Notice2023-05916
Importer of Controlled Substances Application: Lipomed
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 23, 2023
Issuing agencies
Justice DepartmentDrug Enforcement Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 56 (Thursday, March 23, 2023)</title>
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[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17623-17627]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-05916]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-1159]
Importer of Controlled Substances Application: Lipomed
AGENCY: Drug Enforcement Administration, Justice.
ACTION: Notice of application.
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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
April 24, 2023. Such persons may also file a written request for a
hearing on the application on or before April 24, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 February 9, 2023 Lipomed, 150 Cambridepark 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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Controlled substance Drug code Schedule
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3-Fluoro-N-methylcathinone (3-FMC)......... 1233 I
Cathinone.................................. 1235 I
Methcathinone.............................. 1237 I
4-Fluoro-N-methylcathinone (4-FMC)......... 1238 I
Pentedrone ([alpha]- 1246 I
methylaminovalerophenone).
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
Gamma Hydroxybutyric Acid.................. 2010 I
Methaqualone............................... 2565 I
Mecloqualone............................... 2572 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) 6250 I
indole).
SR-18 (Also known as RCS-8) (1- 7008 I
Cyclohexylethyl-3-(2-methoxyphenylacetyl)
indole).
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1- 7010 I
oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 ([1-(5-Fluoro- 7011 I
pentyl)1H-indol-3-yl](2,2,3,3-
tetramethylcyclopropyl)methanone).
AB-FUBINACA (N-(1-amino-3-methyl-1-oxobutan- 7012 I
2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-
carboxamide).
JWH-019 (1-Hexyl-3-(1-naphthoyl)indole).... 7019 I
MDMB-FUBINACA (Methyl 2-(1-(4-fluorobenzyl)- 7020 I
1H-indazole-3-carboxamido)-3,3-
dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA (2-(1- 7021 I
(4-fluorobenzyl)-1Hindazole-3-carboxamido)-
3-methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-oxobutan-2- 7023 I
yl)-1-pentyl-1H-indazole-)3-carboxamide.
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3- 7024 I
yl](naphthalen-1-yl)methanone).
5F-AB-PINACA (N-(1-amino-3methyl-1-oxobutan- 7025 I
2-yl)-1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1-oxobutan- 7031 I
2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-1- 7032 I
oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-
indazole-3-carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-1H- 7033 I
indazole-3-carboxamido)-3-methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-(5- 7034 I
fluoropentyl)-1H-indazole-3-carboxamido)-
3,3-dimethylbutanoate).
ADB-PINACA (N-(1-amino-3,3-dimethyl-1- 7035 I
oxobutan-2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
Ethyl 2-(1-(5-fluoropentyl)-1H-indazole-3- 7036 I
carboxamido) 3,3-dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-(1- 7042 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3,3-dimethylbutanoate).
MMB-CHMICA, AMB-CHMICA (methyl 2-(1- 7044 I
(cyclohexylmethyl)-1H-indole-3-
carboxamido)-3-methylbutanoate).
N-(Adamantan-1-yl)-1-(4-fluorobenzyl)-1H- 7047 I
indazole-3-carboximide).
APINACA and AKB48 (N-(1-Adamantyl)-1-pentyl- 7048 I
1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)-1- 7049 I
(5-fluoropentyl)-1H-indazole-3-
carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) 7081 I
indole).
1-(5-Fluoropentyl)-1H-indazole-3- 7083 I
carboxamide.
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-(2- 7085 I
phenylpropan-2-yl)-1H-pyrrolo[2,3-
b]pyridine-3-carboxamide).
4-CN-CUMYL-BUTINACA, 4-cyano-CUMYL- 7089 I
BUTINACA, 4-CN-CUMYL BINACA, CUMYL-4CN-
BINACA, SGT-78 (1-(4-cyanobutyl)-N-(2-
phenylpropan-2-yl)-1H-indazole-3-
carboximide).
SR-19 (Also known as RCS-4) (1-Pentyl-3-[(4- 7104 I
methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).
[[Page 17624]]
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) 7122 I
indole).
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3- 7144 I
tetramethylcyclopropyl)methanone).
JWH-073 (1-Butyl-3-(1-naphthoyl)indole).... 7173 I
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1- 7200 I
naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) 7201 I
indole).
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) 7203 I
indole).
NM2201, CBL2201 (Naphthalen-1-yl 1-(5- 7221 I
fluoropentyl)-1H-indole-3-carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H-indole-3- 7222 I
carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-fluoropentyl)- 7225 I
1H-indole-3-carboxylate).
4-methyl-alpha-ethylaminopentiophenone (4- 7245 I
MEAP).
N-ethylhexedrone........................... 7246 I
Alpha-ethyltryptamine...................... 7249 I
Ibogaine................................... 7260 I
CP-47,497 (5-(1,1-Dimethylheptyl)-2- 7297 I
[(1R,3S)-3-hydroxycyclohexyl-phenol).
CP-47,497 C8 Homologue (5-(1,1- 7298 I
Dimethyloctyl)-2-[(1R,3S)3-
hydroxycyclohexyl-phenol).
Lysergic acid diethylamide................. 7315 I
2,5-Dimethoxy-4-(n)- 7348 I
propylthiophenethylamine (2C-T-7).
Marihuana extract.......................... 7350 I
Marihuana.................................. 7360 I
Tetrahydrocannabinols...................... 7370 I
Parahexyl.................................. 7374 I
Mescaline.................................. 7381 I
2C-T-2, (2-(4-Ethylthio-2,5- 7385 I
dimethoxyphenyl) ethanamine).
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) 7398 I
indole).
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- 7443 I
chloro-a-PVP).
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- 7498 I
alphapyrrolidinopropiophenone).
2C-D (2-(2,5-Dimethoxy-4-methylphenyl) 7508 I
ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I
ethanamine).
2C-H (2-(2,5-Dimethoxyphenyl) ethanamine).. 7517 I
2C-I (2-(4-iodo-2,5-dimethoxyphenyl) 7518 I
ethanamine).
2C-C (2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I
ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-phenyl) 7521 I
ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)-propylphenyl) 7524 I
ethanamine).
2C-T-4 (2-(4-Isopropylthio)-2,5- 7532 I
dimethoxyphenyl) ethanamine).
MDPV (3,4-Methylenedioxypyrovalerone)...... 7535 I
25B-NBOMe (2-(4-bromo-2,5-dimethoxyphenyl)- 7536 I
N-(2-methoxybenzyl) ethanamine).
25C-NBOMe (2-(4-chloro-2,5-dimethoxyphenyl)- 7537 I
N-(2-methoxybenzyl) ethanamine).
25I-NBOMe (2-(4-iodo-2,5-dimethoxyphenyl)-N- 7538 I
(2-methoxybenzyl) ethanamine).
Methylone (3,4-Methylenedioxy-N- 7540 I
methylcathinone).
Butylone................................... 7541 I
Pentylone.................................. 7542 I
N-Ethylpentylone, ephylone (1-(1,3- 7543 I
benzodioxol-5-yl)-2-(ethylamino)-pentan-1-
one).
[alpha]-PHP, alpha-Pyrrolidinohexanophenone 7544 I
[alpha]-PVP (alpha- 7545 I
pyrrolidinopentiophenone).
[alpha]-PBP (alpha-pyrrolidinobutiophenone) 7546 I
PV8, alpha-Pyrrolidinoheptaphenone......... 7548 I
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).
[[Page 17625]]
Norfentanyl................................ 8366 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
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- 9547 I
(dimethylamino)cyclohexyl]-N-
methylbenzamide).
AH-7921 (3,4-dichloro-N-[(1- 9551 I
dimethylamino)cyclohexylmethyl]benzamide)).
MT-45 (1-cyclohexyl-4-(1,2- 9560 I
diphenylethyl)piperazine)).
Acetylmethadol............................. 9601 I
Allylprodine............................... 9602 I
Alphacetylmethadol except levo- 9603 I
alphacetylmethadol.
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- 9663 I
acetoxypiperidine.
Tilidine................................... 9750 I
Acryl fentanyl (N-(1-phenethylpiperidin-4- 9811 I
yl)-N-phenylacrylamide).
[[Page 17626]]
Para-Fluorofentanyl........................ 9812 I
3-Methylfentanyl........................... 9813 I
Alpha-Methylfentanyl....................... 9814 I
Acetyl-alpha-methylfentanyl................ 9815 I
N-(2-fluorophenyl)-N-(1-phenethylpiperidin- 9816 I
4-yl)propionamide.
Acetyl Fentanyl (N-(1-phenethylpiperidin-4- 9821 I
yl)-N-phenylacetamide).
Butyryl Fentanyl........................... 9822 I
Para-fluorobutyryl fentanyl................ 9823 I
4-Fluoroisobutyryl fentanyl (N-(4- 9824 I
fluorophenyl)-N-(1-phenethylpiperidin-4-
yl)isobutyramide).
2-methoxy-N-(1-phenethylpiperidin-4-yl)-N- 9825 I
phenylacetamide.
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- 9834 I
yl)-N-phenylfuran-2-carboxamide).
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- 9843 I
phenyltetrahydrofuran-2-carboxamide).
Cyclopropyl Fentanyl....................... 9845 I
Cyclopentyl fentanyl....................... 9847 I
Fentanyl related-compounds as defined in 21 9850 I
CFR 1308.11(h).
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 7365 II
product approved for marketing by the U.S.
Food and Drug Administration (FDA).
Nabilone................................... 7379 II
1-Phenylcyclohexylamine.................... 7460 II
Phencyclidine.............................. 7471 II
ANPP (4-Anilino-N-phenethyl-4-piperidine).. 8333 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
[[Page 17627]]
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. Approval of permit applications will
occur only when the registrant's business activity is consistent with
what is authorized in 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. 2023-05916 Filed 3-22-23; 8:45 am]
BILLING CODE P
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</html>Indexed from Federal Register on March 23, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.