Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Application - 2016

[Federal Register Volume 81, Number 249 (Wednesday, December 28, 2016)]
[Notices]
[Pages 95644-95647]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31285]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

ACTION: Notice of application.


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 in accordance with 21 CFR 1301.33(a) on or before February 27, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement

[[Page 95645]]

Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 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 August 16, 2016, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Controlled Substance Drug Code Schedule
3-Fluoro-N-methylcathinone (3–FMC) 1233 I
Cathinone 1235 I
Methcathinone 1237 I
4-Fluoro-N-methylcathinone (4–FMC) 1238 I
Pentedrone (a-methylaminovalerophenone) 1246 I
Mephedrone (4-Methyl-N-methylcathinone) 1248 I
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-methoxyphenylacetyl) indole)  6250 I
SR–18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole)  7008 I
5-Flouro-UR-144 and XLR11 [1-(5-Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone  7011 I
AB–FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)  7012 I
JWH–019 (1-Hexyl-3-(1-naphthoyl)indole)  7019 I
AB–PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole- 3-carboxamide) 7023 I
THJ–2201 [1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone 7024 I
AB–CHMINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide 7031 I
MAB–CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) 7032 I
ADB–PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)  7035 I
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide  7048 I
JWH–081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole)  7081 I
SR–19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole  7104 I
JWH–018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole)  7118 I
JWH–122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole)  7122 I
UR–144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone  7144 I
JWH–073 (1-Butyl-3-(1-naphthoyl)indole)  7173 I
JWH–200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)  7200 I
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole)  7201 I
JWH–203 (1-Pentyl-3-(2-chlorophenylacetyl) indole)  7203 I
PB–22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate)  7222 I
5F–PB–22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate)  7225 I
Alpha-ethyltryptamine 7249 I
Ibogaine 7260 I
CP–47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol)  7297 I
CP–47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol)  7298 I
Lysergic acid diethylamide 7315 I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C–T–7)  7348 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Mescaline 7381 I
2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C–T–2 )  7385 I
3,4,5-Trimethoxyamphetamine 7390 I
4-Bromo-2,5-dimethoxyamphetamine 7391 I
4-Bromo-2,5-dimethoxyphenethylamine  7392 I
4-Methyl-2,5-dimethoxyamphetamine 7395 I
2,5-Dimethoxyamphetamine 7396 I
JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole)  7398 I
2,5-Dimethoxy-4-ethylamphetamine 7399 I
3,4-Methylenedioxyamphetamine 7400 I
5-Methoxy-3,4-methylenedioxyamphetamine  7401 I
N-Hydroxy-3,4-methylenedioxyamphetamine  7402 I
3,4-Methylenedioxy-N-ethylamphetamine  7404 I
3,4-Methylenedioxymethamphetamine  7405 I
4-Methoxyamphetamine 7411 I
5-Methoxy-N–N-dimethyltryptamine 7431 I
Alpha-methyltryptamine 7432 I
Bufotenine 7433 I
Diethyltryptamine 7434 I
Dimethyltryptamine 7435 I
Psilocybin 7437 I
Psilocyn 7438 I
5-Methoxy-N,N-diisopropyltryptamine 7439 I
N-Benzylpiperazine 7493 I
2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C–D)  7508 I
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C–E )  7509 I
2-(2,5-Dimethoxyphenyl) ethanamine (2C–H)  7517 I
2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C–I)  7518 I
2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C–C)  7519 I
2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine (2C–N)  7521 I
2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C–P)  7524 I
2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C–T–4 )  7532 I
MDPV (3,4-Methylenedioxypyrovalerone)  7535 I
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25B–NBOMe)  7536 I
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C–NBOMe)  7537 I
2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25I–NBOMe)  7538 I
Methylone (3,4-Methylenedioxy-N-methylcathinone)  7540 I
Butylone 7541 I
Pentylone 7542 I
alpha-pyrrolidinopentiophenone (a-PVP) 7545 I
alpha-pyrrolidinobutiophenone (a-PBP) 7546 I
AM–694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) 7694 I
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
Tilidine 9750 I
Para-Fluorofentanyl 9812 I
3-Methylfentanyl 9813 I
Alpha-methylfentanyl 9814 I
Acetyl-alpha-methylfentanyl 9815 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I
Butyryl Fentanyl 9822 I
Beta-hydroxyfentanyl 9830 I
Beta-hydroxy-3-methylfentanyl 9831 I
3-Methylthiofentanyl 9833 I
Thiofentanyl 9835 I
Beta-hydroxythiofentanyl 9836 I
Amphetamine 1100 II
Methamphetamine 1105 II
Lisdexamfetamine 1205 II
Phenmetrazine 1631 II
Methylphenidate 1724 II
Amobarbital 2125 II
Pentobarbital 2270 II
Secobarbital 2315 II
Phencyclidine 7471 II
Phenylacetone 8501 II
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-dosage forms) 9273 II
Morphine 9300 II
Thebaine 9333 II
Oxymorphone 9652 II
Alfentanil 9737 II
Remifentanil 9739 II
Sufentanil 9740 II
Carfentanil 9743 II
Tapentadol 9780 II
Fentanyl 9801 II

The company plans to manufacture bulk controlled substances for use in product development of analytical reference standards, for distribution to its customers.

Dated: December 20, 2016.

Louis J. Milione,
Assistant Administrator.

[FR Doc. 2016-31285 Filed 12-27-16; 8:45 am]

BILLING CODE 4410-09-P

 

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Printing Office (GPO).

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