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Drug Enforcement Administration, Justice Pt. 1308

is listed in Schedule I or II) shall be ex- PART 1308—SCHEDULES OF empt from the requirement of registra- CONTROLLED SUBSTANCES tion pursuant to part 1301 of this chap- ter and, if such incidentally manufac- GENERAL INFORMATION tured substance is listed in Schedule I or II, shall be exempt from the require- Sec. ment of an individual manufacturing 1308.01 Scope of this part. quota pursuant to part 1303 of this 1308.02 Definitions. 1308.03 Administration Controlled Sub- chapter, if such substances are disposed stances Code Number. of in accordance with part 1317 of this chapter. SCHEDULES [79 FR 53565, Sept. 9, 2014] 1308.11 Schedule I. 1308.12 Schedule II. DISPOSAL OF CONTROLLED SUBSTANCES 1308.13 Schedule III. 1308.14 Schedule IV. § 1307.22 Delivery of surrendered and 1308.15 Schedule V. forfeited controlled substances. EXCLUDED NONNARCOTIC SUBSTANCES Any controlled substance surren- dered by delivery to the Administra- 1308.21 Application for exclusion of a non- narcotic substance. tion under part 1317 of this chapter or 1308.22 Excluded substances. forfeited pursuant to section 511 of the Act (21 U.S.C. 881) may be delivered to EXEMPT CHEMICAL PREPARATIONS any department, bureau, or other agen- 1308.23 Exemption of certain chemical prep- cy of the United States or of any State arations; application. upon proper application addressed to 1308.24 Exemption chemical preparations. the Office of Diversion Control, Drug Enforcement Administration. See the EXCLUDED VETERINARY ANABOLIC STEROID Table of DEA Mailing Addresses in IMPLANT PRODUCTS § 1321.01 of this chapter for the current 1308.25 Exclusion of a veterinary anabolic mailing address. The application shall steroid implant product; application. show the name, address, and official 1308.26 Excluded veterinary anabolic steroid title of the person or agency to whom implant products. the controlled drugs are to be deliv- EXEMPTED PRESCRIPTION PRODUCTS ered, including the name and quantity 1308.31 Application for exemption of a non- of the substances desired and the pur- narcotic prescription product. pose for which intended. The delivery 1308.32 Exempted prescription products. of such controlled drugs shall be or- dered by the Administrator, if, in his EXEMPT ANABOLIC STEROID PRODUCTS opinion, there exists a medical or sci- 1308.33 Exemption of certain anabolic ster- entific need therefor. oid products; application. 1308.34 Exempt anabolic steroid products. [75 FR 10678, Mar. 9, 2010, as amended at 79 FR 53565, Sept. 9, 2014] EXEMPT CANNABIS PLANT MATERIAL, AND PRODUCTS MADE THEREFROM, THAT CONTAIN SPECIAL EXEMPT PERSONS TETRAHYDROCANNABINOLS § 1307.31 Native American Church. 1308.35 Exemption of certain cannabis plant material, and products made therefrom, The listing of peyote as a controlled that contain tetrahydrocannabinols. substance in Schedule I does not apply to the nondrug use of peyote in bona HEARINGS fide religious ceremonies of the Native 1308.41 Hearings generally. American Church, and members of the 1308.42 Purpose of hearing. Native American Church so using pe- 1308.43 Initiation of proceedings for rule- yote are exempt from registration. Any making. person who manufactures peyote for or 1308.44 Request for hearing or appearance; distributes peyote to the Native Amer- waiver. 1308.45 Final order. ican Church, however, is required to 1308.46 Control required under international obtain registration annually and to treaty. comply with all other requirements of 1308.47 Control of immediate precursors. law. 1308.49 Temporary scheduling.

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AUTHORITY: 21 U.S.C. 811, 812, 871(b), 956(b), Substances Code Number beneath or unless otherwise noted. beside the name of each controlled sub- SOURCE: 38 FR 8254, Mar. 30, 1973, unless stance listed on the DEA Form 236 otherwise noted. Redesignated at 38 FR 26609, (Controlled Substance Import/Export Sept. 24, 1973. Declaration) which is executed for such importation or exportation as required GENERAL INFORMATION in §§ 1312.18(c) and 1312.27(b) of this § 1308.01 Scope of this part. chapter. (b) Except as stated in paragraph (a) Schedules of controlled substances established by section 202 of the Act (21 of this section, no applicant or reg- U.S.C. 812) and nonnarcotic substances, istrant is required to use the Adminis- chemical preparations, veterinary ana- tration Controlled Substances Code bolic steroid implant products, pre- Number for any purpose. scription products, anabolic steroid [38 FR 8254, Mar. 30, 1973. Redesignated at 38 products, and cannabis plant material FR 26609, Sept. 24, 1973 and amended at 51 FR and products made therefrom that con- 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] tain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 SCHEDULES U.S.C. 811), as they are changed, up- dated, and republished from time to § 1308.11 Schedule I. time, are set forth in this part. (a) Schedule I shall consist of the [81 FR 97021, Dec. 30, 2016] drugs and other substances, by what- ever official name, common or usual § 1308.02 Definitions. name, chemical name, or brand name Any term contained in this part shall designated, listed in this section. Each have the definition set forth in section drug or substance has been assigned 102 of the Act (21 U.S.C. 802) or part the DEA Controlled Substances Code 1300 of this chapter. Number set forth opposite it. (b) Opiates. Unless specifically ex- [62 FR 13967, Mar. 24, 1997] cepted or unless listed in another § 1308.03 Administration Controlled schedule, any of the following opiates, Substances Code Number. including their isomers, esters, ethers, (a) Each controlled substance, or salts, and salts of isomers, esters and basic class thereof, has been assigned ethers, whenever the existence of such an ‘‘Administration Controlled Sub- isomers, esters, ethers and salts is pos- stances Code Number’’ for purposes of sible within the specific chemical des- identification of the substances or ignation (for purposes of paragraph class on certain Certificates of Reg- (b)(39) only, the term isomer includes istration issued by the Administration the optical and geometric isomers): pursuant to §§ 1301.35 of this chapter (1) Acetyl-alpha- and on certain order forms issued by methylfentanyl (N-[1-(1-meth- the Administration pursuant to yl-2-phenethyl)-4- § 1305.05(d) of this chapter. Applicants piperidinyl]-N- for procurement and/or individual man- phenylacetamide) ...... 9815 ufacturing quotas must include the ap- (2) Acetylmethadol ...... 9601 propriate code number on the applica- (3) Acetyl fentanyl (N-(1- tion as required in §§ 1303.12(b) and phenethylpiperidin-4-yl)-N- 1303.22(a) of this chapter. Applicants phenylacetamide) ...... 9821 for import and export permits must in- clude the appropriate code number on (4) Acryl fentanyl (N-(1- the application as required in phenethylpiperidin-4-yl)-N- §§ 1312.12(a) and 1312.22(a) of this chap- phenylacrylamide; other ter. Authorized registrants who desire name: acryloylfentanyl) ...... 9811 to import or export a controlled sub- (5) AH-7921 (3,4-dichloro-N-[(1- stance for which an import or export dimethylamino) permit is not required must include the cyclohexylmethyl]benzamide 9551 appropriate Administration Controlled (6) Allylprodine ...... 9602

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(7) Alphacetylmethadol (except (37) Ketobemidone ...... 9628 levo-alphacetylmethadol also (38) Levomoramide ...... 9629 known as levo-alpha- (39) Levophenacylmorphan ...... 9631 acetylmethadol, (40) 3-Methylfentanyl (N-[3- levomethadyl acetate, or methyl-1-(2-phenylethyl)-4- LAAM) ...... 9603 piperidyl]-N- (8) Alphameprodine ...... 9604 phenylpropanamide) ...... 9813 (9) Alphamethadol ...... 9605 (41) 3-methylthiofentanyl (N- (10) Alpha-methylfentanyl (N- [(3-methyl-1-(2-thienyl)ethyl- [1-(alpha-methyl-beta- 4-piperidinyl]-N- phenyl)ethyl-4-piperidyl] phenylpropanamide) ...... 9833 propionanilide; 1-(1-methyl-2- (42) Morpheridine ...... 9632 phenylethyl)-4-(N- (43) MPPP (1-methyl-4-phenyl- propanilido) ) ...... 9814 4-propionoxypiperidine) ...... 9661 (11) Alpha-methylthiofentanyl (44) MT–45 (1-cyclohexyl-4-(1,2- (N-[1-methyl-2-(2- diphenylethyl)) ..... (9560) thienyl)ethyl-4-piperidinyl]- (45) Noracymethadol ...... 9633 N-phenylpropanamide) ...... 9832 (46) Norlevorphanol ...... 9634 (12) Benzethidine ...... 9606 (47) Normethadone ...... 9635 (13) Betacetylmethadol ...... 9607 (48) Norpipanone ...... 9636 (14) Beta-hydroxyfentanyl (N- (49) Ocfentanil (N-(2- [1-(2-hydroxy-2-phenethyl)-4- fluorophenyl)-2-methoxy-N- piperidinyl]-N- (1-phenethylpiperidin-4- phenylpropanamide) ...... 9830 yl)acetamide) ...... 9838 (15) Beta-hydroxy-3- (50) Para-fluorofentanyl (N-(4- methylfentanyl (other name: fluorophenyl)-N-[1-(2- N-[1-(2-hydroxy-2-phenethyl)- phenethyl)-4-piperidinyl] 3-methyl-4-piperidinyl]-N- propanamide ...... 9812 phenylpropanamide ...... 9831 (51) PEPAP (1-(-2-phenethyl)-4- (16) Betameprodine ...... 9608 phenyl-4-acetoxypiperidine ... 9663 (17) Betamethadol ...... 9609 (52) Phenadoxone ...... 9637 (18) Betaprodine ...... 9611 (53) Phenampromide ...... 9638 (19) Butyryl fentanyl (N-(1- (54) Phenomorphan ...... 9647 phenethylpiperidin-4-yl)-N- (55) Phenoperidine ...... 9641 phenylbutyramide) ...... 9822 (56) Piritramide ...... 9642 (20) Clonitazene ...... 9612 (57) Proheptazine ...... 9643 (21) Dextromoramide ...... 9613 (58) Properidine ...... 9644 (22) Diampromide ...... 9615 (59) Propiram ...... 9649 (23) Diethylthiambutene ...... 9616 (60) Racemoramide ...... 9645 (24) Difenoxin ...... 9168 (61) Tetrahydrofuranyl fentanyl (25) Dimenoxadol ...... 9617 (N-(1-phenethylpiperidin-4- (26) Dimepheptanol ...... 9618 yl)-N-phenyltetrahydrofuran- (27) Dimethylthiambutene ...... 9619 2-carboxamide) ...... 9843 (28) Dioxaphetyl butyrate ...... 9621 (62) Thiofentanyl (N-phenyl-N- (29) Dipipanone ...... 9622 [1-(2-thienyl)ethyl-4- (30) Ethylmethylthiambutene .. 9623 piperidinyl]-propanamide ...... 9835 (31) Etonitazene ...... 9624 (63) Tilidine ...... 9750 (32) Etoxeridine ...... 9625 (64) Trimeperidine ...... 9646 (65) U–47700 (3,4-Dichloro-N-[2- (33) 4-Fluoroisobutyryl (dimethylamino)cyclohexyl]- fentanyl (N-(4-fluorophenyl)- N-methylbenzamide) ...... 9547 N-(1-phenethylpiperidin-4- yl)isobutyramide; other (c) Opium derivatives. Unless specifi- name: para-fluoroisobutyryl cally excepted or unless listed in an- fentanyl) ...... 9824 other schedule, any of the following (34) Furanyl fentanyl (N-(1- opium derivatives, its salts, isomers, phenethylpiperidin-4-yl)-N- and salts of isomers whenever the ex- phenylfuran-2-carboxamide) .. 9834 istence of such salts, isomers, and salts (35) Furethidine ...... 9626 of isomers is possible within the spe- (36) Hydroxypethidine ...... 9627 cific chemical designation: 113

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(1) Acetorphine ...... 9319 Some trade or other names: (2) Acetyldihydrocodeine ...... 9051 2-(4-bromo-2,5- (3) Benzylmorphine ...... 9052 dimethoxyphenyl)-1- aminoethane; alpha- (4) Codeine methylbromide ...... 9070 desmethyl DOB; -B, (5) Codeine-N-Oxide ...... 9053 Nexus. (6) Cyprenorphine ...... 9054 (4) 2,5- 7396 (7) Desomorphine ...... 9055 Some trade or other names: (8) Dihydromorphine ...... 9145 2,5-dimethoxy-a- (9) Drotebanol ...... 9335 methylphenethylamine; (10) Etorphine (except hydro- 2,5-DMA chloride salt) ...... 9056 (5) 2,5-dimethoxy-4- (11) Heroin ...... 9200 ethylamphet- ...... 7399 (12) Hydromorphinol ...... 9301 Some trade or other names: (13) Methyldesorphine ...... 9302 DOET (14) Methyldihydromorphine ...... 9304 (6) 2,5-dimethoxy-4-(n)- (15) Morphine methylbromide .... 9305 propylthiophenethylamine (16) Morphine methylsulfonate .. 9306 (other name: 2C–T–7) ...... 7348 (17) Morphine-N-Oxide ...... 9307 (7) 4-methoxyamphetamine ...... 7411 (18) Myrophine ...... 9308 Some trade or other names: (19) Nicocodeine ...... 9309 4-methoxy-a- (20) Nicomorphine ...... 9312 methylphenethylamine; (21) Normorphine ...... 9313 paramethoxyamphetami- ne, PMA (22) Pholcodine ...... 9314 (8) 5-methoxy-3,4- (23) Thebacon ...... 9315 methylenedioxy-amphet- (d) Hallucinogenic substances. Unless amine ...... 7401 specifically excepted or unless listed in (9) 4-methyl-2,5-dimethoxy-am- another schedule, any material, com- phetamine ...... 7395 pound, mixture, or preparation, which Some trade and other contains any quantity of the following names: 4-methyl-2,5- hallucinogenic substances, or which dimethoxy-a- contains any of its salts, isomers, and methylphenethylamine; salts of isomers whenever the existence ‘‘DOM’’; and ‘‘STP’’ of such salts, isomers, and salts of iso- (10) 3,4-methylenedioxy am- mers is possible within the specific phetamine ...... 7400 chemical designation (for purposes of (11) 3,4- this paragraph only, the term ‘‘isomer’’ methylenedioxymethamphet- includes the optical, position and geo- amine (MDMA) ...... 7405 metric isomers): (12) 3,4-methylenedioxy-N- ethylamphetamine (also (1) Alpha-ethyltryptamine ...... 7249 known as N-ethyl-alpha- Some trade or other names: methyl-3,4(methylenedioxy)- etryptamine; Monase; a- phenethylamine, N-ethyl ethyl-1H-indole-3- MDA, MDE, MDEA ...... 7404 ethanamine; 3-(2- (13) N-hydroxy-3,4- aminobutyl) indole; -ET; a methylenedioxyamphetamine and AET. (also known as N-hydroxy- (2) 4-bromo-2,5-dimethoxy-am- alpha-methyl- phetamine ...... 7391 3,4(methylenedioxy)- Some trade or other names: phenethylamine, and N-hy- 4-bromo-2,5-dimethoxy-a- droxy MDA ...... 7402 methylphenethylamine; (14) 3,4,5-trimethoxy amphet- 4-bromo-2,5-DMA amine ...... 7390 (3) 4-Bromo-2,5- dimethoxyphenethylamine .... 7392

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(15) 5-methoxy-N,N- Meaning all parts of the dimethyltryptamine Some plant presently classified trade or other names: 5- botanically as Lophophora methoxy-3-[2- williamsii Lemaire, wheth- (dimethylamino)ethyl]indole; er growing or not, the 5-MeO-DMT ...... 7431 seeds thereof, any extract (16) Alpha-methyltryptamine from any part of such (other name: AMT) ...... 7432 plant, and every com- (17) Bufotenine ...... 7433 pound, manufacture, Some trade and other salts, derivative, mixture, names: 3-(b- or preparation of such Dimethylaminoethyl)-5- plant, its seeds or ex- hydroxyindole; 3-(2- tracts dimethylaminoethyl)-5- (Interprets 21 USC 812(c), indolol; N, N- Schedule I(c) (12)) dimethylserotonin; 5-hy- (27) N-ethyl-3-piperidyl droxy-N,N- benzilate ...... 7482 dimethyltryptamine; (28) N-methyl-3-piperidyl mappine benzilate ...... 7484 (18) Diethyltryptamine ...... 7434 (29) Psilocybin ...... 7437 (30) Psilocyn ...... 7438 Some trade and other (31) Tetrahydrocannabinols ...... 7370 names: N,N- Meaning Diethyltryptamine; DET tetrahydrocannabinols (19) Dimethyltryptamine ...... 7435 naturally contained in a Some trade or other names: plant of the genus Can- DMT nabis (cannabis plant), as (20) 5-methoxy-N,N- well as synthetic equiva- diisopropyltryptamine (other lents of the substances name: 5-MeO-DIPT) ...... 7439 contained in the cannabis (21) ...... 7260 plant, or in the resinous Some trade and other extractives of such plant, names: 7-Ethyl- and/or synthetic sub- 6,6b,7,8,9,10,12,13- stances, derivatives, and octahydro-2-methoxy-6,9- their isomers with simi- methano-5H-pyrido [1′, lar chemical structure 2′:1,2] azepino [5,4-b] and pharmacological ac- indole; Tabernanthe iboga tivity to those substances (22) Lysergic acid diethylamide 7315 contained in the plant, (23) Marihuana ...... 7360 such as the following: (24) ...... 7381 1 cis or trans (25) Parahexyl—7374; some tetrahydrocannabinol, trade or other names: 3- and their optical isomers Hexyl-1-hydroxy-7,8,9,10- 6 cis or trans tetrahydro-6,6,9-trimethyl- tetrahydrocannabinol, 6H-dibenzo[b,d]pyran; and their optical isomers Synhexyl. 3, 4 cis or trans (26) Peyote ...... 7415 tetrahydrocannabinol, and its optical isomers (Since nomenclature of these substances is not internationally standard- ized, compounds of these structures, regardless of numerical designation of atomic positions cov- ered.) (32) Ethylamine analog of ...... 7455 115

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Some trade or other names: (48) (1-pentyl-1H-indol-3- N-ethyl-1- yl)(2,2,3,3- phenylcyclohexylamine, tetramethylcyclopropy- (1- l)methanone (UR-144) ...... (7144) phenylcyclohexy- (49) [1-(5-fluoro-pentyl)-1H- l)ethylamine, N-(1- indol-3-yl](2,2,3,3- phenylcyclohexy- tetramethylcyclopropy- l)ethylamine, l)methanone (5-fluoro-UR-144, cyclohexamine, PCE XLR11) ...... (7011) (33) analog of (50) N-(1-adamantyl)-1-pentyl- phencyclidine ...... 7458 1H-indazole-3-carboxamide Some trade or other names: (APINACA, AKB48) ...... (7048) 1-(1-phenylcyclohexyl)- (51) quinolin-8-yl 1-pentyl-1H- pyrrolidine, PCPy, PHP indole-3-carboxylate (PB-22; (34) Thiophene analog of QUPIC) ...... (7222) phencyclidine ...... 7470 (52) quinolin-8-yl 1-(5- Some trade or other names: fluoropentyl)-1H-indole-3- 1-[1-(2-thienyl)- carboxylate (5-fluoro-PB-22; cyclohexyl]-piperidine, 2- 5F-PB-22) ...... (7225) thienylanalog of (53) N-(1-amino-3-methyl-1- phencyclidine, TPCP, oxobutan-2-yl)-1-(4- TCP fluorobenzyl)-1H-indazole-3- (35) 1-[1-(2- carboxamide (AB- thieny- FUBINACA) ...... (7012) l)cyclohexyl]pyrrolidine ...... 7473 (54) N-(1-amino-3,3-dimethyl-1- Some other names: TCPy oxobutan-2-yl)-1-pentyl-1H- (36) 4-methylmethcathinone indazole-3-carboxamide () ...... 1248 (ADB-PINACA) ...... (7035) (37) 3,4- (55) 2-(4-iodo-2,5- methylenedioxypyrovalerone dimethoxyphenyl)-N-(2-me- (MDPV) ...... 7535 thoxybenzyl)ethanamine (25I- (38) 2-(2,5-Dimethoxy-4- NBOMe, 2C-I-NBOMe) ...... (7538) ethylphenyl)ethanamine (2C– (56) 2-(4-chloro-2,5- E) ...... 7509 dimethoxyphenyl)-N-(2-me- (39) 2-(2,5-Dimethoxy-4- thoxybenzyl)ethanamine methylphenyl)ethanamine (25C-NBOMe, 2C-C-NBOMe) ... (7537) (2C–D) ...... 7508 (57) 2-(4-bromo-2,5- (40) 2-(4-Chloro-2,5- dimethoxyphenyl)-N-(2-me- dimethoxyphenyl)ethanamine thoxybenzyl)ethanamine (2C–C) ...... 7519 (25B-NBOMe, 2C-B-NBOMe) ... (7536) (41) 2-(4-Iodo-2,5- (58) Marihuana Extract—Mean- dimethoxyphenyl)ethanamine ing an extract containing one (2C–I) ...... 7518 or more cannabinoids that (42) 2-[4-(Ethylthio)-2,5- has been derived from any dimethoxyphenyl]ethanamine plant of the genus Cannabis, (2C–T–2) ...... 7385 other than the separated (43) 2-[4-(Isopropylthio)-2,5- resin (whether crude or puri- dimethoxyphenyl]ethanamine fied) obtained from the plant (7350) (2C–T–4) ...... 7532 (59) 4-methyl-N-ethylcathinone (44) 2-(2,5- (4-MEC) ...... (1249) Dimethoxypheny- (60) 4-methyl-alpha- l)ethanamine (2C–H) ...... 7517 pyrrolidinopropiophenone (4- (45) 2-(2,5-Dimethoxy-4-nitro- MePPP) ...... (7498) phenyl)ethanamine (2C–N) .... 7521 (61) alpha- (46) 2-(2,5-Dimethoxy-4-(n)- pyrrolidinopentiophenone (a- propylphenyl)ethanamine PVP) ...... (7545) (2C–P) ...... 7524 (62) 1-(1,3-benzodioxol-5-yl)-2- (47) 3,4-Methylenedioxy-N- (methylamino)butan-1-one methylcathinone () 7540 (, bk-MBDB) ...... (7541) 116

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(63) 2-(methylamino)-1- mixture, or preparation which contains phenylpentan-1-one any quantity of the following sub- () ...... (1246) stances having a effect on (64) 1-(1,3-benzodioxol-5-yl)-2- the central nervous system, including (methylamino)pentan-1-one its salts, isomers, and salts of isomers: (, bk-MBDP) ...... (7542) (1) (Some other (65) 4-fluoro-N-methylcathinone names: aminoxaphen; 2-amino- (4-FMC; ) ...... (1238) 5-phenyl-2-; or 4,5- (66) 3-fluoro-N-methylcathinone dihydro-5-phenly-2- (3-FMC) ...... (1233) oxazolamine) ...... 1585 (67) 1-(naphthalen-2-yl)-2- (2) N- (some (pyrrolidin-1-yl)pentan-1-one other names: BZP, 1- () ...... (1258) benzylpiperazine) ...... 7493 (68) alpha- (3) ...... 1235 pyrrolidinobutiophenone (a- Some trade or other names: PBP) ...... (7546) 2-amino-1-phenyl-1- (69) N-(1-amino-3-methyl-1- propanone, alpha- oxobutan-2-yl)-1- aminopropiophenone, 2- (cyclohexylmethyl)-1H-inda- aminopropiophenone, and zole-3-carboxamide (AB- norephedrone CHMINACA) ...... (7031) (4) ...... 1503 (70) N-(1-amino-3-methyl-1- (5) (Some other oxobutan-2-yl)-1-pentyl-1H- names: 2-(methylamino)- indazole-3-carboxamide (AB- propiophenone; alpha- PINACA) ...... (7023) (methylamino)propiophenone; (71) [1-(5-fluoropentyl)-1H- 2-(methylamino)-1- indazol-3-yl](naphthalen-1- phenylpropan-1-one; alpha-N- yl)methanone (THJ-2201) ...... (7024) methylaminopropiophenone; (72) N-(1-amino-3,3-dimethyl-1- monomethylpropion; oxobutan-2-yl)-1- ephedrone; N- (cyclohexylmethyl)-1H-inda- methylcathinone; zole-3-carboxamide (MAB- methylcathinone; AL–464; AL– CHMINACA; ADB- 422; AL–463 and UR1432), its CHMINACA) ...... (7032) salts, optical isomers and salts (e) Depressants. Unless specifically of optical isomers ...... 1237 excepted or unless listed in another (6) (±)cis-4-methylaminorex schedule, any material, compound, ((±)cis-4,5-dihydro-4-methyl-5- mixture, or preparation which contains phenyl-2-oxazolamine) ...... 1590 any quantity of the following sub- (7) N-ethylamphetamine ...... 1475 stances having a depressant effect on (8) N,N- the central nervous system, including (also known as N,N-alpha- its salts, isomers, and salts of isomers trimethyl-benzeneethanamine; whenever the existence of such salts, N,N-alpha- isomers, and salts of isomers is possible trimethylphenethylamine) ..... 1480 within the specific chemical designa- (g) Cannabimimetic agents. Unless spe- tion: cifically exempted or unless listed in (1) gamma-hydroxybutyric acid another schedule, any material, com- (some other names include pound, mixture, or preparation which GHB; gamma- contains any quantity of the following hydroxybutyrate; 4- substances, or which contains their hydroxybutyrate; 4- salts, isomers, and salts of isomers hydroxybutanoic acid; sodium whenever the existence of such salts, oxybate; sodium oxybutyrate) 2010 isomers, and salts of isomers is possible (2) Mecloqualone ...... 2572 within the specific chemical designa- (3) Methaqualone ...... 2565 tion: (f) . Unless specifically ex- (1) 5-(1,1-dimethylheptyl)-2- cepted or unless listed in another [(1R,3S)-3-hydroxycyclohexyl]- schedule, any material, compound, phenol (CP–47,497) ...... 7297 117

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(2) 5-(1,1-dimethyloctyl)-2- (6) methyl 2-(1-(5- [(1R,3S)-3-hydroxycyclohexyl]- fluoropentyl)-1H-indazole-3- phenol (cannabicyclohexanol carboxamido)-3,3- or CP–47,497 C8-homolog) ...... 7298 dimethylbutanoate, its opti- (3) 1-pentyl-3-(1-naph- cal, positional, and geo- thoyl)indole (JWH–018 and metric isomers, salts and AM678) ...... 7118 salts of isomers (Other (4) 1-butyl-3-(1-naphthoyl)indole names: 5F–ADB; 5F–MDMB– (JWH–073) ...... 7173 PINACA) ...... (7034) (5) 1-hexyl-3-(1-naphthoyl)indole (7) methyl 2-(1-(5- (JWH–019) ...... 7019 fluoropentyl)-1H-indazole-3- (6) 1-[2-(4-morpholinyl)ethyl]-3- carboxamido)-3- (1-naphthoyl)indole (JWH–200) 7200 methylbutanoate, its opti- (7) 1-pentyl-3-(2- cal, positional, and geo- methoxyphenylacetyl)indole metric isomers, salts and (JWH–250) ...... 6250 salts of isomers (Other names: 5F–AMB)...... (7033) (8) 1-pentyl-3-[1-(4- methoxynaphthoyl)]indole (8) N-(adamantan-1-yl)-1-(5- (JWH–081) ...... 7081 fluoropentyl)-1H-indazole-3- carboxamide, its optical, po- (9) 1-pentyl-3-(4-methyl-1-naph- sitional, and geometric iso- thoyl)indole (JWH–122) ...... 7122 mers, salts and salts of iso- (10) 1-pentyl-3-(4-chloro-1-naph- mers (Other names: 5F– thoyl)indole (JWH–398) ...... 7398 APINACA, 5F–AKB48) ...... (7049) (11) 1-(5-fluoropentyl)-3-(1-naph- (9) N-(1-amino-3,3-dimethyl-1- thoyl)indole (AM2201) ...... 7201 oxobutan-2-yl)-1-(4- (12) 1-(5-fluoropentyl)-3-(2- fluorobenzyl)-1H-indazole-3- iodobenzoyl)indole (AM694) ..... 7694 carboxamide, its optical, po- (13) 1-pentyl-3-[(4-methoxy)-ben- sitional, and geometric iso- zoyl]indole (SR–19 and RCS–4) 7104 mers, salts and salts of iso- (14) 1-cyclohexylethyl-3-(2- mers (Other names: ADB– methoxyphenylacetyl)indole FUBINACA) ...... (7010) 7008 (SR–18 and RCS–8) ...... 7008 (10) methyl 2-(1- (15) 1-pentyl-3-(2- (cyclohexylmethyl)-1H- chlorophenylacetyl)indole indole-3-carboxamido)-3,3- (JWH–203) ...... 7203 dimethylbutanoate, its opti- (h) Temporary listing of substances sub- cal, positional, and geo- ject to emergency scheduling. Any mate- metric isomers, salts and rial, compound, mixture or preparation salts of isomers (Other names: MDMB–CHMICA, which contains any quantity of the fol- MMB–CHMINACA) ...... (7042) lowing substances: (11) methyl 2-(1-(4- (1) [Reserved]. fluorobenzyl)-1H-indazole-3- (2) [Reserved]. carboxamido)-3,3- (3) N-[1-[2-hydroxy-2- dimethylbutanoate, its opti- (thiophen-2- cal, positional, and geo- yl)ethyl]piperidin-4-yl]-N- metric isomers, salts and phenylpropionamide, its iso- salts of isomers (Other mers, esters, ethers, salts names: MDMB–FUBINACA) (7020) and salts of isomers, esters (12) [Reserved]. and ethers (Other names: (13) [Reserved]. beta-hydroxythiofentanyl) .. (9836) (14) [Reserved]. (4) [Reserved]. (15) [Reserved]. (5) [Reserved]. (16) [Reserved]. (17) [Reserved].

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(18) methyl 2-(1-(4- (26) N-(4-chlorophenyl)-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4- carboxamido)-3- yl)isobutyramide, its iso- methylbutanoate, its opti- mers, esters, ethers, salts cal, positional, and geo- and salts of isomers, esters metric isomers, salts and and ethers (Other name: salts of isomers (Other para-chloroisobutyryl names: FUB–AMB, MMB– fentanyl) ...... (9826) FUBINACA, AMB– (27) N-(1-phenethylpiperidin-4- FUBINACA) ...... (7021) yl)-N-phenylisobutyramide, (19) N-(2-fluorophenyl)-N-(1- its isomers, esters, ethers, phenethylpiperidin-4- salts and salts of isomers, yl)propionamide, its iso- esters and ethers (Other mers, esters, ethers, salts name: isobutyryl fentanyl) .. (9827) and salts of isomers, esters (28) N-(1-phenethylpiperidin-4- and ethers (Other names: yl)-N- ortho-fluorofentanyl, 2- phenylcyclopentanecarboxa- fluorofentanyl) ...... (9816) mide, its isomers, esters, (20) [Reserved]. ethers, salts and salts of iso- (21) 2-methoxy-N-(1- mers, esters and ethers phenethylpiperidin-4-yl)-N- (Other name: cyclopentyl phenylacetamide, its iso- fentanyl) ...... (9847) (29) [Reserved]. mers, esters, ethers, salts (30) Fentanyl-related sub- and salts of isomers, esters stances, their isomers, and ethers (Other name: esters, ethers, salts and salts methoxyacetyl fentanyl) ..... (9825) of isomers, esters and ethers 9850 (22) N-(1-phenethylpiperidin-4- yl)-N- (i) Fentanyl-related substance means phenylcyclopropanecarboxa- any substance not otherwise listed mide, its isomers, esters, under another Administration Con- ethers, salts and salts of iso- trolled Substance Code Number, and mers, esters and ethers for which no exemption or approval is (Other name: cyclopropyl in effect under section 505 of the Fed- fentanyl) ...... (9845) eral Food, Drug, and Cosmetic Act [21 (23) N-(1-phenethylpiperidin-4- U.S.C. 355], that is structurally related yl)-N-phenylpentanamide, to fentanyl by one or more of the fol- its isomers, esters, ethers, lowing modifications: salts and salts of isomers, (A) Replacement of the phenyl por- esters and ethers (Other tion of the phenethyl group by any name: Valeryl fentanyl) ...... (9840) monocycle, whether or not further sub- stituted in or on the monocycle; (24) N-(4-fluorophenyl)-N-(1- (B) Substitution in or on the phenethylpiperidin-4- phenethyl group with alkyl, alkenyl, yl)butyramide, its isomers, alkoxyl, hydroxyl, halo, haloalkyl, esters, ethers, salts and salts amino or nitro groups; of isomers, esters and ethers (C) Substitution in or on the piper- (Other name: para- idine ring with alkyl, alkenyl, alkoxyl, fluorobutyryl fentanyl) ...... (9823) ester, ether, hydroxyl, halo, haloalkyl, (25) N-(4-methoxyphenyl)-N-(1- amino or nitro groups; phenethylpiperidin-4- (D) Replacement of the aniline ring yl)butyramide, its isomers, with any aromatic monocycle whether esters, ethers, salts and salts or not further substituted in or on the of isomers, esters and ethers aromatic monocycle; and/or (Other name: para- (E) Replacement of the N-propionyl methoxybutyryl fentanyl) ... (9837) group by another acyl group. (ii) This definition includes, but is not limited to, the following sub- stances: (A)–(B) [Reserved] 119

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EFFECTIVE DATE NOTES: At 82 FR 17123, (31) Naphthalen-1-yl 1-(5- Apr. 10, 2017, § 1308.11 was amended by adding fluoropentyl)-1H-indole-3- paragraphs (h)(10) through (15), effective Apr. carboxylate, its optical, po- 10. 2017 through Apr. 10, 2019. sitional, and geometric iso- 2. At 82 FR 20547, May 3, 2017, § 1308.11 was mers, salts and salts of iso- amended by adding (h)(16), effective May 3, mers (Other names: NM2201; 2017, until May 3, 2019. At 82 FR 47974, Oct. 16, CBL2201) ...... (7221) 2017, § 1308.11 was amended by redesignating (h)(16) as paragraph (h)(13). (32) N-(1-amino-3-methyl-1- 3. At 82 FR 32457, July 14, 2017, § 1308.11 was oxobutan-2-yl)-1-(5- amended by adding (h)(17), effective July 14, fluoropentyl)-1H-indazole-3- 2017, until July 15, 2019. At 82 FR 47974, Oct. carboxamide, its optical, po- 16, 2017, § 1308.11 was amended by redesig- sitional, and geometric iso- nating (h)(17) as paragraph (h)(14). mers, salts and salts of iso- 4. At 82 FR 49508, Oct. 26, 2017, § 1308.11 was mers (Other names: 5F-AB- amended by adding reserved paragraphs PINACA) ...... (7025) (h)(15) through (h)(18) and (h)(19), (20) and (33) 1-(4-cyanobutyl)-N-(2- (21), effective Oct. 26, 2017,, through Oct. 28, 2019. phenylpropan-2-yl)-1H-inda- 5. At 82 FR 51558, Nov. 3, 2017, § 1308.11 was zole-3-carboxamide, its opti- amended by adding paragraph (h)(18), effec- cal, positional, and geo- tive Nov. 3, 2017, through Nov. 4, 2019. metric isomers, salts and 6. At 83 FR 472, Jan. 4, 2018, § 1308.11 was salts of isomers (Other amended by adding paragraph (h)(22), effec- names: 4-CN-CUMYL- tive Jan. 4, 2018, through Jan. 4, 2020. BUTINACA; 4-cyano- 7. At 83 FR 4584, Feb. 1, 2018, § 1308.11 was CUMYL-BUTINACA; 4-CN- amended by adding paragraphs (h)(23) CUMYL BINACA; CUMYL- through (h)(29), effective Feb. 1, 2018, through Feb. 1, 2020. 4CN-BINACA; SGT-78) ...... (7089) 8. At 83 FR 5191, Feb. 6, 2018, § 1308.11 was (34) methyl 2-(1- amended by adding paragraph (h)(30), effec- (cyclohexylmethyl)-1H- tive Feb. 6, 2018, through Feb. 6, 2020. indole-3-carboxamido)-3- 9. At 83 FR 10368, Mar. 9, 2018, § 1308.11 was methylbutanoate, its opti- amended by revising paragraphs (h)(23) and cal, positional, and geo- (h)(29), effective Mar. 9, 2018, through Feb. 1, metric isomers, salts and 2020. salts of isomers (Other 10. At 83 FR 31882, July 10, 2018, § 1308.11 names: MMB-CHMICA, was amended by adding paragraphs (h)(31) through (h)(35) effective July 10, 2018 through AMB-CHMICA) ...... (7044) July 10, 2020. (35) 1-(5-fluoropentyl)-N-(2- 11. At 83 FR 44478, Aug. 31, 2018, § 1308.11 phenylpropan-2-yl)-1H- was amended by adding paragraph (h)(36) ef- pyrrolo[2,3-b]pyridine-3- fective Aug. 31, 2018 through Aug. 31, 2020. carboxamide, its optical, po- sitional, and geometric iso- § 1308.12 Schedule II. mers, salts and salts of iso- (a) Schedule II shall consist of the mers (Other names: 5F- drugs and other substances, by what- CUMYL-P7AICA) ...... (7085) ever official name, common or usual (36) N-Ethylpentylone, its op- name, chemical name, or brand name tical, positional, and geo- designated, listed in this section. Each metric isomers, salts and drug or substance has been assigned salts of isomers (Other the Controlled Substances Code Num- names: ephylone, 1-(1,3- ber set forth opposite it. benzodioxol-5-yl)-2- (b) Substances, vegetable origin or (ethylamino)-pentan-1-one) (7543) chemical synthesis. Unless specifically excepted or unless listed in another [39 FR 22141, June 20, 1974] schedule, any of the following sub- EDITORIAL NOTE: For FEDERAL REGISTER ci- stances whether produced directly or tations affecting § 1308.11, see the List of CFR indirectly by extraction from sub- Sections Affected, which appears in the stances of vegetable origin, or inde- Finding Aids section of the printed volume pendently by means of chemical syn- and at www.govinfo.gov. thesis, or by a combination of extrac- tion and chemical synthesis:

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(1) Opium and opiate, and any salt, its isomers, esters, ethers, salts and compound, derivative, or preparation salts of isomers, esters and ethers of opium or opiate excluding whenever the existence of such iso- apomorphine, thebaine-derived mers, esters, ethers, and salts is pos- butorphanol, , nalbuphine, sible within the specific chemical des- naldemedine, nalmefene, naloxegol, ignation, dextrorphan and , and naltrexone, and their re- levopropoxyphene excepted: spective salts, but including the fol- (1) Alfentanil ...... 9737 lowing: (2) Alphaprodine ...... 9010 (i) Codeine ...... 9050 (3) Anileridine ...... 9020 (ii) Dihydroetorphine ...... 9334 (4) Bezitramide ...... 9800 (iii) Ethylmorphine ...... 9190 (5) Bulk (iv) Etorphine hydrochloride ..... 9059 (non-dosage forms) ...... 9273 (v) Granulated opium ...... 9640 (6) Carfentanil ...... 9743 (vi) Hydrocodone ...... 9193 (7) Dihydrocodeine ...... 9120 (vii) Hydromorphone ...... 9150 (8) Diphenoxylate ...... 9170 (viii) Metopon ...... 9260 (9) Fentanyl ...... 9801 (ix) Morphine ...... 9300 (10) Isomethadone ...... 9226 (x) Opium extracts ...... 9610 (11) Levo-alphacetylmethadol .... 9648 (xi) Opium fluid ...... 9620 [Some other names: levo- (xii) Oripavine ...... 9330 alpha-acetylmethadol, (xiii) Oxycodone ...... 9143 levomethadyl acetate, (xiv) Oxymorphone ...... 9652 LAAM] (xv) Powdered opium ...... 9639 (12) ...... 9210 (xvi) Raw opium ...... 9600 (13) ...... 9220 (xvii) Thebaine ...... 9333 (14) Metazocine ...... 9240 (xviii) Tincture of opium ...... 9630 (15) ...... 9250 (2) Any salt, compound, derivative, or (16) Methadone-Intermediate, 4- preparation thereof which is chemi- cyano-2-dimethylamino-4,4-di- cally equivalent or identical with any phenyl butane ...... 9254 of the substances referred to in para- (17) Moramide-Intermediate, 2- graph (b) (1) of this section, except that methyl-3-morpholino-1, 1- these substances shall not include the diphenylpropane-carboxylic isoquinoline alkaloids of opium. acid ...... 9802 (3) Opium poppy and poppy straw. (18) (meperidine) ...... 9230 (4) leaves (9040) and any salt, (19) Pethidine-Intermediate-A, 4- compound, derivative or preparation of cyano-1-methyl-4- coca leaves (including (9041) phenylpiperidine ...... 9232 and ecgonine (9180) and their salts, iso- (20) Pethidine-Intermediate-B, mers, derivatives and salts of isomers ethyl-4-phenylpiperidine-4- and derivatives), and any salt, com- carboxylate ...... 9233 pound, derivative, or preparation (21) Pethidine-Intermediate-C, 1- thereof which is chemically equivalent methyl-4-phenylpiperidine-4- or identical with any of these sub- carboxylic acid ...... 9234 stances, except that the substances (22) Phenazocine ...... 9715 shall not include: (23) Piminodine ...... 9730 (i) Decocainized coca leaves or ex- (24) Racemethorphan ...... 9732 traction of coca leaves, which extrac- (25) ...... 9733 tions do not contain cocaine or ecgo- (26) Remifentanil ...... 9739 (27) Sufentanil ...... 9740 nine; or (28) ...... 9780 (ii) [123I]. (5) Concentrate of poppy straw (the (29) Thiafentanil ...... 9729 crude extract of poppy straw in either (d) Stimulants. Unless specifically ex- liquid, solid or powder form which con- cepted or unless listed in another tains the phenanthrene alkaloids of the schedule, any material, compound, opium poppy), 9670. mixture, or preparation which contains (c) Opiates. Unless specifically ex- any quantity of the following sub- cepted or unless in another schedule stances having a stimulant effect on any of the following opiates, including the central nervous system:

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contains any quantity of the following (1) , its salts, opti- substances: cal isomers, and salts of its optical isomers ...... 1100 (1) Immediate precursor to amphet- amine and : (2) Methamphetamine, its salts, isomers, and salts of its iso- (i) Phenylacetone ...... 8501 mers ...... 1105 Some trade or other names: (3) and its salts 1631 phenyl-2-propanone; P2P; (4) ...... 1724 benzyl methyl ketone; methyl benzyl ketone; (5) , its salts, (2) Immediate precursors to isomers, and salts of its iso- phencyclidine (PCP): mers ...... 1205. (i) 1-phenylcyclohexylamine ...... 7460 (e) Depressants. Unless specifically (ii) 1- excepted or unless listed in another piperidinocyclohexanecarboni- schedule, any material, compound, trile (PCC) ...... 8603 mixture, or preparation which contains (3) Immediate precursor to any quantity of the following sub- fentanyl: stances having a depressant effect on (i) 4-anilino-N- the central nervous system, including phenethylpiperidine (ANPP) ... 8333 its salts, isomers, and salts of isomers (ii) [Reserved] whenever the existence of such salts, isomers, and salts of isomers is possible [39 FR 22142, June 20, 1974] within the specific chemical designa- EDITORIAL NOTE: For FEDERAL REGISTER ci- tion: tations affecting § 1308.12, see the List of CFR (1) Amobarbital ...... 2125 Sections Affected, which appears in the (2) Glutethimide ...... 2550 Finding Aids section of the printed volume and at www.govinfo.gov. (3) Pentobarbital ...... 2270 (4) Phencyclidine ...... 7471 § 1308.13 Schedule III. (5) Secobarbital ...... 2315 (a) Schedule III shall consist of the (f) Hallucinogenic substances. drugs and other substances, by what- ever official name, common or usual (1) Nabilone ...... 7379 name, chemical name, or brand name [Another name for designated, listed in this section. Each ± nabilone: ( )-trans-3-(1,1- drug or substance has been assigned dimethylheptyl)- the DEA Controlled Substances Code 6,6a,7,8,10,10a-hexahydro- Number set forth opposite it. 1-hydroxy-6,6-dimethyl- (b) Stimulants. Unless specifically ex- 9H-dibenzo[b,d]pyran-9- cepted or unless listed in another one] schedule, any material, compound, (2) Dronabinol [(-)-delta-9-trans mixture, or preparation which contains tetrahydrocannabinol] in an any quantity of the following sub- oral solution in a drug prod- stances having a stimulant effect on uct approved for marketing the central nervous system, including by the U.S. Food and Drug its salts, isomers (whether optical, po- Administration ...... (7365) sitional, or geometric), and salts of (g) Immediate precursors. Unless spe- such isomers whenever the existence of cifically excepted or unless listed in such salts, isomers, and salts of iso- another schedule, any material, com- mers is possible within the specific pound, mixture, or preparation which chemical designation:

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(1) Those compounds, mixtures, (4) Chlorhexadol ...... 2510 or preparations in dosage unit (5) Embutramide ...... 2020 form containing any stimu- (6) Any drug product containing lant substances listed in gamma hydroxybutyric acid, schedule II which compounds, including its salts, isomers, mixtures, or preparations were and salts of isomers, for which listed on August 25, 1971, as ex- an application is approved cepted compounds under under section 505 of the Fed- § 1308.32, and any other drug of eral Food, Drug, and Cosmetic the quantitative composition Act ...... 2012 shown in that list for those (7) , its salts, isomers, drugs or which is the same ex- and salts of isomers ...... 7285 cept that it contains a lesser [Some other names for quantity of controlled sub- ketamine: (±)-2-(2- stances ...... 1405 chlorophenyl)-2- (2) ...... 1228 (methylamino)- (3) ...... 1645 cyclohexanone] (4) ...... 1647 (8) Lysergic acid ...... 7300 (5) ...... 1615 (9) Lysergic acid amide ...... 7310 (c) Depressants. Unless specifically (10) Methyprylon ...... 2575 excepted or unless listed in another (11) Perampanel, and its salts, schedule, any material, compound, isomers, and salts of isomers .. 2261 mixture, or preparation which contains (12) Sulfondiethylmethane ...... 2600 any quantity of the following sub- (13) Sulfonethylmethane ...... 2605 stances having a depressant effect on the central nervous system: (14) Sulfonmethane ...... 2610 (15) and zolazepam (1) Any compound, mixture or or any salt thereof ...... 7295 preparation containing: (i) Amobarbital ...... 2126 Some trade or other names (ii) Secobarbital ...... 2316 for a tiletamine-zolazepam combination product: (iii) Pentobarbital ...... 2271 or any salt thereof and one Telazol.. or more other active me- Some trade or other names dicinal ingredients which for tiletamine: are not listed in any 2-(ethylamino)-2-(2- schedule. thienyl)- (2) Any suppository dosage form cyclohexanone.. containing: Some trade or other names (i) Amobarbital ...... 2126 for zolazepam: (ii) Secobarbital ...... 2316 4-(2-fluorophenyl)-6,8- (iii) Pentobarbital ...... 2271 dihydro-1,3,8- or any salt of any of these trimethylpyrazolo-[3,4- drugs and approved by the e] [1,4]-diazepin-7(1H)- Food and Drug Adminis- one, flupyrazapon.. tration for marketing only as a suppository. (d) Nalorphine 9400. (3) Any substance which con- (e) Narcotic drugs. Unless specifically tains any quantity of a deriva- excepted or unless listed in another tive of barbituric acid or any schedule: salt thereof ...... 2100

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(1) Any material, compound, (vi) Not more than 50 mixture, or preparation con- milligrams of mor- taining any of the following phine per 100 milli- narcotic drugs, or their salts liters or per 100 grams, calculated as the free anhy- with one or more ac- drous base or alkaloid, in lim- tive, nonnarcotic in- ited quantities as set forth gredients in recognized below: therapeutic amounts ... 9810 (i) Not more than 1.8 (2) Any material, compound, grams of codeine per mixture, or preparation con- 100 milliliters or not taining any of the following more than 90 milli- narcotic drugs or their salts, grams per dosage unit, as set forth below: with an equal or great- (i) Buprenorphine ...... 9064 er quantity of an (ii) [Reserved]. isoquinoline alkaloid (f) Anabolic Steroids. Unless specifi- of opium ...... 9803 cally excepted or unless listed in an- (ii) Not more than 1.8 other schedule, any material, com- grams of codeine per pound, mixture or preparation con- 100 milliliters or not taining any quantity of the following more than 90 milli- substances, including its salts, esters grams per dosage unit, and ethers: with one or more ac- (1) Anabolic steroids (see § 1300.01 of tive, nonnarcotic in- this chapter)—4000 gredients in recognized (2) [Reserved] therapeutic amounts ... 9804 (iii) Not more than 1.8 (g) Hallucinogenic substances. (1) grams of Dronabinol (synthetic) in sesame oil dihydrocodeine per 100 and encapsulated in a soft gelatin cap- milliliters or not more sule in a U.S. Food and Drug Adminis- than 90 milligrams per tration approved product—7369. dosage unit, with one [Some other names for dronabinol: (6aR- or more active nonnar- trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- cotic ingredients in pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- recognized therapeutic delta-9-(trans)-tetrahydrocannabinol] amounts ...... 9807 (2) [Reserved] (iv) Not more than 300 milligrams of [39 FR 22142, June 20, 1974] ethylmorphine per 100 EDITORIAL NOTE: For FEDERAL REGISTER ci- milliliters or not more tations affecting § 1308.13, see the List of CFR than 15 milligrams per Sections Affected, which appears in the dosage unit, with one Finding Aids section of the printed volume or more active, non- and at www.govinfo.gov. narcotic ingredients in recognized therapeutic § 1308.14 Schedule IV. amounts ...... 9808 (a) Schedule IV shall consist of the (v) Not more than 500 drugs and other substances, by what- milligrams of opium ever official name, common or usual per 100 milliliters or name, chemical name, or brand name per 100 grams or not designated, listed in this section. Each more than 25 milli- drug or substance has been assigned grams per dosage unit, the DEA Controlled Substances Code with one or more ac- Number set forth opposite it. tive, nonnarcotic in- (b) Narcotic drugs. Unless specifically gredients in recognized excepted or unless listed in another therapeutic amounts ... 9809 schedule, any material, compound, mixture, or preparation containing any of the following narcotic drugs, or 124

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their salts calculated as the free anhy- (31) Lormetazepam ...... 2774 drous base or alkaloid, in limited quan- (32) Mebutamate ...... 2800 tities as set forth below: (33) Medazepam ...... 2836 (1) Not more than 1 milligram of (34) Meprobamate ...... 2820 difenoxin and not less than 25 (35) Methohexital ...... 2264 micrograms of atropine sul- (36) Methylphenobarbital fate per dosage unit ...... 9167 (mephobarbital) ...... 2250 (2) Dextropropoxyphene (alpha- (37) Midazolam ...... 2884 (+)-4-dimethylamino-1,2-di- (38) Nimetazepam ...... 2837 phenyl-3-methyl-2- (39) Nitrazepam ...... 2834 propionoxybutane) ...... 9278 (40) Nordiazepam ...... 2838 (3) 2-[(dimethylamino)methyl]-1- (41) Oxazepam ...... 2835 (3- (42) Oxazolam ...... 2839 methoxyphenyl)cyclohexanol, (43) Paraldehyde ...... 2585 its salts, optical and geo- (44) Petrichloral ...... 2591 metric isomers and salts of (45) Phenobarbital ...... 2285 these isomers (including (46) Pinazepam ...... 2883 ) ...... 9752 (47) Prazepam ...... 2764 (48) Quazepam ...... 2881 (c) Depressants. Unless specifically (49) Suvorexant ...... 2223 excepted or unless listed in another (50) Temazepam ...... 2925 schedule, any material, compound, (51) Tetrazepam ...... 2886 mixture, or preparation which contains (52) Triazolam ...... 2887 any quantity of the following sub- (53) Zaleplon ...... 2781 stances, including its salts, isomers, (54) Zolpidem ...... 2783 and salts of isomers whenever the ex- (55) Zopiclone ...... 2784 istence of such salts, isomers, and salts of isomers is possible within the spe- (d) . Any material, com- cific chemical designation: pound, mixture, or preparation which contains any quantity of the following (1) Alfaxalone ...... 2731 substances, including its salts, isomers (2) Alprazolam ...... 2882 (whether optical, position, or geo- (3) Barbital ...... 2145 metric), and salts of such isomers, (4) Bromazepam ...... 2748 whenever the existence of such salts, (5) Camazepam ...... 2749 isomers, and salts of isomers is pos- (6) Carisoprodol ...... 8192 sible: (7) Chloral betaine ...... 2460 (8) Chloral hydrate ...... 2465 (1) Fenfluramine ...... 1670 (9) Chlordiazepoxide ...... 2744 (e) . Any material, com- (10) Clobazam ...... 2751 pound, mixture, or preparation which (11) Clonazepam ...... 2737 contains any quantity of the following (12) Clorazepate ...... 2768 substances, including its salts, isomers, (13) Clotiazepam ...... 2752 and salts of such isomers, whenever the (14) Cloxazolam ...... 2753 existence of such salts, isomers, and (15) Delorazepam ...... 2754 salts of isomers is possible: (16) Diazepam ...... 2765 (1) Lorcaserin ...... 1625 (17) Dichloralphenazone ...... 2467 (18) Estazolam ...... 2756 (f) Stimulants. Unless specifically ex- (19) Ethchlorvynol ...... 2540 cepted or unless listed in another (20) Ethinamate ...... 2545 schedule, any material, compound, (21) Ethyl loflazepate ...... 2758 mixture, or preparation which contains (22) Fludiazepam ...... 2759 any quantity of the following sub- (23) Flunitrazepam ...... 2763 stances having a stimulant effect on (24) Flurazepam ...... 2767 the central nervous system, including (25) Fospropofol ...... 2138 its salts, isomers and salts of isomers: (26) Halazepam ...... 2762 (1) ((+)- (27) Haloxazolam ...... 2771 norpseudoephedrine) ...... 1230 (28) Ketazolam ...... 2772 (2) Diethylpropion ...... 1610 (29) Loprazolam ...... 2773 (3) Fencamfamin ...... 1760 (30) Lorazepam ...... 2885 (4) ...... 1575 125

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(5) ...... 1605 narcotic active medicinal ingredients (6) ...... 1580 in sufficient proportion to confer upon (7) ...... 1680 the compound, mixture, or preparation (8) (including valuable medicinal qualities other than organometallic complexes and those possessed by narcotic drugs chelates thereof) ...... 1530 alone: (9) ...... 1640 (1) Not more than 200 milligrams of (10) ...... 1750 codeine per 100 milliliters or per 100 (11) ...... 1675 grams. (12) SPA ((-)-1-dimethylamino- (2) Not more than 100 milligrams of 1,2-diphenylethane) ...... 1635 dihydrocodeine per 100 milliliters or (g) Other substances. Unless specifi- per 100 grams. cally excepted or unless listed in an- (3) Not more than 100 milligrams of other schedule, any material, com- ethylmorphine per 100 milliliters or per pound, mixture or preparation which 100 grams. contains any quantity of the following (4) Not more than 2.5 milligrams of substances, including its salts: diphenoxylate and not less than 25 (1) Pentazocine ...... 9709 micrograms of atropine sulfate per dos- (2) Butorphanol (including its age unit. optical isomers) ...... 9720 (5) Not more than 100 milligrams of (3) Eluxadoline (5-[[[(2S)-2- opium per 100 milliliters or per 100 amino-3-[4-aminocarbonyl)-2,6- grams. dimethylphenyl]-1- (6) Not more than 0.5 milligram of oxopropyl][(1S)-1-(4-phenyl-1H- difenoxin and not less than 25 imidazol-2- micrograms of atropine sulfate per dos- yl)ethyl]amino]methyl]-2- methoxybenzoic acid) (includ- age unit. ing its optical isomers) and its (d) Stimulants. Unless specifically ex- salts, isomers, and salts of iso- empted or excluded or unless listed in mers (9725).. another schedule, any material, com- pound, mixture, or preparation which [39 FR 22143, June 20, 1974] contains any quantity of the following EDITORIAL NOTE: For FEDERAL REGISTER ci- substances having a stimulant effect tations affecting § 1308.14, see the List of CFR on the central nervous system, includ- Sections Affected, which appears in the ing its salts, isomers and salts of iso- Finding Aids section of the printed volume mers: and at www.govinfo.gov. (1) ...... 1485. § 1308.15 Schedule V. (2) [Reserved]. (a) Schedule V shall consist of the (e) Depressants. Unless specifically drugs and other substances, by what- exempted or excluded or unless listed ever official name, common or usual in another schedule, any material, name, chemical name, or brand name compound, mixture, or preparation designated, listed in this section. which contains any quantity of the fol- (b) Narcotic drugs. Unless specifically lowing substances having a depressant excepted or unless listed in another effect on the central nervous system, schedule, any material, compound, including its salts: mixture, or preparation containing any of the following narcotic drugs and (1) Brivaracetam ((2S)-2-[(4R)-2- their salts, as set forth below: oxo-4-propylpyrrolidin-1-yl] (1) [Reserved] butanamide) (also referred to (c) Narcotic drugs containing non-nar- as BRV; UCB–34714; Briviact) cotic active medicinal ingredients. Any (including its salts) ...... 2710 compound, mixture, or preparation (2) Ezogabine [N-[2-amino-4-(4- containing any of the following nar- fluorobenzylamino)-phenyl]- cotic drugs, or their salts calculated as carbamic acid ethyl ester] ...... 2779 the free anhydrous base or alkaloid, in (3) Lacosamide [(R)-2- limited quantities as set forth below, acetoamido-N-benzyl-3- which shall include one or more non- methoxy-propionamide] ...... 2746 126

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(4) Pregabalin [(S)-3- cepted, the reason therefore. The Ad- (aminomethyl)-5- ministrator need not accept an applica- methylhexanoic acid] ...... 2782 tion for filing if any of the require- (f) Approved cannabidiol drugs. (1) ments prescribed in paragraph (b) of A drug product in finished dos- this section is lacking or is not set age formulation that has been forth as to be readily understood. If the approved by the U.S. Food and applicant desires, he may amend the Drug Administration that con- application to meet the requirements tains cannabidiol (2-[1R-3- of paragraph (b) of this section. If the methyl-6R-(1-methylethenyl)- application is accepted for filing, the 2-cyclohexen-1-yl]-5-pentyl-1,3- Administrator shall issue and publish benzenediol) derived from can- in the FEDERAL REGISTER his order on nabis and no more than 0.1 the application, which shall include a percent (w/w) residual reference to the legal authority under tetrahydrocannabinols ...... 7367 which the order is issued and the find- (2) [Reserved] ings of fact and conclusions of law [39 FR 22143, June 20, 1974, as amended at 43 upon which the order is based. This FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, order shall specify the date on which it 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. shall take effect. The Administrator 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, shall permit any interested person to Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR file written comments on or objections 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; to the order within 60 days of the date 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, of publication of his order in the FED- Sept 28, 2018] ERAL REGISTER. If any such comments or objections raise significant issues EXCLUDED NONNARCOTIC SUBSTANCES regarding any finding of fact or conclu- sion of law upon which the order is § 1308.21 Application for exclusion of a based, the Administrator shall imme- nonnarcotic substance. diately suspend the effectiveness of the (a) Any person seeking to have any order until he may reconsider the ap- nonnarcotic drug that may, under the plication in light of the comments and Federal Food, Drug, and Cosmetic Act objections filed. Thereafter, the Ad- (21 U.S.C. 301), be lawfully sold over the ministrator shall reinstate, revoke, or counter without a prescription, ex- amend his original order as he deter- cluded from any schedule, pursuant to mines appropriate. section 201(g)(1) of the Act (21 U.S.C. 811(g)(1)), may apply to the Drug and (d) The Administrator may at any Chemical Evaluation Section, Diver- time revoke any exclusion granted pur- sion Control Division, Drug Enforce- suant to section 201(g) of the Act (21 ment Administration. See the Table of U.S.C. 811(g)) by following the proce- DEA Mailing Addresses in § 1321.01 of dures set forth in paragraph (c) of this this chapter for the current mailing ad- section for handling an application for dress. an exclusion which has been accepted (b) An application for an exclusion for filing. under this section shall contain the fol- [38 FR 8254, Mar. 30, 1973, as amended at 70 lowing information: FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, (1) The name and address of the ap- 2010; 81 FR 97021, Dec. 30, 2016] plicant; (2) The name of the substance for § 1308.22 Excluded substances. which exclusion is sought; and The following nonnarcotic substances (3) The complete quantitative com- which may, under the Federal Food, position of the substance. (c) Within a reasonable period of Drug, and Cosmetic Act (21 U.S.C. 301), time after the receipt of an application be lawfully sold over the counter with- for an exclusion under this section, the out a prescription, are excluded from Administrator shall notify the appli- all schedules pursuant to section 201(g) cant of his acceptance or nonaccept- (1) of the Act (21 U.S.C. 811(g) (1)): ance of his application, and if not ac- 127

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EXCLUDED NONNARCOTIC PRODUCTS

(mg or mg/ Company Trade name NDC code Form Controlled substance ml)

Aphena Pharma Solu- Nasal Decongestant In- ...... IN Levmetamfetamine (l-Des- 50.00 tions—New York, LLC. haler/Vapor Inhaler. oxyephedrine). 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 Procter & Gamble Co., The Vicks VapoInhaler ...... 37000–686–01 IN Levmetamfetamine (l-Des- 50.00 oxyephedrine). Rondex Labs ...... Azma-Aids ...... 00367–3153 TB Phenobarbital ...... 8.00 Smith Kline Consumer ...... Benzedrex ...... 49692–0928 IN ...... 250.00 Sterling Drug, Inc ...... Bronkolixir ...... 00057–1004 EL Phenobarbital ...... 0.80 Sterling Drug, Inc ...... Bronkotabs ...... 00057–1005 TB Phenobarbital ...... 8.00 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, 1973, and amended at 41 FR 16553, Apr. 20, 1976; 41 FR 53477, Dec. 7, 1976; 46 FR 51603, Oct. 21, 1981; 47 FR 45867, Oct. 14, 1982; 54 FR 2100, Jan. 19, 1989; 55 FR 12162, Mar. 30, 1990; 62 FR 13968, Mar. 24, 1997; 74 FR 44283, Aug. 28, 2009; 80 FR 65634, 65637, Oct. 27, 2015; 81 FR 6453, Feb. 8, 2016]

EXEMPT CHEMICAL PREPARATIONS narcotic controlled substance, the preparation or mixture must be formu- § 1308.23 Exemption of certain chem- lated in such a manner that it incor- ical preparations; application. porates methods of denaturing or other (a) The Administrator may, by regu- means so that the preparation or mix- lation, exempt from the application of ture is not liable to be abused or have all or any part of the Act any chemical ill effects, if abused, and so that the preparation or mixture containing one narcotic substance cannot in practice or more controlled substances listed in be removed. any schedule, which preparation or (b) Any person seeking to have any mixture is intended for laboratory, in- preparation or mixture containing a dustrial, educational, or special re- controlled substance and one or more search purposes and not for general ad- noncontrolled substances exempted ministration to a human being or other from the application of all or any part animal, if the preparation or mixture of the Act, pursuant to paragraph (a) of either: this section, may apply to the Drug (1) Contains no narcotic controlled and Chemical Evaluation Section, Di- substance and is packaged in such a version Control Division, Drug En- form or concentration that the pack- forcement Administration. See the aged quantity does not present any sig- Table of DEA Mailing Addresses in nificant potential for abuse (the type of § 1321.01 of this chapter for the current packaging and the history of abuse of mailing address. the same or similar preparations may (c) An application for an exemption be considered in determining the po- under this section shall contain the fol- tential for abuse of the preparation or lowing information: mixture); or (1) The name, address, and registra- (2) Contains either a narcotic or non- tion number, if any, of the applicant; narcotic controlled substance and one (2) The name, address, and registra- or more adulterating or denaturing tion number, if any, of the manufac- agents in such a manner, combination, turer or importer of the preparation or quantity, proportion, or concentration, mixture, if not the applicant; that the preparation or mixture does (3) The exact trade name or other not present any potential for abuse. If designation of the preparation or mix- the preparation or mixture contains a ture;

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(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 or any other law restricting public dis- under the old criteria) and modify the closure of information. scope of exemptions at any time. (d) The Administrator may require [38 FR 8254, Mar. 30, 1973. Redesignated at 38 the applicant to submit such docu- FR 26609, Sept. 24, 1973, and amended at 46 ments or written statements of fact FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, relevant to the application as he deems 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, necessary to determine whether the ap- Dec. 30, 2016] plication should be granted. (e) Within a reasonable period of § 1308.24 Exempt chemical prepara- time after the receipt of an application tions. for an exemption under this section, (a) The chemical preparations and the Administrator shall notify the ap- mixtures approved pursuant to § 1308.23 plicant of his acceptance or nonaccept- are exempt from application of sec- ance of his application, and if not ac- tions 302, 303, 305, 306, 307, 308, 309, 1002, cepted, the reason therefor. The Ad- 1003 and 1004 of the Act (21 U.S.C. 822– ministrator need not accept an applica- 823, 825–829, 952–954) and § 1301.74 of this tion for filing if any of the require- chapter, to the extent described in ments prescribed in paragraph (c) or re- paragraphs (b) to (h) of this section. quested pursuant to paragraph (d) is Substances set forth in paragraph (j) of lacking or is not set forth as to be this section shall be exempt from the readily understood. If the applicant de- application of sections 305, 306, 307, 308, sires, he may amend the application to 309, 1002, 1003 and 1004 of the Act (21 meet the requirements of paragraphs U.S.C. 825–829, 952–954) and §§ 1301.71– (c) and (d) of this section. If the appli- 1301.73 and 1301.74 (a), (b), (d), (e) and (f) cation is accepted for filing, the Ad- of this chapter to the extent as herein- ministrator shall issue and publish in after may be provided.

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(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 preparation. Each importer or exporter be registered under the Act and comply of an exempt narcotic chemical prepa- with all relevant security requirements ration must submit a semiannual re- regarding controlled substances being port of the total quantity of each sub- used in the manufacturing process stance imported or exported in each until the preparation or mixture is in calendar half-year within 30 days of the the form described in paragraph (i) of close of the period to the Drug and this section. Any other person who Chemical Evaluation Section, Drug En- handles an exempt chemical prepara- forcement Administration. See the tion after it is in the form described in Table of DEA Mailing Addresses in paragraph (i) of this section is not re- § 1321.01 of this chapter for the current quired to be registered under the Act mailing address. Any other person who to handle that preparation, and the handles an exempt chemical prepara- preparation is not required to be stored tion after it is in the form described in in accordance with security require- paragraph (i) of this section is not re- ments regarding controlled substances. quired to maintain records or file re- (c) Labeling: In lieu of the require- ports. ments set forth in part 1302 of this (e) Quotas, order forms, prescrip- chapter, the label and the labeling of tions, import, export, and trans- an exempt chemical preparation must shipment requirements: Once an ex- be prominently marked with its full empt chemical preparation is in the trade name or other description and form described in paragraph (i) of this the name of the manufacturer or sup- section, the requirements regarding plier as set forth in paragraph (i) of quotas, order forms, prescriptions, im- this section, in such a way that the port permits and declarations, export product can be readily identified as an permit and declarations, and trans- exempt chemical preparation. The shipment and intransit permits and label and labeling must also include in declarations do not apply. These re- a prominent manner the statement quirements do apply, however, to any ‘‘For industrial use only’’ or ‘‘For controlled substances used in manufac- chemical use only’’ or ‘‘For in vitro use turing the exempt chemical prepara- only—not for human or animal use’’ or tion before it is in the form described ‘‘Diagnostic reagent—for professional in paragraph (i) of this section. use only’’ or a comparable statement warning the person reading it that (f) Criminal penalties: No exemption human or animal use is not intended. granted pursuant to § 1308.23 affects the The symbol designating the schedule of criminal liability for illegal manufac- the controlled substance is not re- ture, distribution, or possession of con- quired on either the label or the label- trolled substances contained in the ex- ing of the exempt chemical prepara- empt chemical preparation. Distribu- tion, nor is it necessary to list all in- tion, possession, and use of an exempt gredients of the preparation. chemical preparation are lawful for (d) Records and reports: Any person registrants and nonregistrants only as who manufactures an exempt chemical long as such distribution, possession, preparation or mixture must keep com- or use is intended for laboratory, in- plete and accurate records and file all dustrial, or educational purposes and reports required under part 1304 of this not for immediate or subsequent ad- chapter regarding all controlled sub- ministration to a human being or other stances being used in the manufac- animal. turing process until the preparation or (g) Bulk materials: For materials ex- mixture is in the form described in empted in bulk quantities, the Admin- paragraph (i) of this section. In lieu of istrator may prescribe requirements records and reports required under part other than those set forth in para- 1304 of this chapter regarding exempt graphs (b) through (e) of this section on chemical preparations, the manufac- a case-by-case basis. turer need only record the name, ad- (h) Changes in chemical preparations: dress, and registration number, if any, Any change in the quantitative or

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qualitative composition of the prepara- (b) An application for any exclusion tion or mixture after the date of appli- under this section shall be submitted cation, or change in the trade name or in triplicate and contain the following other designation of the preparation or information: mixture, set forth in paragraph (i) of (1) The name and address of the ap- this section, requires a new application plicant; for exemption. (2) The name of the product; (i) A listing of exempt chemical prep- (3) The chemical structural formula arations may be obtained by submit- or description for any anabolic steroid ting a written request to the Drug and contained in the product; Chemical Evaluation Section, Drug En- (4) A complete description of dosage forcement Administration. See the and quantitative composition of the Table of DEA Mailing Addresses in dosage form;. § 1321.01 of this chapter for the current (5) The conditions of use including mailing address. whether or not Federal law restricts (j) The following substances are des- this product to use by or on the order ignated as exempt chemical prepara- of a licensed veterinarian; tions for the purposes set forth in this (6) A description of the delivery sys- section. tem in which the dosage form will be 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. R mediate container and the commercial (2) Emit 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- tations affecting § 1308.24, see the List of CFR istration through implant to cattle or Sections Affected, which appears in the other nonhuman species. Finding Aids section of the printed volume (c) Within a reasonable period of and at www.govinfo.gov. time after the receipt of an application for an exclusion under this section, the EXCLUDED VETERINARY ANABOLIC Administrator shall notify the appli- STEROID IMPLANT PRODUCTS cant of his acceptance or nonaccept- ance of the application, and if not ac- § 1308.25 Exclusion of a veterinary an- cepted, the reason therefore. The Ad- abolic steroid implant product; ap- ministrator need not accept an applica- plication. tion for filing if any of the require- (a) Any person seeking to have any ments prescribed in paragraph (b) of anabolic steroid product, which is ex- this section is lacking or is not set pressly intended for administration forth as to be readily understood. The through implants to cattle or other applicant may amend the application nonhuman species and which has been to meet the requirements of paragraph approved by the Secretary of Health (b) of this section. If the application is and Human Services for such adminis- accepted for filing, the Administrator tration, identified as being excluded shall issue and have published in the from any schedule, pursuant to section FEDERAL REGISTER his order on the ap- 102(41)(B)(i) of the Act (21 U.S.C. plication, which shall include a ref- 802(41)(B)(i)), may apply to the Drug erence to the legal authority under and Chemical Evaluation Section, Di- which the order is issued and the find- version Control Division, Drug En- ings of fact and conclusions of law forcement Administration . See the upon which the order is based. This Table of DEA Mailing Addresses in order shall specify the date on which it § 1321.01 of this chapter for the current will take effect. The Administrator mailing address. shall permit any interested person to

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file written comments on or objections EXEMPTED PRESCRIPTION PRODUCTS to the order within 60 days of the date of publication in the FEDERAL REG- § 1308.31 Application for exemption of ISTER. If any such comments or objec- a nonnarcotic prescription product. tions raise significant issues regarding (a) Any person seeking to have any any finding of fact or conclusion of law compound, mixture, or preparation upon which the order is based, the Ad- containing any nonnarcotic controlled ministrator shall immediately suspend substance listed in § 1308.12(e), or in the effectiveness of the order until he § 1308.13(b) or (c), or in § 1308.14, or in may reconsider the application in light § 1308.15, exempted from application of of the comments and objections filed. all or any part of the Act pursuant to Thereafter, the Administrator shall re- section 201(g)(3)(A), of the Act (21 instate, revoke, or amend his original U.S.C. 811(g)(3)(A)) may apply to the order as he determines appropriate. Drug and Chemical Evaluation Section, (d) The Administrator may at any Diversion Control Division, Drug En- time revoke or modify any designation forcement Administration. See the of excluded status granted pursuant to Table of DEA Mailing Addresses in this section by following the proce- § 1321.01 of this chapter for the current dures set forth in paragraph (c) of this mailing address. section for handling an application for (b) An application for an exemption an exclusion which has been accepted under this section shall contain the fol- for filing. lowing information: [56 FR 42936, Aug. 30, 1991, as amended at 75 (1) The complete quantitative com- FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, position of the dosage form. 2016] (2) Description of the unit dosage § 1308.26 Excluded veterinary anabolic form together with complete labeling. steroid implant products. (3) A summary of the pharmacology of the product including animal inves- (a) Products containing an anabolic tigations and clinical evaluations and steroid, that are expressly intended for studies, with emphasis on the psychic administration through implants to and/or physiological dependence liabil- cattle or other nonhuman species and ity (this must be done for each of the which have been approved by the Sec- active ingredients separately and for retary of Health and Human Services the combination product). for such administration are excluded from all schedules pursuant to section (4) Details of synergisms and antag- 102(41)(B)(i) of the Act (21 U.S.C. onisms among ingredients. 802(41)(B)(i)). A listing of the excluded (5) Deterrent effects of the noncon- products may be obtained by submit- trolled ingredients. ting a written request to the Drug and (6) Complete copies of all literature Chemical Evaluation Section, Drug En- in support of claims. forcement Administration. See the (7) Reported instances of abuse. Table of DEA Mailing Addresses in (8) Reported and anticipated adverse § 1321.01 of this chapter for the current effects. mailing address. (9) Number of dosage units produced (b) In accordance with section for the past 2 years. 102(41)(B)(ii) of the Act (21 U.S.C. (c) Within a reasonable period of 802(41)(B)(ii)) if any person prescribes, time after the receipt of an application dispenses, or distributes a product list- for an exemption under this section, ed in paragraph (a) of this section for the Administrator shall notify the ap- human use, such person shall be con- plicant of his acceptance or non-ac- sidered to have prescribed, dispensed, ceptance of the application, and if not or distributed an anabolic steroid with- accepted, the reason therefor. The Ad- in the meaning of section 102(41)(A) of ministrator need not accept an applica- the Act (21 U.S.C. 802(41)(A)). tion for filing if any of the require- [56 FR 42936, Aug. 30, 1991, as amended at 57 ments prescribed in paragraph (b) of FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, this section is lacking or is not set 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, forth so as to be readily understood. If Mar. 9, 2010] the applicant desires, he may amend

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the application to meet the require- ucts have been exempted by the Ad- ments of paragraph (b) of this section. ministrator from the application of If accepted for filing, the Adminis- sections 302 through 305, 307 through trator shall publish in the FEDERAL 309, and 1002 through 1004 of the Act (21 REGISTER general notice of this pro- U.S.C. 822–825, 827–829, and 952–954) and posed rulemaking in granting or deny- §§ 1301.13, 1301.22, and §§ 1301.71 through ing the application. Such notice shall 1301.76 of this chapter for administra- include a reference to the legal author- tive purposes only. An exception to the ity under which the rule is proposed, a above is that those products containing statement of the proposed rule grant- butalbital shall not be exempt from the ing or denying an exemption, and, in requirement of 21 U.S.C. 952–954 con- the discretion of the Administrator, a cerning importation, exportation, summary of the subjects and issues in- transshipment and in-transit shipment volved. The Administrator shall permit of controlled substances. Any deviation any interested person to file written from the quantitative composition of comments on or objections to the pro- any of the listed drugs shall require a posal and shall designate in the notice petition of exemption in order for the of proposed rule making the time dur- product to be exempted. A listing of ing which such filings may be made. the Exempted Prescription Products After consideration of the application may be obtained by submitting a writ- and any comments on or objections to ten request to the Drug and Chemical his proposed rulemaking, the Adminis- Evaluation Section, Drug Enforcement trator shall issue and publish in the Administration. See the Table of DEA FEDERAL REGISTER his final order on Mailing Addresses in § 1321.01 of this the application, which shall set forth chapter for the current mailing ad- the findings of fact and conclusions of dress. law upon which the order is based. This order shall specify the date on which it [75 FR 10679, Mar. 9, 2010] shall take effect, which shall not be less than 30 days from the date of pub- EXEMPT ANABOLIC STEROID PRODUCTS lication in the FEDERAL REGISTER un- less the Administrator finds that con- § 1308.33 Exemption of certain ana- bolic steroid products; application. ditions of public health or safety neces- sitate an earlier effective date, in (a) The Administrator, upon the rec- which event the Administrator shall ommendation of Secretary of Health specify in the order his findings as to and Human Services, may, by regula- such conditions. tion, exempt from the application of (d) The Administrator may revoke all or any part of the Act any com- any exemption granted pursuant to pound, mixture, or preparation con- section 201(g)(3)(A) of the Act (21 U.S.C. taining an anabolic steroid as defined 811(g)(3)(A)) by following the proce- in part 1300 of this chapter, which is in- dures set forth in paragraph (c) of this tended for administration to a human section for handling an application for being or animal, if, because of its con- an exemption which has been accepted centration, preparation, formulation, for filing. or delivery system, it has no signifi- cant potential for abuse. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, as amended at 44 FR (b) Any person seeking to have any 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; compound, mixture, or preparation 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, containing an anabolic steroid as de- 2016] fined in part 1300 of this chapter ex- empted from the application of all or § 1308.32 Exempted prescription prod- any part of the Act, pursuant to para- ucts. graph (a) of this section, may apply to The compounds, mixtures, or prep- the Drug and Chemical Evaluation Sec- arations that contain a nonnarcotic tion, Diversion Control Division, Drug controlled substance listed in Enforcement Administration. See the § 1308.12(e) or in § 1308.13(b) or (c) or in Table of DEA Mailing Addresses in § 1308.14 or in § 1308.15 listed in the § 1321.01 of this chapter for the current Table of Exempted Prescription Prod- mailing address.

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(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- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion for an exemption under this sec- 31, 1992, as amended at 62 FR 13968, Mar. 24, tion, the Administrator shall notify 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, the applicant of his acceptance or non- Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] acceptance of the application, and if § 1308.34 Exempt anabolic steroid not accepted, the reason therefor. The products. Administrator need not accept an ap- 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 Human Services his recommendation, be obtained by submitting a written re- as to whether such product which con- quest to the Drug and Chemical Eval- tains an anabolic steroid should be con- uation Section, Drug Enforcement Ad- sidered for exemption from certain por- ministration. See the Table of DEA tions of the Controlled Substances Act. Mailing Addresses in § 1321.01 of this On receipt of the recommendation of chapter for the current mailing ad- the Secretary, the Administrator shall dress. make a determination as to whether [75 FR 10679, Mar. 9, 2010]

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EXEMPT CANNABIS PLANT MATERIAL, (iii) Distributed, exported, or im- AND PRODUCTS MADE THEREFROM, ported, with the intent that it be used THAT CONTAIN for human consumption. TETRAHYDROCANNABINOLS (c) In any proceeding arising under the Act or this chapter, the burden of § 1308.35 Exemption of certain can- going forward with the evidence that a nabis plant material, and products material, compound, mixture, or prepa- made therefrom, that contain ration containing THC is exempt from tetrahydrocannabinols. control pursuant to this section shall (a) Any processed plant material or be upon the person claiming such ex- animal feed mixture containing any emption, as set forth in section amount of tetrahydrocannabinols 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). (THC) that is both: In order to meet this burden with re- (1) Made from any portion of a plant spect to a product or plant material of the genus Cannabis excluded from that has not been expressly exempted the definition of marijuana under the from control by the Administrator pur- Act [i.e., the mature stalks of such suant to § 1308.23, the person claiming plant, fiber produced from such stalks, the exemption must present rigorous oil or cake made from the seeds of such scientific evidence, including well-doc- plant, any other compound, manufac- umented scientific studies by experts ture, salt, derivative, mixture, or prep- trained and qualified to evaluate the aration of such mature stalks (except effects of drugs on humans. the resin extracted therefrom), fiber, [66 FR 51544, Oct. 9, 2001] oil, or cake, or the sterilized seed of such plant which is incapable of germi- HEARINGS nation] and (2) Not used, or intended for use, for § 1308.41 Hearings generally. human consumption, has been exempt- In any case where the Administrator ed by the Administrator from the ap- shall hold a hearing on the issuance, plication of the Act and this chapter. amendment, or repeal of rules pursuant (b) As used in this section, the fol- to section 201 of the Act, the proce- lowing terms shall have the meanings dures for such hearing and accom- specified: panying proceedings shall be governed (1) The term processed plant material generally by the rulemaking proce- means cannabis plant material that dures set forth in the Administrative has been subject to industrial proc- Procedure Act (5 U.S.C. 551–559) and esses, or mixed with other ingredients, specifically by section 201 of the Act (21 such that it cannot readily be con- U.S.C. 811), by §§ 1308.42–1308.51, and by verted into any form that can be used §§ 1316.41–1316.67 of this chapter. for human consumption. (2) The term animal feed mixture § 1308.42 Purpose of hearing. means sterilized cannabis seeds mixed If requested by any interested person with other ingredients (not derived after proceedings are initiated pursu- from the cannabis plant) in a formula- ant to § 1308.43, the Administrator shall tion that is designed, marketed, and hold a hearing for the purpose of re- distributed for animal consumption ceiving factual evidence and expert (and not for human consumption). opinion regarding the issues involved (3) The term used for human consump- in the issuance, amendment or repeal tion means either: of a rule issuable pursuant to section (i) Ingested orally or 201(a) of the Act (21 U.S.C. 811(a)). Ex- (ii) Applied by any means such that tensive argument should not be offered THC enters the human body. into evidence but rather presented in (4) The term intended for use for opening or closing statements of coun- human consumption means any of the sel or in memoranda or proposed find- following: ings of fact and conclusions of law. Ad- (i) Designed by the manufacturer for ditional information relating to hear- human consumption; ings to include waivers or modification (ii) Marketed for human consump- of rules, request for hearing, burden of tion; or proof, time and place, and final order

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are set forth in part 1316 of this chap- desires, he may amend the petition to ter. meet the requirements of paragraph (b) of this section. If accepted for filing, a [62 FR 13968, Mar. 24, 1997] petition may be denied by the Adminis- § 1308.43 Initiation of proceedings for trator within a reasonable period of rulemaking. time thereafter if he finds the grounds (a) Any interested person may sub- upon which the petitioner relies are mit a petition to initiate proceedings not sufficient to justify the initiation for the issuance, amendment, or repeal of proceedings. of any rule or regulation issuable pur- (d) The Administrator shall, before suant to the provisions of section 201 of initiating proceedings for the issuance, the Act. amendment, or repeal of any rule ei- (b) Petitions shall be submitted in ther to control a drug or other sub- quintuplicate to the Administrator. stance, or to transfer a drug or other See the Table of DEA Mailing Address- substance from one schedule to an- es in § 1321.01 of this chapter for the other, or to remove a drug or other current mailing address. Petitions substance entirely from the schedules, shall be in the following form: and after gathering the necessary data, request from the Secretary a scientific llllllllll (Date) and medical evaluation and the Sec- Administrator, Drug Enforcement Adminis- retary’s recommendations as to wheth- tration llllll (Mailing Address) er such drug or other substance should Dear Sir: The undersigned llllllll be so controlled, transferred, or re- hereby petitions the Administrator to ini- moved as a controlled substance. The tiate proceedings for the issuance (amend- ment or repeal) of a rule or regulation pursu- recommendations of the Secretary to ant to section 201 of the Controlled Sub- the Administrator shall be binding on stances Act. the Administrator as to such scientific Attached hereto and constituting a part of and medical matters, and if the Sec- this petition are the following: retary recommends that a drug or (A) The proposed rule in the form proposed other substance not be controlled, the by the petitioner. (If the petitioner seeks the Administrator shall not control that amendment or repeal of an existing rule, the drug or other substance. existing rule, together with a reference to the section in the Code of Federal Regula- (e) If the Administrator determines tions where it appears, should be included.) that the scientific and medical evalua- (B) A statement of the grounds which the tion and recommendations of the Sec- petitioner relies for the issuance (amend- retary and all other relevant data con- ment or repeal) of the rule. (Such grounds stitute substantial evidence of poten- shall include a reasonably concise statement tial for abuse such as to warrant con- of the facts relied upon by the petitioner, in- trol or additional control over the drug cluding a summary of any relevant medical or other substance, or substantial evi- or scientific evidence known to the peti- tioner.) dence that the drug or other sub- All notices to be sent regarding this peti- stances should be subjected to lesser tion should be addressed to: control or removed entirely from the llllllllll (Name) schedules, he shall initiate proceedings llllllllll (Street Address) for control, transfer, or removal as the llllllllll (City and State) case may be. Respectfully yours, (f) If and when the Administrator de- llllllllll (Signature of petitioner) termines to initiate proceedings, he (c) Within a reasonable period of shall publish in the FEDERAL REGISTER time after the receipt of a petition, the general notice of any proposed rule Administrator shall notify the peti- making to issue, amend, or repeal any tioner of his acceptance or nonaccept- rule pursuant to section 201 of the Act. ance of the petition, and if not accept- Such published notice shall include a ed, the reason therefor. The Adminis- statement of the time, place, and na- trator need not accept a petition for ture of any hearings on the proposal in filing if any of the requirements pre- the event a hearing is requested pursu- scribed in paragraph (b) of this section ant to § 1308.44. Such hearings may not is lacking or is not set forth so as to be be commenced until after the expira- readily understood. If the petitioner tion of at least 30 days from the date

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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 (g) The Administrator may permit hearing, the Administrator may cancel any interested persons to file written the hearing, if scheduled, and issue his comments on or objections to the pro- final order pursuant to § 1308.45 without posal and shall designate in the notice a hearing. of proposed rule making the time dur- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 ing which such filings may be made. FR 26609, Sept. 24, 1973, and further redesig- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 nated and amended at 62 FR 13968, Mar. 24, FR 26609, Sept. 24, 1973, and further redesig- 1997] nated and amended at 62 FR 13968, Mar. 24, 1997; 75 FR 10679, Mar. 9, 2010] § 1308.45 Final order. As soon as practicable after the pre- § 1308.44 Request for hearing or ap- siding officer has certified the record pearance; waiver. to the Administrator, the Adminis- (a) Any interested person desiring a trator shall cause to be published in hearing on a proposed rulemaking, the FEDERAL REGISTER his order in the shall, within 30 days after the date of proceeding, which shall set forth the publication of notice of the proposed final rule and the findings of fact and rulemaking in the FEDERAL REGISTER, conclusions of law upon which the rule file with the Administrator a written is based. This order shall specify the request for a hearing in the form pre- date on which it shall take effect, scribed in § 1316.47 of this chapter. which shall not be less than 30 days (b) Any interested person desiring to from the date of publication in the participate in a hearing pursuant to FEDERAL REGISTER unless the Adminis- § 1308.41 shall, within 30 days after the trator finds that conditions of public date of publication of the notice of health or safety necessitate an earlier hearing in the FEDERAL REGISTER, file effective date, in which event the Ad- with the Administrator a written no- ministrator shall specify in the order tice of his intention to participate in his findings as to such conditions. such hearing in the form prescribed in [38 FR 8254, Mar. 30, 1973. Redesignated at 38 § 1316.48 of this chapter. Any person fil- FR 26609, Sept. 24, 1973, and further redesig- ing a request for a hearing need not nated at 62 FR 13968, Mar. 24, 1997] also file a notice of appearance; the re- quest for a hearing shall be deemed to § 1308.46 Control required under inter- be a notice of appearance. national treaty. (c) Any interested person may, with- Pursuant to section 201(d) of the Act in the period permitted for filing a re- (21 U.S.C. 811(d)), where control of a quest for a hearing, file with the Ad- substance is required by U.S. obliga- ministrator a waiver of an opportunity tions under international treaties, con- for a hearing or to participate in a ventions, or protocols in effect on May hearing, together with a written state- 1, 1971, the Administrator shall issue ment regarding his position on the and publish in the FEDERAL REGISTER matters of fact and law involved in an order controlling such substance such hearing. Such statement, if ad- under the schedule he deems most ap- missible, shall be made a part of the propriate to carry out obligations. record and shall be considered in light Issuance of such an order shall be with- of the lack of opportunity for cross-ex- out regard to the findings required by amination in determining the weight subsections 201(a) or 202(b) of the Act to be attached to matters of fact as- (21 U.S.C. 811(a) or 812(b)) and without serted therein. regard to the procedures prescribed by (d) If any interested person fails to § 1308.41 or subsections 201 (a) and (b) of file a request for a hearing; or if he so the Act (21 U.S.C. 811 (a) and (b)). An

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order controlling a substance shall be- before the expiration of 30 calendar come effective 30 days from the date of days from: publication in the FEDERAL REGISTER, (1) The date of publication by the Ad- unless the Administrator finds that ministration of a notice in the FED- conditions of public health or safety ERAL REGISTER of its intention to issue necessitate an earlier effective date, in such order and the grounds upon which which event the Administrator shall such order is to be issued; and specify in the order his findings as to (2) The date the Administration has such conditions. transmitted notification to the Sec- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 retary of Health and Human Services FR 26609, Sept. 24, 1973, and further redesig- of the Administration’s intention to nated at 62 FR 13968, Mar. 24, 1997] issue such order. (b) An order issued under this section § 1308.47 Control of immediate precur- will be vacated upon the conclusion of sors. a subsequent rulemaking proceeding Pursuant to section 201(e) of the Act initiated under section 201(a) (21 U.S.C. (21 U.S.C. 811(e)), the Administrator 811(a)) with respect to such substance may, without regard to the findings re- or at the end of two years from the ef- quired by subsection 201(a) or 202 (b) of fective date of the order scheduling the the Act (21 U.S.C. 811(a) or 812(b)) and substance, except that during the pend- without regard to the procedures pre- ency of proceedings under section scribed by § 1308.41 or subsections 201 201(a) (21 U.S.C. 811(a)) with respect to (a) and (b) of the Act (21 U.S.C. 811(a) the substance, the Administration may and (b)), issue and publish in the FED- extend the temporary scheduling for up ERAL REGISTER an order controlling an to one year. immediate precursor. The order shall designate the schedule in which the im- [81 FR 97021, Dec. 30, 2016] mediate precursor is to be placed, which shall be the same schedule in PART 1309—REGISTRATION OF which the controlled substance of MANUFACTURERS, DISTRIBUTORS, which it is an immediate precursor is IMPORTERS AND EXPORTERS OF placed or any other schedule with a LIST I CHEMICALS higher numerical designation. An order controlling an immediate precursor GENERAL INFORMATION shall become effective 30 days from the date of publication in the FEDERAL Sec. REGISTER, unless the Administrator 1309.01 Scope of part 1309. finds that conditions of public health 1309.02 Definitions. or safety necessitate an earlier effec- 1309.03 Information; special instructions. tive date, in which event the Adminis- FEES FOR REGISTRATION AND REREGISTRATION trator shall specify in the order his findings as to such conditions. 1309.11 Fee amounts. 1309.12 Time and method of payment; re- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 fund. FR 26609, Sept. 24, 1973, and further redesig- nated at 62 FR 13968, Mar. 24, 1997] REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. § 1308.49 Temporary scheduling. 1309.22 Separate registration for inde- (a) Pursuant to 21 U.S.C. 811(h) and pendent activities. without regard to the requirements of 1309.23 Separate registration for separate 21 U.S.C. 811(b) relating to the sci- locations. entific and medical evaluation of the 1309.24 Waiver of registration requirement Secretary of Health and Human Serv- for certain activities. 1309.25 Temporary exemption from registra- ices, the Drug Enforcement Adminis- tion for chemical registration applicants. tration may place a substance into 1309.26 Exemption of law enforcement offi- Schedule I on a temporary basis, if it cials. determines that such action is nec- essary to avoid an imminent hazard to APPLICATION FOR REGISTRATION the public safety. An order issued 1309.31 Time for application for registra- under this section may not be effective tion; expiration date.

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