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§ 1307.22 21 CFR Ch. II (4–1–20 Edition)

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 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 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 of this section, no applicant or reg- established by section 202 of the Act (21 istrant is required to use the Adminis- U.S.C. 812) and nonnarcotic substances, tration Controlled Substances Code chemical preparations, veterinary ana- Number for any purpose. bolic steroid implant products, pre- 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 drugs and other substances, by what- [81 FR 97021, Dec. 30, 2016] ever official name, common or usual § 1308.02 Definitions. name, chemical name, or brand name designated, listed in this section. Each Any term contained in this part shall drug or substance has been assigned have the definition set forth in section the DEA Controlled Substances Code 102 of the Act (21 U.S.C. 802) or part Number set forth opposite it. 1300 of this chapter. (b) Opiates. Unless specifically ex- [62 FR 13967, Mar. 24, 1997] cepted or unless listed in another schedule, any of the following opiates, § 1308.03 Administration Controlled including their , esters, ethers, Substances Code Number. salts, and salts of isomers, esters and (a) Each controlled substance, or ethers, whenever the existence of such basic class thereof, has been assigned isomers, esters, ethers and salts is pos- an ‘‘Administration Controlled Sub- sible within the specific chemical des- stances Code Number’’ for purposes of ignation (for purposes of 3- identification of the substances or methylthiofentanyl only, the term iso- class on certain Certificates of Reg- mer includes the optical and geometric istration issued by the Administration isomers): pursuant to §§ 1301.35 of this chapter (1) Acetyl-alpha- and on certain order forms issued by methylfentanyl ( -[1-(1-meth- the Administration pursuant to N yl-2-phenethyl)-4- § 1305.05(d) of this chapter. Applicants piperidinyl]- - for procurement and/or individual man- N phenylacetamide) ...... 9815 ufacturing quotas must include the ap- propriate code number on the applica- (2) Acetylmethadol ...... 9601 tion as required in §§ 1303.12(b) and (3) Acetyl fentanyl (N-(1- 1303.22(a) of this chapter. Applicants phenethylpiperidin-4-yl)-N- for import and export permits must in- phenylacetamide) ...... 9821 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 (35) 4-Fluoroisobutyryl levo-alphacetylmethadol also fentanyl (N-(4-fluorophenyl)- known as levo-alpha- N-(1-phenethylpiperidin-4- acetylmethadol, yl)isobutyramide; other levomethadyl acetate, or name: para-fluoroisobutyryl LAAM) ...... 9603 fentanyl) ...... 9824 (8) Alphameprodine ...... 9604 (36) Furanyl fentanyl (N-(1- (9) Alphamethadol ...... 9605 phenethylpiperidin-4-yl)-N- (10) Alpha-methylfentanyl (N- phenylfuran-2-carboxamide) .. 9834 [1-(alpha-methyl-beta- (37) Furethidine ...... 9626 phenyl)ethyl-4-piperidyl] (38) Hydroxypethidine ...... 9627 propionanilide; 1-(1-methyl-2- (39) Ketobemidone ...... 9628 phenylethyl)-4-(N- (40) Levomoramide ...... 9629 propanilido) ) ...... 9814 (41) Levophenacylmorphan ...... 9631 (11) Alpha-methylthiofentanyl (42) Methoxyacetyl fentanyl (2- (N-[1-methyl-2-(2- methoxy-N-(1- thienyl)ethyl-4-piperidinyl]- phenethylpiperidin-4-yl)-N- N-phenylpropanamide) ...... 9832 phenylacetamide) ...... 9825 (12) Benzethidine ...... 9606 (43) 3-Methylfentanyl (N-[3- (13) Betacetylmethadol ...... 9607 methyl-1-(2-phenylethyl)-4- (14) Beta-hydroxyfentanyl (N- piperidyl]-N- [1-(2-hydroxy-2-phenethyl)-4- phenylpropanamide) ...... 9813 piperidinyl]-N- (44) 3-methylthiofentanyl (N- phenylpropanamide) ...... 9830 [(3-methyl-1-(2-thienyl)ethyl- (15) Beta-hydroxy-3- 4-piperidinyl]-N- methylfentanyl (other name: phenylpropanamide) ...... 9833 N-[1-(2-hydroxy-2-phenethyl)- (45) Morpheridine ...... 9632 3-methyl-4-piperidinyl]-N- (46) MPPP (1-methyl-4-phenyl- phenylpropanamide ...... 9831 4-propionoxypiperidine) ...... 9661 (16) N-[1-[2-hydroxy-2- (47) MT–45 (1-cyclohexyl-4-(1,2- (thiophen-2- diphenylethyl)) ..... (9560) yl)ethyl]piperidin-4-yl]-N- (48) Noracymethadol ...... 9633 phenylpropionamide (Other (49) Norlevorphanol ...... 9634 name: beta- (50) Normethadone ...... 9635 Hydroxythiofentanyl) ...... 9836 (51) Norpipanone ...... 9636 (52) Ocfentanil (N-(2- (17) Betameprodine ...... 9608 fluorophenyl)-2-methoxy-N- (18) Betamethadol ...... 9609 (1-phenethylpiperidin-4- (19) Betaprodine ...... 9611 yl)acetamide) ...... 9838 (20) Butyryl fentanyl (N-(1- (53) ortho-Fluorofentanyl (N-(2- phenethylpiperidin-4-yl)-N- fluorophenyl)-N-(1- phenylbutyramide) ...... 9822 phenethylpiperidin-4- (21) Clonitazene ...... 9612 yl)propionamide); other (22) Cyclopropyl fentanyl (N-(1- name: 2-fluorofentanyl) ...... 9816 phenethylpiperidin-4-yl)-N- (54) para-Fluorobutyryl phenylcyclopropanecarboxa- fentanyl (N-(4-fluorophenyl)- mide) ...... 9845 N-(1-phenethylpiperidin-4- (23) Dextromoramide ...... 9613 yl)butyramide) ...... 9823 (24) Diampromide ...... 9615 (55) Para-fluorofentanyl (N-(4- (25) Diethylthiambutene ...... 9616 fluorophenyl)-N-[1-(2- (26) Difenoxin ...... 9168 phenethyl)-4-piperidinyl] (27) Dimenoxadol ...... 9617 propanamide ...... 9812 (28) Dimepheptanol ...... 9618 (56) PEPAP (1-(-2-phenethyl)-4- (29) Dimethylthiambutene ...... 9619 phenyl-4-acetoxypiperidine ... 9663 (30) Dioxaphetyl butyrate ...... 9621 (57) Phenadoxone ...... 9637 (31) Dipipanone ...... 9622 (58) Phenampromide ...... 9638 (32) Ethylmethylthiambutene .. 9623 (59) Phenomorphan ...... 9647 (33) Etonitazene ...... 9624 (60) Phenoperidine ...... 9641 (34) Etoxeridine ...... 9625 (61) Piritramide ...... 9642 116

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(62) Proheptazine ...... 9643 chemical designation (for purposes of (63) Properidine ...... 9644 this paragraph only, the term ‘‘’’ (64) Propiram ...... 9649 includes the optical, position and geo- (65) Racemoramide ...... 9645 metric isomers): (66) Tetrahydrofuranyl fentanyl (1) Alpha-ethyltryptamine ...... 7249 (N-(1-phenethylpiperidin-4- Some trade or other names: yl)-N-phenyltetrahydrofuran- etryptamine; Monase; a- 2-carboxamide) ...... 9843 ethyl-1H-indole-3- (67) Thiofentanyl (N-phenyl-N- ethanamine; 3-(2- [1-(2-thienyl)ethyl-4- aminobutyl) indole; a-ET; piperidinyl]-propanamide ...... 9835 and AET. (68) Tilidine ...... 9750 (2) 4-bromo-2,5-dimethoxy-am- (69) Trimeperidine ...... 9646 phetamine ...... 7391 (70) U–47700 (3,4-Dichloro-N-[2- Some trade or other names: (dimethylamino)cyclohexyl]- 4-bromo-2,5-dimethoxy-a- N-methylbenzamide) ...... 9547 methylphenethylamine; (c) Opium derivatives. Unless specifi- 4-bromo-2,5-DMA cally excepted or unless listed in an- (3) 4-Bromo-2,5- other schedule, any of the following dimethoxyphenethylamine .... 7392 opium derivatives, its salts, isomers, Some trade or other names: and salts of isomers whenever the ex- 2-(4-bromo-2,5- istence of such salts, isomers, and salts dimethoxyphenyl)-1- of isomers is possible within the spe- aminoethane; alpha- cific chemical designation: desmethyl DOB; -B, (1) Acetorphine ...... 9319 Nexus. (2) Acetyldihydrocodeine ...... 9051 (4) 2,5- 7396 (3) Benzylmorphine ...... 9052 Some trade or other names: (4) Codeine methylbromide ...... 9070 2,5-dimethoxy-a- (5) Codeine-N-Oxide ...... 9053 methylphenethylamine; (6) Cyprenorphine ...... 9054 2,5-DMA (7) Desomorphine ...... 9055 (5) 2,5-dimethoxy-4- (8) Dihydromorphine ...... 9145 ethylamphet-amine ...... 7399 (9) Drotebanol ...... 9335 Some trade or other names: (10) Etorphine (except hydro- DOET chloride salt) ...... 9056 (6) 2,5-dimethoxy-4-(n)- (11) Heroin ...... 9200 propylthiophenethylamine (12) Hydromorphinol ...... 9301 (other name: 2C–T–7) ...... 7348 (13) Methyldesorphine ...... 9302 (7) 4-methoxyamphetamine ...... 7411 (14) Methyldihydromorphine .... 9304 Some trade or other names: (15) Morphine methylbromide .. 9305 4-methoxy-a- (16) Morphine methylsulfonate 9306 methylphenethylamine; (17) Morphine-N-Oxide ...... 9307 paramethoxyamphetami- (18) Myrophine ...... 9308 ne, PMA (19) Nicocodeine ...... 9309 (8) 5-methoxy-3,4- (20) Nicomorphine ...... 9312 methylenedioxy-amphet- (21) Normorphine ...... 9313 amine ...... 7401 (22) Pholcodine ...... 9314 (9) 4-methyl-2,5-dimethoxy-am- (23) Thebacon ...... 9315 phetamine ...... 7395 (d) Hallucinogenic substances. Unless Some trade and other specifically excepted or unless listed in names: 4-methyl-2,5- another schedule, any material, com- dimethoxy-a- pound, mixture, or preparation, which methylphenethylamine; contains any quantity of the following ‘‘DOM’’; and ‘‘STP’’ hallucinogenic substances, or which (10) 3,4-methylenedioxy am- contains any of its salts, isomers, and phetamine ...... 7400 salts of isomers whenever the existence (11) 3,4- of such salts, isomers, and salts of iso- methylenedioxymethamphet- mers is possible within the specific amine (MDMA) ...... 7405 117

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(12) 3,4-methylenedioxy-N- (21) ...... 7260 ethylamphetamine (also Some trade and other known as N-ethyl-alpha- names: 7-Ethyl- methyl-3,4(methylenedioxy)- 6,6b,7,8,9,10,12,13- , N-ethyl octahydro-2-methoxy-6,9- MDA, MDE, MDEA ...... 7404 methano-5H-pyrido [1′, (13) N-hydroxy-3,4- 2′:1,2] azepino [5,4-b] methylenedioxyamphetamine indole; Tabernanthe iboga (also known as N-hydroxy- (22) Lysergic acid diethylamide 7315 alpha-methyl- 3,4(methylenedioxy)- (23) Marihuana ...... 7360 phenethylamine, and N-hy- (24) ...... 7381 droxy MDA ...... 7402 (25) Parahexyl—7374; some (14) 3,4,5-trimethoxy amphet- trade or other names: 3- amine ...... 7390 Hexyl-1-hydroxy-7,8,9,10- (15) 5-methoxy-N,N- tetrahydro-6,6,9-trimethyl- dimethyltryptamine Some 6H-dibenzo[b,d]pyran; trade or other names: 5- Synhexyl. methoxy-3-[2- (26) Peyote ...... 7415 (dimethylamino)ethyl]indole; Meaning all parts of the 5-MeO-DMT ...... 7431 plant presently classified (16) Alpha-methyltryptamine botanically as Lophophora (other name: AMT) ...... 7432 williamsii Lemaire, wheth- (17) Bufotenine ...... 7433 er growing or not, the Some trade and other seeds thereof, any extract names: 3-(b- from any part of such Dimethylaminoethyl)-5- plant, and every com- hydroxyindole; 3-(2- pound, manufacture, dimethylaminoethyl)-5- salts, derivative, mixture, indolol; N, N- or preparation of such dimethylserotonin; 5-hy- plant, its seeds or ex- droxy-N,N- tracts dimethyltryptamine; (Interprets 21 USC 812(c), mappine Schedule I(c) (12)) (18) Diethyltryptamine ...... 7434 (27) N-ethyl-3-piperidyl Some trade and other benzilate ...... 7482 names: N,N- (28) N-methyl-3-piperidyl Diethyltryptamine; DET benzilate ...... 7484 (19) Dimethyltryptamine ...... 7435 Some trade or other names: (29) ...... 7437 DMT (30) Psilocyn ...... 7438 (20) 5-methoxy-N,N- (31) Tetrahydrocannabinols ...... 7370 diisopropyltryptamine (other name: 5-MeO-DIPT) ...... 7439

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Meaning Some trade or other names: tetrahydrocannabinols 1-[1-(2-thienyl)- naturally contained in a cyclohexyl]-piperidine, 2- plant of the genus Can- thienylanalog of nabis (cannabis plant), as , TPCP, well as synthetic equiva- TCP lents of the substances (35) 1-[1-(2- contained in the cannabis thieny- plant, or in the resinous l)cyclohexyl] ...... 7473 extractives of such plant, Some other names: TCPy and/or synthetic sub- (36) 4-methylmethcathinone stances, derivatives, and () ...... 1248 their isomers with simi- (37) 3,4- lar chemical structure methylenedioxypyrovalerone and pharmacological ac- (MDPV) ...... 7535 tivity to those substances (38) 2-(2,5-Dimethoxy-4- contained in the plant, ethylphenyl)ethanamine (2C– such as the following: E) ...... 7509 1 cis or trans (39) 2-(2,5-Dimethoxy-4- tetrahydrocannabinol, methylphenyl)ethanamine and their optical isomers (2C–D) ...... 7508 6 cis or trans (40) 2-(4-Chloro-2,5- tetrahydrocannabinol, dimethoxyphenyl)ethanamine and their optical isomers (2C–C) ...... 7519 3, 4 cis or trans (41) 2-(4-Iodo-2,5- tetrahydrocannabinol, dimethoxyphenyl)ethanamine and its optical isomers (2C–I) ...... 7518 (Since nomenclature of (42) 2-[4-(Ethylthio)-2,5- these substances is not dimethoxyphenyl]ethanamine internationally standard- (2C–T–2) ...... 7385 ized, compounds of these (43) 2-[4-(Isopropylthio)-2,5- structures, regardless of dimethoxyphenyl]ethanamine numerical designation of (2C–T–4) ...... 7532 atomic positions cov- (44) 2-(2,5- ered.) Dimethoxypheny- (32) Ethylamine analog of l)ethanamine (2C–H) ...... 7517 phencyclidine ...... 7455 (45) 2-(2,5-Dimethoxy-4-nitro- Some trade or other names: phenyl)ethanamine (2C–N) .... 7521 N-ethyl-1- (46) 2-(2,5-Dimethoxy-4-(n)- phenylcyclohexylamine, propylphenyl)ethanamine (1- (2C–P) ...... 7524 phenylcyclohexy- (47) 3,4-Methylenedioxy-N- l)ethylamine, N-(1- methylcathinone () 7540 phenylcyclohexy- (48) (1-pentyl-1H-indol-3- l)ethylamine, yl)(2,2,3,3- cyclohexamine, PCE tetramethylcyclopropy- (33) Pyrrolidine analog of l)methanone (UR-144) ...... (7144) phencyclidine ...... 7458 (49) [1-(5-fluoro-pentyl)-1H- Some trade or other names: indol-3-yl](2,2,3,3- 1-(1-phenylcyclohexyl)- tetramethylcyclopropy- pyrrolidine, PCPy, PHP l)methanone (5-fluoro-UR-144, (34) Thiophene analog of XLR11) ...... (7011) phencyclidine ...... 7470 (50) N-(1-adamantyl)-1-pentyl- 1H-indazole-3-carboxamide (APINACA, AKB48) ...... (7048) (51) quinolin-8-yl 1-pentyl-1H- indole-3-carboxylate (PB-22; QUPIC) ...... (7222) 119

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(52) quinolin-8-yl 1-(5- (68) alpha- fluoropentyl)-1H-indole-3- pyrrolidinobutiophenone (a- carboxylate (5-fluoro-PB-22; PBP) ...... (7546) 5F-PB-22) ...... (7225) (69) N-(1-amino-3-methyl-1- (53) N-(1-amino-3-methyl-1- oxobutan-2-yl)-1- oxobutan-2-yl)-1-(4- (cyclohexylmethyl)-1H-inda- fluorobenzyl)-1H-indazole-3- zole-3-carboxamide (AB- carboxamide (AB- CHMINACA) ...... (7031) FUBINACA) ...... (7012) (70) N-(1-amino-3-methyl-1- (54) N-(1-amino-3,3-dimethyl-1- oxobutan-2-yl)-1-pentyl-1H- oxobutan-2-yl)-1-pentyl-1H- indazole-3-carboxamide (AB- indazole-3-carboxamide PINACA) ...... (7023) (ADB-PINACA) ...... (7035) (71) [1-(5-fluoropentyl)-1H- (55) 2-(4-iodo-2,5- indazol-3-yl](naphthalen-1- dimethoxyphenyl)-N-(2-me- yl)methanone (THJ-2201) ...... (7024) thoxybenzyl)ethanamine (25I- (72) N-(1-amino-3,3-dimethyl-1- NBOMe, 2C-I-NBOMe) ...... (7538) oxobutan-2-yl)-1- (56) 2-(4-chloro-2,5- (cyclohexylmethyl)-1H-inda- dimethoxyphenyl)-N-(2-me- zole-3-carboxamide (MAB- thoxybenzyl)ethanamine CHMINACA; ADB- (25C-NBOMe, 2C-C-NBOMe) ... (7537) CHMINACA) ...... (7032) (57) 2-(4-bromo-2,5- (73) methyl 2-(1-(5- dimethoxyphenyl)-N-(2-me- fluoropentyl)-1H-indazole-3- thoxybenzyl)ethanamine carboxamido)-3,3- (25B-NBOMe, 2C-B-NBOMe) ... (7536) dimethylbutanoate (Other (58) Marihuana Extract—Mean- names: 5F-ADB; 5F-MDMB- ing an extract containing one PINACA) ...... 7034 or more cannabinoids that (74) methyl 2-(1-(5- has been derived from any fluoropentyl)-1H-indazole-3- plant of the genus Cannabis, carboxamido)-3- other than the separated methylbutanoate (Other resin (whether crude or puri- names: 5F-AMB) ...... 7033 fied) obtained from the plant (7350) (75) N-(adamantan-1-yl)-1-(5- (59) 4-methyl-N-ethylcathinone fluoropentyl)-1H-indazole-3- (4-MEC) ...... (1249) carboxamide (Other names: (60) 4-methyl-alpha- 5F-APINACA, 5F-AKB48) ...... 7049 pyrrolidinopropiophenone (4- (76) N-(1-amino-3,3-dimethyl-1- MePPP) ...... (7498) oxobutan-2-yl)-1-(4- (61) alpha- fluorobenzyl)-1H-indazole-3- pyrrolidinopentiophenone (a- carboxamide (Other names: PVP) ...... (7545) ADB-FUBINACA) ...... 7010 (62) 1-(1,3-benzodioxol-5-yl)-2- (77) methyl 2-(1- (methylamino)butan-1-one (cyclohexylmethyl)-1H- (, bk-MBDB) ...... (7541) indole-3-carboxamido)-3,3- (63) 2-(methylamino)-1- dimethylbutanoate (Other phenylpentan-1-one names: MDMB-CHMICA, () ...... (1246) MMB-CHMINACA) ...... 7042 (64) 1-(1,3-benzodioxol-5-yl)-2- (78) methyl 2-(1-(4- (methylamino)pentan-1-one fluorobenzyl)-1H-indazole-3- (, bk-MBDP) ...... (7542) carboxamido)-3,3- (65) 4-fluoro-N-methylcathinone dimethylbutanoate (Other (4-FMC; ) ...... (1238) names: MDMB-FUBINACA) ... 7020 (66) 3-fluoro-N-methylcathinone (79) methyl 2-(1-(4- (3-FMC) ...... (1233) fluorobenzyl)-1H-indazole-3- (67) 1-(naphthalen-2-yl)-2- carboxamido)-3- (pyrrolidin-1-yl)pentan-1-one methylbutanoate, (FUB– () ...... (1258) AMB, MMB–FUBINACA, AMB–FUBINACA) ...... (7021) 120

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(e) Depressants. Unless specifically (5) (Some other excepted or unless listed in another names: 2-(methylamino)- schedule, any material, compound, propiophenone; alpha- mixture, or preparation which contains (methylamin- any quantity of the following sub- o)propiophenone; 2- stances having a depressant effect on (methylamino)-1- the central nervous system, including phenylpropan-1-one; alpha-N- its salts, isomers, and salts of isomers methylaminopropiophenone; whenever the existence of such salts, monomethylpropion; isomers, and salts of isomers is possible ephedrone; N- within the specific chemical designa- methylcathinone; tion: methylcathinone; AL–464; AL–422; AL–463 and UR1432), (1) gamma-hydroxybutyric acid its salts, optical isomers and (some other names include salts of optical isomers ...... 1237 GHB; gamma- (6) (±)cis-4-methylaminorex hydroxybutyrate; 4- ((±)cis-4,5-dihydro-4-methyl-5- hydroxybutyrate; 4- phenyl-2-oxazolamine) ...... 1590 hydroxybutanoic acid; so- (7) N-ethylamphetamine ...... 1475 dium oxybate; sodium (8) N,N- oxybutyrate) ...... 2010 (also known as N,N-alpha- (2) Mecloqualone ...... 2572 trimethyl- (3) Methaqualone ...... 2565 benzeneethanamine; N,N- (f) . Unless specifically ex- alpha- cepted or unless listed in another trimethylphenethylamine) .... 1480 schedule, any material, compound, (g) Cannabimimetic agents. Unless spe- mixture, or preparation which contains cifically exempted or unless listed in any quantity of the following sub- another schedule, any material, com- stances having a effect on pound, mixture, or preparation which the central nervous system, including contains any quantity of the following its salts, isomers, and salts of isomers: substances, or which contains their salts, isomers, and salts of isomers (1) (Some other whenever the existence of such salts, names: aminoxaphen; 2- isomers, and salts of isomers is possible amino-5-phenyl-2-; within the specific chemical designa- or 4,5-dihydro-5-phenly-2- tion: oxazolamine) ...... 1585 (2) N- (some (1) 5-(1,1-dimethylheptyl)-2- other names: BZP, 1- [(1R,3S)-3- benzylpiperazine) ...... 7493 hydroxycyclohexyl]-phenol (3) ...... 1235 (CP–47,497) ...... 7297 (2) 5-(1,1-dimethyloctyl)-2- Some trade or other names: [(1R,3S)-3- 2-amino-1-phenyl-1- hydroxycyclohexyl]-phenol propanone, alpha- (cannabicyclohexanol or CP– aminopropiophenone, 2- 47,497 C8-homolog) ...... 7298 aminopropiophenone, and norephedrone (3) 1-pentyl-3-(1-naph- thoyl)indole (JWH–018 and (4) ...... 1503 AM678) ...... 7118 (4) 1-butyl-3-(1-naph- thoyl)indole (JWH–073) ...... 7173 (5) 1-hexyl-3-(1-naph- thoyl)indole (JWH–019) ...... 7019 (6) 1-[2-(4-morpholinyl)ethyl]-3- (1-naphthoyl)indole (JWH– 200) ...... 7200 (7) 1-pentyl-3-(2- methoxyphenylacetyl)indole (JWH–250) ...... 6250 121

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(8) 1-pentyl-3-[1-(4- (27) N-(1-phenethylpiperidin-4- methoxynaphthoyl)]indole yl)-N-phenylisobutyramide, (JWH–081) ...... 7081 its isomers, esters, ethers, (9) 1-pentyl-3-(4-methyl-1-naph- salts and salts of isomers, thoyl)indole (JWH–122) ...... 7122 esters and ethers (Other (10) 1-pentyl-3-(4-chloro-1-naph- name: isobutyryl fentanyl) .. (9827) thoyl)indole (JWH–398) ...... 7398 (28) N-(1-phenethylpiperidin-4- (11) 1-(5-fluoropentyl)-3-(1-naph- yl)-N- thoyl)indole (AM2201) ...... 7201 phenylcyclopentanecarboxa- mide, its isomers, esters, (12) 1-(5-fluoropentyl)-3-(2- ethers, salts and salts of iso- iodobenzoyl)indole (AM694) ... 7694 mers, esters and ethers (13) 1-pentyl-3-[(4-methoxy)- (Other name: cyclopentyl benzoyl]indole (SR–19 and fentanyl) ...... (9847) RCS–4) ...... 7104 (29) [Reserved]. (14) 1-cyclohexylethyl-3-(2- (30) [Reserved]. methoxyphenylacetyl)indole (31) Naphthalen-1-yl 1-(5- 7008 (SR–18 and RCS–8) ...... 7008 fluoropentyl)-1H-indole-3- (15) 1-pentyl-3-(2- carboxylate, its optical, po- chlorophenylacetyl)indole sitional, and geometric iso- (JWH–203) ...... 7203 mers, salts and salts of iso- (h) Temporary listing of substances sub- mers (Other names: NM2201; ject to emergency scheduling. Any mate- CBL2201) ...... (7221) rial, compound, mixture or preparation (32) N-(1-amino-3-methyl-1- which contains any quantity of the fol- oxobutan-2-yl)-1-(5- lowing substances: fluoropentyl)-1H-indazole-3- carboxamide, its optical, po- (1)–(17) [Reserved]. sitional, and geometric iso- (18) [Reserved]. mers, salts and salts of iso- (19) [Reserved]. mers (Other names: 5F-AB- (20) [Reserved]. PINACA) ...... (7025) (21) [Reserved]. (33) 1-(4-cyanobutyl)-N-(2- (22) [Reserved]. phenylpropan-2-yl)-1H-inda- (23) N-(1-phenethylpiperidin-4- zole-3-carboxamide, its opti- yl)-N-phenylpentanamide, cal, positional, and geo- its isomers, esters, ethers, metric isomers, salts and salts and salts of isomers, salts of isomers (Other esters and ethers (Other names: 4-CN-CUMYL- name: Valeryl fentanyl) ...... (9840) BUTINACA; 4-cyano- (24) [Reserved]. CUMYL-BUTINACA; 4-CN- CUMYL BINACA; CUMYL- (25) N-(4-methoxyphenyl)-N-(1- 4CN-BINACA; SGT-78) ...... (7089) phenethylpiperidin-4- (34) methyl 2-(1- yl)butyramide, its isomers, (cyclohexylmethyl)-1H- esters, ethers, salts and salts indole-3-carboxamido)-3- of isomers, esters and ethers methylbutanoate, its opti- (Other name: para- cal, positional, and geo- methoxybutyryl fentanyl) ... (9837) metric isomers, salts and (26) N-(4-chlorophenyl)-N-(1- salts of isomers (Other phenethylpiperidin-4- names: MMB-CHMICA, yl)isobutyramide, its iso- AMB-CHMICA) ...... (7044) mers, esters, ethers, salts (35) 1-(5-fluoropentyl)-N-(2- and salts of isomers, esters phenylpropan-2-yl)-1H- and ethers (Other name: pyrrolo[2,3-b]pyridine-3- para-chloroisobutyryl carboxamide, its optical, po- fentanyl) ...... (9826) sitional, and geometric iso- mers, salts and salts of iso- mers (Other names: 5F- CUMYL-P7AICA) ...... (7085) 122

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(36) N-Ethylpentylone, its op- (43) alpha- tical, positional, and geo- Pyrrolidinohexanophenone, metric isomers, salts and its optical, positional, and salts of isomers (Other geometric isomers, salts and names: ephylone, 1-(1,3- salts of isomers (Other benzodioxol-5-yl)-2- names: a-PHP; alpha- (ethylamino)-pentan-1-one) (7543) pyrrolidinohexiophenone; 1- (37) ethyl 2-(1-(5-fluoropentyl)- phenyl-2-(pyrrolidin-1- 1H-indazole-3-carboxamido)- yl)hexan-1-one) ...... 7544 3,3-dimethylbutanoate, its (44) 4-Methyl-alpha- optical, positional, and geo- ethylaminopentiophenone, metric isomers, salts and its optical, positional, and salts of isomers (trivial geometric isomers, salts and name: 5F-EDMB-PINACA) ... 7036 salts of isomers (Other (38) methyl 2-(1-(5- names: 4–MEAP; 2- fluoropentyl)-1H-indole-3- (ethylamino)-1-(4- carboxamido)-3,3- methylphenyl)pentan-1-one) 7245 dimethylbutanoate, its opti- (45) 4′-Methyl-alpha- cal, positional, and geo- pyrrolidinohexiophenone, its metric isomers, salts and optical, positional, and geo- salts of isomers (trivial metric isomers, salts and name: 5F-MDMB-PICA) ...... 7041 salts of isomers (Other (39) N-(adamantan-1-yl)-1-(4- names: MPHP; 4′-methyl- fluorobenzyl)-1H-indazole-3- alpha- carboxamide, its optical, po- pyrrolidinohexanophenone; sitional, and geometric iso- 1-(4-methylphenyl)-2- mers, salts and salts of iso- (pyrrolidin-1-yl)hexan-1-one) 7446 mers (trivial names: FUB- (46) alpha- AKB48; FUB-APINACA; Pyrrolidinoheptaphenone, AKB48 N-(4- its optical, positional, and FLUOROBENZYL)) ...... 7047 geometric isomers, salts and (40) 1-(5-fluoropentyl)-N-(2- salts of isomers (Other phenylpropan-2-yl)-1H-inda- names: PV8; 1-phenyl-2- zole-3-carboxamide, its opti- (pyrrolidin-1-yl)heptan-1- cal, positional, and geo- one) ...... 7548 metric isomers, salts and (47) 4′-Chloro-alpha- salts of isomers (trivial pyrrolidinovalerophenone, names: 5F-CUMYL-PINACA; its optical, positional, and SGT-25) ...... 7083 geometric isomers, salts and (41) (1-(4-fluorobenzyl)-1H- salts of isomers (Other indol-3-yl)(2,2,3,3- names: 4-chloro-a-PVP; 4′- tetramethylcyclopropyl) chloro-alpha- methanone, its optical, posi- pyrrolidinopentiophenone; 1- tional, and geometric iso- (4-chlorophenyl)-2- mers, salts and salts of iso- (pyrrolidin-1-yl)pentan-1- mers (trivial name: FUB-144) 7014 one) ...... 7443 (42) N-Ethylhexedrone, its op- tical, positional, and geo- [39 FR 22141, June 20, 1974] metric isomers, salts and EDITORIAL NOTE: For FEDERAL REGISTER ci- salts of isomers (Other tations affecting § 1308.11, see the List of CFR name: 2-(ethylamino)-1- Sections Affected, which appears in the phenylhexan-1-one) ...... 7246 Finding Aids section of the printed volume and at www.govinfo.gov.

EFFECTIVE DATE NOTES: 1. At 83 FR 31882, July 10, 2018, § 1308.11 was amended by adding paragraphs (h)(31) through (h)(35) effective July 10, 2018 through July 10, 2020.

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2. At 83 FR 44478, Aug. 31, 2018, § 1308.11 was (xiv) Oxycodone ...... 9143 amended by adding paragraph (h)(36) effec- (xv) Oxymorphone ...... 9652 tive Aug. 31, 2018 through Aug. 31, 2020. 3. At 84 FR 13796, Apr. 10, 2019,§ 1308.11 was (xvi) Powdered opium ...... 9639 amended by extending the order at 82 FR (xvii) Raw opium ...... 9600 17119, Apr. 10, 2017, is effective Apr. 10, 2019 (xviii) Thebaine ...... 9333 and will expire on Apr. 10, 2020. (xix) Tincture of opium ...... 9630 4. At 84 FR 15511, Apr. 16, 2019, § 1308.11 was amended by adding paragraphs (h)(37) (2) Any salt, compound, derivative, or through (h)(41) effective Apr. 16, 2019 through preparation thereof which is chemi- Apr. 16, 2021. cally equivalent or identical with any 5. At 84 FR 34297, July 17, 2019, § 1308.11 was of the substances referred to in para- amended by adding paragraphs (h)(42) graph (b) (1) of this section, except that through (h)(47) effective July 18, 2019 through July 18, 2021. these substances shall not include the 6. At 85 FR 5322, Jan. 30, 2020, § 1308.11 was isoquinoline alkaloids of opium. amended by extending the order at 83 FR (3) Opium poppy and poppy straw. 4580, Feb. 1, 2018, is effective Feb. 1, 2020 and (4) leaves (9040) and any salt, expires Feb. 1. 2021. compound, derivative or preparation of coca leaves (including (9041) § 1308.12 Schedule II. and ecgonine (9180) and their salts, iso- (a) Schedule II shall consist of the mers, derivatives and salts of isomers drugs and other substances, by what- and derivatives), and any salt, com- ever official name, common or usual pound, derivative, or preparation name, chemical name, or brand name thereof which is chemically equivalent designated, listed in this section. Each or identical with any of these sub- drug or substance has been assigned stances, except that the substances the Controlled Substances Code Num- shall not include: ber set forth opposite it. (i) Decocainized coca leaves or ex- (b) Substances, vegetable origin or traction of coca leaves, which extrac- chemical synthesis. Unless specifically tions do not contain cocaine or ecgo- excepted or unless listed in another nine; or schedule, any of the following sub- (ii) [123I]. stances whether produced directly or (5) Concentrate of poppy straw (the indirectly by extraction from sub- crude extract of poppy straw in either stances of vegetable origin, or inde- liquid, solid or powder form which con- pendently by means of chemical syn- tains the phenanthrene alkaloids of the thesis, or by a combination of extrac- opium poppy), 9670. tion and chemical synthesis: (c) Opiates. Unless specifically ex- (1) Opium and opiate, and any salt, cepted or unless in another schedule compound, derivative, or preparation any of the following opiates, including of opium or opiate excluding its isomers, esters, ethers, salts and apomorphine, thebaine-derived salts of isomers, esters and ethers butorphanol, , nalbuphine, whenever the existence of such iso- naldemedine, nalmefene, naloxegol, mers, esters, ethers, and salts is pos- , 6b-naltrexol and , sible within the specific chemical des- and their respective salts, but includ- ignation, dextrorphan and ing the following: levopropoxyphene excepted: (i) Codeine ...... 9050 (1) Alfentanil ...... 9737 (ii) Dihydroetorphine ...... 9334 (iii) Ethylmorphine ...... 9190 (2) Alphaprodine ...... 9010 (iv) Etorphine hydrochloride ..... 9059 (3) Anileridine ...... 9020 (v) Granulated opium ...... 9640 (4) Bezitramide ...... 9800 (vi) Hydrocodone ...... 9193 (5) Bulk (vii) Hydromorphone ...... 9150 (non-dosage forms) ...... 9273 (viii) Metopon ...... 9260 (6) Carfentanil ...... 9743 (ix) Morphine ...... 9300 (7) Dihydrocodeine ...... 9120 (x) Noroxymorphone ...... 9668 (8) Diphenoxylate ...... 9170 (xi) Opium extracts ...... 9610 (9) Fentanyl ...... 9801 (xii) Opium fluid ...... 9620 (10) Isomethadone ...... 9226 (xiii) Oripavine ...... 9330 (11) Levo-alphacetylmethadol .... 9648 124

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[Some other names: levo- its salts, isomers, and salts of isomers alpha-acetylmethadol, whenever the existence of such salts, levomethadyl acetate, isomers, and salts of isomers is possible LAAM] within the specific chemical designa- (12) ...... 9210 tion: (13) ...... 9220 (1) Amobarbital ...... 2125 (14) Metazocine ...... 9240 (2) Glutethimide ...... 2550 (15) ...... 9250 (3) Pentobarbital ...... 2270 (16) Methadone-Intermediate, 4- (4) Phencyclidine ...... 7471 cyano-2-dimethylamino-4,4-di- (5) Secobarbital ...... 2315 phenyl butane ...... 9254 (17) Moramide-Intermediate, 2- (f) Hallucinogenic substances. methyl-3-morpholino-1, 1- (1) Nabilone ...... 7379 diphenylpropane-carboxylic [Another name for acid ...... 9802 nabilone: (±)-trans-3-(1,1- (18) (meperidine) ...... 9230 dimethylheptyl)- (19) Pethidine-Intermediate-A, 4- 6,6a,7,8,10,10a-hexahydro- cyano-1-methyl-4- 1-hydroxy-6,6-dimethyl- phenylpiperidine ...... 9232 9H-dibenzo[b,d]pyran-9- (20) Pethidine-Intermediate-B, one] ethyl-4-phenylpiperidine-4- (2) Dronabinol [(-)-delta-9-trans carboxylate ...... 9233 tetrahydrocannabinol] in an (21) Pethidine-Intermediate-C, 1- oral solution in a drug prod- methyl-4-phenylpiperidine-4- uct approved for marketing carboxylic acid ...... 9234 (22) Phenazocine ...... 9715 by the U.S. Food and Drug (23) Piminodine ...... 9730 Administration ...... (7365) (24) Racemethorphan ...... 9732 (g) Immediate precursors. Unless spe- (25) ...... 9733 cifically excepted or unless listed in (26) Remifentanil ...... 9739 another schedule, any material, com- (27) Sufentanil ...... 9740 pound, mixture, or preparation which (28) ...... 9780 contains any quantity of the following (29) Thiafentanil ...... 9729 substances: (d) Stimulants. Unless specifically ex- (1) Immediate precursor to amphet- cepted or unless listed in another amine and : schedule, any material, compound, (i) Phenylacetone ...... 8501 mixture, or preparation which contains Some trade or other names: any quantity of the following sub- phenyl-2-propanone; P2P; stances having a stimulant effect on benzyl methyl ketone; the central nervous system: methyl benzyl ketone; (1) , its salts, opti- (2) Immediate precursors to cal isomers, and salts of its phencyclidine (PCP): optical isomers ...... 1100 (2) Methamphetamine, its salts, (i) 1-phenylcyclohexylamine ...... 7460 isomers, and salts of its iso- (ii) 1- mers ...... 1105 piperidinocyclohexanecarboni- (3) and its salts 1631 trile (PCC) ...... 8603 (4) ...... 1724 (3) Immediate precursor to fentanyl: (5) , its salts, (i) 4-anilino-N- isomers, and salts of its iso- phenethylpiperidine (ANPP) ... 8333 mers ...... 1205. (ii) [Reserved]. (e) Depressants. Unless specifically excepted or unless listed in another [39 FR 22142, June 20, 1974] schedule, any material, compound, EDITORIAL NOTE: For FEDERAL REGISTER ci- mixture, or preparation which contains tations affecting § 1308.12, see the List of CFR any quantity of the following sub- Sections Affected, which appears in the stances having a depressant effect on Finding Aids section of the printed volume the central nervous system, including and at www.govinfo.gov. 125

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§ 1308.13 Schedule III. or any salt thereof and one (a) Schedule III shall consist of the or more other active me- drugs and other substances, by what- dicinal ingredients which ever official name, common or usual are not listed in any schedule. name, chemical name, or brand name designated, listed in this section. Each (2) Any suppository dosage form containing: drug or substance has been assigned the DEA Controlled Substances Code (i) Amobarbital ...... 2126 Number set forth opposite it. (ii) Secobarbital ...... 2316 (b) Stimulants. Unless specifically ex- (iii) Pentobarbital ...... 2271 cepted or unless listed in another or any salt of any of these schedule, any material, compound, drugs and approved by the mixture, or preparation which contains Food and Drug Adminis- tration for marketing only any quantity of the following sub- as a suppository. stances having a stimulant effect on (3) Any substance which con- the central nervous system, including tains any quantity of a deriva- its salts, isomers (whether optical, po- tive of barbituric acid or any sitional, or geometric), and salts of salt thereof ...... 2100 such isomers whenever the existence of (4) Chlorhexadol ...... 2510 such salts, isomers, and salts of iso- (5) Embutramide ...... 2020 mers is possible within the specific (6) Any drug product containing chemical designation: gamma hydroxybutyric acid, (1) Those compounds, mixtures, including its salts, isomers, or preparations in dosage unit and salts of isomers, for which form containing any stimu- an application is approved lant substances listed in under section 505 of the Fed- schedule II which compounds, eral Food, Drug, and Cosmetic mixtures, or preparations were Act ...... 2012 listed on August 25, 1971, as ex- (7) , its salts, isomers, cepted compounds under and salts of isomers ...... 7285 § 1308.32, and any other drug of [Some other names for the quantitative composition ketamine: (±)-2-(2- shown in that list for those chlorophenyl)-2- drugs or which is the same ex- (methylamino)- cept that it contains a lesser cyclohexanone] quantity of controlled sub- (8) Lysergic acid ...... 7300 stances ...... 1405 (9) Lysergic acid amide ...... 7310 (2) ...... 1228 (10) Methyprylon ...... 2575 (3) ...... 1645 (11) Perampanel, and its salts, (4) ...... 1647 isomers, and salts of isomers .. 2261 (5) ...... 1615 (12) Sulfondiethylmethane ...... 2600 (c) Depressants. Unless specifically (13) Sulfonethylmethane ...... 2605 excepted or unless listed in another (14) Sulfonmethane ...... 2610 schedule, any material, compound, (15) and zolazepam mixture, or preparation which contains or any salt thereof ...... 7295 any quantity of the following sub- Some trade or other names stances having a depressant effect on for a tiletamine-zolazepam the central nervous system: combination product: (1) Any compound, mixture or Telazol. preparation containing: Some trade or other names (i) Amobarbital ...... 2126 for tiletamine: (ii) Secobarbital ...... 2316 2-(ethylamino)-2-(2- (iii) Pentobarbital ...... 2271 thienyl)- cyclohexanone.

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Some trade or other names (v) Not more than 500 for zolazepam: milligrams of opium 4-(2-fluorophenyl)-6,8- per 100 milliliters or dihydro-1,3,8- per 100 grams or not trimethylpyrazolo-[3,4- more than 25 milli- e] [1,4]-diazepin-7(1H)- grams per dosage unit, one, flupyrazapon. with one or more ac- tive, nonnarcotic in- (d) Nalorphine 9400. gredients in recognized (e) Narcotic drugs. Unless specifically therapeutic amounts ... 9809 excepted or unless listed in another (vi) Not more than 50 schedule: milligrams of mor- (1) Any material, compound, phine per 100 milli- mixture, or preparation con- liters or per 100 grams, taining any of the following with one or more ac- narcotic drugs, or their salts tive, nonnarcotic in- calculated as the free anhy- gredients in recognized drous base or alkaloid, in lim- therapeutic amounts ... 9810 ited quantities as set forth (2) Any material, compound, below: mixture, or preparation con- (i) Not more than 1.8 taining any of the following grams of codeine per narcotic drugs or their salts, 100 milliliters or not as set forth below: more than 90 milli- (i) Buprenorphine ...... 9064 grams per dosage unit, (ii) [Reserved] ...... with an equal or great- (f) Anabolic Steroids. Unless specifi- er quantity of an cally excepted or unless listed in an- isoquinoline alkaloid other schedule, any material, com- of opium ...... 9803 pound, mixture or preparation con- (ii) Not more than 1.8 taining any quantity of the following grams of codeine per substances, including its salts, esters 100 milliliters or not and ethers: more than 90 milli- (1) Anabolic steroids (see § 1300.01 of grams per dosage unit, this chapter)—4000 with one or more ac- (2) [Reserved] tive, nonnarcotic in- gredients in recognized (g) Hallucinogenic substances. (1) therapeutic amounts ... 9804 Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin cap- (iii) Not more than 1.8 sule in a U.S. Food and Drug Adminis- grams of tration approved product—7369. dihydrocodeine per 100 milliliters or not more [Some other names for dronabinol: (6aR- than 90 milligrams per trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- dosage unit, with one pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- or more active nonnar- delta-9-(trans)-tetrahydrocannabinol] cotic ingredients in (2) [Reserved] recognized therapeutic [39 FR 22142, June 20, 1974] amounts ...... 9807 (iv) Not more than 300 EDITORIAL NOTE: For FEDERAL REGISTER ci- milligrams of tations affecting § 1308.13, see the List of CFR Sections Affected, which appears in the ethylmorphine per 100 Finding Aids section of the printed volume milliliters or not more and at www.govinfo.gov. than 15 milligrams per dosage unit, with one § 1308.14 Schedule IV. or more active, non- (a) Schedule IV shall consist of the narcotic ingredients in drugs and other substances, by what- recognized therapeutic ever official name, common or usual amounts ...... 9808 name, chemical name, or brand name 127

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designated, listed in this section. Each (22) Ethyl loflazepate ...... 2758 drug or substance has been assigned (23) Fludiazepam ...... 2759 the DEA Controlled Substances Code (24) Flunitrazepam ...... 2763 Number set forth opposite it. (25) Flurazepam ...... 2767 (b) Narcotic drugs. Unless specifically (26) Fospropofol ...... 2138 excepted or unless listed in another (27) Halazepam ...... 2762 schedule, any material, compound, (28) Haloxazolam ...... 2771 mixture, or preparation containing any (29) Ketazolam ...... 2772 of the following narcotic drugs, or (30) Loprazolam ...... 2773 their salts calculated as the free anhy- (31) Lorazepam ...... 2885 drous base or alkaloid, in limited quan- (32) Lormetazepam ...... 2774 tities as set forth below: (33) Mebutamate ...... 2800 (34) Medazepam ...... 2836 (1) Not more than 1 milligram of (35) Meprobamate ...... 2820 difenoxin and not less than 25 (36) Methohexital ...... 2264 micrograms of atropine sul- (37) Methylphenobarbital fate per dosage unit ...... 9167 (mephobarbital) ...... 2250 (2) Dextropropoxyphene (alpha- (38) Midazolam ...... 2884 (+)-4-dimethylamino-1,2-di- (39) Nimetazepam ...... 2837 phenyl-3-methyl-2- (40) Nitrazepam ...... 2834 propionoxybutane) ...... 9278 (41) Nordiazepam ...... 2838 (3) 2-[(dimethylamino)methyl]-1- (42) Oxazepam ...... 2835 (3- (43) Oxazolam ...... 2839 methoxyphenyl)cyclohexanol, (44) Paraldehyde ...... 2585 its salts, optical and geo- (45) Petrichloral ...... 2591 metric isomers and salts of (46) Phenobarbital ...... 2285 these isomers (including (47) Pinazepam ...... 2883 ) ...... 9752 (48) Prazepam ...... 2764 (c) Depressants. Unless specifically (49) Quazepam ...... 2881 excepted or unless listed in another (50) Suvorexant ...... 2223 schedule, any material, compound, (51) Temazepam ...... 2925 mixture, or preparation which contains (52) Tetrazepam ...... 2886 any quantity of the following sub- (53) Triazolam ...... 2887 stances, including its salts, isomers, (54) Zaleplon ...... 2781 and salts of isomers whenever the ex- (55) Zolpidem ...... 2783 istence of such salts, isomers, and salts (56) Zopiclone ...... 2784 of isomers is possible within the spe- (d) . Any material, com- cific chemical designation: pound, mixture, or preparation which (1) Alfaxalone ...... 2731 contains any quantity of the following (2) Alprazolam ...... 2882 substances, including its salts, isomers (3) Barbital ...... 2145 (whether optical, position, or geo- (4) Brexanolone ...... 2400 metric), and salts of such isomers, (5) Bromazepam ...... 2748 whenever the existence of such salts, (6) Camazepam ...... 2749 isomers, and salts of isomers is pos- (7) Carisoprodol ...... 8192 sible: (8) Chloral betaine ...... 2460 (1) Fenfluramine ...... 1670 (9) Chloral hydrate ...... 2465 (e) . Any material, com- (10) Chlordiazepoxide ...... 2744 pound, mixture, or preparation which (11) Clobazam ...... 2751 contains any quantity of the following (12) Clonazepam ...... 2737 substances, including its salts, isomers, (13) Clorazepate ...... 2768 and salts of such isomers, whenever the (14) Clotiazepam ...... 2752 existence of such salts, isomers, and (15) Cloxazolam ...... 2753 salts of isomers is possible: (16) Delorazepam ...... 2754 (17) Diazepam ...... 2765 (1) Lorcaserin ...... 1625 (18) Dichloralphenazone ...... 2467 (f) Stimulants. Unless specifically ex- (19) Estazolam ...... 2756 cepted or unless listed in another (20) Ethchlorvynol ...... 2540 schedule, any material, compound, (21) Ethinamate ...... 2545 mixture, or preparation which contains 128

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any quantity of the following sub- (b) Narcotic drugs. Unless specifically stances having a stimulant effect on excepted or unless listed in another the central nervous system, including schedule, any material, compound, its salts, isomers and salts of isomers: mixture, or preparation containing any (1) ((+)- of the following narcotic drugs and norpseudoephedrine) ...... 1230 their salts, as set forth below: (2) Diethylpropion ...... 1610 (1) [Reserved] (3) ...... 1760 (c) Narcotic drugs containing non-nar- cotic active medicinal ingredients. Any (4) ...... 1575 compound, mixture, or preparation (5) ...... 1605 containing any of the following nar- (6) ...... 1580 cotic drugs, or their salts calculated as (7) ...... 1680 the free anhydrous base or alkaloid, in (8) (including limited quantities as set forth below, organometallic complexes and which shall include one or more non- chelates thereof) ...... 1530 narcotic active medicinal ingredients (9) ...... 1640 in sufficient proportion to confer upon (10) ...... 1750 the compound, mixture, or preparation (11) ...... 1675 valuable medicinal qualities other than (12) (2-amino-3- those possessed by narcotic drugs phenylpropyl carbamate; alone: benzenepropanol, beta-amino-, (1) Not more than 200 milligrams of carbamate (ester)) ...... 1650 codeine per 100 milliliters or per 100 (13) SPA ((-)-1-dimethylamino- grams. 1,2-diphenylethane) ...... 1635 (2) Not more than 100 milligrams of dihydrocodeine per 100 milliliters or (g) Other substances. Unless specifi- per 100 grams. cally excepted or unless listed in an- other schedule, any material, com- (3) Not more than 100 milligrams of pound, mixture or preparation which ethylmorphine per 100 milliliters or per contains any quantity of the following 100 grams. substances, including its salts: (4) Not more than 2.5 milligrams of 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- age unit. methoxybenzoic acid) (includ- (d) Stimulants. Unless specifically ex- ing its optical isomers) and its empted or excluded or unless listed in salts, isomers, and salts of iso- another schedule, any material, com- mers (9725).. pound, mixture, or preparation which contains any quantity of the following [39 FR 22143, June 20, 1974] substances having a stimulant effect EDITORIAL NOTE: For FEDERAL REGISTER ci- on the central nervous system, includ- tations affecting § 1308.14, see the List of CFR ing its salts, isomers and salts of iso- Sections Affected, which appears in the mers: Finding Aids section of the printed volume and at www.govinfo.gov. (1) ...... 1485. (2) [Reserved]. § 1308.15 Schedule V. (e) Depressants. Unless specifically (a) Schedule V shall consist of the exempted or excluded or unless listed drugs and other substances, by what- in another schedule, any material, ever official name, common or usual compound, mixture, or preparation name, chemical name, or brand name which contains any quantity of the fol- designated, listed in this section. lowing substances having a depressant

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effect on the central nervous system, (21 U.S.C. 301), be lawfully sold over the including its salts: counter without a prescription, ex- (1) Brivaracetam ((2S)-2-[(4R)-2- cluded from any schedule, pursuant to oxo-4-propylpyrrolidin-1-yl] section 201(g)(1) of the Act (21 U.S.C. butanamide) (also referred to 811(g)(1)), may apply to the Drug and as BRV; UCB–34714; Briviact) Chemical Evaluation Section, Diver- (including its salts) ...... 2710 sion Control Division, Drug Enforce- (2) Cenobamate ([(1R)-1-(2- ment Administration. See the Table of chlorophenyl)-2-(tetrazol-2- DEA Mailing Addresses in § 1321.01 of yl)ethyl] carbamate; 2H- this chapter for the current mailing ad- tetrazole-2-ethanol, alpha-(2- dress. chlorophenyl)-, carbamate (b) An application for an exclusion (ester), (alphaR)-; carbamic under this section shall contain the fol- acid (R)-(+)-1-(2-chlorophenyl)- lowing information: 2-(2H-tetrazol-2-yl)ethyl ester) 2720 (1) The name and address of the ap- (3) Ezogabine [N-[2-amino-4-(4- plicant; fluorobenzylamino)-phenyl]- (2) The name of the substance for carbamic acid ethyl ester] ...... 2779 which exclusion is sought; and (4) Lacosamide [(R)-2- (3) The complete quantitative com- acetoamido-N-benzyl-3- position of the substance. methoxy-propionamide] ...... 2746 (c) Within a reasonable period of (5) Lasmiditan [2,4,6-trifluoro-N- time after the receipt of an application (6-(1-methylpiperidine-4-car- for an exclusion under this section, the bonyl)pyridine-2-yl-benz- Administrator shall notify the appli- amide] ...... 2790 cant of his acceptance or nonaccept- (6) Pregabalin [(S)-3- ance of his application, and if not ac- (aminomethyl)-5- cepted, the reason therefore. The Ad- methylhexanoic acid] ...... 2782 ministrator need not accept an applica- (f) Approved cannabidiol drugs. (1) tion for filing if any of the require- A drug product in finished dos- ments prescribed in paragraph (b) of age formulation that has been this section is lacking or is not set approved by the U.S. Food and forth as to be readily understood. If the Drug Administration that con- applicant desires, he may amend the tains cannabidiol (2-[1R-3- application to meet the requirements methyl-6R-(1-methylethenyl)- of paragraph (b) of this section. If the 2-cyclohexen-1-yl]-5-pentyl-1,3- application is accepted for filing, the benzenediol) derived from can- Administrator shall issue and publish nabis and no more than 0.1 in the FEDERAL REGISTER his order on percent (w/w) residual the application, which shall include a tetrahydrocannabinols ...... 7367 reference to the legal authority under 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, of publication of his order in the FED- 2011; 81 FR 29491, May 12, 2016; 83 FR 48953, Sept 28, 2018; 85 FR 5562, Jan. 31, 2020; 85 FR ERAL REGISTER. If any such comments 13746, Mar. 10, 2020] or objections raise significant issues regarding any finding of fact or conclu- EXCLUDED NONNARCOTIC SUBSTANCES sion of law upon which the order is based, the Administrator shall imme- § 1308.21 Application for exclusion of a diately suspend the effectiveness of the nonnarcotic substance. order until he may reconsider the ap- (a) Any person seeking to have any plication in light of the comments and nonnarcotic drug that may, under the objections filed. Thereafter, the Ad- Federal Food, Drug, and Cosmetic Act ministrator shall reinstate, revoke, or

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amend his original order as he deter- § 1308.22 Excluded substances. mines appropriate. (d) The Administrator may at any The following nonnarcotic substances time revoke any exclusion granted pur- which may, under the Federal Food, suant to section 201(g) of the Act (21 Drug, and Cosmetic Act (21 U.S.C. 301), U.S.C. 811(g)) by following the proce- be lawfully sold over the counter with- dures set forth in paragraph (c) of this out a prescription, are excluded from section for handling an application for all schedules pursuant to section 201(g) an exclusion which has been accepted (1) of the Act (21 U.S.C. 811(g) (1)): for filing. [38 FR 8254, Mar. 30, 1973, as amended at 70 FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016]

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 nificant potential for abuse (the type of packaging and the history of abuse of § 1308.23 Exemption of certain chem- the same or similar preparations may ical preparations; application. be considered in determining the po- (a) The Administrator may, by regu- tential for abuse of the preparation or lation, exempt from the application of mixture); or all or any part of the Act any chemical (2) Contains either a narcotic or non- preparation or mixture containing one narcotic controlled substance and one or more controlled substances listed in or more adulterating or denaturing any schedule, which preparation or agents in such a manner, combination, mixture is intended for laboratory, in- quantity, proportion, or concentration, dustrial, educational, or special re- that the preparation or mixture does search purposes and not for general ad- not present any potential for abuse. If ministration to a human being or other the preparation or mixture contains a animal, if the preparation or mixture narcotic controlled substance, the either: preparation or mixture must be formu- (1) Contains no narcotic controlled lated in such a manner that it incor- substance and is packaged in such a porates methods of denaturing or other form or concentration that the pack- means so that the preparation or mix- aged quantity does not present any sig- ture is not liable to be abused or have

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ill effects, if abused, and so that the titled to protection under subsection narcotic substance cannot in practice 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) be removed. or any other law restricting public dis- (b) Any person seeking to have any closure of information. preparation or mixture containing a (d) The Administrator may require controlled substance and one or more the applicant to submit such docu- noncontrolled substances exempted ments or written statements of fact from the application of all or any part relevant to the application as he deems of the Act, pursuant to paragraph (a) of necessary to determine whether the ap- this section, may apply to the Drug plication should be granted. and Chemical Evaluation Section, Di- (e) Within a reasonable period of version Control Division, Drug En- time after the receipt of an application forcement Administration. See the for an exemption under this section, Table of DEA Mailing Addresses in the Administrator shall notify the ap- § 1321.01 of this chapter for the current plicant of his acceptance or nonaccept- mailing address. ance of his application, and if not ac- (c) An application for an exemption cepted, the reason therefor. The Ad- under this section shall contain the fol- ministrator need not accept an applica- lowing information: tion for filing if any of the require- (1) The name, address, and registra- ments prescribed in paragraph (c) or re- tion number, if any, of the applicant; quested pursuant to paragraph (d) is (2) The name, address, and registra- lacking or is not set forth as to be tion number, if any, of the manufac- readily understood. If the applicant de- turer or importer of the preparation or sires, he may amend the application to mixture, if not the applicant; meet the requirements of paragraphs (3) The exact trade name or other (c) and (d) of this section. If the appli- designation of the preparation or mix- cation is accepted for filing, the Ad- ture; ministrator shall issue and publish in (4) The complete qualitative and the FEDERAL REGISTER his order on the quantitative composition of the prepa- application, which shall include a ref- ration or mixture (including all active erence to the legal authority under and inactive ingredients and all con- which the order is based. This order trolled and noncontrolled substances); shall specify the date on which it shall (5) The form of the immediate con- take effect. The Administrator shall tainer in which the preparation or mix- permit any interested person to file ture will be distributed with sufficient written comments on or objections to descriptive detail to identify the prepa- the order within 60 days of the date of ration or mixture (e.g., bottle, packet, publication of his order in the FEDERAL vial, soft plastic pillow, agar gel plate, REGISTER. If any such comments or ob- etc.); jections raise significant issues regard- (6) The dimensions or capacity of the ing any finding of fact or conclusion of immediate container of the prepara- law upon which the order is based, the tion or mixture; Administrator shall immediately sus- (7) The label and labeling, as defined pend the effectiveness of the order in part 1300 of this chapter, of the im- until he may reconsider the application mediate container and the commercial in light of the comments and objec- containers, if any, of the preparation tions filed. Thereafter, the Adminis- or mixture; trator shall reinstate, revoke, or (8) A brief statement of the facts amend his original order as he deter- which the applicant believes justify the mines appropriate. granting of an exemption under this (f) The Administrator may at any paragraph, including information on time revoke or modify any exemption the use to which the preparation or granted pursuant to this section by fol- mixture will be put; lowing the procedures set forth in para- (9) The date of the application; and graph (e) of this section for handling an (10) Which of the information sub- application for an exemption which has mitted on the application, if any, is been accepted for filing. The Adminis- deemed by the applicant to be a trade trator may also modify or revoke the secret or otherwise confidential and en- criteria by which exemptions are

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granted (and thereby modify or revoke ‘‘For industrial use only’’ or ‘‘For all preparations and mixtures granted chemical use only’’ or ‘‘For in vitro use under the old criteria) and modify the only—not for human or animal use’’ or scope of exemptions at any time. ‘‘Diagnostic reagent—for professional use only’’ or a comparable statement [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 warning the person reading it that FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, human or animal use is not intended. 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, The symbol designating the schedule of Dec. 30, 2016] the controlled substance is not re- quired on either the label or the label- § 1308.24 Exempt chemical prepara- ing of the exempt chemical prepara- tions. tion, nor is it necessary to list all in- (a) The chemical preparations and gredients of the preparation. mixtures approved pursuant to § 1308.23 (d) Records and reports: Any person are exempt from application of sec- who manufactures an exempt chemical tions 302, 303, 305, 306, 307, 308, 309, 1002, preparation or mixture must keep com- 1003 and 1004 of the Act (21 U.S.C. 822– plete and accurate records and file all 823, 825–829, 952–954) and § 1301.74 of this reports required under part 1304 of this chapter, to the extent described in chapter regarding all controlled sub- paragraphs (b) to (h) of this section. stances being used in the manufac- Substances set forth in paragraph (j) of turing process until the preparation or this section shall be exempt from the mixture is in the form described in application of sections 305, 306, 307, 308, paragraph (i) of this section. In lieu of 309, 1002, 1003 and 1004 of the Act (21 records and reports required under part U.S.C. 825–829, 952–954) and §§ 1301.71– 1304 of this chapter regarding exempt 1301.73 and 1301.74 (a), (b), (d), (e) and (f) chemical preparations, the manufac- of this chapter to the extent as herein- turer need only record the name, ad- after may be provided. dress, and registration number, if any, (b) Registration and security: Any of each person to whom the manufac- person who manufactures an exempt turer distributes any exempt chemical chemical preparation or mixture must 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

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controlled substances used in manufac- Finding Aids section of the printed volume turing the exempt chemical prepara- and at www.govinfo.gov. tion before it is in the form described in paragraph (i) of this section. EXCLUDED VETERINARY ANABOLIC (f) Criminal penalties: No exemption STEROID IMPLANT PRODUCTS granted pursuant to § 1308.23 affects the § 1308.25 Exclusion of a veterinary an- criminal liability for illegal manufac- abolic steroid implant product; ap- ture, distribution, or possession of con- plication. trolled substances contained in the ex- empt chemical preparation. Distribu- (a) Any person seeking to have any tion, possession, and use of an exempt anabolic steroid product, which is ex- chemical preparation are lawful for pressly intended for administration registrants and nonregistrants only as through implants to cattle or other long as such distribution, possession, nonhuman species and which has been or use is intended for laboratory, in- approved by the Secretary of Health dustrial, or educational purposes and and Human Services for such adminis- not for immediate or subsequent ad- tration, identified as being excluded ministration to a human being or other from any schedule, pursuant to section animal. 102(41)(B)(i) of the Act (21 U.S.C. (g) Bulk materials: For materials ex- 802(41)(B)(i)), may apply to the Drug empted in bulk quantities, the Admin- and Chemical Evaluation Section, Di- istrator may prescribe requirements version Control Division, Drug En- other than those set forth in para- forcement Administration . See the graphs (b) through (e) of this section on Table of DEA Mailing Addresses in a case-by-case basis. § 1321.01 of this chapter for the current (h) Changes in chemical preparations: mailing address. Any change in the quantitative or (b) An application for any exclusion qualitative composition of the prepara- under this section shall be submitted tion or mixture after the date of appli- in triplicate and contain the following cation, or change in the trade name or information: other designation of the preparation or (1) The name and address of the ap- mixture, set forth in paragraph (i) of plicant; this section, requires a new application (2) The name of the product; for exemption. (3) The chemical structural formula (i) A listing of exempt chemical prep- or description for any anabolic steroid arations may be obtained by submit- contained in the product; ting a written request to the Drug and (4) A complete description of dosage Chemical Evaluation Section, Drug En- and quantitative composition of the forcement Administration. See the dosage form;. Table of DEA Mailing Addresses in (5) The conditions of use including § 1321.01 of this chapter for the current whether or not Federal law restricts mailing address. this product to use by or on the order (j) The following substances are des- of a licensed veterinarian; ignated as exempt chemical prepara- (6) A description of the delivery sys- tions for the purposes set forth in this tem in which the dosage form will be section. distributed with sufficient detail to (1) Chloral. When packaged in a identify the product (e.g. 20 cartridge sealed, oxygen-free environment, under brown plastic belt); nitrogen pressure, safeguarded against (7) The label and labeling of the im- exposure to the air. mediate container and the commercial (2) R 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 EDITORIAL NOTE: For FEDERAL REGISTER ci- Health and Human Services for admin- tations affecting § 1308.24, see the List of CFR istration through implant to cattle or Sections Affected, which appears in the other nonhuman species.

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(c) Within a reasonable period of retary of Health and Human Services time after the receipt of an application for such administration are excluded for an exclusion under this section, the from all schedules pursuant to section Administrator shall notify the appli- 102(41)(B)(i) of the Act (21 U.S.C. cant of his acceptance or nonaccept- 802(41)(B)(i)). A listing of the excluded ance of the application, and if not ac- products may be obtained by submit- cepted, the reason therefore. The Ad- ting a written request to the Drug and ministrator need not accept an applica- Chemical Evaluation Section, Drug En- tion for filing if any of the require- forcement Administration. See the ments prescribed in paragraph (b) of Table of DEA Mailing Addresses in this section is lacking or is not set § 1321.01 of this chapter for the current forth as to be readily understood. The mailing address. applicant may amend the application (b) In accordance with section to meet the requirements of paragraph 102(41)(B)(ii) of the Act (21 U.S.C. (b) of this section. If the application is 802(41)(B)(ii)) if any person prescribes, accepted for filing, the Administrator dispenses, or distributes a product list- shall issue and have published in the ed in paragraph (a) of this section for FEDERAL REGISTER his order on the ap- human use, such person shall be con- plication, which shall include a ref- sidered to have prescribed, dispensed, erence to the legal authority under or distributed an anabolic steroid with- which the order is issued and the find- in the meaning of section 102(41)(A) of ings of fact and conclusions of law the Act (21 U.S.C. 802(41)(A)). upon which the order is based. This order shall specify the date on which it [56 FR 42936, Aug. 30, 1991, as amended at 57 FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, will take effect. The Administrator 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, shall permit any interested person to Mar. 9, 2010] file written comments on or objections to the order within 60 days of the date EXEMPTED PRESCRIPTION PRODUCTS of publication in the FEDERAL REG- ISTER. If any such comments or objec- § 1308.31 Application for exemption of tions raise significant issues regarding a nonnarcotic prescription product. any finding of fact or conclusion of law (a) Any person seeking to have any upon which the order is based, the Ad- compound, mixture, or preparation ministrator shall immediately suspend containing any nonnarcotic controlled the effectiveness of the order until he substance listed in § 1308.12(e), or in may reconsider the application in light § 1308.13(b) or (c), or in § 1308.14, or in of the comments and objections filed. § 1308.15, exempted from application of Thereafter, the Administrator shall re- all or any part of the Act pursuant to instate, revoke, or amend his original section 201(g)(3)(A), of the Act (21 order as he determines appropriate. U.S.C. 811(g)(3)(A)) may apply to the (d) The Administrator may at any Drug and Chemical Evaluation Section, time revoke or modify any designation Diversion Control Division, Drug En- of excluded status granted pursuant to forcement Administration. See the this section by following the proce- Table of DEA Mailing Addresses in dures set forth in paragraph (c) of this § 1321.01 of this chapter for the current section for handling an application for mailing address. an exclusion which has been accepted (b) An application for an exemption for filing. under this section shall contain the fol- [56 FR 42936, Aug. 30, 1991, as amended at 75 lowing information: FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, (1) The complete quantitative com- 2016] position of the dosage form. (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 (a) Products containing an anabolic of the product including animal inves- steroid, that are expressly intended for tigations and clinical evaluations and administration through implants to studies, with emphasis on the psychic cattle or other nonhuman species and and/or physiological dependence liabil- which have been approved by the Sec- ity (this must be done for each of the

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active ingredients separately and for sitate an earlier effective date, in the combination product). which event the Administrator shall (4) Details of synergisms and antag- specify in the order his findings as to onisms among ingredients. such conditions. (5) Deterrent effects of the noncon- (d) The Administrator may revoke trolled ingredients. any exemption granted pursuant to (6) Complete copies of all literature section 201(g)(3)(A) of the Act (21 U.S.C. in support of claims. 811(g)(3)(A)) by following the proce- (7) Reported instances of abuse. dures set forth in paragraph (c) of this (8) Reported and anticipated adverse effects. section for handling an application for (9) Number of dosage units produced an exemption which has been accepted for the past 2 years. for filing. (c) Within a reasonable period of [38 FR 8254, Mar. 30, 1973. Redesignated at 38 time after the receipt of an application FR 26609, Sept. 24, 1973, as amended at 44 FR for an exemption under this section, 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; the Administrator shall notify the ap- 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, plicant of his acceptance or non-ac- 2016] ceptance of the application, and if not accepted, the reason therefor. The Ad- § 1308.32 Exempted prescription prod- ministrator need not accept an applica- ucts. tion for filing if any of the require- The compounds, mixtures, or prep- ments prescribed in paragraph (b) of arations that contain a nonnarcotic this section is lacking or is not set controlled substance listed in forth so as to be readily understood. If § 1308.12(e) or in § 1308.13(b) or (c) or in the applicant desires, he may amend § 1308.14 or in § 1308.15 listed in the the application to meet the require- Table of Exempted Prescription Prod- ments of paragraph (b) of this section. If accepted for filing, the Adminis- ucts have been exempted by the Ad- trator shall publish in the FEDERAL ministrator from the application of REGISTER general notice of this pro- sections 302 through 305, 307 through posed rulemaking in granting or deny- 309, and 1002 through 1004 of the Act (21 ing the application. Such notice shall U.S.C. 822–825, 827–829, and 952–954) and include a reference to the legal author- §§ 1301.13, 1301.22, and §§ 1301.71 through ity under which the rule is proposed, a 1301.76 of this chapter for administra- statement of the proposed rule grant- tive purposes only. An exception to the ing or denying an exemption, and, in above is that those products containing the discretion of the Administrator, a butalbital shall not be exempt from the summary of the subjects and issues in- requirement of 21 U.S.C. 952–954 con- volved. The Administrator shall permit cerning importation, exportation, any interested person to file written transshipment and in-transit shipment comments on or objections to the pro- of controlled substances. Any deviation posal and shall designate in the notice from the quantitative composition of of proposed rule making the time dur- any of the listed drugs shall require a ing which such filings may be made. petition of exemption in order for the After consideration of the application product to be exempted. A listing of and any comments on or objections to his proposed rulemaking, the Adminis- the Exempted Prescription Products trator shall issue and publish in the may be obtained by submitting a writ- FEDERAL REGISTER his final order on ten request to the Drug and Chemical the application, which shall set forth Evaluation Section, Drug Enforcement the findings of fact and conclusions of Administration. See the Table of DEA law upon which the order is based. This Mailing Addresses in § 1321.01 of this order shall specify the date on which it chapter for the current mailing ad- shall take effect, which shall not be dress. less than 30 days from the date of pub- [75 FR 10679, Mar. 9, 2010] lication in the FEDERAL REGISTER un- less the Administrator finds that con- ditions of public health or safety neces-

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EXEMPT ANABOLIC STEROID PRODUCTS (i) A determination that the product has no significant potential for abuse § 1308.33 Exemption of certain ana- and bolic steroid products; application. (ii) a granting of an exemption under (a) The Administrator, upon the rec- this section. ommendation of Secretary of Health (d) Within a reasonable period of and Human Services, may, by regula- time after the receipt of the applica- tion, exempt from the application of tion for an exemption under this sec- all or any part of the Act any com- tion, the Administrator shall notify pound, mixture, or preparation con- the applicant of his acceptance or non- taining an anabolic steroid as defined acceptance of the application, and if in part 1300 of this chapter, which is in- not accepted, the reason therefor. The tended for administration to a human Administrator need not accept an ap- being or animal, if, because of its con- plication for filing if any of the re- centration, preparation, formulation, quirements prescribed in paragraph (c) or delivery system, it has no signifi- of this section is lacking or is not set cant potential for abuse. forth so as to be readily understood. (b) Any person seeking to have any The applicant may amend the applica- compound, mixture, or preparation tion to meet the requirements of para- containing an anabolic steroid as de- graph (c) of this section. If accepted for fined in part 1300 of this chapter ex- empted from the application of all or filing, the Administrator will request any part of the Act, pursuant to para- from the Secretary for Health and graph (a) of this section, may apply to Human Services his recommendation, the Drug and Chemical Evaluation Sec- as to whether such product which con- tion, Diversion Control Division, Drug tains an anabolic steroid should be con- Enforcement Administration. See the sidered for exemption from certain por- Table of DEA Mailing Addresses in tions of the Controlled Substances Act. § 1321.01 of this chapter for the current On receipt of the recommendation of mailing address. the Secretary, the Administrator shall (c) An application for an exemption make a determination as to whether under this section shall be submitted the evidence submitted or otherwise in triplicate and contain the following available sufficiently establishes that information: the product possesses no significant po- (1) The name and address of the ap- tential for abuse. The Administrator plicant; shall issue and publish in the FEDERAL (2) The name of the product; REGISTER his order on the application, (3) The chemical structural formula which shall include a reference to the or description for any anabolic steroid legal authority under which the order contained in the product; is issued, and the findings of fact and (4) The complete description of dos- conclusions of law upon which the age and quantitative composition of order is based. This order shall specify the dosage form; the date on which it will take effect. (5) A description of the delivery sys- The Administrator shall permit any in- tem, if applicable; terested person to file written com- (6) The indications and conditions for ments on or objections to the order use in which species, including whether within 60 days of the date of publica- or not this product is a prescription tion of his order in the FEDERAL REG- drug; ISTER. If any such comments or objec- (7) Information to facilitate identi- tions raise significant issues regarding fication of the dosage form, such as any finding of fact or conclusion of law shape, color, coating, and scoring; upon which the order is based, the Ad- (8) The label and labeling of the im- ministrator shall immediately suspend mediate container and the commercial the effectiveness of the order until he containers, if any, of the product; may reconsider the application in light (9) The units in which the dosage of the comments and objections filed. form is ordinarily available; and Thereafter, the Administrator shall re- (10) The facts which the applicant be- instate, revoke, or amend his original lieves justify: order as he determines appropriate.

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(e) The Administrator may revoke (2) Not used, or intended for use, for any exemption granted pursuant to human consumption, has been exempt- section 1903(a) of Public Law 101–647 by ed by the Administrator from the ap- following the procedures set forth in plication of the Act and this chapter. paragraph (d) of this section for han- (b) As used in this section, the fol- dling an application for an exemption lowing terms shall have the meanings which has been accepted for filing. specified: [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. (1) The term processed plant material 31, 1992, as amended at 62 FR 13968, Mar. 24, means cannabis plant material that 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, has been subject to industrial proc- Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] esses, or mixed with other ingredients, such that it cannot readily be con- § 1308.34 Exempt anabolic steroid verted into any form that can be used products. for human consumption. The list of compounds, mixtures, or (2) The term animal feed mixture preparations that contain an anabolic means sterilized cannabis seeds mixed steroid that have been exempted by the with other ingredients (not derived Administrator from application of sec- from the cannabis plant) in a formula- tions 302 through 309 and 1002 through tion that is designed, marketed, and 1004 of the Act (21 U.S.C. 822–829 and distributed for animal consumption 952–954) and §§ 1301.13, 1301.22, and (and not for human consumption). 1301.71 through 1301.76 of this chapter (3) The term used for human consump- for administrative purposes only may tion means either: be obtained by submitting a written re- (i) Ingested orally or quest to the Drug and Chemical Eval- uation Section, Drug Enforcement Ad- (ii) Applied by any means such that ministration. See the Table of DEA THC enters the human body. Mailing Addresses in § 1321.01 of this (4) The term intended for use for chapter for the current mailing ad- human consumption means any of the dress. following: (i) Designed by the manufacturer for [75 FR 10679, Mar. 9, 2010] human consumption; EXEMPT CANNABIS PLANT MATERIAL, (ii) Marketed for human consump- AND PRODUCTS MADE THEREFROM, tion; or THAT CONTAIN (iii) Distributed, exported, or im- TETRAHYDROCANNABINOLS ported, with the intent that it be used for human consumption. § 1308.35 Exemption of certain can- (c) In any proceeding arising under nabis plant material, and products the Act or this chapter, the burden of made therefrom, that contain going forward with the evidence that a tetrahydrocannabinols. material, compound, mixture, or prepa- (a) Any processed plant material or ration containing THC is exempt from animal feed mixture containing any control pursuant to this section shall amount of tetrahydrocannabinols be upon the person claiming such ex- (THC) that is both: emption, as set forth in section (1) Made from any portion of a plant 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). of the genus Cannabis excluded from In order to meet this burden with re- the definition of marijuana under the spect to a product or plant material Act [i.e., the mature stalks of such that has not been expressly exempted plant, fiber produced from such stalks, from control by the Administrator pur- oil or cake made from the seeds of such suant to § 1308.23, the person claiming plant, any other compound, manufac- the exemption must present rigorous ture, salt, derivative, mixture, or prep- scientific evidence, including well-doc- aration of such mature stalks (except umented scientific studies by experts the resin extracted therefrom), fiber, trained and qualified to evaluate the oil, or cake, or the sterilized seed of effects of drugs on humans. such plant which is incapable of germi- nation] and [66 FR 51544, Oct. 9, 2001]

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HEARINGS tiate proceedings for the issuance (amend- ment or repeal) of a rule or regulation pursu- § 1308.41 Hearings generally. ant to section 201 of the Controlled Sub- stances Act. In any case where the Administrator Attached hereto and constituting a part of shall hold a hearing on the issuance, this petition are the following: amendment, or repeal of rules pursuant (A) The proposed rule in the form proposed to section 201 of the Act, the proce- by the petitioner. (If the petitioner seeks the dures for such hearing and accom- amendment or repeal of an existing rule, the panying proceedings shall be governed existing rule, together with a reference to the section in the Code of Federal Regula- generally by the rulemaking proce- tions where it appears, should be included.) dures set forth in the Administrative (B) A statement of the grounds which the Procedure Act (5 U.S.C. 551–559) and petitioner relies for the issuance (amend- specifically by section 201 of the Act (21 ment or repeal) of the rule. (Such grounds U.S.C. 811), by §§ 1308.42–1308.51, and by shall include a reasonably concise statement §§ 1316.41–1316.67 of this chapter. of the facts relied upon by the petitioner, in- cluding a summary of any relevant medical § 1308.42 Purpose of hearing. or scientific evidence known to the peti- tioner.) If requested by any interested person All notices to be sent regarding this peti- after proceedings are initiated pursu- tion should be addressed to: ant to § 1308.43, the Administrator shall llllllllll (Name) hold a hearing for the purpose of re- llllllllll (Street Address) ceiving factual evidence and expert llllllllll (City and State) Respectfully yours, opinion regarding the issues involved llllllllll (Signature of petitioner) in the issuance, amendment or repeal of a rule issuable pursuant to section (c) Within a reasonable period of 201(a) of the Act (21 U.S.C. 811(a)). Ex- time after the receipt of a petition, the tensive argument should not be offered Administrator shall notify the peti- into evidence but rather presented in tioner of his acceptance or nonaccept- opening or closing statements of coun- ance of the petition, and if not accept- sel or in memoranda or proposed find- ed, the reason therefor. The Adminis- ings of fact and conclusions of law. Ad- trator need not accept a petition for ditional information relating to hear- filing if any of the requirements pre- ings to include waivers or modification scribed in paragraph (b) of this section of rules, request for hearing, burden of is lacking or is not set forth so as to be proof, time and place, and final order readily understood. If the petitioner 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- trator within a reasonable period of § 1308.43 Initiation of proceedings for rulemaking. time thereafter if he finds the grounds upon which the petitioner relies are (a) Any interested person may sub- not sufficient to justify the initiation mit a petition to initiate proceedings of proceedings. for the issuance, amendment, or repeal (d) The Administrator shall, before of any rule or regulation issuable pur- initiating proceedings for the issuance, suant to the provisions of section 201 of amendment, or repeal of any rule ei- the Act. ther to control a drug or other sub- (b) Petitions shall be submitted in stance, or to transfer a drug or other quintuplicate to the Administrator. substance from one schedule to an- See the Table of DEA Mailing Address- other, or to remove a drug or other es in § 1321.01 of this chapter for the substance entirely from the schedules, current mailing address. Petitions and after gathering the necessary data, shall be in the following form: 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

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recommendations of the Secretary to publication of notice of the proposed the Administrator shall be binding on rulemaking in the FEDERAL REGISTER, the Administrator as to such scientific file with the Administrator a written and medical matters, and if the Sec- request for a hearing in the form pre- retary recommends that a drug or scribed in § 1316.47 of this chapter. other substance not be controlled, the (b) Any interested person desiring to Administrator shall not control that participate in a hearing pursuant to drug or other substance. § 1308.41 shall, within 30 days after the (e) If the Administrator determines date of publication of the notice of that the scientific and medical evalua- hearing in the FEDERAL REGISTER, file tion and recommendations of the Sec- with the Administrator a written no- retary and all other relevant data con- tice of his intention to participate in stitute substantial evidence of poten- such hearing in the form prescribed in tial for abuse such as to warrant con- § 1316.48 of this chapter. Any person fil- trol or additional control over the drug ing a request for a hearing need not or other substance, or substantial evi- also file a notice of appearance; the re- dence that the drug or other sub- quest for a hearing shall be deemed to stances should be subjected to lesser be a notice of appearance. control or removed entirely from the (c) Any interested person may, with- schedules, he shall initiate proceedings in the period permitted for filing a re- for control, transfer, or removal as the quest for a hearing, file with the Ad- case may be. ministrator a waiver of an opportunity (f) If and when the Administrator de- for a hearing or to participate in a termines to initiate proceedings, he hearing, together with a written state- shall publish in the FEDERAL REGISTER ment regarding his position on the general notice of any proposed rule matters of fact and law involved in making to issue, amend, or repeal any such hearing. Such statement, if ad- rule pursuant to section 201 of the Act. missible, shall be made a part of the Such published notice shall include a record and shall be considered in light statement of the time, place, and na- of the lack of opportunity for cross-ex- ture of any hearings on the proposal in amination in determining the weight the event a hearing is requested pursu- to be attached to matters of fact as- ant to § 1308.44. Such hearings may not serted therein. be commenced until after the expira- (d) If any interested person fails to tion of at least 30 days from the date file a request for a hearing; or if he so the general notice is published in the files and fails to appear at the hearing, FEDERAL REGISTER. Such published no- he shall be deemed to have waived his tice shall also include a reference to opportunity for the hearing or to par- the legal authority under which the ticipate in the hearing, unless he shows rule is proposed, a statement of the good cause for such failure. proposed rule, and, in the discretion of (e) If all interested persons waive or the Administrator, a summary of the are deemed to waive their opportunity subjects and issues involved. for the hearing or to participate in the (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

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final rule and the findings of fact and ERAL REGISTER an order controlling an conclusions of law upon which the rule immediate precursor. The order shall is based. This order shall specify the designate the schedule in which the im- date on which it shall take effect, mediate precursor is to be placed, which shall not be less than 30 days which shall be the same schedule in from the date of publication in the which the controlled substance of FEDERAL REGISTER unless the Adminis- which it is an immediate precursor is trator finds that conditions of public placed or any other schedule with a health or safety necessitate an earlier higher numerical designation. An order effective date, in which event the Ad- controlling an immediate precursor ministrator shall specify in the order shall become effective 30 days from the his findings as to such conditions. date of publication in the FEDERAL [38 FR 8254, Mar. 30, 1973. Redesignated at 38 REGISTER, unless the Administrator FR 26609, Sept. 24, 1973, and further redesig- finds that conditions of public health nated at 62 FR 13968, Mar. 24, 1997] or safety necessitate an earlier effec- tive date, in which event the Adminis- § 1308.46 Control required under inter- trator shall specify in the order his national treaty. findings as to such conditions. Pursuant to section 201(d) of the Act (21 U.S.C. 811(d)), where control of a [38 FR 8254, Mar. 30, 1973. Redesignated at 38 substance is required by U.S. obliga- FR 26609, Sept. 24, 1973, and further redesig- nated at 62 FR 13968, Mar. 24, 1997] tions under international treaties, con- ventions, or protocols in effect on May § 1308.49 Temporary scheduling. 1, 1971, the Administrator shall issue and publish in the FEDERAL REGISTER (a) Pursuant to 21 U.S.C. 811(h) and an order controlling such substance without regard to the requirements of under the schedule he deems most ap- 21 U.S.C. 811(b) relating to the sci- propriate to carry out obligations. entific and medical evaluation of the Issuance of such an order shall be with- Secretary of Health and Human Serv- out regard to the findings required by ices, the Drug Enforcement Adminis- subsections 201(a) or 202(b) of the Act tration may place a substance into (21 U.S.C. 811(a) or 812(b)) and without Schedule I on a temporary basis, if it regard to the procedures prescribed by determines that such action is nec- § 1308.41 or subsections 201 (a) and (b) of essary to avoid an imminent hazard to the Act (21 U.S.C. 811 (a) and (b)). An the public safety. An order issued order controlling a substance shall be- under this section may not be effective come effective 30 days from the date of before the expiration of 30 calendar publication in the FEDERAL REGISTER, days from: unless the Administrator finds that (1) The date of publication by the Ad- conditions of public health or safety ministration of a notice in the FED- necessitate an earlier effective date, in ERAL REGISTER of its intention to issue which event the Administrator shall such order and the grounds upon which specify in the order his findings as to such order is to be issued; and such conditions. (2) The date the Administration has [38 FR 8254, Mar. 30, 1973. Redesignated at 38 transmitted notification to the Sec- FR 26609, Sept. 24, 1973, and further redesig- retary of Health and Human Services nated at 62 FR 13968, Mar. 24, 1997] of the Administration’s intention to issue such order. § 1308.47 Control of immediate precur- (b) An order issued under this section sors. will be vacated upon the conclusion of Pursuant to section 201(e) of the Act a subsequent rulemaking proceeding (21 U.S.C. 811(e)), the Administrator initiated under section 201(a) (21 U.S.C. may, without regard to the findings re- 811(a)) with respect to such substance quired by subsection 201(a) or 202 (b) of or at the end of two years from the ef- the Act (21 U.S.C. 811(a) or 812(b)) and fective date of the order scheduling the without regard to the procedures pre- substance, except that during the pend- scribed by § 1308.41 or subsections 201 ency of proceedings under section (a) and (b) of the Act (21 U.S.C. 811(a) 201(a) (21 U.S.C. 811(a)) with respect to and (b)), issue and publish in the FED- the substance, the Administration may

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extend the temporary scheduling for up 1309.54 Burden of proof. to one year. 1309.55 Time and place of hearing.

[81 FR 97021, Dec. 30, 2016] MODIFICATION, TRANSFER AND TERMINATION OF REGISTRATION PART 1309—REGISTRATION OF 1309.61 Modification in registration. MANUFACTURERS, DISTRIBUTORS, 1309.62 Termination of registration. IMPORTERS AND EXPORTERS OF 1309.63 Transfer of registration. LIST I CHEMICALS SECURITY REQUIREMENTS 1309.71 General security requirements. GENERAL INFORMATION 1309.72 Felony conviction; employer respon- Sec. sibilities. 1309.01 Scope of part 1309. 1309.73 Employee responsibility to report di- 1309.02 Definitions. version. 1309.03 Information; special instructions. AUTHORITY: 21 U.S.C. 802, 821, 822, 823, 824, FEES FOR REGISTRATION AND REREGISTRATION 830, 871(b), 875, 877, 886a, 952, 953, 957, 958.

1309.11 Fee amounts. SOURCE: 60 FR 32454, June 22, 1995, unless 1309.12 Time and method of payment; re- otherwise noted. fund. GENERAL INFORMATION REQUIREMENTS FOR REGISTRATION 1309.21 Persons required to register. § 1309.01 Scope of part 1309. 1309.22 Separate registration for inde- pendent activities. Procedures governing the registra- 1309.23 Separate registration for separate tion of manufacturers, distributors, locations. importers and exporters of List I 1309.24 Waiver of registration requirement chemicals pursuant to Sections 102, 302, for certain activities. 303, 1007 and 1008 of the Act (21 U.S.C. 1309.25 Temporary exemption from registra- 802, 822, 823, 957 and 958) are set forth tion for chemical registration applicants. generally by those sections and specifi- 1309.26 Exemption of law enforcement offi- cials. cally by the sections of this part.

APPLICATION FOR REGISTRATION § 1309.02 Definitions. 1309.31 Time for application for registra- Any term used in this part shall have tion; expiration date. the definition set forth in section 102 of 1309.32 Application forms; contents, signa- the Act (21 U.S.C. 802) or part 1300 of ture. this chapter. 1309.33 Filing of application; joint filings. 1309.34 Acceptance for filing; defective ap- [62 FR 13968, Mar. 24, 1997] plications. 1309.35 Additional information. § 1309.03 Information; special instruc- 1309.36 Amendments to and withdrawals of tions. applications. Information regarding procedures ACTION ON APPLICATIONS FOR REGISTRATION: under these rules and instructions REVOCATION OR SUSPENSION OF REGISTRATION supplementing these rules will be fur- 1309.41 Administrative review generally. nished upon request by writing to the 1309.42 Certificate of registration; denial of Registration Section, Drug Enforce- registration. ment Administration. See the Table of 1309.43 Suspension or revocation of registra- DEA Mailing Addresses in § 1321.01 of tion. this chapter for the current mailing ad- 1309.44 Suspension of registration pending final order. dress. 1309.45 Extension of registration pending [75 FR 10680, Mar. 9, 2010] final order. 1309.46 Order to show cause. FEES FOR REGISTRATION AND HEARINGS REREGISTRATION 1309.51 Hearings generally. § 1309.11 Fee amounts. 1309.52 Purpose of hearing. 1309.53 Request for hearing or appearance; (a) For each application for registra- waiver. tion or reregistration to manufacture

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