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 5 VerDate 11<MAY>2000 08:46 May 09, 2001 Jkt 194070 PO 00000 Frm 00005 Fmt 8010 Sfmt 8010 Y:\SGML\194070T.XXX pfrm13 PsN: 194070T § 1300.01 21 CFR Ch. II (4–1–01 Edition) 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, 6 VerDate 11<MAY>2000 08:46 May 09, 2001 Jkt 194070 PO 00000 Frm 00006 Fmt 8010 Sfmt 8010 Y:\SGML\194070T.XXX pfrm13 PsN: 194070T Drug Enforcement Administration, Justice § 1300.01 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.