Importer of Controlled Substances Application: Lipomed, 17623-17627 [2023-05916]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 88, Number 56 (Thursday, March 23, 2023)]
[Notices]
[Pages 17623-17627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05916]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 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 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):

------------------------------------------------------------------------
            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
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