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88 FR 200 pgs. 71885-71889 - Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

Type: NOTICEVolume: 88Number: 200Pages: 71885 - 71889
Docket number: [Docket No. DEA-1281]
FR document: [FR Doc. 2023-22954 Filed 10-17-23; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version:  PDF Version
Pages: 71885, 71886, 71887

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1281]

Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

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:


[top] Registered bulk manufacturers of the affected basic class(es), and page 71886 applicants therefore, may submit electronic comments on or objections to the issuance of the proposed registration on or before December 18, 2023. Such persons may also file a written request for a hearing on the application on or before December 18, 2023.

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 25, 2023, 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
3-Fluoro-N-methylcathinone (3-FMC) 1233 I
Cathinone 1235 I
Methcathinone 1237 I
4-Fluoro-N-methylcathinone (4-FMC) 1238 I N flephedrone; 1-(4-fluorophenyl)-2-(methylamino)propan-1- one) (Positional isomer: 2-FMC) 1238 I
Para-Methoxymethamphetamine (PMMA), 1-(4- 1245 I N methoxyphenyl)-N-methylpropan-2-amine 1245 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
Methiopropamine (N-methyl-1-(thiophen-2-yl)propan-2-amine) 1478 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-dihydro-4- 1595 I N methyl-5-(4-methylphenyl)-2-oxazolamine; 4-methyl-5- (4-methylphenyl)-4,5-dihydro-1,3-oxazol-2-amine) 1595 I
Gamma Hydroxybutyric Acid 2010 I
Methaqualone 2565 I
Mecloqualone 2572 I
Etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine 2780 I
Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) 2785 I
Clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4Hbenzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine 2786 I
Flubromazolam (8-bromo-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine 2788 I
Diclazepam (7-chloro-5-(2-chloro-5-(2-chlorophenyl)-1-methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one 2789 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
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) 7010 I
5-Fluoro-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
FUB-144 (1-(4-fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone) 7014 I
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) 7019 I
MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7020 I
FUB-AMB, MMB- FUBINACA, AMB-FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate) 7021 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
5F-AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(5-fluropentyl)-1H-indazole-3-carboximide) 7025 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
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) 7033 I
5F-ADB, 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7034 I
ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 7035 I
5F-EDMB-PINACA (ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7036 I
5F-MDMB-PICA (methyl 2-(1-(5-fluoropentyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 7041 I
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) 7042 I
4F-MDMB-BINACA (4F-MDMB-BUTINACA or methyl 2-(1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) 7043 I
MMB-CHMICA, AMB-CHMICA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate) 7044 I
FUB-AKB48, FUB-APINACA, AKB48 N-(4-FLUOROBENZYL) (N-(adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboximide) 7047 I
APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 7048 I
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 7049 I
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) 7081 I
5F-CUMYL-PINACA, 5GT-25 (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide) 7083 I
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide) 7085 I
4-CN-CUML-BUTINACA, 4-cyano-CUMYL-BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-BINACA, SGT-78 (1-(4-cyanobutyl)-N-(2-phenylpropan-2-yl)-1H-indazole-3-carboxamide) 7089 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
NM2201, CBL2201 (Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate 7221 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
4-methyl-alpha-ethylaminopentiophenone (4-MEAP) 7245 I N 4-MEAP 7245 I
N-ethylhexedrone 7246 I N 7246 I
Alpha-ethyltryptamine 7249 I
Ibogaine 7260 I
2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one (methoxetamine) 7286 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
2C-T-7 (2,5-Dimethoxy-4-(n)-propylthiophenethylamine 7348 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Mescaline 7381 I
2C-T-2 (2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine ) 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
4-chloro-alpha-pyrrolidinovalerophenone (4-chloro-aPV 7443 I
4´-methyl-alpha-pyrrolidinohexiophenone (MPHP 7446 I
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) ethanamine) 7508 I
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine) 7509 I
2C-H 2-(2,5-Dimethoxyphenyl) ethanamine) 7517 I
2C-I 2-(4-iodo-2,5-dimethoxyphenyl) ethanamine) 7518 I
2C-C 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine) 7519 I
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine) 7521 I
2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine) 7524 I
2C-T-4 (2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine) 7532 I
MDPV (3,4-Methylenedioxypyrovalerone) 7535 I
25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) 7536 I
25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) 7537 I
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) 7538 I
Methylone (3,4-Methylenedioxy-N-methylcathinone) 7540 I
Butylone 7541 I
Pentylone 7542 I
alpha-pyrrolidinohexanophenone (a-PHP) 7544 I
alpha-pyrrolidinopentiophenone (a-PVP) 7545 I
alpha-pyrrolidinobutiophenone (a-PBP) 7546 I
Ethylone 7547 I
alpha-pyrrolidinoheptaphenone (PV8) 7548 I
Eutylone 7549 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
Brorphine (1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-4l)1,3-dihydro-2H-benzo[d]imidazol-2-one) 9098 I
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-(dimethylamino)cyclohexyl]-N-methylbenzamide) 9547 I
AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide)) 9551 I
MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine)) 9560 I
Clonitazene 9612 I
Isotonotazene (N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan-1-amine) 9614 I
Dipipanone 9622 I
Etonitazene 9624 I
Ketobemidone 9628 I
Trimeperidine 9646 I
Tilidine 9750 I
Butonitazene (2-(2-(4-butoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)-N,N-diethylethan-1-amine) 9751 I
lunitazene (N,N-diethyl-2-(2-(4-fluorobenzyl)-5- nitro1H-benzimidazol-1-yl)ethan-1- amine) 9756 I
Metonitazene (N,N-diethyl-2-(2-(4- methoxybenzyl)-5- nitro-1Hbenzimidazol-1-yl)ethan-1-amine 9757 I
N-pyrrolidino etonitazene; etonitazepyne (2-(4-ethoxybenzyl)-5-nitro-1-(2- (pyrrolidin-1-yl)ethyl)- 1Hbenzimidazole) 9758 I
Protonitazene (N,N-diethyl-2-(5-nitro-2-(4- propoxybenzyl)-1H-benzimidazol-1- yl)ethan-1-amine) 9759 I
Metodesnitazene (N,N-diethyl-2-(2-(4- methoxybenzyl)- 1H-benzimidazol-1- yl)ethan-1-amine) 9764 I
Etodesnitazene; etazene (2-(2-(4-ethoxybenzyl)- 1Hbenzimidazol-1-yl)-N,N-diethylethan-1- amine) 9765 I
Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide) 9811 I
Para-Fluorofentanyl 9812 I
3-Methylfentanyl 9813 I
Alpha-methylfentanyl 9814 I
Acetyl-alpha-methylfentanyl 9815 I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide 9816 I
Para-Methylfentanyl (N-(4-methylphenyl)-N-(1- phenethylpiperidin-4-yl)propionamide; also known as 4- methylfentanyl) 9817 I
4'-Methyl acetyl fentanyl (N-(1-(4- methylphenethyl)piperidin-4-yl)-N-phenylacetamide) 9819 I
ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2- methylphenyl)-N-(1-phenethylpiperidin-4-yl)acetamide) 9820 I
Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) 9821 I
Butyryl Fentanyl 9822 I
Para-fluorobutyryl fentanyl 9823 I
4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide) 9824 I
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide 9825 I
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-4-yl)-N-phenylfuran-2-carboxamide) 9834 I
Thiofentanyl 9835 I
Beta-hydroxythiofentanyl 9836 I
Para-methoxybutyryl fentanyl 9837 I
Ocfentanil 9838 I
Thiofuranyl fentanyl (N-(1-phenethylpiperidin-4-yl)-Nphenylthiophene-2-carboxamide; also known as 2- thiofuranyl fentanyl; thiophene fentanyl) 9839 I
Valeryl fentanyl 9840 I
Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-Nphenylbenzamide; also known as benzoyl fentanyl) 9841 I
beta'-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N,3- diphenylpropanamide; also known as ß'-phenyl fentanyl; 3-phenylpropanoyl fentanyl) 9842 I
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide 9843 I
Crotonyl fentanyl ((E-N-(1-phenethylpiperidin-4-yl)-N-phenylbut-2-enamide) 9844 I
Cyclopropyl Fentanyl 9845 I
ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)butyramide; also known as 2- fluorobutyryl fentanyl) 9846 I
Cyclopentyl fentanyl 9847 I
ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1- phenethylpiperidin-4-yl)acetamide; also known as 2- methyl acetylfentanyl) 9848 I
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) 9850 I
Fentanyl carbamate (ethyl (1-phenethylpiperidin-4- yl)(phenyl)carbamate) 9851 I
ortho-Fluoroacryl fentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)acrylamide) 9852 I
ortho-Fluoroisobutyryl fentanyl (N-(2-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)isobutyramide) 9853 I
Para-Fluoro furanyl fentanyl (N-(4-fluorophenyl)-N-(1- phenethylpiperidin-4-yl)furan-2-carboxamide) 9854 I
2'-Fluoro ortho-fluorofentanyl (N-(1-(2- fluorophenethyl)piperidin-4-yl)-N-(2- fluorophenyl)propionamide; also known as 2'-fluoro 2- fluorofentanyl) 9855 I
beta-Methyl fentanyl (N-phenyl-N-(1-(2- phenylpropyl)piperidin-4-yl)propionamide; also known as ß-methyl fentanyl) 9856 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
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) propionamide) 8366 II
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-2yl)methyl] ({2-[9r)-9-(pyridin-2-yl)-6-oxaspiro[4.5] decan-9-yl] ethyl {time})amine fumarate) 9245 II
Methadone 9250 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
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 forensic purposes, to research analytical reference standards and as Active Pharmaceutical Ingredients for Phase 1 trials. 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.

Claude Redd,

Acting Deputy Assistant Administrator.

[FR Doc. 2023-22954 Filed 10-17-23; 8:45 am]

BILLING CODE P