[Federal Register Volume 87, Number 173 (Thursday, September 8, 2022)]
[Notices]
[Pages 55037-55040]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19391]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1070]
Bulk Manufacturer of Controlled Substances Application: Cayman
Chemical Company
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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SUMMARY: Cayman Chemical Company, has applied to be registered as a
bulk manufacturer of basic class(es) of controlled substance(s). Refer
to Supplementary Information listed below for further drug information.
DATES: Registered bulk manufacturers of the affected basic class(es),
and applicants therefore, may submit electronic comments on or
objections to the issuance of the proposed registration on or before
November 7, 2022. Such persons may also file a written request for a
hearing on the application on or before November 7, 2022.
ADDRESSES: The Drug Enforcement Administration requires that all
comments be submitted electronically through the Federal eRulemaking
Portal, which provides the ability to type short comments directly into
the comment field on the web page or attach a file for lengthier
comments. Please go to https://www.regulations.gov and follow the
online instructions at that site for submitting comments. Upon
submission of your comment, you will receive a Comment Tracking Number.
Please be aware that submitted comments are not instantaneously
available for public view on https://www.regulations.gov. If you have
received a Comment Tracking Number, your comment has been successfully
submitted and there is no need to resubmit the same comment.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 26, 2022, Cayman Chemical Company, 1180 East
Ellsworth Road, Ann Arbor, Michigan 48108-2419, applied to be
registered as a bulk manufacturer of the following basic class(es) of
controlled substance(s):
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Controlled substance Drug code Schedule
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3-Fluoro-N-methylcathinone (3-FMC)....... 1233 I
Cathinone................................ 1235 I
Methcathinone............................ 1237 I
4-Fluoro-N-methylcathinone (4-FMC) 1238 I 1238 I
N flephedrone; 1-(4-fluorophenyl)-2-
(methylamino)propan-1-one) (Positional
isomer: 2-FMC).
Para-Methoxymethamphetamine (PMMA), 1-(4- 1245 I
1245 I N methoxyphenyl)-N-methylpropan-2-
amine.
Pentedrone ([alpha]- 1246 I
methylaminovalerophenone).
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
4,4'-Dimethylaminorex (4,4'-DMAR; 4,5- 1595 I
dihydro-4-1595 I N methyl-5-(4-
methylphenyl)-2-oxazolamine; 4-methyl-5-
(4-methylphenyl)-4,5-dihydro-1,3-oxazol-
2-amine).
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-dimethyl-1- 7010 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 [1-(5-Fluoro- 7011 I
pentyl)1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone.
AB-FUBINACA (N-(1-amino-3-methyl-1- 7012 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
FUB-144 (1-(4-fluorobenzyl)-1H-indol-3- 7014 I
yl)(2,2,3,3-
tetramethylcyclopropyl)methanone).
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).. 7019 I
MDMB-FUBINACA (Methyl 2-(1-(4- 7020 I
fluorobenzyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1- 7021 I
(4-fluorobenzyl)-1Hindazole-3-
carboxamido)-3-methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan- 7023 I
2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol- 7024 I
3-yl](naphthalen-1-yl)methanone).
5F-AB-PINACA (N-(1-amino-3-methyl-1- 7025 I
oxobutan-2-yl)-1-(5-fluropentyl)-1H-
indazole-3-carboximide).
AB-CHMINACA (N-(1-amino-3-methyl-1- 7031 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I
indazole-3-carboxamido)-3-
methylbutanoate).
5F-ADB, 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1- 7035 I
oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
5F-EDMB-PINACA (ethyl 2-(1-(5- 7036 I
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
5F-MDMB-PICA (methyl 2-(1-(5- 7041 I
fluoropentyl)-1H-indole-3-carboxamido)-
3,3-dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1- 7042 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-(1- 7044 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate).
FUB-AKB48, FUB-APINACA, AKB48 N-(4- 7047 I
FLUOROBENZYL) (N-(adamantan-1-yl)-1-(4-
fluorobenzyl)-1H-indazole-3-carboximide).
APINACA and AKB48 (N-(1-Adamantyl)-1- 7048 I
pentyl-1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)- 7049 I
1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
[[Page 55038]]
5F-CUMYL-PINACA, 5GT-25 (1-(5- 7083 I
fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-
indazole-3-carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2- 7085 I
phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide).
4-CN-CUML-BUTINACA, 4-cyano-CUMYL- 7089 I
BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-
BINACA, SGT-78 (1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-
carboxamide).
SR-19 (Also known as RCS-4) (1-Pentyl-3- 7104 I
[(4-methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I
naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3- 7144 I
tetramethylcyclopropyl)methanone.
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).. 7173 I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 7200 I
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 1-(5- 7221 I
fluoropentyl)-1H-indole-3-carboxylate.
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3- 7222 I
carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5- 7225 I
fluoropentyl)-1H-indole-3-carboxylate).
4-methyl-alpha-ethylaminopentiophenone (4- 7245 I
MEAP) 7245 I N 4-MEAP.
N-ethylhexedrone 7246 I N................ 7246 I
Alpha-ethyltryptamine.................... 7249 I
Ibogaine................................. 7260 I
2-(ethylamino)-2-(3- 7286 I
methoxyphenyl)cyclohexan-1-one
(methoxetamine).
CP-47,497 (5-(1,1-Dimethylheptyl)-2- 7297 I
[(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
2C-T-7 (2,5-Dimethoxy-4-(n)- 7348 I
propylthiophenethylamine.
Marihuana................................ 7360 I
Tetrahydrocannabinols.................... 7370 I
Mescaline................................ 7381 I
2C-T-2 (2-(4-Ethylthio-2,5- 7385 I
dimethoxyphenyl) ethanamine).
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- 7398 I
naphthoyl) indole).
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
4-chloro-alpha-pyrrolidinovalerophenone 7443 I
(4-chloro-aPV.
4[acute]-methyl-alpha- 7446 I
pyrrolidinohexiophenone (MPHP.
N-Ethyl-1-phenylcyclohexylamine.......... 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine........ 7458 I
1-[1-(2-Thienyl)cyclohexyl]piperidine.... 7470 I
1-[1-(2-Thienyl)cyclohexyl]pyrrolidine... 7473 I
N-Benzylpiperazine....................... 7493 I
2C-D (2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I
ethanamine).
2C-H 2-(2,5-Dimethoxyphenyl) ethanamine). 7517 I
2C-I 2-(4-iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine).
2C-C 2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I
ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I
ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)- 7524 I
propylphenyl) ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone).... 7535 I
25B-NBOMe (2-(4-bromo-2,5- 7536 I
dimethoxyphenyl)-N-(2-methoxybenzyl)
ethanamine).
25C-NBOMe (2-(4-chloro-2,5- 7537 I
dimethoxyphenyl)-N-(2-methoxybenzyl)
ethanamine).
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)- 7538 I
N-(2-methoxybenzyl) ethanamine).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone................................. 7541 I
Pentylone................................ 7542 I
alpha-pyrrolidinohexanophenone (a-PHP)... 7544 I
alpha-pyrrolidinopentiophenone ([alpha]- 7545 I
PVP).
alpha-pyrrolidinobutiophenone ([alpha]- 7546 I
PBP).
[[Page 55039]]
Ethylone................................. 7547 I
alpha-pyrrolidinoheptaphenone (PV8)...... 7548 I
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
Brorphine (1-(1-(1-(4- 9098 I
bromophenyl)ethyl)piperidin-4-4l)1,3-
dihydro-2H-benzo[d]imidazol-2-one).
Dihydromorphine.......................... 9145 I
Difenoxin................................ 9168 I
Heroin................................... 9200 I
Hydromorphinol........................... 9301 I
Morphine-N-oxide......................... 9307 I
Normorphine.............................. 9313 I
Thebacon................................. 9315 I
U-47700 (3,4-dichloro-N-[2- 9547 I
(dimethylamino)cyclohexyl]-N-
methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1- 9551 I
dimethylamino)cyclohexylmethyl]benzamide
)).
MT-45 (1-cyclohexyl-4-(1,2- 9560 I
diphenylethyl)piperazine)).
Clonitazene.............................. 9612 I
Isotonotazene (N,N-diethyl-2-(2-(4 9614 I
isopropoxybenzyl)-5-nitro-1H-
benzimidazol-1-yl)ethan-1-amine).
Etonitazene.............................. 9624 I
Ketobemidone............................. 9628 I
Trimeperidine............................ 9646 I
Tilidine................................. 9750 I
lunitazene (N,N-diethyl-2-(2-(4- 9756 I
fluorobenzyl)-5-nitro1H-benzimidazol-1-
yl)ethan-1-amine).
Metonitazene (N,N-diethyl-2-(2-(4- 9757 I
methoxybenzyl)-5-nitro-1Hbenzimidazol-1-
yl)ethan-1-amine.
N-pyrrolidino etonitazene; etonitazepyne 9758 I
(2-(4-ethoxybenzyl)-5-nitro-1-(2-
(pyrrolidin-1-yl)ethyl)-1Hbenzimidazole).
Protonitazene (N,N-diethyl-2-(5-nitro-2- 9759 I
(4-propoxybenzyl)-1H-benzimidazol-1-
yl)ethan-1-amine).
Metodesnitazene (N,N-diethyl-2-(2-(4- 9764 I
methoxybenzyl)-1H-benzimidazol-1-
yl)ethan-1-amine).
Etodesnitazene; etazene (2-(2-(4- 9765 I
ethoxybenzyl)-1Hbenzimidazol-1-yl)-N,N-
diethylethan-1-amine).
Acryl fentanyl (N-(1-phenethylpiperidin-4- 9811 I
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.
Para-Methylfentanyl (N-(4-methylphenyl)-N- 9817 I
(1-phenethylpiperidin-4-yl)propionamide;
also known as 4-methylfentanyl).
4'-Methyl acetyl fentanyl (N-(1-(4- 9819 I
methylphenethyl)piperidin-4-yl)-N-
phenylacetamide).
ortho-Methyl methoxyacetyl fentanyl (2- 9820 I
methoxy-N-(2-methylphenyl)-N-(1-
phenethylpiperidin-4-yl)acetamide).
Acetyl Fentanyl (N-(1-phenethylpiperidin- 9821 I
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-4-yl)-N- 9825 I
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-phenethylpiperidin- 9834 I
4-yl)-N-phenylfuran-2-carboxamide).
Thiofentanyl............................. 9835 I
Beta-hydroxythiofentanyl................. 9836 I
Para-methoxybutyryl fentanyl............. 9837 !
Ocfentanil............................... 9838 I
Thiofuranyl fentanyl (N-(1- 9839 I
phenethylpiperidin-4-yl)-
Nphenylthiophene-2-carboxamide; also
known as 2-thiofuranyl fentanyl;
thiophene fentanyl).
Valeryl fentanyl......................... 9840 I
Phenyl fentanyl (N-(1-phenethylpiperidin- 9841 I
4-yl)-Nphenylbenzamide; also known as
benzoyl fentanyl).
beta'-Phenyl fentanyl (N-(1- 9842 I
phenethylpiperidin-4-yl)-N,3-
diphenylpropanamide; also known as
[beta]'-phenyl fentanyl; 3-
phenylpropanoyl fentanyl).
N-(1-phenethylpiperidin-4-yl)-N- 9843 I
phenyltetrahydrofuran-2-carboxamide.
Crotonyl fentanyl ((E-N-(1- 9844 I
phenethylpiperidin-4-yl)-N-phenylbut-2-
enamide).
Cyclopropyl Fentanyl..................... 9845 I
ortho-Fluorobutyryl fentanyl (N-(2- 9846 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)butyramide; also known as 2-
fluorobutyryl fentanyl).
Cyclopentyl fentanyl..................... 9847 I
ortho-Methyl acetylfentanyl (N-(2- 9848 I
methylphenyl)-N-(1-phenethylpiperidin-4-
yl)acetamide; also known as 2-methyl
acetylfentanyl).
Fentanyl related-compounds as defined in 9850 I
21 CFR 1308.11(h).
Fentanyl carbamate (ethyl (1- 9851 I
phenethylpiperidin-4-
yl)(phenyl)carbamate).
[[Page 55040]]
ortho-Fluoroacryl fentanyl (N-(2- 9852 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)acrylamide).
ortho-Fluoroisobutyryl fentanyl (N-(2- 9853 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide).
Para-Fluoro furanyl fentanyl (N-(4- 9854 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)furan-2-carboxamide).
2'-Fluoro ortho-fluorofentanyl (N-(1-(2- 9855 I
fluorophenethyl)piperidin-4-yl)-N-(2-
fluorophenyl)propionamide; also known as
2'-fluoro 2-fluorofentanyl).
beta-Methyl fentanyl (N-phenyl-N-(1-(2- 9856 I
phenylpropyl)piperidin-4-
yl)propionamide; also known as [beta]-
methyl fentanyl).
Amphetamine.............................. 1100 II
Methamphetamine.......................... 1105 II
Lisdexamfetamine......................... 1205 II
Phenmetrazine............................ 1631 II
Methylphenidate.......................... 1724 II
Amobarbital.............................. 2125 II
Pentobarbital............................ 2270 II
Secobarbital............................. 2315 II
Glutethimide............................. 2550 II
1-Phenylcyclohexylamine.................. 7460 II
Phencyclidine............................ 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II
Norfentanyl (N-phenyl-N-(piperidin-4-yl) 8366 II
propionamide).
Phenylacetone............................ 8501 II
1-Piperidinocyclohexanecarbonitrile...... 8603 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
Oliceridine (N-[(3-methoxythiophen- 9245 II
2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-
oxaspiro[4.5] decan-9-yl] ethyl
{time{time} )amine fumarate).
Methadone................................ 9250 II
Dextropropoxyphene, bulk (non-dosage 9273 II
forms).
Morphine................................. 9300 II
Thebaine................................. 9333 II
Oxymorphone.............................. 9652 II
Noroxymorphone........................... 9668 II
Thiafentanil............................. 9729 II
Alfentanil............................... 9737 II
Remifentanil............................. 9739 II
Sufentanil............................... 9740 II
Carfentanil.............................. 9743 II
Tapentadol............................... 9780 II
Fentanyl................................. 9801 II
------------------------------------------------------------------------
The company plans to bulk manufacture the listed controlled
substances for internal use or for sale to its customers. In reference
to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the
company plans to bulk manufacture these drugs as synthetic. No other
activities for these drug codes are authorized for this registration.
Kristi O'Malley,
Assistant Administrator.
[FR Doc. 2022-19391 Filed 9-7-22; 8:45 am]
BILLING CODE P