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90 FR 80 pgs. 17615-17620 - Importer of Controlled Substances Application: Lipomed

Type: NOTICEVolume: 90Number: 80Pages: 17615 - 17620
Docket number: [Docket No. DEA-1533]
FR document: [FR Doc. 2025-07283 Filed 4-25-25; 8:45 am]
Agency: Justice Department
Sub Agency: Drug Enforcement Administration
Official PDF Version:  PDF Version
Pages: 17615, 17616, 17617

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-1533]

Importer of Controlled Substances Application: Lipomed

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 May 28, 2025. Such persons may also file a written request for a hearing on the application on or before May 28, 2025.

ADDRESSES:


[top] The Drug Enforcement Administration requires that all comments be submitted electronically through the Federal eRulemaking Portal, page 17616 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 March 21, 2025, 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):

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[top] 
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
Para-Methoxymethamphetamine (PMMA), 1-(4- 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
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- 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-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) 2785 I
Clonazolam (6-(2-chlorophenyl)-1-methyl-8-nitro-4H-benzo[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
(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-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
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
MMB-CHMICA, AMB-CHMICA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3-methylbutanoate) 7044 I
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)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
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, 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) 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-ethylhexedrone 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
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) 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
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
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
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
N-Ethylpentylone, ephylone (1-(1,3-benzodioxol-5-yl)-2-(ethylamino)-pentan-1-one) 7543 I
a-PHP, 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 (1-(1-(1-(4-bromophenyl)ethyl)piperidin-4-yl)- 1,3-dihydro-2H-benzo[d]imidazol-2-one) 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
Betacetylmethadol 9607 I
Betameprodine 9608 I
Betamethadol 9609 I
Betaprodine 9611 I
Clonitazene 9612 I
Dextromoramide 9613 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
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
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
Valeryl fentanyl 9840 I
N-(1-phenethylpiperidin-4-yl)-N-phenyltetrahydrofuran-2-carboxamide) 9843 I
Cyclopropyl Fentanyl 9845 I
Cyclopentyl fentanyl 9847 I
Fentanyl related compounds as defined in 21 CFR 1308.11(h) 9850 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
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 (N-phenyl-N-(piperidin-4-yl)propionamide) 8366 II
Phenylacetone 8501 II
1-Piperidinocyclohexanecarbonitrile 8603 II
Alphaprodine 9010 II
Anileridine 9020 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
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
Levo-alphacetylmethadol 9648 II
Oxymorphone 9652 II
Noroxymorphone 9668 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 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.

Matthew Strait,

Deputy Assistant Administrator.

[FR Doc. 2025-07283 Filed 4-25-25; 8:45 am]

BILLING CODE P