jan. 25, 1978; (26) Lorazepam ...... 2885 44 FR 40888, July 13, l979; 46 FR 52334, Oct. 27, (27) Lormetazepam ...... 2774 (28) Mebutamate ...... 2800 1981; 51 FR 5320, Feb. 13, 1986; 52 FR 2222, Jan. (29) Medazepam ...... 2836 21, 1987; 52 FR 5952, Feb. 27, 1987; 56 FR 5754, (30) Meprobamate ...... 2820 Feb. 13, 1991; 56 FR 11932, Mar. 21, 1991; 62 FR (31) Methohexital ...... 2264 13968, Mar. 24, 1997; 64 FR 35930, July 2, 1999; (32) Methylphenobarbital (mephobarbital) ...... 2250 64 FR 37675, July 13, 1999; 65 FR 13238, Mar. (33) Midazolam ...... 2884 13, 2000; 65 FR 17440, Apr. 3, 2000] (34) Nimetazepam ...... 2837 (35) Nitrazepam ...... 2834 (36) Nordiazepam ...... 2838 § 1308.14 Schedule IV. (37) Oxazepam ...... 2835 (a) Schedule IV shall consist of the (38) Oxazolam ...... 2839 (39) Paraldehyde ...... 2585 drugs and other substances, by what- (40) Petrichloral ...... 2591 ever official name, common or usual (41) Phenobarbital ...... 2285 name, chemical name, or brand name (42) Pinazepam ...... 2883 (43) Prazepam ...... 2764 designated, listed in this section. Each (44) Quazepam ...... 2881 drug or substance has been assigned (45) Temazepam ...... 2925 the DEA Controlled Substances Code (46) Tetrazepam ...... 2886 (47) Triazolam ...... 2887 Number set forth opposite it. (48) Zaleplon ...... 2781 (b) Narcotic drugs. Unless specifically (49) Zolpidem ...... 2783 excepted or unless listed in another (d) Fenfluramine. Any material, com- schedule, any material, compound, pound, mixture, or preparation which mixture, or preparation containing any contains any quantity of the following of the following narcotic drugs, or substances, including its salts, isomers their salts calculated as the free anhy- (whether optical, position, or geo- drous base or alkaloid, in limited quan- metric), and salts of such isomers, tities as set forth below: whenever the existence of such salts, (1) Not more than 1 milligram of difenoxin and not less isomers, and salts of isomers is pos- than 25 micrograms of atropine sulfate per dosage unit ...... 9167 sible: (2) Dextropropoxyphene (alpha-(∂)-4-dimethylamino- (1) Fenfluramine ...... 1670 1,2-diphenyl-3-methyl-2-propionoxybutane) ...... 9278 (e) Stimulants. Unless specifically ex- (c) Depressants. Unless specifically cepted or unless listed in another excepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation which contains mixture, or preparation which contains any quantity of the following sub- any quantity of the following sub- stances having a stimulant effect on stances, including its salts, isomers, the central nervous system, including and salts of isomers whenever the ex- its salts, isomers and salts of isomers: istence of such salts, isomers, and salts (1) Cathine ((∂)-norpseudoephedrine) ...... 1230 of isomers is possible within the spe- (2) Diethylpropion ...... 1610 cific chemical designation: (3) Fencamfamin ...... 1760 (4) Fenproporex ...... 1575 (1) Alprazolam ...... 2882 (5) Mazindol ...... 1605 (2) Barbital ...... 2145 (6) Mefenorex ...... 1580 (3) Bromazepam ...... 2748 (7)Modafinil ...... 1680 (4) Camazepam ...... 2749 (8) Pemoline (including organometallic complexes and (5) Chloral betaine ...... 2460 chelates thereof) ...... 1530 (6) Chloral hydrate ...... 2465 (9) Phentermine ...... 1640 (7) Chlordiazepoxide ...... 2744 (10) Pipradrol ...... 1750 (8) Clobazam ...... 2751 (11) Sibutramine ...... 1675 (9) Clonazepam ...... 2737 (12) SPA ((-)-1-dimethylamino- 1,2-diphenylethane) .... 1635 (10) Clorazepate ...... 2768 (11) Clotiazepam ...... 2752 (f) Other substances. Unless specifi- (12) Cloxazolam ...... 2753 cally excepted or unless listed in an- (13) Delorazepam ...... 2754 (14) Diazepam ...... 2765 other schedule, any material, com- (15) Estazolam ...... 2756 pound, mixture or preparation which (16) Ethchlorvynol ...... 2540 contains any quantity of the following (17) Ethinamate ...... 2545 (18) Ethyl loflazepate ...... 2758 substances, including its salts: (19) Fludiazepam ...... 2759 (1) Pentazocine ...... 9709 (20) Flunitrazepam ...... 2763 (2) Butorphanol (including its optical isomers) ...... 9720 (21) Flurazepam ...... 2767 (22) Halazepam ...... 2762 [39 FR 22143, June 20, 1974] 87
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EDITORIAL NOTE: For FEDERAL REGISTER ci- on the central nervous system, includ- tations affecting § 1308.14, see the List of CFR ing its salts, isomers and salts of iso- Sections Affected, which appears in the mers: Finding Aids section of the printed volume and on GPO Access. (1) Pyrovalerone ...... 1485. (2) [Reserved] § 1308.15 Schedule V. [39 FR 22143, June 20, 1974, as amended at 43 (a) Schedule V shall consist of the FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, drugs and other substances, by what- 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. ever official name, common or usual 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, name, chemical name, or brand name Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991] designated, listed in this section. (b) Narcotic drugs. Unless specifically EXCLUDED NONNARCOTIC SUBSTANCES excepted or unless listed in another § 1308.21 Application for exclusion of a schedule, any material, compound, nonnarcotic substance. mixture, or preparation containing any of the following narcotic drugs and (a) Any person seeking to have any their salts, as set forth below: nonnarcotic substance which may, under the Federal Food, Drug, and Cos- (1) Buprenorphine ...... 9064 metic Act (21 U.S.C. 301), be lawfully (c) Narcotic drugs containing non-nar- sold over the counter without a pre- cotic active medicinal ingredients. Any scription, excluded from any schedule, compound, mixture, or preparation pursuant to section 201(g) (1) of the Act containing any of the following nar- (21 U.S.C. 811 (g) (1)), may apply to the cotic drugs, or their salts calculated as Administrator, Drug Enforcement Ad- the free anhydrous base or alkaloid, in ministration, Department of Justice, limited quantities as set forth below, Washington, DC 20537. which shall include one or more non- (b) An application for an exclusion narcotic active medicinal ingredients under this section shall contain the fol- in sufficient proportion to confer upon lowing information: the compound, mixture, or preparation (1) The name and address of the ap- valuable medicinal qualities other than plicant; those possessed by narcotic drugs (2) The name of the substance for alone: which exclusion is sought; and (1) Not more than 200 milligrams of (3) The complete quantitative com- codeine per 100 milliliters or per 100 position of the substance. grams. (c) Within a reasonable period of (2) Not more than 100 milligrams of time after the receipt of an application dihydrocodeine per 100 milliliters or for an exclusion under this section, the per 100 grams. Administrator shall notify the appli- (3) Not more than 100 milligrams of cant of his acceptance or nonaccept- ethylmorphine per 100 milliliters or per ance of his application, and if not ac- 100 grams. cepted, the reason therefore. The Ad- (4) Not more than 2.5 milligrams of ministrator need not accept an applica- diphenoxylate and not less than 25 tion for filing if any of the require- micrograms of atropine sulfate per dos- ments prescribed in paragraph (b) of age unit. this section is lacking or is not set (5) Not more than 100 milligrams of forth as to be readily understood. If the opium per 100 milliliters or per 100 applicant desires, he may amend the grams. application to meet the requirements (6) Not more than 0.5 milligram of of paragraph (b) of this section. If the difenoxin and not less than 25 application is accepted for filing, the micrograms of atropine sulfate per dos- Administrator shall issue and publish age unit. in the FEDERAL REGISTER his order on (d) Stimulants. Unless specifically ex- the application, which shall include a empted or excluded or unless listed in reference to the legal authority under another schedule, any material, com- which the order is issued and the find- pound, mixture, or preparation which ings of fact and conclusions of law contains any quantity of the following upon which the order is based. This substances having a stimulant effect order shall specify the date on which it
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shall take effect. The Administrator (d) The Administrator may at any shall permit any interested person to time revoke any exclusion granted pur- file written comments on or objections suant to section 201(g) of the Act (21 to the order within 60 days of the date U.S.C. 811(g)) by following the proce- of publication of his order in the FED- dures set forth in paragraph (c) of this ERAL REGISTER. If any such comments section for handling an application for or objections raise significant issues an exclusion which has been accepted regarding any finding of fact or conclu- for filing. sion of law upon which the order is based, the Administrator shall imme- § 1308.22 Excluded substances. diately suspend the effectiveness of the The following nonnarcotic substances order until he may reconsider the ap- which may, under the Federal Food, plication in light of the comments and Drug, and Cosmetic Act (21 U.S.C. 301), objections filed. Thereafter, the Ad- be lawfully sold over the counter with- ministrator shall reinstate, revoke, or out a prescription, are excluded from amend his original order as he deter- all schedules pursuant to section 201(g) mines appropriate. (1) of the Act (21 U.S.C. 811(g) (1)):
EXCLUDED NONNARCOTIC PRODUCTS
(mg or mg/ Company Trade name NDC code Form Controlled substance ml)
Bioline Laboratories ...... Theophed ...... 00719–1945 TB Phenobarbital ...... 8.00 Goldline Laboratories ...... Guiaphed Elixir ...... 00182–1377 EL Phenobarbital ...... 4.00 Goldline Laboratories ...... Tedrigen Tablets ...... 00182–0134 TB Phenobarbital ...... 8.00 Hawthorne Products Inc .... Choate’s Leg Freeze ...... LQ Chloral hydrate ...... 246.67 Parke-Davis & Co ...... Tedral ...... 00071–0230 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Elixir ...... 00071–0242 EX Phenobarbital ...... 40.00 Parke-Davis & Co ...... Tedral S.A...... 00071–0231 TB Phenobarbital ...... 8.00 Parke-Davis & Co ...... Tedral Suspension ...... 00071–0237 SU Phenobarbital ...... 80.00 Parmed Pharmacy ...... Asma-Ese ...... 00349–2018 TB Phenobarbital ...... 8.10 Rondex Labs ...... Azma-Aids ...... 00367–3153 TB Phenobarbital ...... 8.00 Smith Kline Consumer ...... Benzedrex ...... 49692–0928 IN Propylhexedrine ...... 250.00 Sterling Drug, Inc ...... Bronkolixir ...... 00057–1004 EL Phenobarbital ...... 0.80 Sterling Drug, Inc ...... Bronkotabs ...... 00057–1005 TB Phenobarbital ...... 8.00 Vicks Chemical Co ...... Vicks Inhaler ...... 23900–0010 IN I-Desoxyephedrine ...... 113.00 White Hall Labs ...... Primatene (P-tablets) ...... 00573–2940 TB Phenobarbital ...... 8.00
[38 FR 8255, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, l973, 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]
EXEMPT CHEMICAL PREPARATIONS nificant potential for abuse (the type of packaging and the history of abuse of § 1308.23 Exemption of certain chem- the same or similar preparations may ical preparations; application. be considered in determining the po- (a) The Administrator may, by regu- tential for abuse of the preparation or lation, exempt from the application of mixture); or all or any part of the Act any chemical (2) Contains either a narcotic or non- preparation or mixture containing one narcotic controlled substance and one or more controlled substances listed in or more adulterating or denaturing any schedule, which preparation or agents in such a manner, combination, mixture is intended for laboratory, in- quantity, proportion, or concentration, dustrial, educational, or special re- that the preparation or mixture does search purposes and not for general ad- not present any potential for abuse. If ministration to a human being or other the preparation or mixture contains a animal, if the preparation or mixture narcotic controlled substance, the either: preparation or mixture must be formu- (1) Contains no narcotic controlled lated in such a manner that it incor- substance and is packaged in such a porates methods of denaturing or other form or concentration that the pack- means so that the preparation or mix- aged quantity does not present any sig- ture is not liable to be abused or have
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ill effects, if abused, and so that the or any other law restricting public dis- narcotic substance cannot in practice closure of information. be removed. (d) The Administrator may require (b) Any person seeking to have any the applicant to submit such docu- preparation or mixture containing a ments or written statements of fact controlled substance and one or more relevant to the application as he deems noncontrolled substances exempted necessary to determine whether the ap- from the application of all or any part plication should be granted. of the Act, pursuant to paragraph (a) of (e) Within a reasonable period of this section, may apply to the Admin- time after the receipt of an application istrator, Drug Enforcement Adminis- for an exemption under this section, tration, Department of Justice, Wash- the Administrator shall notify the ap- ington, DC 20537. plicant of his acceptance or nonaccept- (c) An application for an exemption ance of his application, and if not ac- under this section shall contain the fol- cepted, the reason therefor. The Ad- lowing information: ministrator need not accept an applica- (1) The name, address, and registra- tion for filing if any of the require- tion number, if any, of the applicant; ments prescribed in paragraph (c) or re- (2) The name, address, and registra- quested pursuant to paragraph (d) is tion number, if any, of the manufac- lacking or is not set forth as to be turer or importer of the preparation or readily understood. If the applicant de- mixture, if not the applicant; sires, he may amend the application to meet the requirements of paragraphs (3) The exact trade name or other (c) and (d) of this section. If the appli- designation of the preparation or mix- cation is accepted for filing, the Ad- ture; ministrator shall issue and publish in (4) The complete qualitative and the FEDERAL REGISTER his order on the quantitative composition of the prepa- application, which shall include a ref- ration or mixture (including all active erence to the legal authority under and inactive ingredients and all con- which the order is based. This order trolled and noncontrolled substances); shall specify the date on which it shall (5) The form of the immediate con- take effect. The Administrator shall tainer in which the preparation or mix- permit any interested person to file ture will be distributed with sufficient written comments on or objections to descriptive detail to identify the prepa- the order within 60 days of the date of ration or mixture (e.g., bottle, packet, publication of his order in the FEDERAL vial, soft plastic pillow, agar gel plate, REGISTER. If any such comments or ob- etc.); jections raise significant issues regard- (6) The dimensions or capacity of the ing any finding of fact or conclusion of immediate container of the prepara- law upon which the order is based, the tion or mixture; Administrator shall immediately sus- (7) The label and labeling, as defined pend the effectiveness of the order in part 1300 of this chapter, of the im- until he may reconsider the application mediate container and the commercial in light of the comments and objec- containers, if any, of the preparation tions filed. Thereafter, the Adminis- or mixture; trator shall reinstate, revoke, or (8) A brief statement of the facts amend his original order as he deter- which the applicant believes justify the mines appropriate. granting of an exemption under this (f) The Administrator may at any paragraph, including information on time revoke or modify any exemption the use to which the preparation or granted pursuant to this section by fol- mixture will be put; lowing the procedures set forth in para- (9) The date of the application; and graph (e) of this section for handling an (10) Which of the information sub- application for an exemption which has mitted on the application, if any, is been accepted for filing. The Adminis- deemed by the applicant to be a trade trator may also modify or revoke the secret or otherwise confidential and en- criteria by which exemptions are titled to protection under subsection granted (and thereby modify or revoke 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) all preparations and mixtures granted
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under the old criteria) and modify the ‘‘Diagnostic reagent—for professional scope of exemptions at any time. use only’’ or a comparable statement [38 FR 8254, Mar. 30, 1973. Redesignated at 38 warning the person reading it that FR 26609, Sept. 24, 1973, and amended at 46 human or animal use is not intended. FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, The symbol designating the schedule of 1997] the controlled substance is not re- quired on either the label or the label- § 1308.24 Exempt chemical prepara- ing of the exempt chemical prepara- tions. tion, nor is it necessary to list all in- (a) The chemical preparations and gredients of the preparation. mixtures approved pursuant to § 1308.23 (d) Records and reports: Any person are exempt from application of sec- who manufactures an exempt chemical tions 302, 303, 305, 306, 307, 308, 309, 1002, preparation or mixture must keep com- 1003 and 1004 of the Act (21 U.S.C. 822– plete and accurate records and file all 823, 825–829, 952–954) and § 1301.74 of this reports required under part 1304 of this chapter, to the extent described in chapter regarding all controlled sub- paragraphs (b) to (h) of this section. stances being used in the manufac- Substances set forth in paragraph (j) of turing process until the preparation or this section shall be exempt from the mixture is in the form described in application of sections 305, 306, 307, 308, paragraph (i) of this section. In lieu of 309, 1002, 1003 and 1004 of the Act (21 records and reports required under part U.S.C. 825–829, 952–954) and §§ 1301.71— 1304 of this chapter regarding exempt 1301.73 and 1301.74 (a), (b), (d), (e) and (f) chemical preparations, the manufac- of this chapter to the extent as herein- turer need only record the name, ad- after may be provided. dress, and registration number, if any, (b) Registration and security: Any of each person to whom the manufac- person who manufactures an exempt turer distributes any exempt chemical chemical preparation or mixture must be registered under the Act and comply preparation. Each importer or exporter with all relevant security requirements of an exempt narcotic chemical prepa- regarding controlled substances being ration must submit a semiannual re- used in the manufacturing process port of the total quantity of each sub- until the preparation or mixture is in stance imported or exported in each the form described in paragraph (i) of calendar half-year within 30 days of the this section. Any other person who close of the period to the Drug and handles an exempt chemical prepara- Chemical Evaluation Section, Drug En- tion after it is in the form described in forcement Administration, Department paragraph (i) of this section is not re- of Justice, Washington, DC 20537. Any quired to be registered under the Act other person who handles an exempt to handle that preparation, and the chemical preparation after it is in the preparation is not required to be stored form described in paragraph (i) of this in accordance with security require- section is not required to maintain ments regarding controlled substances. records or file reports. (c) Labeling: In lieu of the require- (e) Quotas, order forms, prescrip- ments set forth in part 1302 of this tions, import, export, and trans- chapter, the label and the labeling of shipment requirements: Once an ex- an exempt chemical preparation must empt chemical preparation is in the be prominently marked with its full form described in paragraph (i) of this trade name or other description and section, the requirements regarding the name of the manufacturer or sup- quotas, order forms, prescriptions, im- plier as set forth in paragraph (i) of port permits and declarations, export this section, in such a way that the permit and declarations, and trans- product can be readily identified as an shipment and intransit permits and exempt chemical preparation. The declarations do not apply. These re- label and labeling must also include in quirements do apply, however, to any a prominent manner the statement controlled substances used in manufac- ‘‘For industrial use only’’ or ‘‘For turing the exempt chemical prepara- chemical use only’’ or ‘‘For in vitro use tion before it is in the form described only—not for human or animal use’’ or in paragraph (i) of this section.
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(f) Criminal penalties: No exemption EXCLUDED VETERINARY ANABOLIC granted pursuant to § 1308.23 affects the STEROID IMPLANT PRODUCTS criminal liability for illegal manufac- ture, distribution, or possession of con- § 1308.25 Exclusion of a veterinary an- trolled substances contained in the ex- abolic steroid implant product; ap- empt chemical preparation. Distribu- plication. tion, possession, and use of an exempt (a) Any person seeking to have any chemical preparation are lawful for anabolic steroid product, which is ex- registrants and nonregistrants only as pressly intended for administration long as such distribution, possession, through implants to cattle or other or use is intended for laboratory, in- nonhuman species and which has been dustrial, or educational purposes and approved by the Secretary of Health not for immediate or subsequent ad- and Human Services for such adminis- ministration to a human being or other tration, identified as being excluded animal. from any schedule, pursuant to section (g) Bulk materials: For materials ex- 102(41)(B)(i) of the Act (21 U.S.C. empted in bulk quantities, the Admin- 802(41)(B)(i)), may apply to the Admin- istrator may prescribe requirements istrator, Drug Enforcement Adminis- other than those set forth in para- tration, Department of Justice, Wash- graphs (b) through (e) of this section on ington, DC 20537. a case-by-case basis. (b) An application for any exclusion (h) Changes in chemical preparations: under this section shall be submitted Any change in the quantitative or in triplicate and contain the following qualitative composition of the prepara- information: tion or mixture after the date of appli- (1) The name and address of the ap- cation, or change in the trade name or plicant; other designation of the preparation or (2) The name of the product; mixture, set forth in paragraph (i) of (3) The chemical structural formula this section, requires a new application or description for any anabolic steroid for exemption. contained in the product; (i) A listing of exempt chemical prep- (4) A complete description of dosage arations may be obtained by submit- and quantitative composition of the ting a written request to the Drug and dosage form;. Chemical Evaluation Section, Drug En- (5) The conditions of use including forcement Administration, Wash- whether or not Federal law restricts ington, DC 20537. this product to use by or on the order (j) The following substances are des- of a licensed veterinarian; ignated as exempt chemical prepara- (6) A description of the delivery sys- tions for the purposes set forth in this tem in which the dosage form will be section. distributed with sufficient detail to (1) Chloral. When packaged in a identify the product (e.g. 20 cartridge sealed, oxygen-free environment, under brown plastic belt); nitrogen pressure, safeguarded against (7) The label and labeling of the im- exposure to the air. mediate container and the commercial (2) EmitR Phenobarbital Enzyme Rea- containers, if any, of the product;. gent B. In one liter quantities each (8) The name and address of the man- with a 5 ml. retention sample for re- ufacturer of the dosage form if dif- packaging as an exempt chemical prep- ferent from that of the applicant; and aration only. (9) Evidence that the product has [38 FR 8255, Mar. 30, 1973] been approved by the Secretary of Health and Human Services for admin- EDITORIAL NOTE: For FEDERAL REGISTER ci- istration through implant to cattle or tations affecting § 1308.24, see the List of CFR other nonhuman species. Sections Affected, which appears in the Finding Aids section of th e printed volume (c) Within a reasonable period of and on GPO Access. time after the receipt of an application for an exclusion under this section, the
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Administrator shall notify the appli- products may be obtained by submit- cant of his acceptance or nonaccept- ting a written request to the Drug and ance of the application, and if not ac- Chemical Evaluation Section, Drug En- cepted, the reason therefore. The Ad- forcement Administration, Washington ministrator need not accept an applica- DC 20537. tion for filing if any of the require- (b) In accordance with section ments prescribed in paragraph (b) of 102(41)(B)(ii) of the Act (21 U.S.C. this section is lacking or is not set 802(41)(B)(ii)) if any person prescribes, forth as to be readily understood. The dispenses, or distributes a product list- applicant may amend the application ed in paragraph (a) of this section for to meet the requirements of paragraph human use, such person shall be con- (b) of this section. If the application is sidered to have prescribed, dispensed, accepted for filing, the Administrator or distributed an anabolic steroid with- shall issue and have published in the in the meaning of section 102(41)(A) of FEDERAL REGISTER his order on the ap- the Act (21 U.S.C. 802(41)(A)). plication, which shall include a ref- erence to the legal authority under [56 FR 42936, Aug. 30, 1991, as amended at 57 which the order is issued and the find- FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, 1993; 62 FR 13967, Mar. 24, 1997] ings of fact and conclusions of law upon which the order is based. This EXEMPTED PRESCRIPTION PRODUCTS order shall specify the date on which it will take effect. The Administrator § 1308.31 Application for exemption of shall permit any interested person to a nonnarcotic prescription product. file written comments on or objections (a) Any person seeking to have any to the order within 60 days of the date compound, mixture, or preparation of publication in the FEDERAL REG- containing any nonnarcotic controlled ISTER. If any such comments or objec- substance listed in § 1308.12(e), or in tions raise significant issues regarding § 1308.13 (b) or (c), or in § 1308.14, or in any finding of fact or conclusion of law § 1308.15, exempted from application of upon which the order is based, the Ad- all or any part of the Act pursuant to ministrator shall immediately suspend section 201(g)(3)(A), of the Act (21 the effectiveness of the order until he U.S.C. 811(g)(3)(A). may apply to the may reconsider the application in light Administrator, Drug Enforcement Ad- of the comments and objections filed. ministration, Washington, DC 20537, for Thereafter, the Administrator shall re- such exemption. instate, revoke, or amend his original (b) An application for an exemption order as he determines appropriate. under this section shall contain the fol- (d) The Administrator may at any lowing information: time revoke or modify any designation (1) The complete quantitative com- of excluded status granted pursuant to position of the dosage form. this section by following the proce- (2) Description of the unit dosage dures set forth in paragraph (c) of this form together with complete labeling. section for handling an application for (3) A summary of the pharmacology an exclusion which has been accepted of the product including animal inves- for filing. tigations and clinical evaluations and [56 FR 42936, Aug. 30, 1991] studies, with emphasis on the psychic and/or physiological dependence liabil- § 1308.26 Excluded veterinary anabolic ity (this must be done for each of the steroid implant products. active ingredients separately and for (a) Products containing an anabolic the combination product). steroid, that are expressly intended for (4) Details of synergisms and antag- administration through implants to onisms among ingredients. cattle or other nonhuman species and (5) Deterrent effects of the noncon- which have been approved by the Sec- trolled ingredients. retary of Health and Human Services (6) Complete copies of all literature for such administration are excluded in support of claims. from all schedules pursuant to section (7) Reported instances of abuse. 102(41)(B)(I) of the Act (21 U.S.C. (8) Reported and anticipated adverse 802(41)(B)(I)). A listing of the excluded effects.
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(9) Number of dosage units produced an exemption which has been accepted for the past 2 years. for filing. (c) Within a reasonable period of [38 FR 8254, Mar. 30, 1973. Redesignated at 38 time after the receipt of an application FR 26609, Sept. 24, 1973, as amended at 44 FR for an exemption under this section, 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987] the Administrator shall notify the ap- plicant of his acceptance or non-ac- § 1308.32 Exempted prescription prod- ceptance of the application, and if not ucts. accepted, the reason therefor. The Ad- The compounds, mixtures, or prep- ministrator need not accept an applica- arations that contain a nonnarcotic tion for filing if any of the require- controlled substance listed in ments prescribed in paragraph (b) of § 1308.12(e) or in § 1308.13 (b) or (c) or in this section is lacking or is not set § 1308.14 or in § 1308.15 listed in the forth so as to be readily understood. If Table of Exempted Prescription Prod- the applicant desires, he may amend ucts have been exempted by the Ad- the application to meet the require- ministrator from the application of ments of paragraph (b) of this section. sections 302 through 305, 307 through If accepted for filing, the Adminis- 309, 1002 through 1004 of the Act (21 trator shall publish in the FEDERAL U.S.C. 822–825, 827–829, and 952–954) and REGISTER general notice of this pro- §§ 1301.13, 1301.22, and §§ 1301.71 through posed rulemaking in granting or deny- 1301.76 of this chapter for administra- ing the application. Such notice shall tive purposes only. An exception to the include a reference to the legal author- above is that those products containing ity under which the rule is proposed, a butalbital shall not be exempt from the statement of the proposed rule grant- requirement of 21 U.S.C. 952–954 con- ing or denying an exemption, and, in cerning importation, exportation, the discretion of the Administrator, a transshipment and in-transit shipment summary of the subjects and issues in- of controlled substances. Any deviation volved. The Administrator shall permit from the quantitative composition of any interested person to file written any of the listed drugs shall require a comments on or objections to the pro- petition of exemption in order for the posal and shall designate in the notice product to be exempted. A listing of of proposed rule making the time dur- the Exempted Prescription Products ing which such filings may be made. may be obtained by submitting a writ- After consideration of the application ten request to the Drug and Chemical and any comments on or objections to Evaluation Section, Drug Enforcement his proposed rulemaking, the Adminis- Administration, Washington, DC 20537. trator shall issue and publish in the FEDERAL REGISTER his final order on [62 FR 13967, Mar. 24, 1997] the application, which shall set forth the findings of fact and conclusions of EXEMPT ANABOLIC STEROID PRODUCTS law upon which the order is based. This order shall specify the date on which it § 1308.33 Exemption of certain ana- shall take effect, which shall not be bolic steroid products; application. less than 30 days from the date of pub- (a) The Administrator, upon the rec- lication in the FEDERAL REGISTER un- ommendation of the Secretary of less the Administrator finds that con- Health and Human Services, may, by ditions of public health or safety neces- regulation, exempt from the applica- sitate an earlier effective date, in tion of all or any part of the Act any which event the Administrator shall compound, mixture, or preparation specify in the order his findings as to containing an anabolic steroid as de- such conditions. fined in part 1300 of this chapter if, be- (d) The Administrator may revoke cause of its concentration, preparation, any exemption granted pursuant to mixture or delivery system, it has no section 201(g)(3)(A) of the Act (21 U.S.C. significant potential for abuse (Pub. L. 811(g)(3)(A)) by following the proce- 101–647 section 1903(a)). dures set forth in paragraph (c) of this (b) Any person seeking to have any section for handling an application for compound, mixture, or preparation
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containing an anabolic steroid as de- Human Services his recommendation, fined in part 1300 of this chapter ex- as to whether such product which con- empted from the application of all or tains an anabolic steroid should be con- any part of the Act, pursuant to para- sidered for exemption from certain por- graph (a) of this section, may apply to tions of the Controlled Substances Act. the Administrator, Drug Enforcement On receipt of the recommendation of Administration, Department of Jus- the Secretary, the Administrator shall tice, Washington, DC 20537. make a determination as to whether (c) An application for an exemption the evidence submitted or otherwise under this section shall be submitted available sufficiently establishes that in triplicate and contain the following the product possesses no significant po- information: tential for abuse. The Administrator (1) The name and address of the ap- shall issue and publish in the FEDERAL plicant; REGISTER his order on the application, (2) The name of the product; which shall include a reference to the (3) The chemical structural formula legal authority under which the order or description for any anabolic steroid is issued, and the findings of fact and contained in the product; conclusions of law upon which the (4) The complete description of dos- order is based. This order shall specify age and quantitative composition of the date on which it will take effect. the dosage form; The Administrator shall permit any in- (5) A description of the delivery sys- terested person to file written com- tem, if applicable; ments on or objections to the order (6) The indications and conditions for within 60 days of the date of publica- use in which species, including whether tion of his order in the FEDERAL REG- or not this product is a prescription ISTER. If any such comments or objec- drug; tions raise significant issues regarding (7) Information to facilitate identi- any finding of fact or conclusion of law fication of the dosage form, such as upon which the order is based, the Ad- shape, color, coating, and scoring; ministrator shall immediately suspend (8) The label and labeling of the im- the effectiveness of the order until he mediate container and the commercial may reconsider the application in light containers, if any, of the product; of the comments and objections filed. (9) The units in which the dosage Thereafter, the Administrator shall re- form is ordinarily available; and instate, revoke, or amend his original (10) The facts which the applicant be- order as he determines appropriate. lieves justify: (e) The Administrator may revoke (i) A determination that the product any exemption granted pursuant to has no significant potential for abuse section 1903(a) of Public Law 101–647 by and following the procedures set forth in (ii) a granting of an exemption under paragraph (d) of this section for han- this section. dling an application for an exemption (d) Within a reasonable period of which has been accepted for filing. time after the receipt of the applica- tion for an exemption under this sec- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion, the Administrator shall notify 31, 1992, as amended at 62 FR 13968, Mar. 24, the applicant of his acceptance or non- 1997] acceptance of the application, and if not accepted, the reason therefor. The § 1308.34 Exempt anabolic steroid Administrator need not accept an ap- products. plication for filing if any of the re- The list of compounds, mixtures, or quirements prescribed in paragraph (c) preparations that contain an anabolic of this section is lacking or is not set steroid that have been exempted by the forth so as to be readily understood. Administrator from application of sec- The applicant may amend the applica- tions 302 through 309 and 1002 through tion to meet the requirements of para- 1004 of the Act (21 U.S.C. 822–829 and graph (c) of this section. If accepted for 952–954) and §§ 1301.13, 1301.22, and filing, the Administrator will request 1301.71 through 1301.76 of this chapter from the Secretary for Health and for administrative purposes only may
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be obtained by submitting a written re- ADMINISTRATOR, DRUG ENFORCEMENT quest to the Drug and Chemical Eval- ADMINISTRATION uation Section, Drug Enforcement Ad- Department of Justice, ministration, Washington, DC 20537. Washington, DC 20537. DEAR SIR: The undersigned ——————— [62 FR 13967, Mar. 24, 1997] hereby petitions the Administrator to ini- tiate proceedings for the issuance (amend- HEARINGS ment or repeal) of a rule or regulation pursu- ant to section 201 of the Controlled Sub- § 1308.41 Hearings generally. stances Act. In any case where the Administrator Attached hereto and constituting a part of this petition are the following: shall hold a hearing on the issuance, (A) The proposed rule in the form proposed amendment, or repeal of rules pursuant by the petitioner. (If the petitioner seeks the to section 201 of the Act, the proce- amendment or repeal of an existing rule, the dures for such hearing and accom- existing rule, together with a reference to panying proceedings shall be governed the section in the Code of Federal Regula- generally by the rulemaking proce- tions where it appears, should be included.) dures set forth in the Administrative (B) A statement of the grounds which the Procedure Act (5 U.S.C. 551–559) and petitioner relies for the issuance (amend- ment or repeal) of the rule. (Such grounds specifically by section 201 of the Act (21 shall include a reasonably concise statement U.S.C. 811), by §§ 1308.42–1308.51, and by of the facts relied upon by the petitioner, in- §§ 1316.41–1316.67 of this chapter. cluding a summary of any relevant medical or scientific evidence known to the peti- § 1308.42 Purpose of hearing. tioner.) If requested by any interested person All notices to be sent regarding this peti- after proceedings are initiated pursu- tion should be addressed to: ant to § 1308.43, the Administrator shall llllllllllllllllllllllll hold a hearing for the purpose of re- (Name) ceiving factual evidence and expert opinion regarding the issues involved llllllllllllllllllllllll in the issuance, amendment or repeal (Street Address) of a rule issuable pursuant to section 201(a) of the Act (21 U.S.C. 811(a)). Ex- llllllllllllllllllllllll tensive argument should not be offered (City and State) into evidence but rather presented in opening or closing statements of coun- Respectfully yours, sel or in memoranda or proposed find- llllllllllllllllllllllll ings of fact and conclusions of law. Ad- ditional information relating to hear- (Signature of petitioner) ings to include waivers or modification of rules, request for hearing, burden of (c) Within a reasonable period of proof, time and place, and final order time after the receipt of a petition, the are set forth in part 1316 of this chap- Administrator shall notify the peti- ter. tioner of his acceptance or nonaccept- ance of the petition, and if not accept- [62 FR 13968, Mar. 24, 1997] ed, the reason therefor. The Adminis- trator need not accept a petition for § 1308.43 Initiation of proceedings for rulemaking. filing if any of the requirements pre- scribed in paragraph (b) of this section (a) Any interested person may sub- is lacking or is not set forth so as to be mit a petition to initiate proceedings readily understood. If the petitioner for the issuance, amendment, or repeal desires, he may amend the petition to of any rule or regulation issuable pur- meet the requirements of paragraph (b) suant to the provisions of section 201 of of this section. If accepted for filing, a the Act. petition may be denied by the Adminis- (b) Petitions shall be submitted in trator within a reasonable period of quintuplicate to the Administrator in time thereafter if he finds the grounds the following form: upon which the petitioner relies are llllllllllllllllllllllll not sufficient to justify the initiation (Date) of proceedings.
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(d) The Administrator shall, before (g) The Administrator may permit initiating proceedings for the issuance, any interested persons to file written amendment, or repeal of any rule ei- comments on or objections to the pro- ther to control a drug or other sub- posal and shall designate in the notice stance, or to transfer a drug or other of proposed rule making the time dur- substance from one schedule to an- ing which such filings may be made. other, or to remove a drug or other [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance entirely from the schedules, FR 26609, Sept. 24, 1973, and further redesig- and after gathering the necessary data, nated and amended at 62 FR 13968, Mar. 24, request from the Secretary a scientific 1997] and medical evaluation and the Sec- retary’s recommendations as to wheth- § 1308.44 Request for hearing or ap- pearance; waiver. er such drug or other substance should be so controlled, transferred, or re- (a) Any interested person desiring a moved as a controlled substance. The hearing on a proposed rulemaking, recommendations of the Secretary to shall, within 30 days after the date of the Administrator shall be binding on publication of notice of the proposed the Administrator as to such scientific rulemaking in the FEDERAL REGISTER, and medical matters, and if the Sec- file with the Administrator a written retary recommends that a drug or request for a hearing in the form pre- other substance not be controlled, the scribed in § 1316.47 of this chapter. Administrator shall not control that (b) Any interested person desiring to drug or other substance. participate in a hearing pursuant to § 1308.41 shall, within 30 days after the (e) If the Administrator determines date of publication of the notice of that the scientific and medical evalua- hearing in the FEDERAL REGISTER, file tion and recommendations of the Sec- with the Administrator a written no- retary and all other relevant data con- tice of his intention to participate in stitute substantial evidence of poten- such hearing in the form prescribed in tial for abuse such as to warrant con- § 1316.48 of this chapter. Any person fil- trol or additional control over the drug ing a request for a hearing need not or other substance, or substantial evi- also file a notice of appearance; the re- dence that the drug or other sub- quest for a hearing shall be deemed to stances should be subjected to lesser be a notice of appearance. control or removed entirely from the (c) Any interested person may, with- schedules, he shall initiate proceedings in the period permitted for filing a re- for control, transfer, or removal as the quest for a hearing, file with the Ad- case may be. ministrator a waiver of an opportunity (f) If and when the Administrator de- for a hearing or to participate in a termines to initiate proceedings, he hearing, together with a written state- shall publish in the FEDERAL REGISTER ment regarding his position on the general notice of any proposed rule matters of fact and law involved in making to issue, amend, or repeal any such hearing. Such statement, if ad- rule pursuant to section 201 of the Act. missible, shall be made a part of the Such published notice shall include a record and shall be considered in light statement of the time, place, and na- of the lack of opportunity for cross-ex- ture of any hearings on the proposal in amination in determining the weight the event a hearing is requested pursu- to be attached to matters of fact as- ant to § 1308.44. Such hearings may not serted therein. be commenced until after the expira- (d) If any interested person fails to tion of at least 30 days from the date file a request for a hearing; or if he so the general notice is published in the files and fails to appear at the hearing, FEDERAL REGISTER. Such published no- he shall be deemed to have waived his tice shall also include a reference to opportunity for the hearing or to par- the legal authority under which the ticipate in the hearing, unless he shows rule is proposed, a statement of the good cause for such failure. proposed rule, and, in the discretion of (e) If all interested persons waive or the Administrator, a summary of the are deemed to waive their opportunity subjects and issues involved. for the hearing or to participate in the
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hearing, the Administrator may cancel specify in the order his findings as to the hearing, if scheduled, and issue his such conditions. final order pursuant to § 1308.45 without [38 FR 8254, Mar. 30, 1973. Redesignated at 38 a hearing. FR 26609, Sept. 24, 1973, and further redesig- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 nated at 62 FR 13968, Mar. 24, 1997] FR 26609, Sept. 24, 1973, and further redesig- nated and amended at 62 FR 13968, Mar. 24, § 1308.47 Control of immediate precur- 1997] sors. Pursuant to section 201(e) of the Act § 1308.45 Final order. (21 U.S.C. 811(e)), the Administrator As soon as practicable after the pre- may, without regard to the findings re- siding officer has certified the record quired by subsection 201(a) or 202 (b) of to the Administrator, the Adminis- the Act (21 U.S.C. 811(a) or 812(b)) and trator shall cause to be published in without regard to the procedures pre- the FEDERAL REGISTER his order in the scribed by § 1308.41 or subsections 201 proceeding, which shall set forth the (a) and (b) of the Act (21 U.S.C. 811(a) final rule and the findings of fact and and (b)), issue and publish in the FED- conclusions of law upon which the rule ERAL REGISTER an order controlling an is based. This order shall specify the immediate precursor. The order shall date on which it shall take effect, designate the schedule in which the im- which shall not be less than 30 days mediate precursor is to be placed, from the date of publication in the which shall be the same schedule in FEDERAL REGISTER unless the Adminis- which the controlled substance of trator finds that conditions of public which it is an immediate precursor is health or safety necessitate an earlier placed or any other schedule with a effective date, in which event the Ad- higher numerical designation. An order ministrator shall specify in the order controlling an immediate precursor his findings as to such conditions. shall become effective 30 days from the date of publication in the FEDERAL [38 FR 8254, Mar. 30, 1973. Redesignated at 38 REGISTER, unless the Administrator FR 26609, Sept. 24, 1973, and further redesig- nated at 62 FR 13968, Mar. 24, 1997] finds that conditions of public health or safety necessitate an earlier effec- § 1308.46 Control required under inter- tive date, in which event the Adminis- national treaty. trator shall specify in the order his findings as to such conditions. Pursuant to section 201(d) of the Act (21 U.S.C. 811(d) ), where control of a [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance is required by U.S. obliga- FR 26609, Sept. 24, 1973, and further redesig- tions under international treaties, con- nated at 62 FR 13968, Mar. 24, 1997] ventions, or protocols in effect on May 1, 1971, the Administrator shall issue § 1308.49 Emergency scheduling. and publish in the FEDERAL REGISTER Pursuant to 21 U.S.C. 811(h) and with- an order controlling such substance out regard to the requirements of 21 under the schedule he deems most ap- U.S.C. 811(b) relating to the scientific propriate to carry out obligations. and medical evaluation of the Sec- Issuance of such an order shall be with- retary of Health and Human Services, out regard to the findings required by the Administrator may place a sub- subsections 201(a) or 202(b) of the Act stance into Schedule I on a temporary (21 U.S.C. 811(a) or 812(b)) and without basis, if he determines that such action regard to the procedures prescribed by is necessary to avoid an imminent haz- § 1308.41 or subsections 201 (a) and (b) of ard to the public safety. An order the Act (21 U.S.C. 811 (a) and (b)). An issued under this section may not be order controlling a substance shall be- effective before the expiration of 30 come effective 30 days from the date of days from: publication in the FEDERAL REGISTER, (a) The date of publication by the Ad- unless the Administrator finds that ministrator of a notice in the FEDERAL conditions of public health or safety REGISTER of his intention to issue such necessitate an earlier effective date, in order and the grounds upon which such which event the Administrator shall order is to be issued, and
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(b) The date the Administrator has 1309.35 Additional information. transmitted notification to the Sec- 1309.36 Amendments to and withdrawals of retary of Health and Human Services applications. of his intention to issue such order. An ACTION ON APPLICATIONS FOR REGISTRATION: order issued under this section shall be REVOCATION OR SUSPENSION OF REGISTRATION vacated upon the conclusion of a subse- quent rulemaking proceeding initiated 1309.41 Administrative review generally. 1309.42 Certificate of registration; denial of under section 201(a) (21 U.S.C. 811(a)) registration. with respect to such substance or at 1309.43 Suspension or revocation of registra- the end of one year from the effective tion. date of the order scheduling the sub- 1309.44 Suspension of registration pending stance, except that during the pend- final order. ency of proceedings under section 1309.45 Extension of registration pending 201(a) (21 U.S.C. 811(a)) with respect to final order. the substance, the Administrator may 1309.46 Order to show cause. extend the temporary scheduling for up HEARINGS to six months. 1309.51 Hearings generally. [51 FR 15318, Apr. 23, 1986. Redesignated and 1309.52 Purpose of hearing. amended at 62 FR 13968, Mar. 24, 1997] 1309.53 Request for hearing or appearance; waiver. PART 1309—REGISTRATION OF 1309.54 Burden of proof. MANUFACTURERS, DISTRIBUTORS, 1309.55 Time and place of hearing. IMPORTERS AND EXPORTERS OF MODIFICATION, TRANSFER AND TERMINATION LIST I CHEMICALS OF REGISTRATION 1309.61 Modification in registration. GENERAL INFORMATION 1309.62 Termination of registration. Sec. 1309.63 Transfer of registration. 1309.01 Scope of part 1309. 1309.02 Definitions. SECURITY REQUIREMENTS 1309.03 Information; special instructions. 1309.71 General security requirements. FEES FOR REGISTRATION AND REREGISTRATION 1309.72 Felony conviction; employer respon- sibilities. 1309.11 Fee amounts. 1309.73 Employee responsibility to report di- 1309.12 Time and method of payment; re- version. fund. AUTHORITY: 21 U.S.C. 821, 822, 823, 824, 830, REQUIREMENTS FOR REGISTRATION 871(b), 875, 877, 958.
1309.21 Persons required to register. SOURCE: 60 FR 32454, June 22, 1995, unless 1309.22 Separate registration for inde- otherwise noted. pendent activities. 1309.23 Separate registration for separate GENERAL INFORMATION locations. 1309.24 Exemption of agents and employees. § 1309.01 Scope of part 1309. 1309.25 Exemption of certain controlled sub- stance registrants. Procedures governing the registra- 1309.26 Exemption of law enforcement offi- tion of manufacturers, distributors, cials. importers and exporters of List I 1309.27 Exemption of certain manufacturers. chemicals pursuant to Sections 102, 302, 1309.28 Exemption of distributors of regu- 303, 1007 and 1008 of the Act (21 U.S.C. lated prescription drug products. 802, 822, 823, 957 and 958) are set forth 1309.29 Exemption of retail distributors of generally by those sections and specifi- regulated drug products. cally by the sections of this part. APPLICATION FOR REGISTRATION § 1309.02 Definitions. 1309.31 Time for application for registra- tion; expiration date. Any term used in this part shall have 1309.32 Application forms; contents, signa- the definition set forth in section 102 of ture. the Act (21 U.S.C. 802) or part 1300 of 1309.33 Filing of application; joint filings. this chapter. 1309.34 Acceptance for filing; defective ap- plications. [62 FR 13968, Mar. 24, 1997]
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