[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45519-45523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18681]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Bulk Manufacturer of Controlled Substances Application:
Cerilliant Corporation
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 October 28, 2019.
ADDRESSES: Written comments should be sent to: Drug Enforcement
Administration, Attention: DEA Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, Virginia 22152.
SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 1301.33(a), this
is notice that on July 15, 2019, Cerilliant Corporation, 811 Paloma
Drive, Suite A, Round Rock, Texas 78665-2402 applied to be registered
as a bulk manufacturer of the following basic classes of controlled
substances:
[[Page 45520]]
------------------------------------------------------------------------
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
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- 7010 I
dimethyl-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).
FUB-144 (1-(4-fluorobenzyl)-1H- 7014 I
indol-3-yl)(2,2,3,3-
tetramethylcyclopropyl)methanone).
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- 7021 I
FUBINACA (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-3-methyl-1- 7025 I
oxobutan-2-yl)-1-(5-fluropentyl)-
1H-indazole-3-carboximide).
AB-CHMINACA (N-(1-amino-3-methyl-1- 7031 I
oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
MAB-CHMINACA (N-(1-amino- 7032 I
3,3dimethyl-1-oxobutan-2-yl)-1-
(cyclohexylmethyl)-1H-indazole-3-
carboxamide).
5F-AMB (Methyl 2-(1-(5- 7033 I
fluoropentyl)-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- 7035 I
1-oxobutan-2-yl)-1-pentyl-1H-
indazole-3-carboxamide).
5F-EDMB-PINACA (ethyl 2-(1-(5- 7036 I
fluoropentyl)-1H-indazole-3-
carboxamido)-3,3-
dimethylbutanoate).
5F-MDMB-PICA (methyl 2-(1-(5- 7041 I
fluoropentyl)-1H-indole-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).
FUB-AKB48, FUB-APINACA, AKB48 N-(4- 7047 I
FLUOROBENZYL) (N-(adamantan-1-yl)-
1-(4-fluorobenzyl)-1H-indazole-3-
carboximide).
APINACA and AKB48 (N-(1-Adamantyl)- 7048 I
1-pentyl-1H-indazole-3-
carboxamide).
5F-APINACA, 5F-AKB48 (N-(adamantan- 7049 I
1-yl)-1-(5-fluoropentyl)-1H-
indazole-3-carboxamide).
JWH-081 (1-Pentyl-3-(1-(4- 7081 I
methoxynaphthoyl) indole).
5F-CUMYL-PINACA, 5GT-25 (1-(5- 7083 I
fluoropentyl)-N-(2-phenylpropan-2-
yl)-1H-indazole-3-carboxamide).
5F-CUMYL-P7AICA (1-(5-fluoropentyl)- 7085 I
N-(2-phenylpropan-2-yl)-1H-
pyrrolo[2,3-b]pyridine-3-
carboxamide).
4-CN-CUML-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-carboxamide).
SR-19 (Also known as RCS-4) (1- 7104 I
Pentyl-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]- 7200 I
3-(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- 7221 I
(5-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-MEAP (4-Methyl-alpha- 7245 I
ethylaminopentiophenone).
N-Ethylhexedrone................... 7246 I
Alpha-ethyltryptamine.............. 7249 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
2C-T-7 (2,5-Dimethoxy-4-(n)- 7348 I
propylthiophenethylamine.
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 45521]]
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- 7401 I
methylenedioxyamphetamine.
N-Hydroxy-3,4- 7402 I
methylenedioxyamphetamine.
3,4-Methylenedioxy-N- 7404 I
ethylamphetamine.
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.
MPHP, 4'-Methyl-alpha- 7446 I
pyrrolidinohexiophenone.
N-Ethyl-1-phenylcyclohexylamine.... 7455 I
1-(1-Phenylcyclohexyl)pyrrolidine.. 7458 I
1-[1-(2- 7470 I
Thienyl)cyclohexyl]piperidine.
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- 7509 I
ethylphenyl) 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- 7535 I
Methylenedioxypyrovalerone).
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-Ethypentylone, ephylone (1-(1,3- 7543 I
benzodioxol-5-yl)-2-(ethylamino)-
pentan-1-one).
[alpha]-PHP, alpha- 7544 I
Pyrrolidinohexanophenone.
alpha-pyrrolidinopentiophenone 7545 I
([alpha]-PVP).
alpha-pyrrolidinobutiophenone 7546 I
([alpha]-PBP).
PV8, alpha-Pyrrolidinoheptaphenone. 7548 I
AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I
iodobenzoyl) indole).
Acetyldihydrocodeine............... 9051 I
Benzylmorphine..................... 9052 I
Codeine-N-oxide.................... 9053 I
Desomorphine....................... 9055 I
Codeine methylbromide.............. 9070 I
Dihydromorphine.................... 9145 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
Normorphine........................ 9313 I
Pholcodine......................... 9314 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]ben
zamide)).
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
Betacetylmethadol.................. 9607 I
Betameprodine...................... 9608 I
Betamethadol....................... 9609 I
Betaprodine........................ 9611 I
Dipipanone......................... 9622 I
Hydroxypethidine................... 9627 I
[[Page 45522]]
Noracymethadol..................... 9633 I
Norlevorphanol..................... 9634 I
Normethadone....................... 9635 I
Trimeperidine...................... 9646 I
Phenomorphan....................... 9647 I
1-Methyl-4-phenyl-4- 9661 I
propionoxypiperidine.
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 9850 I
defined in 21 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
Nabilone........................... 7379 II
1-Phenylcyclohexylamine............ 7460 II
Phencyclidine...................... 7471 II
ANPP (4-Anilino-N-phenethyl-4- 8333 II
piperidine).
1-Piperidinocyclohexanecarbonitrile 8603 II
Alphaprodine....................... 9010 II
Cocaine............................ 9041 II
Codeine............................ 9050 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
Dextropropoxyphene, bulk (non- 9273 II
dosage forms).
Morphine........................... 9300 II
Thebaine........................... 9333 II
Levo-alphacetylmethadol............ 9648 II
Oxymorphone........................ 9652 II
Noroxymorphone..................... 9668 II
[[Page 45523]]
Thiafentanil....................... 9729 II
Racemethorphan..................... 9732 II
Alfentanil......................... 9737 II
Remifentanil....................... 9739 II
Sufentanil......................... 9740 II
Carfentanil........................ 9743 II
Tapentadol......................... 9780 II
Fentanyl........................... 9801 II
------------------------------------------------------------------------
The company plans to manufacture small quantities of the listed
controlled substances to make reference standards which will be
distributed to its customers.
Dated: August 9, 2019.
Neil D. Doherty,
Acting Assistant Administrator.
[FR Doc. 2019-18681 Filed 8-28-19; 8:45 am]
BILLING CODE 4410-09-P