Importer of Controlled Substances Application: VHG Labs DBA LGC Standards

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Federal RegisterJul 23, 2018
83 Fed. Reg. 34875 (Jul. 23, 2018)

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-FMC) 1233 I
Cathinone 1235 I
Methcathinone 1237 I
4-Fluoro-N-methylcathinone (4-FMC) 1238 I
Pentedrone (α-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
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
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 (α-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 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]

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