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Title 21–Food and Drugs

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Title 21–Food and Drugs Title 21–Food and Drugs (This book contains part 1300 to End) Part CHAPTER II—Drug Enforcement Administration, Depart- ment of Justice .................................................................. 1301 CHAPTER III—Office of National Drug Control Policy ............ 1401 1 VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00011 Fmt 8008 Sfmt 8008 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00012 Fmt 8008 Sfmt 8008 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR CHAPTER II—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE Part Page 1300 Definitions .............................................................. 5 1301 Registration of manufacturers, distributors, and dispensers of controlled substances ..................... 21 1302 Labeling and packaging requirements for con- trolled substances ................................................ 54 1303 Quotas ..................................................................... 56 1304 Records and reports of registrants .......................... 64 1305 Orders for schedule I and II controlled substances 82 1306 Prescriptions ........................................................... 90 1307 Miscellaneous .......................................................... 102 1308 Schedules of controlled substances ......................... 105 1309 Registration of manufacturers, distributors, im- porters and exporters of list I chemicals .............. 129 1310 Records and reports of listed chemicals and certain machines .............................................................. 140 1311 Requirements for electronic orders and prescrip- tions ..................................................................... 164 1312 Importation and exportation of controlled sub- stances ................................................................. 185 1313 Importation and exportation of list I and list II chemicals ............................................................. 199 1314 Retail sale of scheduled listed chemical products ... 210 1315 Importation and production quotas for ephedrine, pseudoephedrine, and phenylpropanolamine ........ 218 1316 Administrative functions, practices, and proce- dures ..................................................................... 228 1321 DEA Mailing addresses ............................................ 241 1322–1399 [Reserved] 3 VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00013 Fmt 8008 Sfmt 8008 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00014 Fmt 8008 Sfmt 8008 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR PART 1300—DEFINITIONS (8) 1-androstenedione ([5a]-androst-1- en-3,17-dione) Sec. (9) 4-androstenedione (androst-4-en- 1300.01 Definitions relating to controlled 3,17-dione) substances. (10) 5-androstenedione (androst-5-en- 1300.02 Definitions relating to listed chemi- 3,17-dione) cals. (11) bolasterone (7a,17a-dimethyl-17b- 1300.03 Definitions relating to electronic or- hydroxyandrost-4-en-3-one) ders for controlled substances and elec- tronic prescriptions for controlled sub- (12) boldenone (17b-hydroxyandrost-1,4- stances. diene-3-one) 1300.04 Definitions relating to the dis- (13) boldione (androsta-1,4-diene-3,17- pensing of controlled substances by dione) means of the Internet. (14) calusterone (7b,17a-dimethyl-17b- AUTHORITY: 21 U.S.C. 802, 821, 829, 871(b), hydroxyandrost-4-en-3-one) 951, 958(f). (15) clostebol (4-chloro-17b- SOURCE: 62 FR 13941, Mar. 24, 1997, unless hydroxyandrost-4-en-3-one) otherwise noted. (16) dehydrochloromethyltestosterone (4-chloro-17b-hydroxy-17a-methyl- § 1300.01 Definitions relating to con- androst-1,4-dien-3-one) trolled substances. (17) desoxymethyltestosterone (17a- (a) Any term not defined in this part methyl-5a-androst-2-en-17b-ol) shall have the definition set forth in (a.k.a. ‘madol‘) section 102 of the Act (21 U.S.C. 802), (18) D1-dihydrotestosterone (a.k.a.‘1- except that certain terms used in part testosterone‘) (17b-hydroxy-5a- 1316 of this chapter are defined at the androst-1-en-3-one) beginning of each subpart of that part. (19) 4-dihydrotestosterone (17b-hy- (b) As used in parts 1301 through 1308 droxy-androstan-3-one) and part 1312 of this chapter, the fol- (20) drostanolone (17b-hydroxy-2a- lowing terms shall have the meanings methyl-5a-androstan-3-one) specified: (21) ethylestrenol (17a-ethyl-17b- Act means the Controlled Substances hydroxyestr-4-ene) Act, as amended (84 Stat. 1242; 21 U.S.C. (22) fluoxymesterone (9-fluoro-17a- 801) and/or the Controlled Substances methyl-11b,17b-dihydroxyandrost-4- Import and Export Act, as amended (84 en-3-one) Stat. 1285; 21 U.S.C. 951). (23) formebolone (2-formyl-17a-methyl- Administration means the Drug En- 11a,17b-dihydroxyandrost-1,4-dien-3- forcement Administration. one) Administrator means the Adminis- (24) furazabol (17a-methyl-17b- trator of the Drug Enforcement Admin- hydroxyandrostano[2,3-c]-furazan) istration. The Administrator has been (25) 13b-ethyl-17b-hydroxygon-4-en-3- delegated authority under the Act by one the Attorney General (28 CFR 0.100). (26) 4-hydroxytestosterone (4,17b- Anabolic steroid means any drug or dihydroxy-androst-4-en-3-one) hormonal substance, chemically and (27) 4-hydroxy-19-nortestosterone pharmacologically related to testos- (4,17b-dihydroxy-estr-4-en-3-one) terone (other than estrogens, (28) mestanolone (17a-methyl-17b-hy- progestins, corticosteroids, and droxy-5-androstan-3-one) dehydroepiandrosterone), and includes: (29) mesterolone (1a-methyl-17b-hy- (1) 3b,17-dihydroxy-5a-androstane droxy-[5a]-androstan-3-one) (2) 3a,17b-dihydroxy-5a-androstane (30) methandienone (17a-methyl-17b- (3) 5a-androstan-3,17-dione hydroxyandrost-1,4-dien-3-one) (4) 1-androstenediol (3b,17b-dihydroxy- (31) methandriol (17a-methyl-3b,17b- 5a-androst-1-ene) dihydroxyandrost-5-ene) (5) 1-androstenediol (3a,17b-dihydroxy- (32) Methasterone (2a,17a-dimethyl-5a- 5a-androst-1-ene) androstan-17b-ol-3-one) (6) 4-androstenediol (3b,17b-dihydroxy- (33) methenolone (1-methyl-17b-hy- androst-4-ene) droxy-5a-androst-1-en-3-one) (7) 5-androstenediol (3b,17b-dihydroxy- (34) 17a-methyl-3b,17b-dihydroxy-5a-an- androst-5-ene) drostane 5 VerDate Mar<15>2010 11:22 May 06, 2014 Jkt 232078 PO 00000 Frm 00015 Fmt 8010 Sfmt 8010 Y:\SGML\232078.XXX 232078 ehiers on DSK2VPTVN1PROD with CFR § 1300.01 21 CFR Ch. II (4–1–14 Edition) (35) 17a-methyl-3a,17b-dihydroxy-5a-an- (61) testolactone (13-hydroxy-3-oxo- drostane 13,17-secoandrosta-1,4-dien-17-oic (36) 17a-methyl-3b,17b- acid lactone) dihydroxyandrost-4-ene (62) testosterone (17b-hydroxyandrost- (37) 17a-methyl-4-hydroxynandrolone 4-en-3-one) (17a-methyl-4-hydroxy-17b- (63) tetrahydrogestrinone (13b, 17a- hydroxyestr-4-en-3-one) diethyl-17b-hydroxygon-4,9,11-trien- (38) methyldienolone (17a-methyl-17b- 3-one) hydroxyestra-4,9(10)-dien-3-one) (64) trenbolone (17b-hydroxyestr-4,9,11- trien-3-one) (39) methyltrienolone (17a-methyl-17b- (65) Any salt, ester, or ether of a drug hydroxyestra-4,9,11-trien-3-one) or substance described in this para- (40) methyltestosterone (17 -methyl- a graph. Except such term does not 17 -hydroxyandrost-4-en-3-one) b include an anabolic steroid that is (41) mibolerone (7a,17a-dimethyl-17b- expressly intended for administra- hydroxyestr-4-en-3-one) tion through implants to cattle or (42) 17a-methyl-D1-dihydrotestosterone other nonhuman species and that (17b-hydroxy-17a-methyl-5a- has been approved by the Secretary androst-1-en-3-one) (a.k.a. ‘17-a- of Health and Human Services for methyl-1-testosterone‘) such administration. If any person (43) nandrolone (17b-hydroxyestr-4-en-3- prescribes, dispenses, or distributes one) such steroid for human use, the (44) 19-nor-4-androstenediol (3b, 17b- person shall be considered to have dihydroxyestr-4-ene) prescribed, dispensed, or distrib- (45) 19-nor-4-androstenediol (3a, 17b- uted an anabolic steroid within the dihydroxyestr-4-ene) meaning of this paragraph. (46) 19-nor-5-androstenediol (3b, 17b- Automated dispensing system means a dihydroxyestr-5-ene) mechanical system that performs oper- (47) 19-nor-5-androstenediol (3a, 17b- ations or activities, other than dihydroxyestr-5-ene) compounding or administration, rel- (48) 19-nor-4,9(10)-androstadienedione ative to the storage, packaging, count- (estra-4,9(10)-diene-3,17-dione) ing, labeling, and dispensing of medica- (49) 19-nor-4-androstenedione (estr-4-en- tions, and which collects, controls, and 3,17-dione) maintains all transaction information. (50) 19-nor-5-androstenedione (estr-5-en- Basic class means, as to controlled 3,17-dione) substances listed in Schedules I and II: (51) norbolethone (13b, 17a-diethyl-17b- (1) Each of the opiates, including its hydroxygon-4-en-3-one) isomers, esters, ethers, salts, and salts (52) norclostebol (4-chloro-17b- of isomers, esters, and ethers whenever hydroxyestr-4-en-3-one) the existence of such isomers, esters, ethers, and salts is possible within the (53) norethandrolone (17a-ethyl-17b- hydroxyestr-4-en-3-one) specific chemical designation, listed in § 1308.11(b) of this chapter; (54) normethandrolone (17 -methyl-17 - a b (2) Each of the opium derivatives, in- hydroxyestr-4-en-3-one) cluding its salts, isomers, and salts of (55) oxandrolone (17a-methyl-17b-hy- isomers whenever the existence of such droxy-2-oxa-[5a]-androstan-3-one) salts, isomers, and salts of isomers is (56) oxymesterone (17a-methyl-4,17b- possible within
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