[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21764-21768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08535]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-821]


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 Supplemental Information 
listed below for further drug information.

DATES: Registered bulk manufacturers of the affected basic class(es), 
and applicants therefore, may file written comments on or objections to 
the issuance of the proposed registration on or before May 24, 2021. 
Such persons may also file a written request for a hearing on the 
application on or before May 24, 2021.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/DPW, 
8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a 
hearing must be sent to: Drug Enforcement Administration, Attn: 
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All 
request for a hearing should also 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.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this 
is notice that on February 26, 2021, 150 Cambridgepark Drive, Suite 
705, Cambridge, Massachusetts 02140, applied to be registered as an 
importer of the following basic class(es) of controlled substance(s):

[[Page 21765]]



------------------------------------------------------------------------
         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-                       1248  I
 methylcathinone).
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-                       6250  I
 methoxyphenylacetyl) indole).
SR-18 (Also known as RCS-8) (1-               7008  I
 Cyclohexylethyl-3-(2-
 methoxyphenylacetyl) indole).
ADB-FUBINACA (N-(1-amino-3,3-dimethyl-        7010  I
 1-oxobutan-2-yl)-1-(4-fluorobenzyl)-
 1H-indazole-3-carboxamide).
5-Fluoro-UR-144 and XLR11 ([1-(5-             7011  I
 Fluoro-pentyl)1H-indol-3-yl](2,2,3,3-
 tetramethylcyclopropyl)methanone).
AB-FUBINACA (N-(1-amino-3-methyl-1-           7012  I
 oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-
 indazole-3-carboxamide).
JWH-019 (1-Hexyl-3-(1-                        7019  I
 naphthoyl)indole).
MDMB-FUBINACA (Methyl 2-(1-(4-                7020  I
 fluorobenzyl)-1H-indazole-3-
 carboxamido)-3,3-dimethylbutanoate).
FUB-AMB, MMB-FUBINACA, AMB-FUBINACA           7021  I
 (2-(1-(4-fluorobenzyl)-1Hindazole-3-
 carboxamido)-3-methylbutanoate).
AB-PINACA (N-(1-amino-3-methyl-1-             7023  I
 oxobutan-2-yl)-1-pentyl-1H-indazole-
 )3-carboxamide.
THJ-2201 ([1-(5-fluoropentyl)-1H-             7024  I
 indazol-3-yl](naphthalen-1-
 yl)methanone).
5F-AB-PINACA (N-(1-amino-3methyl-1-           7025  I
 oxobutan-2-yl)-1-(5-fluoropentyl)-1H-
 indazole-3-carboxamide).
AB-CHMINACA (N-(1-amino-3-methyl-1--          7031  I
 oxobutan-2-yl)-1-(cyclohexylmethyl)--
 1H-indazole-3-carboxamide).
MAB-CHMINACA (N-(1-amino-3,3dimethyl-         7032  I
 1-oxobutan-2-yl)-1-
 (cyclohexylmethyl)-1H-indazole-3-
 carboxamide).
5F-AMB (Methyl 2-(1-(5-fluoropentyl)-         7033  I
 1H-indazole-3-carboxamido)-3-
 methylbutanoate).
5F-ADB; 5F-MDMB-PINACA (Methyl 2-(1-          7034  I
 (5-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-               7036  I
 indazole-3-carboxamido) 3,3-
 dimethylbutanoate).
MDMB-CHMICA, MMB-CHMINACA (Methyl 2-          7042  I
 (1-(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)-        7047  I
 1H-indazole-3-carboximide).
APINACA and AKB48 (N-(1-Adamantyl)-1-         7048  I
 pentyl-1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-         7049  I
 yl)-1-(5-fluoropentyl)-1H-indazole-3-
 carboxamide).
JWH-081 (1-Pentyl-3-(1-(4-                    7081  I
 methoxynaphthoyl) indole).
1-(5-Fluoropentyl)-1H-indazole-3-             7083  I
 carboxamide.
5F-CUMYL-P7AICA (1-(5-fluoropentyl)-N-        7085  I
 (2-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-        7104  I
 3-[(4-methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-             7118  I
 Pentyl-3-(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1-              7122  I
 naphthoyl) indole).
UR-144 (1-Pentyl-1H-indol-3-                  7144  I
 yl)(2,2,3,3-
 tetramethylcyclopropyl)methanone).
JWH-073 (1-Butyl-3-(1-                        7173  I
 naphthoyl)indole).
JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-        7200  I
 (1-naphthoyl)indole).
AM2201 (1-(5-Fluoropentyl)-3-(1-              7201  I
 naphthoyl) indole).
JWH-203 (1-Pentyl-3-(2-                       7203  I
 chlorophenylacetyl) indole).
NM2201, CBL2201 (Naphthalen-1-yl 1-(5-        7221  I
 fluoropentyl)-1H-indole-3-
 carboxylate).
PB-22 (Quinolin-8-yl 1-pentyl-1H-             7222  I
 indole-3-carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5-                 7225  I
 fluoropentyl)-1H-indole-3-
 carboxylate).
4-methyl-alpha-                               7245  I
 ethylaminopentiophenone (4-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-              7398  I
 naphthoyl) indole).

[[Page 21766]]

 
2,5-Dimethoxy-4-ethylamphetamine.....         7399  I
3,4-Methylenedioxyamphetamine........         7400  I
5-Methoxy-3,4-                                7401  I
 methylenedioxyamphetamine.
N-Hydroxy-3,4-                                7402  I
 methylenedioxyamphetamine.
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-                               7443  I
 pyrrolidinovalerophenone (4-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-                                      7473  I
 Thienyl)cyclohexyl]pyrrolidine.
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-                     7508  I
 methylphenyl) ethanamine).
2C-E (2-(2,5-Dimethoxy-4-ethylphenyl)         7509  I
 ethanamine).
2C-H (2-(2,5-Dimethoxyphenyl)                 7517  I
 ethanamine).
2C-I (2-(4-iodo-2,5-dimethoxyphenyl)          7518  I
 ethanamine).
2C-C (2-(4-Chloro-2,5-                        7519  I
 dimethoxyphenyl) ethanamine).
2C-N (2-(2,5-Dimethoxy-4-nitro-               7521  I
 phenyl) ethanamine).
2C-P (2-(2,5-Dimethoxy-4-(n)-                 7524  I
 propylphenyl) 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-                    7536  I
 dimethoxyphenyl)-N-(2-methoxybenzyl)
 ethanamine).
25C-NBOMe (2-(4-chloro-2,5-                   7537  I
 dimethoxyphenyl)-N-(2-methoxybenzyl)
 ethanamine).
25I-NBOMe (2-(4-iodo-2,5-                     7538  I
 dimethoxyphenyl)-N-(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-                           7544  I
 Pyrrolidinohexanophenone.
[alpha]-PVP (alpha-                           7545  I
 pyrrolidinopentiophenone).
[alpha]-PBP (alpha-                           7546  I
 pyrrolidinobutiophenone).
PV8, alpha-Pyrrolidinoheptaphenone...         7548  I
AM-694 (1-(5-Fluoropentyl)-3-(2-              7694  I
 iodobenzoyl) indole).
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]benza
 mide)).
MT-45 (1-cyclohexyl-4-(1,2-                   9560  I
 diphenylethyl)piperazine)).
Acetylmethadol.......................         9601  I

[[Page 21767]]

 
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-                          9661  I
 propionoxypiperidine.
1-(2-Phenylethyl)-4-phenyl-4-                 9663  I
 acetoxypiperidine.
Tilidine.............................         9750  I
Acryl fentanyl (N-(1-                         9811  I
 phenethylpiperidin-4-yl)-N-
 phenylacrylamide).
Para-Fluorofentanyl..................         9812  I
3-Methylfentanyl.....................         9813  I
Alpha-Methylfentanyl.................         9814  I
Acetyl-alpha-methylfentanyl..........         9815  I
N-(2-fluorophenyl)-N-(1-                      9816  I
 phenethylpiperidin-4-yl)propionamide.
Acetyl Fentanyl (N-(1-                        9821  I
 phenethylpiperidin-4-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-          9825  I
 yl)-N-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-                       9834  I
 phenethylpiperidin-4-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         9850  I
 in 21 CFR 1308.11(h).
Amphetamine..........................         1100  II
Methamphetamine......................         1105  II
Lisdexamfetamine.....................         1205  II

[[Page 21768]]

 
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           7365  II
 drug 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-                8333  II
 piperidine).
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          9273  II
 forms).
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. 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 FDA-approved or non-approved finished dosage 
forms for commercial sale.

William T. McDermott,
Assistant Administrator.
[FR Doc. 2021-08535 Filed 4-22-21; 8:45 am]
BILLING CODE 4410-09-P