88 FR 231 pgs. 84167-84171 - Importer of Controlled Substances Application: Restek Corporation
Type: NOTICEVolume: 88Number: 231Pages: 84167 - 84171
Pages: 84167, 84168Docket number: [Docket No. DEA-1305]
FR document: [FR Doc. 2023-26555 Filed 12-1-23; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version: PDF Version
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1305]
Importer of Controlled Substances Application: Restek Corporation
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):
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| 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 (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-2-1478 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 |
| 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 |
| 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 |
| a-PVP (alpha-pyrrolidinopentiophenone) | 7545 | I |
| a-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 |
| 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 |
| 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]
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