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Notice

Importer of Controlled Substances Application: Restek Corporation

A Notice by the Drug Enforcement Administration on 12/04/2023

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Published Document: 2023-26555 (88 FR 84167)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Justice
Drug Enforcement Administration
  1. [Docket No. DEA-1305]

AGENCY:

Drug Enforcement Administration, Justice.

ACTION:

Notice of application.

SUMMARY:

Restek Corporation has applied to be registered as an importer 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 January 3, 2024. Such persons may also file a written request for a hearing on the application on or before January 3, 2024.

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. All requests for a hearing must be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION:

In accordance with 21 CFR 1301.34(a), this is notice that on November 6, 2023, Restek Corporation, 110 Benner Circle, Bellefonte, Pennsylvania 16823-8433, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

Controlled substance Drug code Schedule
Amineptine 1219 I
Mesocarb 1227 I
3-Fluoro-N-methylcathinone (3-FMC) 1233 I
Cathinone 1235 I
Methcathinone 1237 I
4-Fluoro-N-methylcathinone (4-FMC) 1238 I
Para-Methoxymethamphetamine (PMMA), 1-(4-1245 I N methoxyphenyl)-N-methylpropan-2-amine 1245 I
Pentedrone (α-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-2-1478 I N amine) 1478 I
N,N-Dimethylamphetamine 1480 I
Fenethylline 1503 I
Aminorex 1585 I
4-Methylaminorex (cis isomer) 1590 I
4,4′-Dimethylaminorex 1595 I
Gamma Hydroxybutyric Acid 2010 I
Methaqualone 2565 I
Mecloqualone 2572 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) 6250 I
SR-18 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) 7008 I N SR-18 and RCS-8 indole) SR-19 (1-P 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
1-(4-Fluorobenzyl)-1H-indol-3-yl)(2,2,3,3-7014 I N FUB-144 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-3methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) 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
Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido) 3,3-dimethylbutanoate) 7036 I
5F-MDMB-PICA 7041
MDMB-CHMICA, MMB-CHMINACA 7042 I
Methyl 2-7043 I N (1-(4-fluorobutyl)-1H-indazole-3-carboxamido)-3,3dimethylbutanoate) 7043 I
MMB-CHMICA 7044 I
FUB-AKB48; FUB-APINACA; AKB48 N-(4-FLUOROBENZYL) 7047 I
( printed page 84168)
APINACA and AKB48 7048 I
5F-APINACA, 5F-AKB48 7049 I
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) 7081 I
1-(5-Fluoropentyl)-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-CUMYL-BUTINACA 7089 I
SR-19 (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 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-ethylhexedrone 7246 I
Alpha-ethyltryptamine 7249 I
Ibogaine 7260 I
2-(ethylamino)-2-(3-methoxyphenyl)cyclohexan-1-one 7286 I N MXE, methoxetamine (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
2,5-Dimethoxy-4-(n)-propylthiophenethylamine 7348 I
Marihuana extract 7350 I
Marihuana 7360 I
Tetrahydrocannabinols 7370 I
Parahexyl 7374 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
Peyote 7415 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-a-PVP) 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-Ethyl-3-piperidyl benzilate 7482 I
N-Methyl-3-piperidyl benzilate 7484 I
N-Benzylpiperazine 7493 I
4-MePPP (4-Methyl-alphapyrrolidinopropiophenone) 7498 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
( printed page 84169)
2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) 7536 I
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine) 7537 I
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
N-Ethylpentylone, ephylone (1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one) 7543 I
Alpha-Pyrrolidinohexanophenone 7544 I
α-PVP (alpha-pyrrolidinopentiophenone) 7545 I
α-PBP (alpha-pyrrolidinobutiophenone) 7546 I
Ethylone 7547 I
PV8, alpha-Pyrrolidinoheptaphenone 7548 I
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) 7694 I
Acetyldihydrocodeine 9051 I
Benzylmorphine 9052 I
Codeine-N-oxide 9053 I
Cyprenorphine 9054 I
Desomorphine 9055 I
Etorphine (except HCl) 9056 I
Codeine methylbromide 9070 I
Brorphine 9098 I
Dihydromorphine 9145 I
Difenoxin 9168 I
Heroin 9200 I
Hydromorphinol 9301 I
Methyldesorphine 9302 I
Methyldihydromorphine 9304 I
Morphine methylbromide 9305 I
Morphine methylsulfonate 9306 I
Morphine-N-oxide 9307 I
Myrophine 9308 I
Nicocodeine 9309 I
Nicomorphine 9312 I
Normorphine 9313 I
Pholcodine 9314 I
Thebacon 9315 I
Acetorphine 9319 I
Drotebanol 9335 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
Acetylmethadol 9601 I
Allylprodine 9602 I
Alphacetylmethadol except levo-alphacetylmethadol 9603 I
Alphameprodine 9604 I
Alphamethadol 9605 I
Benzethidine 9606 I
Betameprodine 9608 I
Betamethadol 9609 I
Betaprodine 9611 I
Clonitazene 9612 I
Dextromoramide 9613 I
Isotonitazene (N,N-diethyl-2-(2-(4 isopropoxybenzyl)-5-nitro nitro-1H-benzimidazol-1-yl)ethan-1-amine) 9614 I
Diampromide 9615 I
Diethylthiambutene 9616 I
Dimenoxadol 9617 I
Dimepheptanol 9618 I
Dimethylthiambutene 9619 I
Dioxaphetyl butyrate 9621 I
Dipipanone 9622 I
Ethylmethylthiambutene 9623 I
Etonitazene 9624 I
Etoxeridine 9625 I
Furethidine 9626 I
Hydroxypethidine 9627 I
Ketobemidone 9628 I
Levomoramide 9629 I
Levophenacylmorphan 9631 I
Morpheridine 9632 I
Noracymethadol 9633 I
Norlevorphanol 9634 I
Normethadone 9635 I
Norpipanone 9636 I
( printed page 84170)
Phenadoxone 9637 I
Phenampromide 9638 I
Phenoperidine 9641 I
Piritramide 9642 I
Proheptazine 9643 I
Properidine 9644 I
Racemoramide 9645 I
Trimeperidine 9646 I
Phenomorphan 9647 I
Propiram 9649 I
1-Methyl-4-phenyl-4-propionoxypiperidine 9661 I
1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine 9663 I
Tilidine 9750 I
Butonitazene 9751 I
Flunitazene 9756 I
METONITAZENE 9757 I
N-PYRROLIDINO ETONITAZENE; ETONITAZEPYNE 9758 I
PROTONITAZENE 9759 I
METODESNITAZENE 9764 I
ETODESNITAZENE; ETAZENE 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 9817 I
4′-Methyl Acetyl fentanyl 9819 I
Ortho-Methyl methoxyacetyl fentanyl 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 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 9834 I
Thiofentanyl 9835 I
Beta-hydroxythiofentanyl 9836 I
Para-methoxybutyryl fentanyl 9837 I
Ocfentanil 9838 I
Thiofuranyl fentanyl 9839 I
Valeryl fentanyl 9840 I
Phenyl fentanyl 9841 I
Beta′-Phenyl fentanyl 9842 I
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide) 9843 I
Crotonyl fentanyl 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 9848 I
Fentanyl related-compounds as defined in 21 CFR 1308.11(h) 9850 I
Fentanyl Carbamate 9851 I
ORTHO-FLUOROACRYL FENTANYL 9852 I
ORTHO-FLUOROISOBUTYRYL FENTANYL 9853 I
Para-Fluoro furanyl fentanyl 9854 I
2′-Fluoro ortho-fluorofentanyl 9855 I
Beta-Methyl fentanyl 9856 I
Zipeprol 9873 I
Amphetam 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
( printed page 84171)
Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration (FDA) 7365 II
Nabilone 7379 II
1-Phenylcyclohexylamine 7460 II
Phencyclidine 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine) 8333 II
Norfentanyl 8366 II
Phenylacetone 8501 II
1-Piperidinocyclohexanecarbonitrile 8603 II
Alphaprodine 9010 II
Anileridine 9020 II
Coca Leaves 9040 II
Cocaine 9041 II
Codeine 9050 II
Etorphine HCl 9059 II
Dihydrocodeine 9120 II
Oxycodone 9143 II
Hydromorphone 9150 II
Diphenoxylate 9170 II
Ecgonine 9180 II
Ethylmorphine 9190 II
Hydrocodone 9193 II
Levomethorphan 9210 II
Levorphanol 9220 II
Isomethadone 9226 II
Meperidine 9230 II
Meperidine-intermediate-A 9232 II
Meperidine intermediate-B 9233 II
Meperidine intermediate-C 9234 II
Metazocine 9240 II
Oliceridine 9245 II
Methadone 9250 II
Methadone intermediate 9254 II
Metopon 9260 II
Dextropropoxyphene, bulk (non-dosage forms) 9273 II
Morphine 9300 II
Oripavine 9330 II
Thebaine 9333 II
Dihydroetorphine 9334 II
Opium, raw 9600 II
Opium extracts 9610 II
Opium fluid extract 9620 II
Opium tincture 9630 II
Opium, powdered 9639 II
Opium, granulated 9640 II
Levo-alphacetylmethadol 9648 II
Opium poppy 9650 II
Oxymorphone 9652 II
Noroxymorphone 9668 II
Poppy Straw Concentrate 9670 II
Phenazocine 9715 II
Thiafentanil 9729 II
Piminodine 9730 II
Racemethorphan 9732 II
Racemorphan 9733 II
Alfentanil 9737 II
Remifentanil 9739 II
Sufentanil 9740 II
Carfentanil 9743 II
Tapentadol 9780 II
Bezitramide 9800 II
Fentanyl 9801 II
Moramide-intermediate 9802 II

The company plans to import the listed controlled substances for the use in the manufacture of exempted certified reference materials. No other activities for these drug codes are authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

Claude Redd,

Acting Deputy Assistant Administrator.

[FR Doc. 2023-26555 Filed 12-1-23; 8:45 am]

BILLING CODE P

Published Document: 2023-26555 (88 FR 84167)