110 Part 1308—Schedules of Controlled Substances

Home , Naphyrone, Native American Church, Pyrovalerone

§ 1307.13 21 CFR Ch. II (4–1–18 Edition)

distributed and dispensed by him dur- the controlled drugs are to be deliv- ing that calendar year, the practitioner ered, including the name and quantity shall obtain a registration to distribute of the substances desired and the pur- controlled substances. pose for which intended. The delivery (c) The distributions that a reg- of such controlled drugs shall be or- istered retail pharmacy makes to auto- dered by the Administrator, if, in his mated dispensing systems at long term opinion, there exists a medical or sci- care facilities for which the retail entific need therefor. pharmacy also holds registrations do [75 FR 10678, Mar. 9, 2010, as amended at 79 not count toward the 5 percent limit in FR 53565, Sept. 9, 2014] paragraphs (a)(1)(iv) and (b) of this section. SPECIAL EXEMPT PERSONS [68 FR 41229, July 11, 2003, as amended at 70 FR 25466, May 13, 2005; 79 FR 53565, Sept. 9, § 1307.31 Native American Church. 2014] The listing of peyote as a controlled substance in Schedule I does not apply § 1307.13 Incidental manufacture of to the nondrug use of peyote in bona controlled substances. fide religious ceremonies of the Native Any registered manufacturer who, in- American Church, and members of the cidentally but necessarily, manufac- Native American Church so using pe- tures a controlled substance as a result yote are exempt from registration. Any of the manufacture of a controlled sub- person who manufactures peyote for or stance or basic class of controlled sub- distributes peyote to the Native Amer- stance for which he is registered and ican Church, however, is required to has been issued an individual manufac- obtain registration annually and to turing quota pursuant to part 1303 of comply with all other requirements of this chapter (if such substance or class law. is listed in Schedule I or II) shall be exempt from the requirement of registra- PART 1308—SCHEDULES OF tion pursuant to part 1301 of this chap- CONTROLLED SUBSTANCES ter and, if such incidentally manufac- tured substance is listed in Schedule I GENERAL INFORMATION or II, shall be exempt from the requirement of an individual manufacturing Sec. quota pursuant to part 1303 of this 1308.01 Scope of this part. 1308.02 Definitions. chapter, if such substances are disposed 1308.03 Administration Controlled Sub- of in accordance with part 1317 of this stances Code Number. chapter. SCHEDULES [79 FR 53565, Sept. 9, 2014] 1308.11 Schedule I. DISPOSAL OF CONTROLLED SUBSTANCES 1308.12 Schedule II. 1308.13 Schedule III. § 1307.22 Delivery of surrendered and 1308.14 Schedule IV. forfeited controlled substances. 1308.15 Schedule V. Any controlled substance surren- EXCLUDED NONNARCOTIC SUBSTANCES dered by delivery to the Administra- 1308.21 Application for exclusion of a non- tion under part 1317 of this chapter or narcotic substance. forfeited pursuant to section 511 of the 1308.22 Excluded substances. Act (21 U.S.C. 881) may be delivered to any department, bureau, or other agen- EXEMPT CHEMICAL PREPARATIONS cy of the United States or of any State 1308.23 Exemption of certain chemical prep- upon proper application addressed to arations; application. the Office of Diversion Control, Drug 1308.24 Exemption chemical preparations. 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.

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EXEMPTED PRESCRIPTION PRODUCTS § 1308.03 Administration Controlled 1308.31 Application for exemption of a non- Substances Code Number. narcotic prescription product. (a) Each controlled substance, or 1308.32 Exempted prescription products. basic class thereof, has been assigned an ‘‘Administration Controlled Sub- EXEMPT ANABOLIC STEROID PRODUCTS stances Code Number’’ for purposes of 1308.33 Exemption of certain anabolic ster- identification of the substances or oid products; application. class on certain Certificates of Reg- 1308.34 Exempt anabolic steroid products. istration issued by the Administration EXEMPT CANNABIS PLANT MATERIAL, AND pursuant to §§ 1301.35 of this chapter PRODUCTS MADE THEREFROM, THAT CONTAIN and on certain order forms issued by TETRAHYDROCANNABINOLS the Administration pursuant to § 1305.05(d) of this chapter. Applicants 1308.35 Exemption of certain cannabis plant material, and products made therefrom, for procurement and/or individual man- that contain tetrahydrocannabinols. ufacturing quotas must include the appropriate code number on the applica- HEARINGS tion as required in §§ 1303.12(b) and 1308.41 Hearings generally. 1303.22(a) of this chapter. Applicants 1308.42 Purpose of hearing. for import and export permits must in- 1308.43 Initiation of proceedings for rule- clude the appropriate code number on making. the application as required in 1308.44 Request for hearing or appearance; §§ 1312.12(a) and 1312.22(a) of this chap- waiver. ter. Authorized registrants who desire 1308.45 Final order. to import or export a controlled sub- 1308.46 Control required under international stance for which an import or export treaty. permit is not required must include the 1308.47 Control of immediate precursors. appropriate Administration Controlled 1308.49 Temporary scheduling. Substances Code Number beneath or AUTHORITY: 21 U.S.C. 811, 812, 871(b), 956(b), beside the name of each controlled sub- unless otherwise noted. stance listed on the DEA Form 236 SOURCE: 38 FR 8254, Mar. 30, 1973, unless (Controlled Substance Import/Export otherwise noted. Redesignated at 38 FR 26609, Declaration) which is executed for such Sept. 24, 1973. importation or exportation as required in §§ 1312.18(c) and 1312.27(b) of this GENERAL INFORMATION chapter. (b) Except as stated in paragraph (a) § 1308.01 Scope of this part. of this section, no applicant or reg- Schedules of controlled substances istrant is required to use the Adminis- established by section 202 of the Act (21 tration Controlled Substances Code U.S.C. 812) and nonnarcotic substances, Number for any purpose. chemical preparations, veterinary anabolic steroid implant products, pre- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973 and amended at 51 FR scription products, anabolic steroid 15318, Apr. 23, 1986; 62 FR 13968, Mar. 24, 1997] products, and cannabis plant material and products made therefrom that con- SCHEDULES tain tetrahydrocannabinols excluded pursuant to section 201 of the Act (21 § 1308.11 Schedule I. U.S.C. 811), as they are changed, up- (a) Schedule I shall consist of the dated, and republished from time to drugs and other substances, by what- time, are set forth in this part. ever official name, common or usual [81 FR 97021, Dec. 30, 2016] name, chemical name, or brand name designated, listed in this section. Each § 1308.02 Definitions. drug or substance has been assigned the DEA Controlled Substances Code Any term contained in this part shall Number set forth opposite it. have the definition set forth in section (b) Opiates. Unless specifically ex- 102 of the Act (21 U.S.C. 802) or part cepted or unless listed in another 1300 of this chapter. schedule, any of the following opiates, [62 FR 13967, Mar. 24, 1997] including their isomers, esters, ethers,

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salts, and salts of isomers, esters and (27) Dipipanone ...... 9622 ethers, whenever the existence of such (28) Ethylmethylthiambutene .... 9623 isomers, esters, ethers and salts is pos- (29) Etonitazene ...... 9624 sible within the specific chemical des- (30) Etoxeridine ...... 9625 ignation (for purposes of paragraph (31) Furethidine ...... 9626 (b)(34) only, the term isomer includes (32) Hydroxypethidine ...... 9627 the optical and geometric isomers): (33) Ketobemidone ...... 9628 (1) Acetyl-alpha-methylfentanyl (34) Levomoramide ...... 9629 (N-[1-(1-methyl-2-phenethyl)-4- (35) Levophenacylmorphan ...... 9631 piperidinyl]-N- (36) 3-Methylfentanyl (N-[3- phenylacetamide) ...... 9815 methyl-1-(2-phenylethyl)-4- (2) Acetylmethadol ...... 9601 piperidyl]-N- (3) Acetyl fentanyl (N-(1- phenylpropanamide) ...... 9813 phenethylpiperidin-4-yl)-N- (37) 3-methylthiofentanyl (N-[(3- phenylacetamide) ...... 9821 methyl-1-(2-thienyl)ethyl-4- (4) AH-7921 (3,4-dichloro-N-[(1- piperidinyl]-N- dimethylamino) phenylpropanamide) ...... 9833 cyclohexylmethyl]benzamide 9551 (38) Morpheridine ...... 9632 (5) Allylprodine ...... 9602 (39) MPPP (1-methyl-4-phenyl-4- (6) Alphacetylmethadol (except propionoxypiperidine) ...... 9661 levo-alphacetylmethadol also (40) MT–45 (1-cyclohexyl-4-(1,2- known as levo-alpha- diphenylethyl)piperazine) ...... 9560 acetylmethadol, levomethadyl (41) Noracymethadol ...... 9633 (42) Norlevorphanol ...... 9634 acetate, or LAAM) ...... 9603 (43) Normethadone ...... 9635 (7) Alphameprodine ...... 9604 (44) Norpipanone ...... 9636 (8) Alphamethadol ...... 9605 (45) Para-fluorofentanyl (N-(4- (9) Alpha-methylfentanyl (N-[1- fluorophenyl)-N-[1-(2- (alpha-methyl-beta- phenethyl)-4-piperidinyl] phenyl)ethyl-4-piperidyl] propanamide ...... 9812 propionanilide; 1-(1-methyl-2- (46) PEPAP (1-(-2-phenethyl)-4- phenylethyl)-4-(N-propanilido) phenyl-4-acetoxypiperidine ..... 9663 piperidine) ...... 9814 (47) Phenadoxone ...... 9637 (10) Alpha-methylthiofentanyl (48) Phenampromide ...... 9638 (N-[1-methyl-2-(2- (49) Phenomorphan ...... 9647 thienyl)ethyl-4-piperidinyl]-N- (50) Phenoperidine ...... 9641 phenylpropanamide) ...... 9832 (51) Piritramide ...... 9642 (11) Benzethidine ...... 9606 (52) Proheptazine ...... 9643 (12) Betacetylmethadol ...... 9607 (53) Properidine ...... 9644 (13) Beta-hydroxyfentanyl (N-[1- (54) Propiram ...... 9649 (2-hydroxy-2-phenethyl)-4- (55) Racemoramide ...... 9645 piperidinyl]-N- (56) Thiofentanyl (N-phenyl-N-[1- phenylpropanamide) ...... 9830 (2-thienyl)ethyl-4-piperidinyl]- (14) Beta-hydroxy-3- propanamide ...... 9835 methylfentanyl (other name: (57) Tilidine ...... 9750 N-[1-(2-hydroxy-2-phenethyl)- (58) Trimeperidine ...... 9646 3-methyl-4-piperidinyl]-N- phenylpropanamide ...... 9831 (c) Opium derivatives. Unless specifi- (15) Betameprodine ...... 9608 cally excepted or unless listed in an- (16) Betamethadol ...... 9609 other schedule, any of the following (17) Betaprodine ...... 9611 opium derivatives, its salts, isomers, (18) Clonitazene ...... 9612 and salts of isomers whenever the ex- (19) Dextromoramide ...... 9613 istence of such salts, isomers, and salts (20) Diampromide ...... 9615 of isomers is possible within the spe- (21) Diethylthiambutene ...... 9616 cific chemical designation: (22) Difenoxin ...... 9168 (1) Acetorphine ...... 9319 (23) Dimenoxadol ...... 9617 (2) Acetyldihydrocodeine ...... 9051 (24) Dimepheptanol ...... 9618 (3) Benzylmorphine ...... 9052 (25) Dimethylthiambutene ...... 9619 (4) Codeine methylbromide ...... 9070 (26) Dioxaphetyl butyrate ...... 9621 (5) Codeine-N-Oxide ...... 9053 112

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(6) Cyprenorphine ...... 9054 Some trade or other (7) Desomorphine ...... 9055 names: 2,5-dimethoxy-a- (8) Dihydromorphine ...... 9145 methylphenethylamine; (9) Drotebanol ...... 9335 2,5-DMA (10) Etorphine (except hydro- (5) 2,5-dimethoxy-4- chloride salt) ...... 9056 ethylamphet-amine ...... 7399 (11) Heroin ...... 9200 Some trade or other (12) Hydromorphinol ...... 9301 names: DOET (13) Methyldesorphine ...... 9302 (6) 2,5-dimethoxy-4-(n)- (14) Methyldihydromorphine ...... 9304 propylthiophenethylamine (other name: 2C–T–7) ...... 7348 (15) Morphine methylbromide .... 9305 (7) 4-methoxyamphetamine ..... 7411 (16) Morphine methylsulfonate .. 9306 Some trade or other (17) Morphine-N-Oxide ...... 9307 names: 4-methoxy-a- (18) Myrophine ...... 9308 methylphenethylamine; (19) Nicocodeine ...... 9309 paramethoxyamphetami- (20) Nicomorphine ...... 9312 ne, PMA (21) Normorphine ...... 9313 (8) 5-methoxy-3,4- (22) Pholcodine ...... 9314 methylenedioxy-amphet- (23) Thebacon ...... 9315 amine ...... 7401 (d) Hallucinogenic substances. Unless (9) 4-methyl-2,5-dimethoxy- specifically excepted or unless listed in amphetamine ...... 7395 another schedule, any material, com- Some trade and other pound, mixture, or preparation, which names: 4-methyl-2,5- contains any quantity of the following dimethoxy-a- hallucinogenic substances, or which methylphenethylamine; contains any of its salts, isomers, and ‘‘DOM’’; and ‘‘STP’’ salts of isomers whenever the existence (10) 3,4-methylenedioxy am- of such salts, isomers, and salts of iso- phetamine ...... 7400 mers is possible within the specific (11) 3,4- chemical designation (for purposes of methylenedioxymethamphe- this paragraph only, the term ‘‘isomer’’ tamine (MDMA) ...... 7405 includes the optical, position and geo- (12) 3,4-methylenedioxy-N- metric isomers): ethylamphetamine (also known as N-ethyl-alpha- (1) Alpha-ethyltryptamine ...... 7249 methyl-3,4(methylenedioxy)- Some trade or other phenethylamine, N-ethyl names: etryptamine; MDA, MDE, MDEA ...... 7404 Monase; -ethyl-1H- a (13) N-hydroxy-3,4- indole-3-ethanamine; 3- methylenedioxyamphetami- (2-aminobutyl) indole; - a ne (also known as N-hy- ET; and AET. droxy-alpha-methyl- (2) 4-bromo-2,5-dimethoxy-am- 3,4(methylenedioxy)- phetamine ...... 7391 phenethylamine, and N-hy- Some trade or other droxy MDA ...... 7402 names: 4-bromo-2,5- (14) 3,4,5-trimethoxy amphet- dimethoxy-a- amine ...... 7390 methylphenethylamine; (15) 5-methoxy-N,N- 4-bromo-2,5-DMA dimethyltryptamine Some (3) 4-Bromo-2,5- trade or other names: 5- dimethoxyphenethylamine .. 7392 methoxy-3-[2- Some trade or other (dimethylamin- names: 2-(4-bromo-2,5- o)ethyl]indole; 5-MeO-DMT .. 7431 dimethoxyphenyl)-1- (16) Alpha-methyltryptamine aminoethane; alpha- (other name: AMT) ...... 7432 desmethyl DOB; 2C-B, (17) Bufotenine ...... 7433 Nexus. (4) 2,5-dimethoxyamphetamine 7396 113

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Some trade and other (28) N-methyl-3-piperidyl names: 3-(b- benzilate ...... 7484 Dimethylaminoethyl)-5- (29) Psilocybin ...... 7437 hydroxyindole; 3-(2- (30) Psilocyn ...... 7438 dimethylaminoethyl)-5- (31) Tetrahydrocannabinols .... 7370 indolol; N, N- Meaning dimethylserotonin; 5-hy- tetrahydrocannabinols droxy-N,N- naturally contained in a dimethyltryptamine; plant of the genus Can- mappine nabis (cannabis plant), (18) Diethyltryptamine ...... 7434 as well as synthetic Some trade and other equivalents of the sub- names: N,N- stances contained in the Diethyltryptamine; DET cannabis plant, or in the (19) Dimethyltryptamine ...... 7435 resinous extractives of Some trade or other such plant, and/or syn- names: DMT thetic substances, de- (20) 5-methoxy-N,N- rivatives, and their iso- diisopropyltryptamine mers with similar chem- (other name: 5-MeO-DIPT) ... 7439 ical structure and phar- (21) Ibogaine ...... 7260 macological activity to Some trade and other those substances con- names: 7-Ethyl- tained in the plant, such 6,6b,7,8,9,10,12,13- as the following: octahydro-2-methoxy- 1 cis or trans 6,9-methano-5H-pyrido tetrahydrocannabinol, [1′, 2′:1,2] azepino [5,4-b] and their optical isomers indole; Tabernanthe 6 cis or trans iboga tetrahydrocannabinol, (22) Lysergic acid and their optical isomers diethylamide ...... 7315 3, 4 cis or trans (23) Marihuana ...... 7360 tetrahydrocannabinol, (24) Mescaline ...... 7381 and its optical isomers (25) Parahexyl—7374; some (Since nomenclature of trade or other names: 3- these substances is not Hexyl-1-hydroxy-7,8,9,10- internationally stand- tetrahydro-6,6,9-trimethyl- ardized, compounds of 6H-dibenzo[b,d]pyran; these structures, regard- Synhexyl. less of numerical des- (26) Peyote ...... 7415 ignation of atomic posi- Meaning all parts of the tions covered.) plant presently classified (32) Ethylamine analog of botanically as phencyclidine ...... 7455 Lophophora williamsii Some trade or other Lemaire, whether grow- names: N-ethyl-1- ing or not, the seeds phenylcyclohexylamine, thereof, any extract (1- from any part of such phenylcyclohexy- plant, and every com- l)ethylamine, N-(1- pound, manufacture, phenylcyclohexy- salts, derivative, mix- l)ethylamine, ture, or preparation of cyclohexamine, PCE such plant, its seeds or (33) Pyrrolidine analog of extracts phencyclidine ...... 7458 (Interprets 21 USC 812(c), Schedule I(c) (12)) (27) N-ethyl-3-piperidyl benzilate ...... 7482 114

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Some trade or other (50) N-(1-adamantyl)-1-pentyl- names: 1-(1- 1H-indazole-3-carboxamide phenylcyclohexyl)-pyr- (APINACA, AKB48) ...... (7048) rolidine, PCPy, PHP (51) quinolin-8-yl 1-pentyl-1H- (34) Thiophene analog of indole-3-carboxylate (PB-22; phencyclidine ...... 7470 QUPIC) ...... (7222) Some trade or other (52) quinolin-8-yl 1-(5- names: 1-[1-(2-thienyl)- fluoropentyl)-1H-indole-3- cyclohexyl]-piperidine, 2- carboxylate (5-fluoro-PB-22; thienylanalog of 5F-PB-22) ...... (7225) phencyclidine, TPCP, (53) N-(1-amino-3-methyl-1- TCP oxobutan-2-yl)-1-(4- (35) 1-[1-(2- fluorobenzyl)-1H-indazole-3- thieny- carboxamide (AB- l)cyclohexyl]pyrrolidine ...... 7473 FUBINACA) ...... (7012) Some other names: TCPy (54) N-(1-amino-3,3-dimethyl-1- (36) 4-methylmethcathinone oxobutan-2-yl)-1-pentyl-1H- (Mephedrone) ...... 1248 indazole-3-carboxamide (37) 3,4- (ADB-PINACA) ...... (7035) methylenedioxypyrovaleron- (55) 2-(4-iodo-2,5- e (MDPV) ...... 7535 dimethoxyphenyl)-N-(2-me- (38) 2-(2,5-Dimethoxy-4- thoxybenzyl)ethanamine ethylphenyl)ethanamine (25I-NBOMe, 2C-I-NBOMe) .... (7538) (2C–E) ...... 7509 (39) 2-(2,5-Dimethoxy-4- (56) 2-(4-chloro-2,5- methylphenyl)ethanamine dimethoxyphenyl)-N-(2-me- (2C–D) ...... 7508 thoxybenzyl)ethanamine (40) 2-(4-Chloro-2,5- (25C-NBOMe, 2C-C-NBOMe) .. (7537) dimethoxypheny- (57) 2-(4-bromo-2,5- l)ethanamine (2C–C) ...... 7519 dimethoxyphenyl)-N-(2-me- (41) 2-(4-Iodo-2,5- thoxybenzyl)ethanamine dimethoxypheny- (25B-NBOMe, 2C-B-NBOMe) .. (7536) l)ethanamine (2C–I) ...... 7518 (58) Marihuana Extract— (42) 2-[4-(Ethylthio)-2,5- Meaning an extract con- dimethoxypheny- taining one or more l]ethanamine (2C–T–2) ...... 7385 cannabinoids that has been (43) 2-[4-(Isopropylthio)-2,5- derived from any plant of dimethoxypheny- the genus Cannabis, other l]ethanamine (2C–T–4) ...... 7532 than the separated resin (44) 2-(2,5- (whether crude or purified) Dimethoxypheny- obtained from the plant ...... (7350) l)ethanamine (2C–H) ...... 7517 (59) 4-methyl-N- (45) 2-(2,5-Dimethoxy-4-nitro- ethylcathinone (4-MEC) ...... (1249) phenyl)ethanamine (2C–N) ... 7521 (60) 4-methyl-alpha- (46) 2-(2,5-Dimethoxy-4-(n)- pyrrolidinopropiophenone (4- propylphenyl)ethanamine MePPP) ...... (7498) (2C–P) ...... 7524 (61) alpha- (47) 3,4-Methylenedioxy-N- pyrrolidinopentiophenone methylcathinone (a-PVP) ...... (7545) (Methylone) ...... 7540 (62) 1-(1,3-benzodioxol-5-yl)-2- (48) (1-pentyl-1H-indol-3- (methylamino)butan-1-one yl)(2,2,3,3- (butylone, bk-MBDB) ...... (7541) tetramethylcyclopropy- (63) 2-(methylamino)-1- l)methanone (UR-144) ...... (7144) phenylpentan-1-one (49) [1-(5-fluoro-pentyl)-1H- (pentedrone) ...... (1246) indol-3-yl](2,2,3,3- (64) 1-(1,3-benzodioxol-5-yl)-2- tetramethylcyclopropy- (methylamino)pentan-1-one l)methanone (5-fluoro-UR- (pentylone, bk-MBDP) ...... (7542) 144, XLR11) ...... (7011) 115

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(65) 4-fluoro-N- (2) N-Benzylpiperazine (some methylcathinone (4-FMC; other names: BZP, 1- flephedrone) ...... (1238) benzylpiperazine) ...... 7493 (66) 3-fluoro-N- (3) Cathinone ...... 1235 methylcathinone (3-FMC) .... (1233) Some trade or other names: (67) 1-(naphthalen-2-yl)-2- 2-amino-1-phenyl-1- (pyrrolidin-1-yl)pentan-1-one propanone, alpha- (naphyrone) ...... (1258) aminopropiophenone, 2- (68) alpha- aminopropiophenone, and pyrrolidinobutiophenone (a- norephedrone PBP) ...... (7546) (4) Fenethylline ...... 1503 (69) N-(1-amino-3-methyl-1- (5) Methcathinone (Some other oxobutan-2-yl)-1- names: 2-(methylamino)- (cyclohexylmethyl)-1H-inda- propiophenone; alpha- zole-3-carboxamide (AB- (methylamino)propiophenone; CHMINACA) ...... (7031) 2-(methylamino)-1- (70) N-(1-amino-3-methyl-1- phenylpropan-1-one; alpha-N- oxobutan-2-yl)-1-pentyl-1H- methylaminopropiophenone; indazole-3-carboxamide (AB- monomethylpropion; PINACA) ...... (7023) ephedrone; N- (71) [1-(5-fluoropentyl)-1H- methylcathinone; indazol-3-yl](naphthalen-1- methylcathinone; AL–464; AL– yl)methanone (THJ-2201) ..... (7024) 422; AL–463 and UR1432), its (e) Depressants. Unless specifically salts, optical isomers and salts excepted or unless listed in another of optical isomers ...... 1237 ± schedule, any material, compound, (6) ( )cis-4-methylaminorex ± mixture, or preparation which contains (( )cis-4,5-dihydro-4-methyl-5- any quantity of the following sub- phenyl-2-oxazolamine) ...... 1590 stances having a depressant effect on (7) N-ethylamphetamine ...... 1475 the central nervous system, including (8) N,N-dimethylamphetamine its salts, isomers, and salts of isomers (also known as N,N-alpha- whenever the existence of such salts, trimethyl-benzeneethanamine; isomers, and salts of isomers is possible N,N-alpha- within the specific chemical designa- trimethylphenethylamine) ..... 1480 tion: (g) Cannabimimetic agents. Unless spe- (1) gamma-hydroxybutyric acid cifically exempted or unless listed in (some other names include another schedule, any material, com- GHB; gamma- pound, mixture, or preparation which hydroxybutyrate; 4- contains any quantity of the following hydroxybutyrate; 4- substances, or which contains their hydroxybutanoic acid; sodium salts, isomers, and salts of isomers oxybate; sodium oxybutyrate) 2010 whenever the existence of such salts, (2) Mecloqualone ...... 2572 isomers, and salts of isomers is possible (3) Methaqualone ...... 2565 within the specific chemical designa- (f) Stimulants. Unless specifically ex- tion: cepted or unless listed in another (1) 5-(1,1-dimethylheptyl)-2- schedule, any material, compound, [(1R,3S)-3-hydroxycyclohexyl]- mixture, or preparation which contains phenol (CP–47,497) ...... 7297 any quantity of the following sub- (2) 5-(1,1-dimethyloctyl)-2- stances having a stimulant effect on [(1R,3S)-3-hydroxycyclohexyl]- the central nervous system, including phenol (cannabicyclohexanol its salts, isomers, and salts of isomers: or CP–47,497 C8-homolog) ...... 7298 (1) Aminorex (Some other (3) 1-pentyl-3-(1-naph- names: aminoxaphen; 2-amino- thoyl)indole (JWH–018 and 5-phenyl-2-oxazoline; or 4,5- AM678) ...... 7118 dihydro-5-phenly-2- (4) 1-butyl-3-(1-naphthoyl)indole oxazolamine) ...... 1585 (JWH–073) ...... 7173 116

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(5) 1-hexyl-3-(1-naphthoyl)indole (4) 3,4-Dichloro-N-[2- (JWH–019) ...... 7019 (dimethylamin- (6) 1-[2-(4-morpholinyl)ethyl]-3- o)cyclohexyl]-N- (1-naphthoyl)indole (JWH–200) 7200 methylbenzamide, its iso- (7) 1-pentyl-3-(2- mers, esters, ethers, salts methoxyphenylacetyl)indole and salts of isomers, esters (JWH–250) ...... 6250 and ethers (Other name: U– (8) 1-pentyl-3-[1-(4- 47700) ...... (9547) methoxynaphthoyl)]indole (5) N-(1-phenethylpiperidin-4- (JWH–081) ...... 7081 yl)-N-phenylfuran-2- (9) 1-pentyl-3-(4-methyl-1-naph- carboxamide, its isomers, thoyl)indole (JWH–122) ...... 7122 esters, ethers, salts and salts (10) 1-pentyl-3-(4-chloro-1-naph- of isomers, esters and ethers thoyl)indole (JWH–398) ...... 7398 (Other name: Furanyl fentanyl) ...... (9834). (11) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201) ...... 7201 (6) methyl 2-(1-(5- fluoropentyl)-1 -indazole-3- (12) 1-(5-fluoropentyl)-3-(2- H carboxamido)-3,3- iodobenzoyl)indole (AM694) ..... 7694 dimethylbutanoate, its opti- (13) 1-pentyl-3-[(4-methoxy)-ben- cal, positional, and geo- zoyl]indole (SR–19 and RCS–4) 7104 metric isomers, salts and (14) 1-cyclohexylethyl-3-(2- salts of isomers (Other methoxyphenylacetyl)indole names: 5F–ADB; 5F–MDMB– 7008 (SR–18 and RCS–8) ...... 7008 PINACA) ...... (7034) (15) 1-pentyl-3-(2- (7) methyl 2-(1-(5- chlorophenylacetyl)indole fluoropentyl)-1H-indazole-3- (JWH–203) ...... 7203 carboxamido)-3- (h) Temporary listing of substances sub- methylbutanoate, its opti- ject to emergency scheduling. Any mate- cal, positional, and geo- rial, compound, mixture or preparation metric isomers, salts and which contains any quantity of the fol- salts of isomers (Other lowing substances: names: 5F–AMB)...... (7033) (8) N-(adamantan-1-yl)-1-(5- (1) N-(1-amino-3,3-dimethyl-1- fluoropentyl)-1H-indazole-3- oxobutan-2-yl)-1- carboxamide, its optical, po- (cyclohexylmethyl)-1H-inda- sitional, and geometric iso- zole-3-carboxamide, its opti- mers, salts and salts of iso- cal, positional, and geo- mers (Other names: 5F– metric isomers, salts and APINACA, 5F–AKB48) ...... (7049) salts of isomers (Other (9) N-(1-amino-3,3-dimethyl-1- names: MAB-CHMINACA; oxobutan-2-yl)-1-(4- ADB-CHMINACA) ...... (7032) fluorobenzyl)-1H-indazole-3- (2) N-(1-phenethylpiperidin-4- carboxamide, its optical, po- yl)-N-phenylbutyramide, its sitional, and geometric iso- isomers, esters, ethers, salts mers, salts and salts of iso- and salts of isomers, esters mers (Other names: ADB– and ethers (Other names: FUBINACA) ...... (7010) Butyryl fentanyl) ...... (9822) (10) methyl 2-(1- (3) N-[1-[2-hydroxy-2- (cyclohexylmethyl)-1H- (thiophen-2- indole-3-carboxamido)-3,3- yl)ethyl]piperidin-4-yl]-N- dimethylbutanoate, its opti- phenylpropionamide, its iso- cal, positional, and geo- mers, esters, ethers, salts metric isomers, salts and and salts of isomers, esters salts of isomers (Other and ethers (Other names: names: MDMB–CHMICA, beta-hydroxythiofentanyl) .. (9836) MMB–CHMINACA) ...... (7042)

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(11) methyl 2-(1-(4- (21) 2-methoxy-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4-yl)-N- carboxamido)-3,3- phenylacetamide, its iso- dimethylbutanoate, its opti- mers, esters, ethers, salts cal, positional, and geo- and salts of isomers, esters metric isomers, salts and and ethers (Other name: salts of isomers (Other methoxyacetyl fentanyl) ..... (9825) names: MDMB–FUBINACA) (7020) (22) N-(1-phenethylpiperidin-4- (12) [Reserved]. yl)-N- (13) N-(4-fluorophenyl)-N-(1- phenylcyclopropanecarboxa- phenethylpiperidin-4- mide, its isomers, esters, yl)isobutyramide, its iso- ethers, salts and salts of isomers, esters, ethers, salts mers, esters and ethers and salts of isomers, esters (Other name: cyclopropyl and ethers (Other names: 4- fentanyl) ...... (9845) fluoroisobutyryl fentanyl, (23) N-(1-phenethylpiperidin-4- para-fluoroisobutyryl yl)-N-phenylpentanamide, fentanyl) ...... (9824) its isomers, esters, ethers, (14) N-(1-phenethylpiperidin-4- salts and salts of isomers, yl)-N-phenylacrylamide, its esters and ethers (Other isomers, esters, ethers, salts name: Valeryl fentanyl) ...... (9840) and salts of isomers, esters (24) N-(4-fluorophenyl)-N-(1- and ethers (Other names: phenethylpiperidin-4- acryl fentanyl, yl)butyramide, its isomers, acryloylfentanyl) ...... (9811) esters, ethers, salts and salts (15) [Reserved]. of isomers, esters and ethers (16) [Reserved]. (Other name: para- (17) [Reserved]. fluorobutyryl fentanyl) ...... (9823) (18) methyl 2-(1-(4- (25) N-(4-methoxyphenyl)-N-(1- fluorobenzyl)-1H-indazole-3- phenethylpiperidin-4- carboxamido)-3- yl)butyramide, its isomers, methylbutanoate, its opti- esters, ethers, salts and salts cal, positional, and geo- of isomers, esters and ethers metric isomers, salts and (Other name: para- salts of isomers (Other methoxybutyryl fentanyl) ... (9837) names: FUB–AMB, MMB– (26) N-(4-chlorophenyl)-N-(1- FUBINACA, AMB– phenethylpiperidin-4- FUBINACA) ...... (7021) yl)isobutyramide, its iso- (19) N-(2-fluorophenyl)-N-(1- mers, esters, ethers, salts phenethylpiperidin-4- and salts of isomers, esters yl)propionamide, its iso- and ethers (Other name: mers, esters, ethers, salts para-chloroisobutyryl and salts of isomers, esters fentanyl) ...... (9826) and ethers (Other names: (27) N-(1-phenethylpiperidin-4- ortho-fluorofentanyl, 2- yl)-N-phenylisobutyramide, fluorofentanyl) ...... (9816) its isomers, esters, ethers, (20) N-(1-phenethylpiperidin-4- salts and salts of isomers, yl)-N- esters and ethers (Other phenyltetrahydrofuran-2- name: isobutyryl fentanyl) .. (9827) carboxamide, its isomers, (28) N-(1-phenethylpiperidin-4- esters, ethers, salts and salts yl)-N- of isomers, esters and ethers phenylcyclopentanecarboxa- (Other name: mide, its isomers, esters, tetrahydrofuranyl fentanyl) (9843) ethers, salts and salts of isomers, esters and ethers (Other name: cyclopentyl fentanyl) ...... (9847)

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(29) N-(2-fluorophenyl)-2- 16, 2017, § 1308.11 was amended by redesig- methoxy-N-(1- nating (h)(17) as paragraph (h)(14). 3. At 82 FR 49508, Oct. 26, 2017, § 1308.11 was phenethylpiperidin-4- amended by adding reserved paragraphs yl)acetamide, its isomers, (h)(15) through (h)(18) and (h)(19), (20) and esters, ethers, salts and salts (21), effective Oct. 26, 2017,, through Oct. 28, of isomers, esters and ethers 2019. (Other name: Ocfentanil) ..... (9838) 4. At 82 FR 51558, Nov. 3, 2017, § 1308.11 was (30) Fentanyl-related sub- amended by adding paragraph (h)(18), effective Nov. 3, 2017, through Nov. 4, 2019. stances, their isomers, 5. At 83 FR 472, Jan. 4, 2018, § 1308.11 was esters, ethers, salts and salts amended by adding paragraph (h)(22), effec- of isomers, esters and ethers 9850 tive Jan. 4, 2018, through Jan. 4, 2020. 6. At 83 FR 4584, Feb. 1, 2018, § 1308.11 was (i) Fentanyl-related substance means amended by adding paragraphs (h)(23) any substance not otherwise listed through (h)(29), effective Feb. 1, 2018, under another Administration Con- through Feb. 1, 2020. trolled Substance Code Number, and 7. At 83 FR 5191, Feb. 6, 2018, § 1308.11 was for which no exemption or approval is amended by adding paragraph (h)(30), effec- in effect under section 505 of the Fed- tive Feb. 6, 2018, through Feb. 6, 2020. eral Food, Drug, and Cosmetic Act [21 8. At 83 FR 10368, Mar. 9, 2018, § 1308.11 was amended by revising paragraphs (h)(23) and U.S.C. 355], that is structurally related (h)(29), effective Mar. 9, 2018, through Feb. 1, to fentanyl by one or more of the fol- 2020. lowing modifications: (A) Replacement of the phenyl por- § 1308.12 Schedule II. tion of the phenethyl group by any (a) Schedule II shall consist of the monocycle, whether or not further sub- drugs and other substances, by what- stituted in or on the monocycle; ever official name, common or usual (B) Substitution in or on the name, chemical name, or brand name phenethyl group with alkyl, alkenyl, designated, listed in this section. Each alkoxyl, hydroxyl, halo, haloalkyl, drug or substance has been assigned amino or nitro groups; the Controlled Substances Code Num- (C) Substitution in or on the piper- ber set forth opposite it. idine ring with alkyl, alkenyl, alkoxyl, (b) Substances, vegetable origin or ester, ether, hydroxyl, halo, haloalkyl, chemical synthesis. Unless specifically amino or nitro groups; excepted or unless listed in another (D) Replacement of the aniline ring schedule, any of the following sub- with any aromatic monocycle whether stances whether produced directly or or not further substituted in or on the indirectly by extraction from sub- aromatic monocycle; and/or stances of vegetable origin, or inde- (E) Replacement of the N-propionyl pendently by means of chemical syn- group by another acyl group. thesis, or by a combination of extrac- (ii) This definition includes, but is tion and chemical synthesis: not limited to, the following sub- (1) Opium and opiate, and any salt, stances: compound, derivative, or preparation (A)–(B) [Reserved] of opium or opiate excluding apomorphine, thebaine-derived [39 FR 22141, June 20, 1974] butorphanol, dextrorphan, nalbuphine, EDITORIAL NOTE: For FEDERAL REGISTER ci- naldemedine, nalmefene, naloxegol, tations affecting § 1308.11, see the List of CFR naloxone, and naltrexone, and their re- Sections Affected, which appears in the spective salts, but including the fol- Finding Aids section of the printed volume lowing: and at www.fdsys.gov. (i) Codeine ...... 9050 EFFECTIVE DATE NOTES: At 82 FR 20547, (ii) Dihydroetorphine ...... 9334 May 3, 2017, § 1308.11 was amended by adding (iii) Ethylmorphine ...... 9190 (h)(16), effective May 3, 2017, until May 3, (iv) Etorphine hydrochloride ..... 9059 2019. At 82 FR 47974, Oct. 16, 2017, § 1308.11 was (v) Granulated opium ...... 9640 amended by redesignating (h)(16) as paragraph (h)(13). (vi) Hydrocodone ...... 9193 2. At 82 FR 32457, July 14, 2017, § 1308.11 was (vii) Hydromorphone ...... 9150 amended by adding (h)(17), effective July 14, (viii) Metopon ...... 9260 2017, until July 15, 2019. At 82 FR 47974, Oct. (ix) Morphine ...... 9300 119

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(x) Opium extracts ...... 9610 (11) Levo-alphacetylmethadol .... 9648 (xi) Opium fluid ...... 9620 [Some other names: levo- (xii) Oripavine ...... 9330 alpha-acetylmethadol, (xiii) Oxycodone ...... 9143 levomethadyl acetate, (xiv) Oxymorphone ...... 9652 LAAM] (xv) Powdered opium ...... 9639 (12) Levomethorphan ...... 9210 (xvi) Raw opium ...... 9600 (13) Levorphanol ...... 9220 (xvii) Thebaine ...... 9333 (14) Metazocine ...... 9240 (xviii) Tincture of opium ...... 9630 (15) Methadone ...... 9250 (2) Any salt, compound, derivative, or (16) Methadone-Intermediate, 4- preparation thereof which is chemi- cyano-2-dimethylamino-4,4-di- cally equivalent or identical with any phenyl butane ...... 9254 of the substances referred to in para- (17) Moramide-Intermediate, 2- graph (b) (1) of this section, except that methyl-3-morpholino-1, 1- these substances shall not include the diphenylpropane-carboxylic isoquinoline alkaloids of opium. acid ...... 9802 (3) Opium poppy and poppy straw. (18) Pethidine (meperidine) ...... 9230 (4) Coca leaves (9040) and any salt, (19) Pethidine-Intermediate-A, 4- compound, derivative or preparation of cyano-1-methyl-4- coca leaves (including cocaine (9041) phenylpiperidine ...... 9232 and ecgonine (9180) and their salts, iso- (20) Pethidine-Intermediate-B, mers, derivatives and salts of isomers ethyl-4-phenylpiperidine-4- and derivatives), and any salt, com- carboxylate ...... 9233 pound, derivative, or preparation (21) Pethidine-Intermediate-C, 1- thereof which is chemically equivalent methyl-4-phenylpiperidine-4- or identical with any of these sub- carboxylic acid ...... 9234 stances, except that the substances (22) Phenazocine ...... 9715 shall not include: (23) Piminodine ...... 9730 (i) Decocainized coca leaves or ex- (24) Racemethorphan ...... 9732 traction of coca leaves, which extrac- (25) Racemorphan ...... 9733 tions do not contain cocaine or ecgo- (26) Remifentanil ...... 9739 nine; or (27) Sufentanil ...... 9740 (ii) [123I]ioflupane. (28) Tapentadol ...... 9780 (5) Concentrate of poppy straw (the (29) Thiafentanil ...... 9729 crude extract of poppy straw in either (d) Stimulants. Unless specifically ex- liquid, solid or powder form which con- cepted or unless listed in another tains the phenanthrene alkaloids of the schedule, any material, compound, opium poppy), 9670. mixture, or preparation which contains (c) Opiates. Unless specifically ex- any quantity of the following sub- cepted or unless in another schedule stances having a stimulant effect on any of the following opiates, including the central nervous system: its isomers, esters, ethers, salts and salts of isomers, esters and ethers (1) Amphetamine, its salts, opti- whenever the existence of such iso- cal isomers, and salts of its mers, esters, ethers, and salts is pos- optical isomers ...... 1100 sible within the specific chemical des- (2) Methamphetamine, its salts, ignation, dextrorphan and isomers, and salts of its iso- levopropoxyphene excepted: mers ...... 1105 (3) Phenmetrazine and its salts 1631 (1) Alfentanil ...... 9737 (4) Methylphenidate ...... 1724 (2) Alphaprodine ...... 9010 (5) Lisdexamfetamine, its salts, (3) Anileridine ...... 9020 isomers, and salts of its iso- (4) Bezitramide ...... 9800 mers ...... 1205. (5) Bulk dextropropoxyphene (non-dosage forms) ...... 9273 (e) Depressants. Unless specifically (6) Carfentanil ...... 9743 excepted or unless listed in another (7) Dihydrocodeine ...... 9120 schedule, any material, compound, (8) Diphenoxylate ...... 9170 mixture, or preparation which contains (9) Fentanyl ...... 9801 any quantity of the following sub- (10) Isomethadone ...... 9226 stances having a depressant effect on 120

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the central nervous system, including § 1308.13 Schedule III. its salts, isomers, and salts of isomers (a) Schedule III shall consist of the whenever the existence of such salts, isomers, and salts of isomers is possible drugs and other substances, by what- within the specific chemical designa- ever official name, common or usual tion: name, chemical name, or brand name designated, listed in this section. Each (1) Amobarbital ...... 2125 drug or substance has been assigned (2) Glutethimide ...... 2550 the DEA Controlled Substances Code (3) Pentobarbital ...... 2270 Number set forth opposite it. (4) Phencyclidine ...... 7471 (5) Secobarbital ...... 2315 (b) Stimulants. Unless specifically excepted or unless listed in another (f) Hallucinogenic substances. schedule, any material, compound, (1) Nabilone ...... 7379 mixture, or preparation which contains [Another name for any quantity of the following sub- nabilone: (±)-trans-3-(1,1- stances having a stimulant effect on dimethylheptyl)- the central nervous system, including 6,6a,7,8,10,10a-hexahydro- its salts, isomers (whether optical, po- 1-hydroxy-6,6-dimethyl- sitional, or geometric), and salts of 9H-dibenzo[b,d]pyran-9- such isomers whenever the existence of one] such salts, isomers, and salts of iso- (2) Dronabinol [(-)-delta-9- mers is possible within the specific trans tetrahydrocannabinol] chemical designation: in an oral solution in a drug product approved for mar- (1) Those compounds, mixtures, keting by the U.S. Food and or preparations in dosage unit Drug Administration ...... (7365) form containing any stimulant substances listed in (g) Immediate precursors. Unless spe- schedule II which compounds, cifically excepted or unless listed in mixtures, or preparations were another schedule, any material, com- listed on August 25, 1971, as ex- pound, mixture, or preparation which cepted compounds under contains any quantity of the following § 1308.32, and any other drug of substances: the quantitative composition (1) Immediate precursor to amphet- shown in that list for those amine and methamphetamine: drugs or which is the same ex- (i) Phenylacetone ...... 8501 cept that it contains a lesser Some trade or other names: quantity of controlled sub- phenyl-2-propanone; P2P; stances ...... 1405 benzyl methyl ketone; (2) Benzphetamine ...... 1228 methyl benzyl ketone; (3) Chlorphentermine ...... 1645 (2) Immediate precursors to (4) Clortermine ...... 1647 phencyclidine (PCP): (5) Phendimetrazine ...... 1615 (i) 1-phenylcyclohexylamine ...... 7460 (c) Depressants. Unless specifically (ii) 1- excepted or unless listed in another piperidinocyclohexanecarboni- schedule, any material, compound, trile (PCC) ...... 8603 mixture, or preparation which contains (3) Immediate precursor to fentanyl: any quantity of the following sub- (i) 4-anilino-N-phenethyl-4-pi- stances having a depressant effect on peridine (ANPP) ...... 8333 the central nervous system: (ii) [Reserved] (1) Any compound, mixture or preparation containing: [39 FR 22142, June 20, 1974] (i) Amobarbital ...... 2126 EDITORIAL NOTE: For FEDERAL REGISTER ci- (ii) Secobarbital ...... 2316 tations affecting § 1308.12, see the List of CFR (iii) Pentobarbital ...... 2271 Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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or any salt thereof and one Some trade or other names or more other active me- for zolazepam: dicinal ingredients which 4-(2-fluorophenyl)-6,8- are not listed in any dihydro-1,3,8- schedule. trimethylpyrazolo-[3,4- (2) Any suppository dosage form e] [1,4]-diazepin-7(1H)- containing: one, flupyrazapon.. (i) Amobarbital ...... 2126 (d) Nalorphine 9400. (ii) Secobarbital ...... 2316 (e) Narcotic drugs. Unless specifically (iii) Pentobarbital ...... 2271 excepted or unless listed in another or any salt of any of these schedule: drugs and approved by the Food and Drug Adminis- (1) Any material, compound, tration for marketing only mixture, or preparation con- as a suppository. taining any of the following (3) Any substance which con- narcotic drugs, or their salts tains any quantity of a deriva- calculated as the free anhy- tive of barbituric acid or any drous base or alkaloid, in lim- salt thereof ...... 2100 ited quantities as set forth below: (4) Chlorhexadol ...... 2510 (i) Not more than 1.8 (5) Embutramide ...... 2020 grams of codeine per (6) Any drug product containing 100 milliliters or not gamma hydroxybutyric acid, more than 90 milli- including its salts, isomers, grams per dosage unit, and salts of isomers, for which with an equal or great- an application is approved er quantity of an under section 505 of the Fed- isoquinoline alkaloid eral Food, Drug, and Cosmetic of opium ...... 9803 Act ...... 2012 (ii) Not more than 1.8 (7) Ketamine, its salts, isomers, grams of codeine per and salts of isomers ...... 7285 100 milliliters or not [Some other names for more than 90 milli- ± ketamine: ( )-2-(2- grams per dosage unit, chlorophenyl)-2- with one or more ac- (methylamino)- tive, nonnarcotic in- cyclohexanone] gredients in recognized (8) Lysergic acid ...... 7300 therapeutic amounts ... 9804 (9) Lysergic acid amide ...... 7310 (iii) Not more than 1.8 (10) Methyprylon ...... 2575 grams of (11) Perampanel, and its salts, dihydrocodeine per 100 isomers, and salts of isomers .. 2261 milliliters or not more (12) Sulfondiethylmethane ...... 2600 than 90 milligrams per (13) Sulfonethylmethane ...... 2605 dosage unit, with one (14) Sulfonmethane ...... 2610 or more active nonnar- (15) Tiletamine and zolazepam cotic ingredients in or any salt thereof ...... 7295 recognized therapeutic Some trade or other names amounts ...... 9807 for a tiletamine-zolazepam (iv) Not more than 300 combination product: milligrams of Telazol.. ethylmorphine per 100 Some trade or other names milliliters or not more for tiletamine: than 15 milligrams per dosage unit, with one 2-(ethylamino)-2-(2- or more active, non- thienyl)- narcotic ingredients in cyclohexanone.. recognized therapeutic amounts ...... 9808

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(v) Not more than 500 designated, listed in this section. Each milligrams of opium drug or substance has been assigned per 100 milliliters or the DEA Controlled Substances Code per 100 grams or not Number set forth opposite it. more than 25 milli- (b) Narcotic drugs. Unless specifically grams per dosage unit, excepted or unless listed in another with one or more ac- schedule, any material, compound, tive, nonnarcotic in- mixture, or preparation containing any gredients in recognized of the following narcotic drugs, or therapeutic amounts ... 9809 their salts calculated as the free anhy- (vi) Not more than 50 drous base or alkaloid, in limited quan- milligrams of mor- tities as set forth below: phine per 100 milli- (1) Not more than 1 milligram of liters or per 100 grams, difenoxin and not less than 25 with one or more ac- micrograms of atropine sul- tive, nonnarcotic in- fate per dosage unit ...... 9167 gredients in recognized (2) Dextropropoxyphene (alpha- therapeutic amounts ... 9810 (+)-4-dimethylamino-1,2-di- (2) Any material, compound, phenyl-3-methyl-2- mixture, or preparation con- propionoxybutane) ...... 9278 taining any of the following (3) 2-[(dimethylamino)methyl]-1- narcotic drugs or their salts, (3- as set forth below: methoxyphenyl)cyclohexanol, (i) Buprenorphine ...... 9064 its salts, optical and geo- (ii) [Reserved]. metric isomers and salts of (f) Anabolic Steroids. Unless specifi- these isomers (including cally excepted or unless listed in an- tramadol) ...... 9752 other schedule, any material, com- (c) Depressants. Unless specifically pound, mixture or preparation con- excepted or unless listed in another taining any quantity of the following schedule, any material, compound, substances, including its salts, esters mixture, or preparation which contains and ethers: any quantity of the following sub- (1) Anabolic steroids (see § 1300.01 of stances, including its salts, isomers, this chapter)—4000 and salts of isomers whenever the ex- (2) [Reserved] istence of such salts, isomers, and salts (g) Hallucinogenic substances. (1) of isomers is possible within the spe- Dronabinol (synthetic) in sesame oil cific chemical designation: and encapsulated in a soft gelatin cap- (1) Alfaxalone ...... 2731 sule in a U.S. Food and Drug Adminis- (2) Alprazolam ...... 2882 tration approved product—7369. (3) Barbital ...... 2145 (4) Bromazepam ...... 2748 [Some other names for dronabinol: (6aR- (5) Camazepam ...... 2749 trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3- pentyl-6H-dibenzo [b,d]pyran-1-ol] or (-)- (6) Carisoprodol ...... 8192 delta-9-(trans)-tetrahydrocannabinol] (7) Chloral betaine ...... 2460 (8) Chloral hydrate ...... 2465 (2) [Reserved] (9) Chlordiazepoxide ...... 2744 [39 FR 22142, June 20, 1974] (10) Clobazam ...... 2751 (11) Clonazepam ...... 2737 EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1308.13, see the List of CFR (12) Clorazepate ...... 2768 Sections Affected, which appears in the (13) Clotiazepam ...... 2752 Finding Aids section of the printed volume (14) Cloxazolam ...... 2753 and at www.fdsys.gov. (15) Delorazepam ...... 2754 (16) Diazepam ...... 2765 § 1308.14 Schedule IV. (17) Dichloralphenazone ...... 2467 (a) Schedule IV shall consist of the (18) Estazolam ...... 2756 drugs and other substances, by what- (19) Ethchlorvynol ...... 2540 ever official name, common or usual (20) Ethinamate ...... 2545 name, chemical name, or brand name (21) Ethyl loflazepate ...... 2758 123

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(22) Fludiazepam ...... 2759 stances having a stimulant effect on (23) Flunitrazepam ...... 2763 the central nervous system, including (24) Flurazepam ...... 2767 its salts, isomers and salts of isomers: (25) Fospropofol ...... 2138 (1) Cathine ((+)- (26) Halazepam ...... 2762 norpseudoephedrine) ...... 1230 (27) Haloxazolam ...... 2771 (2) Diethylpropion ...... 1610 (28) Ketazolam ...... 2772 (3) Fencamfamin ...... 1760 (29) Loprazolam ...... 2773 (4) Fenproporex ...... 1575 (30) Lorazepam ...... 2885 (5) Mazindol ...... 1605 (31) Lormetazepam ...... 2774 (6) Mefenorex ...... 1580 (32) Mebutamate ...... 2800 (7)Modafinil ...... 1680 (33) Medazepam ...... 2836 (8) Pemoline (including (34) Meprobamate ...... 2820 (35) Methohexital ...... 2264 organometallic complexes and (36) Methylphenobarbital chelates thereof) ...... 1530 (mephobarbital) ...... 2250 (9) Phentermine ...... 1640 (37) Midazolam ...... 2884 (10) Pipradrol ...... 1750 (38) Nimetazepam ...... 2837 (11) Sibutramine ...... 1675 (39) Nitrazepam ...... 2834 (12) SPA ((-)-1-dimethylamino- (40) Nordiazepam ...... 2838 1,2-diphenylethane) ...... 1635 (41) Oxazepam ...... 2835 (g) Other substances. Unless specifi- (42) Oxazolam ...... 2839 cally excepted or unless listed in an- (43) Paraldehyde ...... 2585 other schedule, any material, com- (44) Petrichloral ...... 2591 pound, mixture or preparation which (45) Phenobarbital ...... 2285 contains any quantity of the following (46) Pinazepam ...... 2883 substances, including its salts: (47) Prazepam ...... 2764 (48) Quazepam ...... 2881 (1) Pentazocine ...... 9709 (49) Suvorexant ...... 2223 (2) Butorphanol (including its (50) Temazepam ...... 2925 optical isomers) ...... 9720 (51) Tetrazepam ...... 2886 (3) Eluxadoline (5-[[[(2S)-2- (52) Triazolam ...... 2887 amino-3-[4-aminocarbonyl)-2,6- (53) Zaleplon ...... 2781 dimethylphenyl]-1- (54) Zolpidem ...... 2783 oxopropyl][(1S)-1-(4-phenyl-1H- (55) Zopiclone ...... 2784 imidazol-2- yl)ethyl]amino]methyl]-2- (d) Fenfluramine. Any material, com- methoxybenzoic acid) (includ- pound, mixture, or preparation which ing its optical isomers) and its contains any quantity of the following salts, isomers, and salts of iso- substances, including its salts, isomers mers (9725).. (whether optical, position, or geometric), and salts of such isomers, [39 FR 22143, June 20, 1974] whenever the existence of such salts, isomers, and salts of isomers is pos- EDITORIAL NOTE: For FEDERAL REGISTER ci- tations affecting § 1308.14, see the List of CFR sible: Sections Affected, which appears in the (1) Fenfluramine ...... 1670 Finding Aids section of the printed volume and at www.fdsys.gov. (e) Lorcaserin. Any material, compound, mixture, or preparation which § 1308.15 Schedule V. contains any quantity of the following substances, including its salts, isomers, (a) Schedule V shall consist of the and salts of such isomers, whenever the drugs and other substances, by what- existence of such salts, isomers, and ever official name, common or usual salts of isomers is possible: name, chemical name, or brand name designated, listed in this section. (1) Lorcaserin ...... 1625 (b) Narcotic drugs. Unless specifically (f) Stimulants. Unless specifically ex- excepted or unless listed in another cepted or unless listed in another schedule, any material, compound, schedule, any material, compound, mixture, or preparation containing any mixture, or preparation which contains of the following narcotic drugs and any quantity of the following sub- their salts, as set forth below: 124

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(1) [Reserved] (1) Brivaracetam ((2S)-2-[(4R)-2- (c) Narcotic drugs containing non-nar- oxo-4-propylpyrrolidin-1-yl] cotic active medicinal ingredients. Any butanamide) (also referred to compound, mixture, or preparation as BRV; UCB–34714; Briviact) containing any of the following nar- (including its salts) ...... 2710 cotic drugs, or their salts calculated as (2) Ezogabine [N-[2-amino-4-(4- the free anhydrous base or alkaloid, in fluorobenzylamino)-phenyl]- limited quantities as set forth below, carbamic acid ethyl ester] ...... 2779 which shall include one or more non- (3) Lacosamide [(R)-2- narcotic active medicinal ingredients acetoamido-N-benzyl-3- in sufficient proportion to confer upon methoxy-propionamide] ...... 2746 the compound, mixture, or preparation (4) Pregabalin [(S)-3- valuable medicinal qualities other than (aminomethyl)-5- those possessed by narcotic drugs methylhexanoic acid] ...... 2782 alone: (1) Not more than 200 milligrams of [39 FR 22143, June 20, 1974, as amended at 43 codeine per 100 milliliters or per 100 FR 38383, Aug. 28, 1978; 44 FR 40888, July 13, grams. 1979; 47 FR 49841, Nov. 3, 1982; 50 FR 8108, Feb. 28, 1985; 52 FR 5952, Feb. 27, 1987; 53 FR 10870, (2) Not more than 100 milligrams of Apr. 4, 1988; 56 FR 61372, Dec. 3, 1991; 67 FR dihydrocodeine per 100 milliliters or 62370, Oct. 7, 2002; 70 FR 43635, July 28, 2005; per 100 grams. 74 FR 23790, May 21, 2009; 76 FR 77899, Dec. 15, (3) Not more than 100 milligrams of 2011; 81 FR 29491, May 12, 2016] ethylmorphine per 100 milliliters or per 100 grams. EXCLUDED NONNARCOTIC SUBSTANCES (4) Not more than 2.5 milligrams of diphenoxylate and not less than 25 § 1308.21 Application for exclusion of a nonnarcotic substance. micrograms of atropine sulfate per dosage unit. (a) Any person seeking to have any (5) Not more than 100 milligrams of nonnarcotic drug that may, under the opium per 100 milliliters or per 100 Federal Food, Drug, and Cosmetic Act grams. (21 U.S.C. 301), be lawfully sold over the (6) Not more than 0.5 milligram of counter without a prescription, ex- difenoxin and not less than 25 cluded from any schedule, pursuant to micrograms of atropine sulfate per dos- section 201(g)(1) of the Act (21 U.S.C. age unit. 811(g)(1)), may apply to the Drug and (d) Stimulants. Unless specifically ex- Chemical Evaluation Section, Diver- empted or excluded or unless listed in sion Control Division, Drug Enforce- another schedule, any material, com- ment Administration. See the Table of pound, mixture, or preparation which DEA Mailing Addresses in § 1321.01 of contains any quantity of the following this chapter for the current mailing ad- substances having a stimulant effect dress. on the central nervous system, includ- (b) An application for an exclusion ing its salts, isomers and salts of iso- under this section shall contain the fol- mers: lowing information: (1) The name and address of the ap- (1) Pyrovalerone ...... 1485. plicant; (2) [Reserved]. (2) The name of the substance for (e) Depressants. Unless specifically which exclusion is sought; and exempted or excluded or unless listed (3) The complete quantitative com- in another schedule, any material, position of the substance. compound, mixture, or preparation (c) Within a reasonable period of which contains any quantity of the fol- time after the receipt of an application lowing substances having a depressant for an exclusion under this section, the effect on the central nervous system, including its salts:

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Administrator shall notify the appli- sion of law upon which the order is cant of his acceptance or nonaccept- based, the Administrator shall imme- ance of his application, and if not ac- diately suspend the effectiveness of the cepted, the reason therefore. The Ad- order until he may reconsider the ap- ministrator need not accept an applica- plication in light of the comments and tion for filing if any of the require- objections filed. Thereafter, the Ad- ments prescribed in paragraph (b) of ministrator shall reinstate, revoke, or this section is lacking or is not set amend his original order as he deter- forth as to be readily understood. If the mines appropriate. applicant desires, he may amend the (d) The Administrator may at any application to meet the requirements time revoke any exclusion granted pur- of paragraph (b) of this section. If the suant to section 201(g) of the Act (21 application is accepted for filing, the U.S.C. 811(g)) by following the proce- Administrator shall issue and publish dures set forth in paragraph (c) of this in the FEDERAL REGISTER his order on section for handling an application for the application, which shall include a an exclusion which has been accepted reference to the legal authority under for filing. which the order is issued and the find- [38 FR 8254, Mar. 30, 1973, as amended at 70 ings of fact and conclusions of law FR 74657, Dec. 16, 2005; 75 FR 10678, Mar. 9, upon which the order is based. This 2010; 81 FR 97021, Dec. 30, 2016] order shall specify the date on which it shall take effect. The Administrator § 1308.22 Excluded substances. shall permit any interested person to The following nonnarcotic substances file written comments on or objections which may, under the Federal Food, to the order within 60 days of the date Drug, and Cosmetic Act (21 U.S.C. 301), of publication of his order in the FED- be lawfully sold over the counter with- ERAL REGISTER. If any such comments out a prescription, are excluded from or objections raise significant issues all schedules pursuant to section 201(g) regarding any finding of fact or conclu- (1) of the Act (21 U.S.C. 811(g) (1)):

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 Propylhexedrine ...... 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]

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EXEMPT CHEMICAL PREPARATIONS (1) The name, address, and registration number, if any, of the applicant; § 1308.23 Exemption of certain chem- (2) The name, address, and registra- ical preparations; application. tion number, if any, of the manufac- (a) The Administrator may, by regu- turer or importer of the preparation or lation, exempt from the application of mixture, if not the applicant; all or any part of the Act any chemical (3) The exact trade name or other preparation or mixture containing one designation of the preparation or mix- or more controlled substances listed in ture; any schedule, which preparation or (4) The complete qualitative and mixture is intended for laboratory, industrial, educational, or special re- quantitative composition of the prepa- search purposes and not for general ad- ration or mixture (including all active ministration to a human being or other and inactive ingredients and all con- animal, if the preparation or mixture trolled and noncontrolled substances); either: (5) The form of the immediate con- (1) Contains no narcotic controlled tainer in which the preparation or mix- substance and is packaged in such a ture will be distributed with sufficient form or concentration that the pack- descriptive detail to identify the prepa- aged quantity does not present any sig- ration or mixture (e.g., bottle, packet, nificant potential for abuse (the type of vial, soft plastic pillow, agar gel plate, packaging and the history of abuse of etc.); the same or similar preparations may (6) The dimensions or capacity of the be considered in determining the po- immediate container of the prepara- tential for abuse of the preparation or tion or mixture; mixture); or (7) The label and labeling, as defined (2) Contains either a narcotic or non- in part 1300 of this chapter, of the im- narcotic controlled substance and one mediate container and the commercial or more adulterating or denaturing containers, if any, of the preparation agents in such a manner, combination, or mixture; quantity, proportion, or concentration, that the preparation or mixture does (8) A brief statement of the facts not present any potential for abuse. If which the applicant believes justify the the preparation or mixture contains a granting of an exemption under this narcotic controlled substance, the paragraph, including information on preparation or mixture must be formu- the use to which the preparation or lated in such a manner that it incor- mixture will be put; porates methods of denaturing or other (9) The date of the application; and means so that the preparation or mix- (10) Which of the information sub- ture is not liable to be abused or have mitted on the application, if any, is ill effects, if abused, and so that the deemed by the applicant to be a trade narcotic substance cannot in practice secret or otherwise confidential and en- be removed. titled to protection under subsection (b) Any person seeking to have any 402(a)(8) of the Act (21 U.S.C. 842(a) (8)) preparation or mixture containing a or any other law restricting public dis- controlled substance and one or more closure of information. noncontrolled substances exempted (d) The Administrator may require from the application of all or any part the applicant to submit such docu- of the Act, pursuant to paragraph (a) of ments or written statements of fact this section, may apply to the Drug relevant to the application as he deems and Chemical Evaluation Section, Di- version Control Division, Drug En- necessary to determine whether the ap- forcement Administration. See the plication should be granted. Table of DEA Mailing Addresses in (e) Within a reasonable period of § 1321.01 of this chapter for the current time after the receipt of an application mailing address. for an exemption under this section, (c) An application for an exemption under this section shall contain the following information:

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the Administrator shall notify the ap- § 1308.24 Exempt chemical prepara- plicant of his acceptance or nonaccept- tions. ance of his application, and if not ac- (a) The chemical preparations and cepted, the reason therefor. The Ad- mixtures approved pursuant to § 1308.23 ministrator need not accept an applica- are exempt from application of section for filing if any of the require- tions 302, 303, 305, 306, 307, 308, 309, 1002, ments prescribed in paragraph (c) or re- 1003 and 1004 of the Act (21 U.S.C. 822– quested pursuant to paragraph (d) is 823, 825–829, 952–954) and § 1301.74 of this lacking or is not set forth as to be chapter, to the extent described in readily understood. If the applicant de- paragraphs (b) to (h) of this section. sires, he may amend the application to Substances set forth in paragraph (j) of meet the requirements of paragraphs this section shall be exempt from the (c) and (d) of this section. If the appli- application of sections 305, 306, 307, 308, cation is accepted for filing, the Ad- 309, 1002, 1003 and 1004 of the Act (21 ministrator shall issue and publish in U.S.C. 825–829, 952–954) and §§ 1301.71– the FEDERAL REGISTER his order on the 1301.73 and 1301.74 (a), (b), (d), (e) and (f) application, which shall include a ref- of this chapter to the extent as herein- erence to the legal authority under after may be provided. which the order is based. This order (b) Registration and security: Any shall specify the date on which it shall person who manufactures an exempt take effect. The Administrator shall chemical preparation or mixture must permit any interested person to file be registered under the Act and comply written comments on or objections to with all relevant security requirements the order within 60 days of the date of regarding controlled substances being publication of his order in the FEDERAL used in the manufacturing process REGISTER. If any such comments or ob- until the preparation or mixture is in jections raise significant issues regard- the form described in paragraph (i) of ing any finding of fact or conclusion of this section. Any other person who law upon which the order is based, the handles an exempt chemical prepara- Administrator shall immediately sus- tion after it is in the form described in pend the effectiveness of the order paragraph (i) of this section is not re- until he may reconsider the application quired to be registered under the Act in light of the comments and objec- to handle that preparation, and the tions filed. Thereafter, the Adminis- preparation is not required to be stored trator shall reinstate, revoke, or in accordance with security require- amend his original order as he deter- ments regarding controlled substances. mines appropriate. (c) Labeling: In lieu of the require- (f) The Administrator may at any ments set forth in part 1302 of this time revoke or modify any exemption chapter, the label and the labeling of granted pursuant to this section by fol- an exempt chemical preparation must lowing the procedures set forth in para- be prominently marked with its full graph (e) of this section for handling an trade name or other description and application for an exemption which has the name of the manufacturer or sup- been accepted for filing. The Adminis- plier as set forth in paragraph (i) of trator may also modify or revoke the this section, in such a way that the criteria by which exemptions are product can be readily identified as an granted (and thereby modify or revoke exempt chemical preparation. The all preparations and mixtures granted label and labeling must also include in under the old criteria) and modify the a prominent manner the statement scope of exemptions at any time. ‘‘For industrial use only’’ or ‘‘For chemical use only’’ or ‘‘For in vitro use [38 FR 8254, Mar. 30, 1973. Redesignated at 38 only—not for human or animal use’’ or FR 26609, Sept. 24, 1973, and amended at 46 ‘‘Diagnostic reagent—for professional FR 28841, May 29, 1981; 62 FR 13968, Mar. 24, use only’’ or a comparable statement 1997; 75 FR 10678, Mar. 9, 2010; 81 FR 97021, warning the person reading it that Dec. 30, 2016] human or animal use is not intended. The symbol designating the schedule of

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the controlled substance is not re- trolled substances contained in the ex- quired on either the label or the label- empt chemical preparation. Distribu- ing of the exempt chemical preparation, possession, and use of an exempt tion, nor is it necessary to list all in- chemical preparation are lawful for gredients of the preparation. registrants and nonregistrants only as (d) Records and reports: Any person long as such distribution, possession, who manufactures an exempt chemical or use is intended for laboratory, in- preparation or mixture must keep com- dustrial, or educational purposes and plete and accurate records and file all not for immediate or subsequent ad- reports required under part 1304 of this ministration to a human being or other chapter regarding all controlled sub- animal. stances being used in the manufac- (g) Bulk materials: For materials ex- turing process until the preparation or mixture is in the form described in empted in bulk quantities, the Admin- paragraph (i) of this section. In lieu of istrator may prescribe requirements records and reports required under part other than those set forth in para- 1304 of this chapter regarding exempt graphs (b) through (e) of this section on chemical preparations, the manufac- a case-by-case basis. turer need only record the name, ad- (h) Changes in chemical preparations: dress, and registration number, if any, Any change in the quantitative or of each person to whom the manufac- qualitative composition of the prepara- turer distributes any exempt chemical tion or mixture after the date of appli- preparation. Each importer or exporter cation, or change in the trade name or of an exempt narcotic chemical prepa- other designation of the preparation or ration must submit a semiannual re- mixture, set forth in paragraph (i) of port of the total quantity of each sub- this section, requires a new application stance imported or exported in each for exemption. calendar half-year within 30 days of the (i) A listing of exempt chemical prep- close of the period to the Drug and arations may be obtained by submit- Chemical Evaluation Section, Drug En- ting a written request to the Drug and forcement Administration. See the Chemical Evaluation Section, Drug En- Table of DEA Mailing Addresses in forcement Administration. See the § 1321.01 of this chapter for the current Table of DEA Mailing Addresses in mailing address. Any other person who § 1321.01 of this chapter for the current handles an exempt chemical preparation after it is in the form described in mailing address. paragraph (i) of this section is not re- (j) The following substances are des- quired to maintain records or file re- ignated as exempt chemical prepara- ports. tions for the purposes set forth in this (e) Quotas, order forms, prescrip- section. tions, import, export, and trans- (1) Chloral. When packaged in a shipment requirements: Once an ex- sealed, oxygen-free environment, under empt chemical preparation is in the nitrogen pressure, safeguarded against form described in paragraph (i) of this exposure to the air. section, the requirements regarding (2) EmitR Phenobarbital Enzyme Rea- quotas, order forms, prescriptions, im- gent B. In one liter quantities each port permits and declarations, export with a 5 ml. retention sample for re- permit and declarations, and trans- packaging as an exempt chemical prep- shipment and intransit permits and aration only. declarations do not apply. These requirements do apply, however, to any [38 FR 8255, Mar. 30, 1973] controlled substances used in manufac- EDITORIAL NOTE: For FEDERAL REGISTER ci- turing the exempt chemical prepara- tations affecting § 1308.24, see the List of CFR tion before it is in the form described Sections Affected, which appears in the in paragraph (i) of this section. Finding Aids section of the printed volume (f) Criminal penalties: No exemption and at www.fdsys.gov. granted pursuant to § 1308.23 affects the criminal liability for illegal manufacture, distribution, or possession of con-

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EXCLUDED VETERINARY ANABOLIC Administrator shall notify the appli- STEROID IMPLANT PRODUCTS cant of his acceptance or nonaccept- ance of the application, and if not ac- § 1308.25 Exclusion of a veterinary an- cepted, the reason therefore. The Ad- abolic steroid implant product; ap- ministrator need not accept an applica- plication. tion for filing if any of the require- (a) Any person seeking to have any ments prescribed in paragraph (b) of anabolic steroid product, which is ex- this section is lacking or is not set pressly intended for administration forth as to be readily understood. The through implants to cattle or other applicant may amend the application nonhuman species and which has been to meet the requirements of paragraph approved by the Secretary of Health (b) of this section. If the application is and Human Services for such adminis- accepted for filing, the Administrator tration, identified as being excluded shall issue and have published in the from any schedule, pursuant to section FEDERAL REGISTER his order on the ap- 102(41)(B)(i) of the Act (21 U.S.C. plication, which shall include a ref- 802(41)(B)(i)), may apply to the Drug erence to the legal authority under and Chemical Evaluation Section, Di- which the order is issued and the find- version Control Division, Drug En- ings of fact and conclusions of law forcement Administration . See the upon which the order is based. This Table of DEA Mailing Addresses in order shall specify the date on which it § 1321.01 of this chapter for the current will take effect. The Administrator mailing address. shall permit any interested person to (b) An application for any exclusion file written comments on or objections under this section shall be submitted to the order within 60 days of the date in triplicate and contain the following of publication in the FEDERAL REG- information: ISTER. If any such comments or objec- (1) The name and address of the ap- tions raise significant issues regarding plicant; any finding of fact or conclusion of law (2) The name of the product; upon which the order is based, the Ad- (3) The chemical structural formula ministrator shall immediately suspend or description for any anabolic steroid the effectiveness of the order until he contained in the product; may reconsider the application in light (4) A complete description of dosage of the comments and objections filed. and quantitative composition of the Thereafter, the Administrator shall re- dosage form;. instate, revoke, or amend his original (5) The conditions of use including order as he determines appropriate. whether or not Federal law restricts (d) The Administrator may at any this product to use by or on the order time revoke or modify any designation of a licensed veterinarian; of excluded status granted pursuant to (6) A description of the delivery sys- this section by following the proce- tem in which the dosage form will be dures set forth in paragraph (c) of this distributed with sufficient detail to section for handling an application for identify the product (e.g. 20 cartridge an exclusion which has been accepted brown plastic belt); for filing. (7) The label and labeling of the im- [56 FR 42936, Aug. 30, 1991, as amended at 75 mediate container and the commercial FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, containers, if any, of the product;. 2016] (8) The name and address of the manufacturer of the dosage form if dif- § 1308.26 Excluded veterinary anabolic ferent from that of the applicant; and steroid implant products. (9) Evidence that the product has (a) Products containing an anabolic been approved by the Secretary of steroid, that are expressly intended for Health and Human Services for admin- administration through implants to istration through implant to cattle or cattle or other nonhuman species and other nonhuman species. which have been approved by the Sec- (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

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102(41)(B)(i) of the Act (21 U.S.C. (4) Details of synergisms and antag- 802(41)(B)(i)). A listing of the excluded onisms among ingredients. products may be obtained by submit- (5) Deterrent effects of the noncon- ting a written request to the Drug and trolled ingredients. Chemical Evaluation Section, Drug En- (6) Complete copies of all literature forcement Administration. See the in support of claims. Table of DEA Mailing Addresses in (7) Reported instances of abuse. § 1321.01 of this chapter for the current (8) Reported and anticipated adverse mailing address. effects. (b) In accordance with section (9) Number of dosage units produced 102(41)(B)(ii) of the Act (21 U.S.C. for the past 2 years. 802(41)(B)(ii)) if any person prescribes, (c) Within a reasonable period of dispenses, or distributes a product list- time after the receipt of an application ed in paragraph (a) of this section for for an exemption under this section, human use, such person shall be con- the Administrator shall notify the ap- sidered to have prescribed, dispensed, plicant of his acceptance or non-ac- or distributed an anabolic steroid with- ceptance of the application, and if not in the meaning of section 102(41)(A) of accepted, the reason therefor. The Ad- the Act (21 U.S.C. 802(41)(A)). ministrator need not accept an application for filing if any of the require- [56 FR 42936, Aug. 30, 1991, as amended at 57 ments prescribed in paragraph (b) of FR 19534, May 7, 1992; 58 FR 15088, Mar. 19, this section is lacking or is not set 1993; 62 FR 13967, Mar. 24, 1997; 75 FR 10679, forth so as to be readily understood. If Mar. 9, 2010] the applicant desires, he may amend the application to meet the require- EXEMPTED PRESCRIPTION PRODUCTS ments of paragraph (b) of this section. § 1308.31 Application for exemption of If accepted for filing, the Adminis- a nonnarcotic prescription product. trator shall publish in the FEDERAL REGISTER general notice of this pro- (a) Any person seeking to have any posed rulemaking in granting or deny- compound, mixture, or preparation ing the application. Such notice shall containing any nonnarcotic controlled include a reference to the legal author- substance listed in § 1308.12(e), or in ity under which the rule is proposed, a § 1308.13(b) or (c), or in § 1308.14, or in statement of the proposed rule grant- § 1308.15, exempted from application of ing or denying an exemption, and, in all or any part of the Act pursuant to the discretion of the Administrator, a section 201(g)(3)(A), of the Act (21 summary of the subjects and issues in- U.S.C. 811(g)(3)(A)) may apply to the volved. The Administrator shall permit Drug and Chemical Evaluation Section, any interested person to file written Diversion Control Division, Drug En- comments on or objections to the pro- forcement Administration. See the posal and shall designate in the notice Table of DEA Mailing Addresses in of proposed rule making the time dur- § 1321.01 of this chapter for the current ing which such filings may be made. mailing address. After consideration of the application (b) An application for an exemption and any comments on or objections to under this section shall contain the fol- his proposed rulemaking, the Adminis- lowing information: trator shall issue and publish in the (1) The complete quantitative com- FEDERAL REGISTER his final order on position of the dosage form. the application, which shall set forth (2) Description of the unit dosage the findings of fact and conclusions of form together with complete labeling. law upon which the order is based. This (3) A summary of the pharmacology order shall specify the date on which it of the product including animal inves- shall take effect, which shall not be tigations and clinical evaluations and less than 30 days from the date of pub- studies, with emphasis on the psychic lication in the FEDERAL REGISTER un- and/or physiological dependence liabil- less the Administrator finds that con- ity (this must be done for each of the ditions of public health or safety neces- active ingredients separately and for sitate an earlier effective date, in the combination product). which event the Administrator shall

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specify in the order his findings as to tion, exempt from the application of such conditions. all or any part of the Act any com- (d) The Administrator may revoke pound, mixture, or preparation con- any exemption granted pursuant to taining an anabolic steroid as defined section 201(g)(3)(A) of the Act (21 U.S.C. in part 1300 of this chapter, which is in- 811(g)(3)(A)) by following the proce- tended for administration to a human dures set forth in paragraph (c) of this being or animal, if, because of its con- section for handling an application for centration, preparation, formulation, an exemption which has been accepted or delivery system, it has no signifi- for filing. cant potential for abuse. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 (b) Any person seeking to have any FR 26609, Sept. 24, 1973, as amended at 44 FR compound, mixture, or preparation 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987; containing an anabolic steroid as de- 75 FR 10679, Mar. 9, 2010; 81 FR 97021, Dec. 30, fined in part 1300 of this chapter ex- 2016] empted from the application of all or § 1308.32 Exempted prescription prod- any part of the Act, pursuant to para- ucts. graph (a) of this section, may apply to The compounds, mixtures, or prep- the Drug and Chemical Evaluation Sec- arations that contain a nonnarcotic tion, Diversion Control Division, Drug controlled substance listed in Enforcement Administration. See the § 1308.12(e) or in § 1308.13(b) or (c) or in Table of DEA Mailing Addresses in § 1308.14 or in § 1308.15 listed in the § 1321.01 of this chapter for the current Table of Exempted Prescription Prod- mailing address. ucts have been exempted by the Ad- (c) An application for an exemption ministrator from the application of under this section shall be submitted sections 302 through 305, 307 through in triplicate and contain the following 309, and 1002 through 1004 of the Act (21 information: U.S.C. 822–825, 827–829, and 952–954) and (1) The name and address of the ap- §§ 1301.13, 1301.22, and §§ 1301.71 through plicant; 1301.76 of this chapter for administra- (2) The name of the product; tive purposes only. An exception to the (3) The chemical structural formula above is that those products containing or description for any anabolic steroid butalbital shall not be exempt from the contained in the product; requirement of 21 U.S.C. 952–954 con- (4) The complete description of dos- cerning importation, exportation, age and quantitative composition of transshipment and in-transit shipment the dosage form; of controlled substances. Any deviation (5) A description of the delivery sys- from the quantitative composition of tem, if applicable; any of the listed drugs shall require a (6) The indications and conditions for petition of exemption in order for the use in which species, including whether product to be exempted. A listing of or not this product is a prescription the Exempted Prescription Products drug; may be obtained by submitting a written request to the Drug and Chemical (7) Information to facilitate identi- Evaluation Section, Drug Enforcement fication of the dosage form, such as Administration. See the Table of DEA shape, color, coating, and scoring; Mailing Addresses in § 1321.01 of this (8) The label and labeling of the im- chapter for the current mailing ad- mediate container and the commercial dress. containers, if any, of the product; (9) The units in which the dosage [75 FR 10679, Mar. 9, 2010] form is ordinarily available; and EXEMPT ANABOLIC STEROID PRODUCTS (10) The facts which the applicant believes justify: § 1308.33 Exemption of certain ana- (i) A determination that the product bolic steroid products; application. has no significant potential for abuse (a) The Administrator, upon the rec- and ommendation of Secretary of Health (ii) a granting of an exemption under and Human Services, may, by regula- this section.

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(d) Within a reasonable period of dling an application for an exemption time after the receipt of the applica- which has been accepted for filing. tion for an exemption under this sec- [56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. tion, the Administrator shall notify 31, 1992, as amended at 62 FR 13968, Mar. 24, the applicant of his acceptance or non- 1997; 70 FR 74657, Dec. 16, 2005; 75 FR 10679, acceptance of the application, and if Mar. 9, 2010; 81 FR 97021, Dec. 30, 2016] not accepted, the reason therefor. The Administrator need not accept an ap- § 1308.34 Exempt anabolic steroid plication for filing if any of the re- products. quirements prescribed in paragraph (c) The list of compounds, mixtures, or of this section is lacking or is not set preparations that contain an anabolic forth so as to be readily understood. steroid that have been exempted by the The applicant may amend the applica- Administrator from application of section to meet the requirements of para- tions 302 through 309 and 1002 through graph (c) of this section. If accepted for 1004 of the Act (21 U.S.C. 822–829 and filing, the Administrator will request 952–954) and §§ 1301.13, 1301.22, and from the Secretary for Health and 1301.71 through 1301.76 of this chapter Human Services his recommendation, for administrative purposes only may as to whether such product which con- be obtained by submitting a written re- tains an anabolic steroid should be con- quest to the Drug and Chemical Eval- sidered for exemption from certain por- uation Section, Drug Enforcement Ad- tions of the Controlled Substances Act. ministration. See the Table of DEA On receipt of the recommendation of Mailing Addresses in § 1321.01 of this the Secretary, the Administrator shall chapter for the current mailing ad- make a determination as to whether dress. the evidence submitted or otherwise available sufficiently establishes that [75 FR 10679, Mar. 9, 2010] the product possesses no significant potential for abuse. The Administrator EXEMPT CANNABIS PLANT MATERIAL, shall issue and publish in the FEDERAL AND PRODUCTS MADE THEREFROM, REGISTER his order on the application, THAT CONTAIN which shall include a reference to the TETRAHYDROCANNABINOLS legal authority under which the order is issued, and the findings of fact and § 1308.35 Exemption of certain can- conclusions of law upon which the nabis plant material, and products made therefrom, that contain order is based. This order shall specify tetrahydrocannabinols. the date on which it will take effect. The Administrator shall permit any in- (a) Any processed plant material or terested person to file written com- animal feed mixture containing any ments on or objections to the order amount of tetrahydrocannabinols within 60 days of the date of publica- (THC) that is both: tion of his order in the FEDERAL REG- (1) Made from any portion of a plant ISTER. If any such comments or objec- of the genus Cannabis excluded from tions raise significant issues regarding the definition of marijuana under the any finding of fact or conclusion of law Act [i.e., the mature stalks of such upon which the order is based, the Ad- plant, fiber produced from such stalks, ministrator shall immediately suspend oil or cake made from the seeds of such the effectiveness of the order until he plant, any other compound, manufac- may reconsider the application in light ture, salt, derivative, mixture, or prep- of the comments and objections filed. aration of such mature stalks (except Thereafter, the Administrator shall re- the resin extracted therefrom), fiber, instate, revoke, or amend his original oil, or cake, or the sterilized seed of order as he determines appropriate. such plant which is incapable of germi- (e) The Administrator may revoke nation] and any exemption granted pursuant to (2) Not used, or intended for use, for section 1903(a) of Public Law 101–647 by human consumption, has been exempt- following the procedures set forth in ed by the Administrator from the ap- paragraph (d) of this section for han- plication of the Act and this chapter.

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(b) As used in this section, the fol- to section 201 of the Act, the proce- lowing terms shall have the meanings dures for such hearing and accom- specified: panying proceedings shall be governed (1) The term processed plant material generally by the rulemaking proce- means cannabis plant material that dures set forth in the Administrative has been subject to industrial proc- Procedure Act (5 U.S.C. 551–559) and esses, or mixed with other ingredients, specifically by section 201 of the Act (21 such that it cannot readily be con- U.S.C. 811), by §§ 1308.42–1308.51, and by verted into any form that can be used §§ 1316.41–1316.67 of this chapter. for human consumption. (2) The term animal feed mixture § 1308.42 Purpose of hearing. means sterilized cannabis seeds mixed If requested by any interested person with other ingredients (not derived after proceedings are initiated pursu- from the cannabis plant) in a formula- ant to § 1308.43, the Administrator shall tion that is designed, marketed, and hold a hearing for the purpose of re- distributed for animal consumption ceiving factual evidence and expert (and not for human consumption). opinion regarding the issues involved (3) The term used for human consump- in the issuance, amendment or repeal tion means either: of a rule issuable pursuant to section (i) Ingested orally or 201(a) of the Act (21 U.S.C. 811(a)). Ex- (ii) Applied by any means such that tensive argument should not be offered THC enters the human body. into evidence but rather presented in (4) The term intended for use for opening or closing statements of coun- human consumption means any of the sel or in memoranda or proposed find- following: ings of fact and conclusions of law. Ad- (i) Designed by the manufacturer for ditional information relating to hear- human consumption; ings to include waivers or modification (ii) Marketed for human consump- of rules, request for hearing, burden of tion; or proof, time and place, and final order (iii) Distributed, exported, or im- are set forth in part 1316 of this chap- ported, with the intent that it be used ter. for human consumption. (c) In any proceeding arising under [62 FR 13968, Mar. 24, 1997] the Act or this chapter, the burden of going forward with the evidence that a § 1308.43 Initiation of proceedings for material, compound, mixture, or prepa- rulemaking. ration containing THC is exempt from (a) Any interested person may sub- control pursuant to this section shall mit a petition to initiate proceedings be upon the person claiming such ex- for the issuance, amendment, or repeal emption, as set forth in section of any rule or regulation issuable pur- 515(a)(1) of the Act (21 U.S.C. 885(a)(1)). suant to the provisions of section 201 of In order to meet this burden with re- the Act. spect to a product or plant material (b) Petitions shall be submitted in that has not been expressly exempted quintuplicate to the Administrator. from control by the Administrator pur- See the Table of DEA Mailing Address- suant to § 1308.23, the person claiming es in § 1321.01 of this chapter for the the exemption must present rigorous current mailing address. Petitions scientific evidence, including well-doc- shall be in the following form: umented scientific studies by experts trained and qualified to evaluate the llllllllll (Date) effects of drugs on humans. Administrator, Drug Enforcement Adminis- tration llllll (Mailing Address) [66 FR 51544, Oct. 9, 2001] Dear Sir: The undersigned llllllll HEARINGS hereby petitions the Administrator to initiate proceedings for the issuance (amend- § 1308.41 Hearings generally. ment or repeal) of a rule or regulation pursuant to section 201 of the Controlled Sub- In any case where the Administrator stances Act. shall hold a hearing on the issuance, Attached hereto and constituting a part of amendment, or repeal of rules pursuant this petition are the following:

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(A) The proposed rule in the form proposed other substance not be controlled, the by the petitioner. (If the petitioner seeks the Administrator shall not control that amendment or repeal of an existing rule, the drug or other substance. existing rule, together with a reference to (e) If the Administrator determines the section in the Code of Federal Regula- tions where it appears, should be included.) that the scientific and medical evalua- (B) A statement of the grounds which the tion and recommendations of the Sec- petitioner relies for the issuance (amend- retary and all other relevant data con- ment or repeal) of the rule. (Such grounds stitute substantial evidence of poten- shall include a reasonably concise statement tial for abuse such as to warrant con- of the facts relied upon by the petitioner, in- trol or additional control over the drug cluding a summary of any relevant medical or other substance, or substantial evi- or scientific evidence known to the peti- dence that the drug or other sub- tioner.) All notices to be sent regarding this peti- stances should be subjected to lesser tion should be addressed to: control or removed entirely from the llllllllll (Name) schedules, he shall initiate proceedings llllllllll (Street Address) for control, transfer, or removal as the llllllllll (City and State) case may be. Respectfully yours, (f) If and when the Administrator de- llllllllll (Signature of petitioner) termines to initiate proceedings, he (c) Within a reasonable period of shall publish in the FEDERAL REGISTER time after the receipt of a petition, the general notice of any proposed rule Administrator shall notify the peti- making to issue, amend, or repeal any tioner of his acceptance or nonaccept- rule pursuant to section 201 of the Act. ance of the petition, and if not accept- Such published notice shall include a ed, the reason therefor. The Adminis- statement of the time, place, and na- trator need not accept a petition for ture of any hearings on the proposal in filing if any of the requirements pre- the event a hearing is requested pursu- scribed in paragraph (b) of this section ant to § 1308.44. Such hearings may not is lacking or is not set forth so as to be be commenced until after the expira- readily understood. If the petitioner tion of at least 30 days from the date desires, he may amend the petition to the general notice is published in the meet the requirements of paragraph (b) FEDERAL REGISTER. Such published no- of this section. If accepted for filing, a tice shall also include a reference to petition may be denied by the Adminis- the legal authority under which the trator within a reasonable period of rule is proposed, a statement of the time thereafter if he finds the grounds proposed rule, and, in the discretion of upon which the petitioner relies are the Administrator, a summary of the not sufficient to justify the initiation subjects and issues involved. of proceedings. (g) The Administrator may permit (d) The Administrator shall, before any interested persons to file written initiating proceedings for the issuance, comments on or objections to the pro- amendment, or repeal of any rule ei- posal and shall designate in the notice ther to control a drug or other sub- of proposed rule making the time dur- stance, or to transfer a drug or other ing which such filings may be made. substance from one schedule to an- [38 FR 8254, Mar. 30, 1973. Redesignated at 38 other, or to remove a drug or other FR 26609, Sept. 24, 1973, and further redesig- substance entirely from the schedules, nated and amended at 62 FR 13968, Mar. 24, and after gathering the necessary data, 1997; 75 FR 10679, Mar. 9, 2010] request from the Secretary a scientific and medical evaluation and the Sec- § 1308.44 Request for hearing or ap- retary’s recommendations as to wheth- pearance; waiver. er such drug or other substance should (a) Any interested person desiring a be so controlled, transferred, or re- hearing on a proposed rulemaking, moved as a controlled substance. The shall, within 30 days after the date of 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.

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(b) Any interested person desiring to from the date of publication in the participate in a hearing pursuant to FEDERAL REGISTER unless the Adminis- § 1308.41 shall, within 30 days after the trator finds that conditions of public date of publication of the notice of health or safety necessitate an earlier hearing in the FEDERAL REGISTER, file effective date, in which event the Ad- with the Administrator a written no- ministrator shall specify in the order tice of his intention to participate in his findings as to such conditions. such hearing in the form prescribed in [38 FR 8254, Mar. 30, 1973. Redesignated at 38 § 1316.48 of this chapter. Any person fil- FR 26609, Sept. 24, 1973, and further redesig- ing a request for a hearing need not nated at 62 FR 13968, Mar. 24, 1997] also file a notice of appearance; the request for a hearing shall be deemed to § 1308.46 Control required under inter- be a notice of appearance. national treaty. (c) Any interested person may, with- Pursuant to section 201(d) of the Act in the period permitted for filing a re- (21 U.S.C. 811(d)), where control of a quest for a hearing, file with the Ad- substance is required by U.S. obliga- ministrator a waiver of an opportunity tions under international treaties, con- for a hearing or to participate in a ventions, or protocols in effect on May hearing, together with a written state- 1, 1971, the Administrator shall issue ment regarding his position on the and publish in the FEDERAL REGISTER matters of fact and law involved in an order controlling such substance such hearing. Such statement, if ad- under the schedule he deems most ap- missible, shall be made a part of the propriate to carry out obligations. record and shall be considered in light Issuance of such an order shall be with- of the lack of opportunity for cross-ex- out regard to the findings required by amination in determining the weight subsections 201(a) or 202(b) of the Act to be attached to matters of fact as- (21 U.S.C. 811(a) or 812(b)) and without serted therein. regard to the procedures prescribed by (d) If any interested person fails to § 1308.41 or subsections 201 (a) and (b) of file a request for a hearing; or if he so the Act (21 U.S.C. 811 (a) and (b)). An files and fails to appear at the hearing, order controlling a substance shall be- he shall be deemed to have waived his come effective 30 days from the date of opportunity for the hearing or to par- publication in the FEDERAL REGISTER, ticipate in the hearing, unless he shows unless the Administrator finds that good cause for such failure. conditions of public health or safety (e) If all interested persons waive or necessitate an earlier effective date, in are deemed to waive their opportunity which event the Administrator shall for the hearing or to participate in the specify in the order his findings as to hearing, the Administrator may cancel such conditions. the hearing, if scheduled, and issue his [38 FR 8254, Mar. 30, 1973. Redesignated at 38 final order pursuant to § 1308.45 without FR 26609, Sept. 24, 1973, and further redesig- a hearing. nated at 62 FR 13968, Mar. 24, 1997] [38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, and further redesig- § 1308.47 Control of immediate precur- nated and amended at 62 FR 13968, Mar. 24, sors. 1997] Pursuant to section 201(e) of the Act (21 U.S.C. 811(e)), the Administrator § 1308.45 Final order. may, without regard to the findings re- As soon as practicable after the pre- quired by subsection 201(a) or 202 (b) of siding officer has certified the record the Act (21 U.S.C. 811(a) or 812(b)) and to the Administrator, the Adminis- without regard to the procedures pre- trator shall cause to be published in scribed by § 1308.41 or subsections 201 the FEDERAL REGISTER his order in the (a) and (b) of the Act (21 U.S.C. 811(a) proceeding, which shall set forth the and (b)), issue and publish in the FED- 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

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which the controlled substance of PART 1309—REGISTRATION OF which it is an immediate precursor is MANUFACTURERS, DISTRIBUTORS, placed or any other schedule with a IMPORTERS AND EXPORTERS OF higher numerical designation. An order LIST I CHEMICALS controlling an immediate precursor shall become effective 30 days from the GENERAL INFORMATION date of publication in the FEDERAL REGISTER, unless the Administrator Sec. finds that conditions of public health 1309.01 Scope of part 1309. or safety necessitate an earlier effec- 1309.02 Definitions. tive date, in which event the Adminis- 1309.03 Information; special instructions. trator shall specify in the order his FEES FOR REGISTRATION AND REREGISTRATION findings as to such conditions. 1309.11 Fee amounts. [38 FR 8254, Mar. 30, 1973. Redesignated at 38 1309.12 Time and method of payment; re- FR 26609, Sept. 24, 1973, and further redesig- fund. nated at 62 FR 13968, Mar. 24, 1997] REQUIREMENTS FOR REGISTRATION § 1308.49 Temporary scheduling. 1309.21 Persons required to register. (a) Pursuant to 21 U.S.C. 811(h) and 1309.22 Separate registration for inde- pendent activities. without regard to the requirements of 1309.23 Separate registration for separate 21 U.S.C. 811(b) relating to the sci- locations. entific and medical evaluation of the 1309.24 Waiver of registration requirement Secretary of Health and Human Serv- for certain activities. ices, the Drug Enforcement Adminis- 1309.25 Temporary exemption from registra- tration may place a substance into tion for chemical registration applicants. Schedule I on a temporary basis, if it 1309.26 Exemption of law enforcement offi- determines that such action is nec- cials. essary to avoid an imminent hazard to APPLICATION FOR REGISTRATION the public safety. An order issued 1309.31 Time for application for registra- under this section may not be effective tion; expiration date. before the expiration of 30 calendar 1309.32 Application forms; contents, signa- days from: ture. (1) The date of publication by the Ad- 1309.33 Filing of application; joint filings. ministration of a notice in the FED- 1309.34 Acceptance for filing; defective ap- ERAL REGISTER of its intention to issue plications. such order and the grounds upon which 1309.35 Additional information. such order is to be issued; and 1309.36 Amendments to and withdrawals of applications. (2) The date the Administration has transmitted notification to the Sec- ACTION ON APPLICATIONS FOR REGISTRATION: retary of Health and Human Services REVOCATION OR SUSPENSION OF REGISTRATION of the Administration’s intention to 1309.41 Administrative review generally. issue such order. 1309.42 Certificate of registration; denial of (b) An order issued under this section registration. will be vacated upon the conclusion of 1309.43 Suspension or revocation of registra- a subsequent rulemaking proceeding tion. 1309.44 Suspension of registration pending initiated under section 201(a) (21 U.S.C. final order. 811(a)) with respect to such substance 1309.45 Extension of registration pending or at the end of two years from the ef- final order. fective date of the order scheduling the 1309.46 Order to show cause. substance, except that during the pend- ency of proceedings under section HEARINGS 201(a) (21 U.S.C. 811(a)) with respect to 1309.51 Hearings generally. the substance, the Administration may 1309.52 Purpose of hearing. extend the temporary scheduling for up 1309.53 Request for hearing or appearance; to one year. waiver. 1309.54 Burden of proof. [81 FR 97021, Dec. 30, 2016] 1309.55 Time and place of hearing.

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