2024-09802. Importer of Controlled Substances Application: Lipomed  

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    AGENCY:

    Drug Enforcement Administration, Justice.

    ACTION:

    Notice of application.

    SUMMARY:

    Lipomed 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 June 5, 2024. Such persons may also file a written request for a hearing on the application on or before June 5, 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.

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    SUPPLEMENTARY INFORMATION:

    In accordance with 21 CFR 1301.34(a), this is notice that on February 7, 2024, Lipomed, 150 Cambridgepark Drive, Suite 705, Cambridge, Massachusetts 02140-2300, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

    Controlled substanceDrug codeSchedule
    3-Fluoro-N-methylcathinone (3-FMC)1233I
    Cathinone1235I
    Methcathinone1237I
    4-Fluoro-N-methylcathinone (4-FMC)1238I
    Pentedrone (α-methylaminovalerophenone)1246I
    Mephedrone (4-Methyl-N-methylcathinone)1248I
    4-Methyl-N-ethylcathinone (4-MEC)1249I
    Naphyrone1258I
    N-Ethylamphetamine1475I
    N,N-Dimethylamphetamine1480I
    Fenethylline1503I
    Aminorex1585I
    4-Methylaminorex (cis isomer)1590I
    Gamma Hydroxybutyric Acid2010I
    Methaqualone2565I
    Mecloqualone2572I
    Etizolam (4-(2-chlorophenyl)-2-ethyl-9-methyl-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine2780I
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    Flualprazolam (8-chloro-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine)2785I
    Clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine2786I
    Flubromazolam (8-bromo-6-(2-fluorophenyl)-1-methyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine2788I
    Diclazepam (7-chloro-5-(2-chloro-5-(2-chlorophenyl)-1- methyl-1,3-dihydro-2H-benzo[e][1,4]diazepin-2-one2789I
    JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole)6250I
    SR-18 (Also known as RCS-8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole)7008I
    ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)7010I
    5-Fluoro-UR-144 and XLR11 ([1-(5-Fluoro-pentyl)1H-indol-3-yl] (2,2,3,3-tetramethylcyclopropyl)methanone)7011I
    AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide)7012I
    JWH-019 (1-Hexyl-3-(1-naphthoyl) indole)7019I
    MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)7020I
    FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3-methylbutanoate)7021I
    AB-PINACA (N-(1-amino-3-methyl- 1-oxobutan-2-yl)-1-pentyl-1H-indazole-)3-carboxamide7023I
    THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- yl](naphthalen-1-yl)methanone)7024I
    5F-AB-PINACA (N-(1-amino-3methyl-1-oxobutan-2-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)7025I
    AB-CHMINACA (N-(1-amino-3-methyl-1- oxobutan-2-yl)-1-(cyclohexylmethyl)- 1H-indazole-3-carboxamide)7031I
    MAB-CHMINACA (N-(1-amino-3,3dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide)7032I
    5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate)7033I
    5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate)7034I
    ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide)7035I
    Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido) 3,3-dimethylbutanoate)7036I
    MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate)7042I
    MMB-CHMICA, AMB-CHMICA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate)7044I
    N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboximide)7047I
    APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide)7048I
    5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide)7049I
    JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole)7081I
    1-(5-Fluoropentyl)-1H-indazole-3-carboxamide7083I
    5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2-phenylpropan-2-yl)-1H-pyrrolo[2,3-b]pyridine-3-carboxamide)7085I
    4-CN-CUMYL-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-carboximide)7089I
    SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole)7104I
    JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole)7118I
    JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole)7122I
    UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone)7144I
    JWH-073 (1-Butyl-3-(1-naphthoyl)indole)7173I
    JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole)7200I
    AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole)7201I
    JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole)7203I
    NM2201, CBL2201 (Naphthalen-1-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate)7221I
    PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3-carboxylate)7222I
    5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)-1H-indole-3-carboxylate)7225I
    4-methyl-alpha-ethylaminopentiophenone (4-MEAP)7245I
    N-ethylhexedrone7246I
    Alpha-ethyltryptamine7249I
    Ibogaine7260I
    CP-47,497 (5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl-phenol)7297I
    CP-47,497 C8 Homologue (5-(1,1-Dimethyloctyl)-2-[(1R,3S)3-hydroxycyclohexyl-phenol)7298I
    Lysergic acid diethylamide7315I
    2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7)7348I
    Marihuana extract7350I
    Marihuana7360I
    Tetrahydrocannabinols7370I
    Parahexyl7374I
    Mescaline7381I
    2C-T-2, (2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine)7385I
    3,4,5-Trimethoxyamphetamine7390I
    4-Bromo-2,5-dimethoxyamphetamine7391I
    4-Bromo-2,5-dimethoxyphenethylamine7392I
    4-Methyl-2,5-dimethoxyamphetamine7395I
    2,5-Dimethoxyamphetamine7396I
    JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole)7398I
    2,5-Dimethoxy-4-ethylamphetamine7399I
    3,4-Methylenedioxyamphetamine7400I
    5-Methoxy-3,4-methylenedioxyamphetamine7401I
    N-Hydroxy-3,4-methylenedioxyamphetamine7402I
    3,4-Methylenedioxy-N-ethylamphetamine7404I
    3,4-Methylenedioxymethamphetamine7405I
    4-Methoxyamphetamine7411I
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    5-Methoxy-N-N-dimethyltryptamine7431I
    Alpha-methyltryptamine7432I
    Bufotenine7433I
    Diethyltryptamine7434I
    Dimethyltryptamine7435I
    Psilocybin7437I
    Psilocyn7438I
    5-Methoxy-N,N-diisopropyltryptamine7439I
    4-chloro-alpha-pyrrolidinovalerophenone (4-chloro-a-PVP)7443I
    N-Ethyl-1-phenylcyclohexylamine7455I
    1-(1-Phenylcyclohexyl)pyrrolidine7458I
    1-[1-(2-Thienyl)cyclohexyl]piperidine7470I
    1-[1-(2-Thienyl)cyclohexyl]pyrrolidine7473I
    N-Ethyl-3-piperidyl benzilate7482I
    N-Methyl-3-piperidyl benzilate7484I
    N-Benzylpiperazine7493I
    4-MePPP (4-Methyl-alphapyrrolidinopropiophenone)7498I
    2C-D (2-(2,5-Dimethoxy-4-methylphenyl) ethanamine)7508I
    2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine)7509I
    2C-H (2-(2,5-Dimethoxyphenyl) ethanamine)7517I
    2C-I (2-(4-iodo-2,5-dimethoxyphenyl) ethanamine)7518I
    2C-C (2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine)7519I
    2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) ethanamine)7521I
    2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine)7524I
    2C-T-4 (2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine)7532I
    MDPV (3,4-Methylenedioxypyrovalerone)7535I
    25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine)7536I
    25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine)7537I
    25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine)7538I
    Methylone (3,4-Methylenedioxy-N-methylcathinone)7540I
    Butylone7541I
    Pentylone7542I
    N-Ethylpentylone, ephylone (1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one)7543I
    α-PHP, alpha-Pyrrolidinohexanophenone7544I
    α-PVP (alpha-pyrrolidinopentiophenone)7545I
    α-PBP (alpha-pyrrolidinobutiophenone)7546I
    PV8, alpha-Pyrrolidinoheptaphenone7548I
    AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole)7694I
    Norfentanyl8366I
    Acetyldihydrocodeine9051I
    Benzylmorphine9052I
    Codeine-N-oxide9053I
    Cyprenorphine9054I
    Desomorphine9055I
    Etorphine (except HCl)9056I
    Codeine methylbromide9070I
    Dihydromorphine9145I
    Difenoxin9168I
    Heroin9200I
    Hydromorphinol9301I
    Methyldesorphine9302I
    Methyldihydromorphine9304I
    Morphine methylbromide9305I
    Morphine methylsulfonate9306I
    Morphine-N-oxide9307I
    Myrophine9308I
    Nicocodeine9309I
    Nicomorphine9312I
    Normorphine9313I
    Pholcodine9314I
    Thebacon9315I
    Acetorphine9319I
    Drotebanol9335I
    U-47700 (3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide)9547I
    AH-7921 (3,4-dichloro-N-[(1-dimethylamino)cyclohexylmethyl]benzamide))9551I
    MT-45 (1-cyclohexyl-4-(1,2-diphenylethyl)piperazine))9560I
    Acetylmethadol9601I
    Allylprodine9602I
    Alphacetylmethadol except levo-alphacetylmethadol9603I
    Alphameprodine9604I
    Alphamethadol9605I
    Benzethidine9606I
    Betacetylmethadol9607I
    Betameprodine9608I
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    Betamethadol9609I
    Betaprodine9611I
    Clonitazene9612I
    Dextromoramide9613I
    Diampromide9615I
    Diethylthiambutene9616I
    Dimenoxadol9617I
    Dimepheptanol9618I
    Dimethylthiambutene9619I
    Dioxaphetyl butyrate9621I
    Dipipanone9622I
    Ethylmethylthiambutene9623I
    Etonitazene9624I
    Etoxeridine9625I
    Furethidine9626I
    Hydroxypethidine9627I
    Ketobemidone9628I
    Levomoramide9629I
    Levophenacylmorphan9631I
    Morpheridine9632I
    Noracymethadol9633I
    Norlevorphanol9634I
    Normethadone9635I
    Norpipanone9636I
    Phenadoxone9637I
    Phenampromide9638I
    Phenoperidine9641I
    Piritramide9642I
    Proheptazine9643I
    Properidine9644I
    Racemoramide9645I
    Trimeperidine9646I
    Phenomorphan9647I
    Propiram9649I
    1-Methyl-4-phenyl-4-propionoxypiperidine9661I
    1-(2-Phenylethyl)-4-phenyl-4-acetoxypiperidine9663I
    Tilidine9750I
    Acryl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide)9811I
    Para-Fluorofentanyl9812I
    3-Methylfentanyl9813I
    Alpha-Methylfentanyl9814I
    Acetyl-alpha-methylfentanyl9815I
    N-(2-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)propionamide9816I
    Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide)9821I
    Butyryl Fentanyl9822I
    Para-fluorobutyryl fentanyl9823I
    4-Fluoroisobutyryl fentanyl (N-(4-fluorophenyl)-N-(1-phenethylpiperidin-4-yl)isobutyramide)9824I
    2-methoxy-N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide9825I
    Para-chloroisobutyryl fentanyl9826I
    Isobutyryl fentanyl9827I
    Beta-hydroxyfentanyl9830I
    Beta-hydroxy-3-methylfentanyl9831I
    Alpha-methylthiofentanyl9832I
    3-Methylthiofentanyl9833I
    Furanyl fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylfuran-2-carboxamide)9834I
    Thiofentanyl9835I
    Beta-hydroxythiofentanyl9836I
    Para-methoxybutyryl fentanyl9837I
    Ocfentanil9838I
    Valeryl fentanyl9840I
    N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide)9843I
    Cyclopropyl Fentanyl9845I
    Cyclopentyl fentanyl9847I
    Fentanyl related-compounds as defined in 21 CFR 1308.11(h)9850I
    Amphetamine1100II
    Methamphetamine1105II
    Lisdexamfetamine1205II
    Phenmetrazine1631II
    Methylphenidate1724II
    Amobarbital2125II
    Pentobarbital2270II
    Secobarbital2315II
    Glutethimide2550II
    Dronabinol in an oral solution in a drug product approved for marketing by the U.S. Food and Drug Administration (FDA)7365II
    Start Printed Page 37251
    Nabilone7379II
    1-Phenylcyclohexylamine7460II
    Phencyclidine7471II
    ANPP (4-Anilino-N-phenethyl-4-piperidine)8333II
    Phenylacetone8501II
    1-Piperidinocyclohexanecarbonitrile8603II
    Alphaprodine9010II
    Anileridine9020II
    Cocaine9041II
    Codeine9050II
    Etorphine HCl9059II
    Dihydrocodeine9120II
    Oxycodone9143II
    Hydromorphone9150II
    Diphenoxylate9170II
    Ecgonine9180II
    Ethylmorphine9190II
    Hydrocodone9193II
    Levomethorphan9210II
    Levorphanol9220II
    Isomethadone9226II
    Meperidine9230II
    Meperidine-intermediate-A9232II
    Meperidine intermediate-B9233II
    Meperidine intermediate-C9234II
    Metazocine9240II
    Methadone9250II
    Methadone intermediate9254II
    Metopon9260II
    Dextropropoxyphene, bulk (non-dosage forms)9273II
    Morphine9300II
    Oripavine9330II
    Thebaine9333II
    Dihydroetorphine9334II
    Levo-alphacetylmethadol9648II
    Oxymorphone9652II
    Noroxymorphone9668II
    Phenazocine9715II
    Thiafentanil9729II
    Piminodine9730II
    Racemethorphan9732II
    Racemorphan9733II
    Alfentanil9737II
    Remifentanil9739II
    Sufentanil9740II
    Carfentanil9743II
    Tapentadol9780II
    Bezitramide9800II
    Fentanyl9801II
    Moramide-intermediate9802II

    The company plans to import analytical reference standards for distribution to its customers for research and analytics purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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.

    Start Signature

    Marsha Ikner,

    Acting Deputy Assistant Administrator.

    End Signature End Supplemental Information

    [FR Doc. 2024-09802 Filed 5-3-24; 8:45 am]

    BILLING CODE P

Document Information

Published:
05/06/2024
Department:
Drug Enforcement Administration
Entry Type:
Notice
Action:
Notice of application.
Document Number:
2024-09802
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 June 5, 2024. Such persons may also file a written request for a hearing on the application on or before June 5, 2024.
Pages:
37247-37251 (5 pages)
Docket Numbers:
Docket No. DEA-1358
PDF File:
2024-09802.pdf