§ 1307.22 21 CFR Ch. II (4±1±96 Edition) laws and regulations adopted by any SCHEDULES State. 1308.11 Schedule I. [36 FR 7801, Apr. 24, 1971, as amended at 37 1308.12 Schedule II. FR 15922, Aug. 8, 1972. Redesignated at 38 FR 1308.13 Schedule III. 26609, Sept. 24, 1973, and amended at 47 FR 1308.14 Schedule IV. 41735, Sept. 22, 1982] 1308.15 Schedule V. § 1307.22 Disposal of controlled sub- EXCLUDED NONNARCOTIC SUBSTANCES stances by the Administration. 1308.21 Application for exclusion of a non- Any controlled substance delivered narcotic substance. to the Administration under § 1307.21 or 1308.22 Excluded substances. forfeited pursuant to section 511 of the EXEMPT CHEMICAL PREPARATIONS Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen- 1308.23 Exemption of certain chemical prep- arations; application. cy of the United States or of any State 1308.24 Exemption chemical preparations. upon proper application addressed to the Administrator, Drug Enforcement EXCLUDED VETERINARY ANABOLIC STEROID Administration, Department of Jus- IMPLANT PRODUCTS tice, Washington, DC 28083. The appli- 1308.25 Exclusion of a veterinary anabolic cation shall show the name, address, steroid implant product; application. and official title of the person or agen- 1308.26 Excluded veterinary anabolic steroid cy to whom the controlled drugs are to implant products. be delivered, including the name and quantity of the substances desired and EXEMPTED PRESCRIPTION PRODUCTS the purpose for which intended. The de- 1308.31 Application for exemption of a non- livery of such controlled drugs shall be narcotic prescription product. ordered by the Administrator, if, in his 1308.32 Exempted prescription products. opinion, there exists a medical or sci- EXEMPT ANABOLIC STEROID PRODUCTS entific need therefor. 1308.33 Exemption of certain anabolic ster- SPECIAL EXEMPT PERSONS oid products; application. 1308.34 Exempt anabolic steroid products. § 1307.31 Native American Church. HEARINGS The listing of peyote as a controlled substance in Schedule I does not apply 1308.41 Hearings generally. 1308.42 Purpose of hearing. to the nondrug use of peyote in bona 1308.43 Waiver or modification of Rules. fide religious ceremonies of the Native 1308.44 Initiation of proceedings for rule- American Church, and members of the making. Native American Church so using pe- 1308.45 Request for hearing or appearance; yote are exempt from registration. Any waiver. person who manufactures peyote for or 1308.46 Burden of proof. distributes peyote to the Native Amer- 1308.47 Time and place of hearing. ican Church, however, is required to 1308.48 Final order. obtain registration annually and to 1308.49 Control required under international comply with all other requirements of treaty. law. 1308.50 Control of immediate precursors. 1308.51 Pending proceedings. 1308.52 Emergency sheduling. PART 1308ÐSCHEDULES OF AUTHORITY: 21 U.S.C. 811, 812, 871(b), unless CONTROLLED SUBSTANCES otherwise noted. Sec. SOURCE: 38 FR 8254, Mar. 30, 1973, unless otherwise noted. Redesignated at 38 FR 26609, GENERAL INFORMATION Sept. 24, 1973. 1308.01 Scope of Part 1308. GENERAL INFORMATION 1308.02 Definitions. 1308.03 Administration Controlled Sub- § 1308.01 Scope of Part 1308. stances Code Number. 1308.04 Submission of information by manu- Schedules of controlled substances facturers. established by section 202 of the Act (21 82 VerDate 14<JUN>96 10:36 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00079 Fmt 8010 Sfmt 8010 C:\CFR\21V9C2.TXT pfrm13 Food and Drug Administration, HHS § 1308.02 U.S.C. 812), as they are changed, up- Services for such administration. If dated, and republished from time to any person prescribes, dispenses, or dis- time, are set forth in this part. tributes such steroid for human use, such person shall be considered to have § 1308.02 Definitions. prescribed, dispensed, or distributed an As used in this part, the following anabolic steroid within the meaning of terms shall have the meanings speci- this paragraph. fied: (c) The term hearing means any hear- (a) The term Act means the Con- ing held pursuant to this part for the trolled Substance Act (84 Stat. 1242; 21 issuance, amendment, or repeal of any U.S.C. 801) and/or the Controlled Sub- rule issuable pursuant to section 201 of stances Import and Export Act (84 the Act. Stat. 1285; 21 U.S.C. 951). (b) The term anabolic steroid means (d) The term isomer means the optical any drug or hormonal substance, isomer, except as used in § 1308.11(d) chemically and pharmacologically re- and § 1308.12(b)(4). As used in § 1308.11(d), lated to testosterone (other than the term isomer means the optical, po- estrogens, progestins, and sitional, or geometric isomer. As used corticosteroids) that promotes muscle in § 1308.12(b)(4), the term isomer means growth, and includes: the optical or geometric isomer. (1) Boldenone; (e) The term interested person means (2) Chlorotestosterone (4- any person adversely affected or ag- chlortestosterone); grieved by any rule or propored rule is- (3) Clostebol; suable pursuant to section 201 of the (4) Dehydrochlormethyltestosterone; Act. (5) Dihydrotestosterone (4- (f) The term narcotic drug means any dihydrotestosterone); of the following whether produced di- (6) Drostanolone; rectly or indirectly by extraction from (7) Ethylestrenol; substances of vegetable origin or inde- (8) Fluoxymesterone; (9) Formebulone (formebolone); pendently by means of chemical syn- (10) Mesterolone; thesis or by a combination of extrac- (11) Methandienone; tion and chemical synthesis: (12) Methandranone; (1) Opium, opiates, derivatives of (13) Methandriol; opium and opiates, including their iso- (14) Methandrostenolone; mers, esters, ethers, salts, and salts of (15) Methenolone; isomers, esters, and ethers whenever (16) Methyltestosterone; the existence of such isomers, esters, (17) Mibolerone; ethers and salts is possible within the (18) Nandrolone; specific chemical designation. Such (19) Norethandrolone; term does not include the isoquinoline (20) Oxandrolone; alkaloids of opium. (21) Oxymesterone; (2) Poppy straw and concentrate of (22) Oxymetholone; (23) Stanolone; poppy straw. (24) Stanozolol; (3) Coca leaves, except coco leaves (25) Testolactone; and extracts of coca leaves from which (26) Testosterone; cocaine, ecgonine and derivatives of ec- (27) Trenbolone; and gonine or their salts have been re- (28) Any salt, ester, or isomer of a moved. drug or substance described or listed in (4) Cocaine, its salts, optical and geo- this paragraph, if that salt, ester, or metric isomers, and salts of isomers. isomer promotes muscle growth. Ex- (5) Ecgonine, its derivatives, their cept such term does not include an an- salts, isomers and salts of isomers. abolic steroid which is expressly in- (6) Any compotnd, mixture, or prepa- tended for administration through im- ration which contains any quantity of plants to cattle or other nonhuman any of the substances referred to in species and which has been approved by subparagraphs (1) through (5). the Secretary of Health and Human 83 VerDate 14<JUN>96 10:36 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00080 Fmt 8010 Sfmt 8010 C:\CFR\21V9C2.TXT pfrm13 § 1308.03 21 CFR Ch. II (4±1±96 Edition) (g) The term proceeding means all ac- tration Controlled Substances Code tions taken for the issuance, amend- Number for any purpose. ment, or repeal of any rule issued pur- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 suant to section 201 of the Act, com- FR 26609, Sept. 24, 1973 and amended at 51 FR mencing with the publication by the 15318, Apr. 23, 1986] Administrator of the proposed rule, amended rule, or repeal in the FEDERAL § 1308.04 Submission of information by REGISTER. manufacturers. (h) Any term not defined in this sec- (a) Each person who manufactures, tion shall have the definition set forth packages, repackages, labels, relabels, in section 102 and 1001 of the Act (21 or distributes under his own label any U.S.C. 802 and 951) and § 1301.02 of this product (including any compound, mix- chapter. ture, or preparation, diagnostic, rea- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 gent, buffer, or biological) containing FR 26609, Sept. 24, 1973, and amended at 51 any quantity of any controlled sub- FR 15317, Apr. 23, 1986; 56 FR 5754, Feb. 13, stance (whether such product is itself 1991] controlled or is excepted, exempted, or excluded from some or all controls pur- § 1308.03 Administration Controlled suant to § 1308.21±24 or § 1308.31±32) shall Substances Code Number. submit information required in para- (a) Each controlled substance, or graph (b) of this section for each such basic class thereof, has been assigned product being manufactured or sold on an ``Administration Controlled Sub- July 1, 1972. The information should be stances Code Number'' for purposes of submitted by registered mail, return identification of the substances or receipt requested, to the Regulatory class on certain Certificates of Reg- Support Section, Attention: Project istration issued by the Administration Label, Drug Enforcement Administra- pursuant to §§ 1301.44 and 1311.43 of this tion, Department of Justice, Washing- chapter and on certain order forms is- ton, DC 20537, by August 31, 1972. In the sued by the Administration pursuant case of new products manufactured to § 1305.05(d) of this chapter. Appli- after July 1, 1972, or new dosage forms cants for procurement and/or individ- or other unit forms manufactured after ual manufacturing quotas must include July 1, 1972, or changes in information the appropriate code number on the ap- submitted by August 31, 1972, the reg- plication as required in §§ 1303.12(b) and istrant shall submit the information 1303.22(a) of this chapter. Applicants regarding such item within 30 days for import and export permits must in- after the date on which the manufac- clude the appropriate code number on ture commences or information change occurs.