[Federal Register Volume 84, Number 127 (Tuesday, July 2, 2019)]
[Notices]
[Pages 31622-31627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14026]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Importer of Controlled Substances Application: Lipomed
ACTION: Notice of application.
-----------------------------------------------------------------------
DATES: Registered bulk manufacturers of the affected basic classes, and
applicants therefore, may file written comments on or objections to the
issuance of the proposed registration on or before August 1, 2019. Such
persons may also file a written request for a hearing on the
application on or before August 1, 2019.
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
hearing must be sent to: Drug Enforcement Administration, Attn:
Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All
requests for 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
[[Page 31623]]
Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia
22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.34(a), this
is notice that on March 28, 2019, Lipomed, 150 Cambridge Park Drive,
Suite 705, Cambridge, Massachusetts 02140 applied to be registered as
an importer of the following basic classes of controlled substances:
------------------------------------------------------------------------
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- 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-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- 7012 I
oxobutan-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- 7020 I
fluorobenzyl)-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- 7023 I
2-yl)-1-pentyl-1H-indazole-3-
carboxamide).
THJ-2201 ([1-(5-fluoropentyl)-1H-indazol- 7024 I
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-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).
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).
APINACA and AKB48 (N-(1-Adamantyl)-1- 7048 I
pentyl-1H-indazole-3-carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan-1-yl)- 7049 I
1-(5-fluoropentyl)-1H-indazole-3-
carboxamide).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
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- 7104 I
[(4-methoxy)-benzoyl] indole).
JWH-018 (also known as AM678) (1-Pentyl-3- 7118 I
(1-naphthoyl)indole).
JWH-122 (1-Pentyl-3-(4-methyl-1- 7122 I
naphthoyl) 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- 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-indole-3- 7222 I
carboxylate).
5F-PB-22 (Quinolin-8-yl 1-(5- 7225 I
fluoropentyl)-1H-indole-3-carboxylate).
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
[[Page 31624]]
2,5-Dimethoxyamphetamine................. 7396 I
JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I
naphthoyl) 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
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)- 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-dimethoxyphenyl)- 7538 I
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]-PVP (alpha- 7545 I
pyrrolidinopentiophenone).
[alpha]-PBP (alpha- 7546 I
pyrrolidinobutiophenone).
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).
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.
[[Page 31625]]
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).
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-phenethylpiperidin- 9821 I
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-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- 9834 I
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 in 9850 I
21 CFR 1308.11(h).
Amphetamine.............................. 1100 II
Methamphetamine.......................... 1105 II
Lisdexamfetamine......................... 1205 II
Phenmetrazine............................ 1631 II
Methylphenidate.......................... 1724 II
[[Page 31626]]
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.
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 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
------------------------------------------------------------------------
[[Page 31627]]
The company plans to import analytical reference standards for
distribution to its customers for research and analytical 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.
Dated: June 18, 2019.
John J. Martin,
Assistant Administrator.
[FR Doc. 2019-14026 Filed 7-1-19; 8:45 am]
BILLING CODE 4410-09-P