Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

Federal Register, Volume 83 Issue 228 (Tuesday, November 27, 2018)

Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)

Notices

Pages 60900-60903

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2018-25865

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Docket No. DEA-392

Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before January 28, 2019.

ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R.

In accordance with 21 CFR 1301.33(a), this is notice that on July 25, 2018, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer for the basic classes of controlled substances:

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Controlled substance Drug code Schedule

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3-Fluoro-N-methylcathinone (3- 1233 I

FMC).

Cathinone........................ 1235 I

Methcathinone.................... 1237 I

4-Fluoro-N-methylcathinone (4- 1238 I

FMC).

Page 60901

Pentedrone (alpha- 1246 I

methylaminovalerophenone).

Mephedrone (4-Methyl-N- 1248 I

methylcathinone).

4-Methyl-N-ethylcathinone (4-MEC) 1249 I

Naphyrone........................ 1258 I

N-Ethylamphetamine............... 1475 I

N,N-Dimethylamphetamine.......... 1480 I

Fenethylline..................... 1503 I

Aminorex......................... 1585 I

4-Methylaminorex (cis isomer).... 1590 I

Gamma Hydroxybutyric Acid........ 2010 I

Methaqualone..................... 2565 I

Mecloqualone..................... 2572 I

JWH-250 (1-Pentyl-3-(2- 6250 I

methoxyphenylacetyl) indole).

SR-18 (Also known as RCS-8) (1- 7008 I

Cyclohexylethyl-3-(2-

methoxyphenylacetyl) indole).

ADB-FUBINACA (N-(1-amino-3,3- 7010 I

dimethyl-1-oxobutan-2-yl)-1-(4-

fluorobenzyl)-1H-indazole-3-

carboxamide).

5-Fluoro-UR-144 and XLR11 1-(5- 7011 I

Fluoro-pentyl)1H-indol-3-

yl(2,2,3,3-

tetramethylcyclopropyl)methanone.

AB-FUBINACA (N-(1-amino-3-methyl- 7012 I

1-oxobutan-2-yl)-1-(4-

fluorobenzyl)-1H-indazole-3-

carboxamide).

JWH-019 (1-Hexyl-3-(1- 7019 I

naphthoyl)indole).

MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I

fluorobenzyl)-1H-indazole-3-

carboxamido)-3,3-

dimethylbutanoate).

2-(1-(4-fluorobenzyl)-1Hinsazole- 7021 I

3-carboxamido)-3-methylbutanoate.

AB-PINACA (N-(1-amino-3-methyl-1- 7023 I

oxobutan-2-yl)-1-pentyl-1H-

indazole-3-carboxamide).

THJ-2201 1-(5-fluoropentyl)-1H- 7024 I

indazol-3-yl(naphthalen-1-

yl)methanone.

5F-AB-PINACA (N-(1-amino-3-methyl- 7025 I

1-oxobutan-2yl)-1-(5-

fluoropentyl)-1 H-indazole-3-

carboxamide).

AB-CHMINACA (N-(1-amino-3-methyl- 7031 I

1-oxobutan-2-yl)-1-

(cyclohexylmethyl)-1H-indazole-3-

carboxamide.

MAB-CHMINACA (N-(1-amino- 7032 I

3,3dimethyl-1-oxobutan-2-yl)-1-

(cyclohexylmethyl)-1H-indazole-3-

carboxamide).

5F-AMB (Methyl 2-(1-(5- 7033 I

fluoropentyl)-1H-indazole-3-

carboxamido)-3-methylbutanoate).

5F-ADB; 5F-MDMB-PINACA (Methyl 2- 7034 I

(1-(5-fluoropentyl)-1H-indazole-

3-carboxamido)-3,3-

dimethylbutanoate).

ADB-PINACA (N-(1-amino-3,3- 7035 I

dimethyl-1-oxobutan-2-yl)-1-

pentyl-1H-indazole-3-

carboxamide).

MDMB-CHMICA, MMB-CHMINACA (Methyl 7042 I

2-(1-(cyclohexylmethyl)-1H-

indole-3-carboxamido)-3,3-

dimethylbutanoate).

MMB-CHMICA, AMB-CHMICA (methyl 2- 7044 I

(1(cyclohexylmethyl)-1 H-indole-

3-carboxamido)-3methylbutanoate).

APINACA and AKB48 N-(1-Adamantyl)- 7048 I

1-pentyl-1H-indazole-3-

carboxamide.

5F-APINACA, 5F-AKB48 (N- 7049 I

(adamantan-1-yl)-1-(5-

fluoropentyl)-1H-indazole-3-

carboxamide).

JWH-081 (1-Pentyl-3-(1-(4- 7081 I

methoxynaphthoyl) indole).

5F-CUMYL-P7AICA (1-(5- 7085 I

fluoropentyl)-N-(2phenylpropan-2-

yl)-1 H-pyrrolo2,3-bpyridine-

3carboxamide).

4-CN-CUMYL-BUTINACA (1-(4- 7089 I

cyanobutyl)-N-(2phenylpropan-2-

yl)-1 H-indazole-3-carboxamide).

SR-19 (Also known as RCS-4) (1- 7104 I

Pentyl-3-(4-methoxy)-benzoyl

indole.

JWH-018 (also known as AM678) (1- 7118 I

Pentyl-3-(1-naphthoyl)indole).

JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I

naphthoyl) indole).

UR-144 (1-Pentyl-1H-indol-3- 7144 I

yl)(2,2,3,3-

tetramethylcyclopropyl)methanone.

JWH-073 (1-Butyl-3-(1- 7173 I

naphthoyl)indole).

JWH-200 (1-2-(4- 7200 I

Morpholinyl)ethyl-3-(1-

naphthoyl)indole).

AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I

naphthoyl) indole).

JWH-203 (1-Pentyl-3-(2- 7203 I

chlorophenylacetyl) indole).

NM2201; CBL2201 (Naphthalen-1-yl 7221 I

1-(5-fluoropentyl)1 H-indole-3-

carboxylate).

PB-22 (Quinolin-8-yl 1-pentyl-1H- 7222 I

indole-3-carboxylate).

5F-PB-22 (Quinolin-8-yl 1-(5- 7225 I

fluoropentyl)-1H-indole-3-

carboxylate).

Alpha-ethyltryptamine............ 7249 I

Ibogaine......................... 7260 I

CP-47,497 (5-(1,1-Dimethylheptyl)- 7297 I

2-(1R,3S)-3-hydroxycyclohexyl-

phenol).

CP-47,497 C8 Homologue (5-(1,1- 7298 I

Dimethyloctyl)-2-(1R,3S)3-

hydroxycyclohexyl-phenol).

Lysergic acid diethylamide....... 7315 I

2,5-Dimethoxy-4-(n)- 7348 I

propylthiophenethylamine (2C-T-

7).

Marihuana........................ 7360 I

Tetrahydrocannabinols............ 7370 I

Mescaline........................ 7381 I

2-(4-Ethylthio-2,5- 7385 I

dimethoxyphenyl) ethanamine (2C-

T-2 ).

3,4,5-Trimethoxyamphetamine...... 7390 I

4-Bromo-2,5-dimethoxyamphetamine. 7391 I

4-Bromo-2,5- 7392 I

dimethoxyphenethylamine.

4-Methyl-2,5-dimethoxyamphetamine 7395 I

2,5-Dimethoxyamphetamine......... 7396 I

JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I

naphthoyl) indole).

2,5-Dimethoxy-4-ethylamphetamine. 7399 I

3,4-Methylenedioxyamphetamine.... 7400 I

5-Methoxy-3,4- 7401 I

methylenedioxyamphetamine.

N-Hydroxy-3,4- 7402 I

methylenedioxyamphetamine.

3,4-Methylenedioxy-N- 7404 I

ethylamphetamine.

3,4-Methylenedioxymethamphetamine 7405 I

4-Methoxyamphetamine............. 7411 I

5-Methoxy-N-N-dimethyltryptamine. 7431 I

Alpha-methyltryptamine........... 7432 I

Diethyltryptamine................ 7434 I

Dimethyltryptamine............... 7435 I

Page 60902

Psilocybin....................... 7437 I

Psilocyn......................... 7438 I

5-Methoxy-N,N- 7439 I

diisopropyltryptamine.

N-Ethyl-1-phenylcyclohexylamine.. 7455 I

1-(1-Phenylcyclohexyl)pyrrolidine 7458 I

1-1-(2- 7470 I

Thienyl)cyclohexylpiperidine.

1-1-(2- 7473 I

Thienyl)cyclohexylpyrrolidine.

N-Benzylpiperazine............... 7493 I

2-(2,5-Dimethoxy-4-methylphenyl) 7508 I

ethanamine (2C-D).

2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I

ethanamine (2C-E ).

2-(2,5-Dimethoxyphenyl) 7517 I

ethanamine (2C-H).

2-(4-iodo-2,5-dimethoxyphenyl) 7518 I

ethanamine (2C-I).

2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I

ethanamine (2C-C).

2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I

ethanamine (2C-N).

2-(2,5-Dimethoxy-4-(n)- 7524 I

propylphenyl) ethanamine (2C-P).

2-(4-Isopropylthio)-2,5- 7532 I

dimethoxyphenyl) ethanamine (2C-

T-4 ).

MDPV (3,4- 7535 I

Methylenedioxypyrovalerone).

2-(4-bromo-2,5-dimethoxyphenyl)-N- 7536 I

(2-methoxybenzyl) ethanamine

(25B-NBOMe).

2-(4-chloro-2,5-dimethoxyphenyl)- 7537 I

N-(2-methoxybenzyl) ethanamine

(25C-NBOMe).

2-(4-iodo-2,5-dimethoxyphenyl)-N- 7538 I

(2-methoxybenzyl) ethanamine

(25I-NBOMe).

Methylone (3,4-Methylenedioxy-N- 7540 I

methylcathinone).

Butylone......................... 7541 I

Pentylone........................ 7542 I

alpha-pyrrolidinopentiophenone 7545 I

(alpha-PVP).

alpha-pyrrolidinobutiophenone 7546 I

(alpha-PBP).

AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I

iodobenzoyl) indole).

Acetyldihydrocodeine............. 9051 I

Benzylmorphine................... 9052 I

Codeine-N-oxide.................. 9053 I

Desomorphine..................... 9055 I

Etorphine (except HCl)........... 9056 I

Codeine methylbromide............ 9070 I

Dihydromorphine.................. 9145 I

Heroin........................... 9200 I

Morphine-N-oxide................. 9307 I

Normorphine...................... 9313 I

U-47700 (3,4-dichloro-N-2- 9547 I

(dimethylamino)cyclohexyl-N-

methylbenzamide).

MT-45 (1-cyclohexyl-4-(1,2- 9560 I

diphenylethyl)piperazine)).

Tilidine......................... 9750 I

Acryl fentanyl (N-(1- 9811 I

phenethylpiperidin-4-yl)-N-

phenylacrylamide).

Para-Fluorofentanyl.............. 9812 I

3-Methylfentanyl................. 9813 I

Alpha-methylfentanyl............. 9814 I

Acetyl-alpha-methylfentanyl...... 9815 I

N-(2-fluorophenyl)-N-(1- 9816 I

phenethylpiperidin-4-

yl)propionamide.

Acetyl Fentanyl (N-(1- 9821 I

phenethylpiperidin-4-yl)-N-

phenylacetamide).

Butyryl Fentanyl................. 9822 I

Para-fluorobutyryl fentanyl...... 9823 I

4-Fluoroisobutyryl fentanyl (N-(4- 9824 I

fluorophenyl)-N-(1-

phenethylpiperidin-4-

yl)isobutyramide).

2-methoxy-N-(1-phenethylpiperidin- 9825 I

4-yl)-N-phenylacetamide.

Para-chloroisobutyryl fentanyl... 9826 I

Isobutyryl fentanyl.............. 9827 I

Beta-hydroxyfentanyl............. 9830 I

Beta-hydroxy-3-methylfentanyl.... 9831 I

Alpha-methylthiofentanyl......... 9832 I

3-Methylthiofentanyl............. 9833 I

Furanyl fentanyl (N-(1- 9834 I

phenethylpiperidin-4-yl)-N-

phenylfuran-2-carboxamide).

Thiofentanyl..................... 9835 I

Beta-hydroxythiofentanyl......... 9836 I

Para-methoxybutyryl fentanyl..... 9837 I

Ocfentanil....................... 9838 I

Valeryl fentanyl................. 9840 I

N-(1-phenethylpiperidin-4-yl)-N- 9843 I

phenyltetrahydrofuran-2-

carboxamide.

Cyclopropyl Fentanyl............. 9845 I

Cyclopentyl fentanyl............. 9847 I

Fentanyl related-compounds as 9850 I

defined in 21 CFR 1308.11&h).

Amphetamine...................... 1100 II

Methamphetamine.................. 1105 II

Lisdexamfetamine................. 1205 II

Phenmetrazine.................... 1631 II

Methylphenidate.................. 1724 II

Amobarbital...................... 2125 II

Pentobarbital.................... 2270 II

Secobarbital..................... 2315 II

Page 60903

Phencyclidine.................... 7471 II

4-Anilino-N-phenethyl-4- 8333 II

piperidine (ANPP).

Phenylacetone.................... 8501 II

1- 8603 II

Piperidinocyclohexanecarbonitril

e.

Cocaine.......................... 9041 II

Codeine.......................... 9050 II

Etorphine HCl.................... 9059 II

Dihydrocodeine................... 9120 II

Oxycodone........................ 9143 II

Hydromorphone.................... 9150 II

Ecgonine......................... 9180 II

Ethylmorphine.................... 9190 II

Hydrocodone...................... 9193 II

Levomethorphan................... 9210 II

Levorphanol...................... 9220 II

Isomethadone..................... 9226 II

Meperidine....................... 9230 II

Meperidine intermediate-B........ 9233 II

Methadone........................ 9250 II

Dextropropoxyphene, bulk (non- 9273 II

dosage forms).

Morphine......................... 9300 II

Thebaine......................... 9333 II

Oxymorphone...................... 9652 II

Thiafentanil..................... 9729 II

Alfentanil....................... 9737 II

Remifentanil..................... 9739 II

Sufentanil....................... 9740 II

Carfentanil...................... 9743 II

Tapentadol....................... 9780 II

Fentanyl......................... 9801 II

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The company plans to bulk manufacture the listed controlled substances to produce forensic and research analytical reference standards for distribution to its customers.

Dated: November 16, 2018.

John J. Martin,

Assistant Administrator.

FR Doc. 2018-25865 Filed 11-26-18; 8:45 am

BILLING CODE 4410-09-P

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