83 FR 34875 - Importer of Controlled Substances Application: VHG Labs DBA LGC Standards
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 83, Issue 141 (July 23, 2018)
Drug Enforcement Administration
Federal Register Volume 83, Issue 141 (July 23, 2018)
| Page Range | 34875-34876 | |
| FR Document | 2018-15721 |
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)] [Notices] [Pages 34875-34876] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-15721] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-392] Importer of Controlled Substances Application: VHG Labs DBA LGC Standards 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 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 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 request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (``Assistant Administrator'') pursuant to section 7 of 28 CFR part 0, appendix to subpart R. In accordance with 21 CFR 1301.34(a), this is notice that on April 13, 2018, VHG Labs DBA LGC Standards, 3 Perimeter Road, Manchaster NH 03103 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- 1233 I FMC). Cathinone....................... 1235 I Methcathinone................... 1237 I 4-Fluoro-N-methylcathinone (4- 1238 I FMC). Pentedrone ([alpha]- 1246 I methylaminovalerophenone). Mephedrone (4-Methyl-N- 1248 I methylcathinone). 4-Methyl-N-ethylcathinone (4- 1249 I MEC). Naphyrone....................... 1258 I N-Ethylamphetamine.............. 1475 I 4-Methylaminorex (cis isomer)... 1590 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). APINACA and AKB48 N-(1- 7048 I Adamantyl)-1-pentyl-1H-indazole- 3-carboxamide. JWH-081 (1-Pentyl-3-(1-(4- 7081 I methoxynaphthoyl) indole). 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)methanon e. AM2201 (1-(5-Fluoropentyl)-3-(1- 7201 I naphthoyl) indole). JWH-203 (1-Pentyl-3-(2- 7203 I chlorophenylacetyl) indole). Ibogaine........................ 7260 I Lysergic acid diethylamide...... 7315 I 2,5-Dimethoxy-4-(n)- 7348 I propylthiophenethylamine (2C-T- 7). Marihuana....................... 7360 I Mescaline....................... 7381 I 2-(4-Ethylthio-2,5- 7385 I dimethoxyphenyl) ethanamine (2C- T-2 ). [[Page 34876]] 4-Bromo-2,5-dimethoxyamphetamine 7391 I 4-Bromo-2,5- 7392 I dimethoxyphenethylamine. JWH-398 (1-Pentyl-3-(4-chloro-1- 7398 I naphthoyl) indole). 3,4-Methylenedioxyamphetamine... 7400 I N-Hydroxy-3,4- 7402 I methylenedioxyamphetamine. 3,4-Methylenedioxy-N- 7404 I ethylamphetamine. 3,4- 7405 I Methylenedioxymethamphetamine. 4-Methoxyamphetamine............ 7411 I 5-Methoxy-N-N-dimethyltryptamine 7431 I Alpha-methyltryptamine.......... 7432 I Bufotenine...................... 7433 I Dimethyltryptamine.............. 7435 I Psilocyn........................ 7438 I N-Benzylpiperazine.............. 7493 I 4-Methyl- 7498 I alphapyrrolidinopropiophenone (4-MePPP). 2-(2,5-Dimethoxy-4-ethylphenyl) 7509 I ethanamine (2C-E ). 2-(4-iodo-2,5-dimethoxyphenyl) 7518 I ethanamine (2C-I). 2-(4-Chloro-2,5-dimethoxyphenyl) 7519 I ethanamine (2C-C). MDPV (3,4- 7535 I Methylenedioxypyrovalerone). 2-(4-chloro-2,5-dimethoxyphenyl)- 7537 I N-(2-methoxybenzyl) ethanamine (25C-NBOMe). Methylone (3,4-Methylenedioxy-N- 7540 I methylcathinone). Butylone........................ 7541 I Pentylone....................... 7542 I alpha-pyrrolidinopentiophenone 7545 I ([alpha]-PVP). AM-694 (1-(5-Fluoropentyl)-3-(2- 7694 I iodobenzoyl) indole). Codeine-N-oxide................. 9053 I Desomorphine.................... 9055 I Dihydromorphine................. 9145 I Heroin.......................... 9200 I Morphine-N-oxide................ 9307 I Normorphine..................... 9313 I Pholcodine...................... 9314 I Dipipanone...................... 9622 I Properidine..................... 9644 I Tilidine........................ 9750 I Alpha-methylfentanyl............ 9814 I Methamphetamine................. 1105 II Phenmetrazine................... 1631 II Amobarbital..................... 2125 II Pentobarbital................... 2270 II Secobarbital.................... 2315 II Glutethimide.................... 2550 II Phencyclidine................... 7471 II Phenylacetone................... 8501 II Alphaprodine.................... 9010 II Dihydrocodeine.................. 9120 II Diphenoxylate................... 9170 II Ecgonine........................ 9180 II Ethylmorphine................... 9190 II Levorphanol..................... 9220 II Isomethadone.................... 9226 II Meperidine...................... 9230 II Meperidine intermediate-B....... 9233 II Meperidine intermediate-C....... 9234 II Dextropropoxyphene, bulk (non- 9273 II dosage forms). 14-Hydroxmorphone............... 9665 II Noroxymorphone.................. 9668 II Remifentanil.................... 9739 II Sufentanil...................... 9740 II ------------------------------------------------------------------------ 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 substance. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 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: July 12, 2018. John J. Martin, Assistant Administrator. [FR Doc. 2018-15721 Filed 7-20-18; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices 34875
Administration, Attn: Administrator, Drug 22152. All requests for hearing must be
Controlled substance Schedule
8701 Morrissette Drive, Springfield, code sent to: Drug Enforcement
Virginia 22152. All request for hearing Administration, Attn: Administrator,
Gamma Hydroxybutyric 2010 I 8701 Morrissette Drive, Springfield,
should also be sent to: (1) Drug
Acid. Virginia 22152. All request for hearing
Enforcement Administration, Attn:
Hearing Clerk/LJ, 8701 Morrissette should also be sent to: (1) Drug
The company plans to import finished
Drive, Springfield, Virginia 22152; and Enforcement Administration, Attn:
dosage unit products containing gamma-
(2) Drug Enforcement Administration, Hearing Clerk/LJ, 8701 Morrissette
hydroxybutyric acid for clinical trials,
Attn: DEA Federal Register Drive, Springfield, Virginia 22152; and
research, and analytical activities.
Representative/DRW, 8701 Morrissette (2) Drug Enforcement Administration,
Dated: July 12, 2018 Attn: DEA Federal Register
Drive, Springfield, Virginia 22152. John J. Martin, Representative/DRW, 8701 Morrissette
SUPPLEMENTARY INFORMATION: The Assistant Administrator. Drive, Springfield, Virginia 22152.
Attorney General has delegated his [FR Doc. 2018–15719 Filed 7–20–18; 8:45 am]
SUPPLEMENTARY INFORMATION: The
authority under the Controlled BILLING CODE 4410–09–P Attorney General has delegated his
Substances Act to the Administrator of authority under the Controlled
the Drug Enforcement Administration Substances Act to the Administrator of
(DEA), 28 CFR 0.100(b). Authority to DEPARTMENT OF JUSTICE
the Drug Enforcement Administration
exercise all necessary functions with (DEA), 28 CFR 0.100(b). Authority to
Drug Enforcement Administration
respect to the promulgation and exercise all necessary functions with
implementation of 21 CFR part 1301, [Docket No. DEA–392] respect to the promulgation and
incident to the registration of implementation of 21 CFR part 1301,
manufacturers, distributors, dispensers, Importer of Controlled Substances
incident to the registration of
Application: VHG Labs DBA LGC
importers, and exporters of controlled manufacturers, distributors, dispensers,
Standards
substances (other than final orders in importers, and exporters of controlled
connection with suspension, denial, or ACTION: Notice of application. substances (other than final orders in
revocation of registration) has been connection with suspension, denial, or
delegated to the Assistant Administrator DATES: Registered bulk manufacturers of revocation of registration) has been
of the DEA Diversion Control Division the affected basic classes, and redelegated to the Assistant
(‘‘Assistant Administrator’’) pursuant to applicants therefore, may file written Administrator of the DEA Diversion
section 7 of 28 CFR part 0, appendix to comments on or objections to the Control Division (‘‘Assistant
subpart R. issuance of the proposed registration on Administrator’’) pursuant to section 7 of
or before August 22, 2018. Such persons 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR may also file a written request for a In accordance with 21 CFR
1301.34(a), this is notice that on June hearing on the application on or before 1301.34(a), this is notice that on April
18, 2018, Catalent Pharma Solutions, August 22, 2018. 13, 2018, VHG Labs DBA LGC
LLC, 3031 Red Lion Road, Philadelphia, ADDRESSES: Written comments should Standards, 3 Perimeter Road,
Pennsylvania 19114, applied to be be sent to: Drug Enforcement Manchaster NH 03103 applied to be
registered as an importer of the Administration, Attention: DEA Federal registered as an importer of the
following basic class of controlled Register Representative/DRW, 8701 following basic classes of controlled
substance: Morrissette Drive, Springfield, Virginia 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 (a-methylaminovalerophenone) ........................................................................................................... 1246 I
Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................ 1248 I
4-Methyl-N-ethylcathinone (4-MEC) ........................................................................................................................ 1249 I
Naphyrone ............................................................................................................................................................... 1258 I
N-Ethylamphetamine ............................................................................................................................................... 1475 I
4-Methylaminorex (cis isomer) ................................................................................................................................ 1590 I
Methaqualone .......................................................................................................................................................... 2565 I
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ........................................................................................... 6250 I
SR-18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ........................................ 7008 I
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ...................................................... 7048 I
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) ........................................................................................... 7081 I
SR-19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole ............................................................. 7104 I
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ...................................................................... 7118 I
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) .............................................................................................. 7122 I
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone .......................................................... 7144 I
amozie on DSK3GDR082PROD with NOTICES1
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ............................................................................................... 7201 I
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) .............................................................................................. 7203 I
Ibogaine ................................................................................................................................................................... 7260 I
Lysergic acid diethylamide ...................................................................................................................................... 7315 I
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) ........................................................................................ 7348 I
Marihuana ................................................................................................................................................................ 7360 I
Mescaline ................................................................................................................................................................ 7381 I
2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2 ) .................................................................................... 7385 I
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![34876 Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
Controlled substance Drug code Schedule
4-Bromo-2,5-dimethoxyamphetamine ..................................................................................................................... 7391 I
4-Bromo-2,5-dimethoxyphenethylamine .................................................................................................................. 7392 I
JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) .............................................................................................. 7398 I
3,4-Methylenedioxyamphetamine ............................................................................................................................ 7400 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
Dimethyltryptamine .................................................................................................................................................. 7435 I
Psilocyn ................................................................................................................................................................... 7438 I
N-Benzylpiperazine ................................................................................................................................................. 7493 I
4-Methyl-alphapyrrolidinopropiophenone (4-MePPP) ............................................................................................. 7498 I
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E ) ............................................................................................ 7509 I
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) ................................................................................................ 7518 I
2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) ........................................................................................... 7519 I
MDPV (3,4-Methylenedioxypyrovalerone) ............................................................................................................... 7535 I
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C-NBOMe) ............................................. 7537 I
Methylone (3,4-Methylenedioxy-N-methylcathinone) .............................................................................................. 7540 I
Butylone ................................................................................................................................................................... 7541 I
Pentylone ................................................................................................................................................................. 7542 I
alpha-pyrrolidinopentiophenone (a-PVP) ................................................................................................................ 7545 I
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) ............................................................................................ 7694 I
Codeine-N-oxide ...................................................................................................................................................... 9053 I
Desomorphine ......................................................................................................................................................... 9055 I
Dihydromorphine ..................................................................................................................................................... 9145 I
Heroin ...................................................................................................................................................................... 9200 I
Morphine-N-oxide .................................................................................................................................................... 9307 I
Normorphine ............................................................................................................................................................ 9313 I
Pholcodine ............................................................................................................................................................... 9314 I
Dipipanone .............................................................................................................................................................. 9622 I
Properidine .............................................................................................................................................................. 9644 I
Tilidine ..................................................................................................................................................................... 9750 I
Alpha-methylfentanyl ............................................................................................................................................... 9814 I
Methamphetamine ................................................................................................................................................... 1105 II
Phenmetrazine ........................................................................................................................................................ 1631 II
Amobarbital ............................................................................................................................................................. 2125 II
Pentobarbital ........................................................................................................................................................... 2270 II
Secobarbital ............................................................................................................................................................. 2315 II
Glutethimide ............................................................................................................................................................ 2550 II
Phencyclidine .......................................................................................................................................................... 7471 II
Phenylacetone ......................................................................................................................................................... 8501 II
Alphaprodine ........................................................................................................................................................... 9010 II
Dihydrocodeine ........................................................................................................................................................ 9120 II
Diphenoxylate .......................................................................................................................................................... 9170 II
Ecgonine .................................................................................................................................................................. 9180 II
Ethylmorphine .......................................................................................................................................................... 9190 II
Levorphanol ............................................................................................................................................................. 9220 II
Isomethadone .......................................................................................................................................................... 9226 II
Meperidine ............................................................................................................................................................... 9230 II
Meperidine intermediate-B ...................................................................................................................................... 9233 II
Meperidine intermediate-C ...................................................................................................................................... 9234 II
Dextropropoxyphene, bulk (non-dosage forms) ...................................................................................................... 9273 II
14-Hydroxmorphone ................................................................................................................................................ 9665 II
Noroxymorphone ..................................................................................................................................................... 9668 II
Remifentanil ............................................................................................................................................................. 9739 II
Sufentanil ................................................................................................................................................................. 9740 II
The company plans to import substance. Approval of permit approved finished dosage forms for
analytical reference standards for applications will occur only when the commercial sale.
distribution to its customers for research registrant’s business activity is Dated: July 12, 2018.
and analytical purposes. Placement of
amozie on DSK3GDR082PROD with NOTICES1
consistent with what is authorized
John J. Martin,
these drug codes onto the company’s under 21 U.S.C. 952(a) (2).
registration does not translate into Assistant Administrator.
Authorization will not extend to the
automatic approval of subsequent [FR Doc. 2018–15721 Filed 7–20–18; 8:45 am]
import of FDA approved or non-
permit applications to import controlled BILLING CODE 4410–09–P
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Document Created: 2018-07-21 00:48:00
Document Modified: 2018-07-21 00:48:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| 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 22, 2018. Such persons may also file a written request for a hearing on the application on or before August 22, 2018. | |
| FR Citation | 83 FR 34875 |
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