Importer of Controlled Substances Application: VHG Labs DBA LGC Standards, 34875-34876 [2018-15721]
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34875
Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
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.
Gamma Hydroxybutyric
Acid.
2010
Schedule
I
The company plans to import finished
dosage unit products containing gammahydroxybutyric acid for clinical trials,
research, and analytical activities.
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
delegated 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 June
18, 2018, Catalent Pharma Solutions,
LLC, 3031 Red Lion Road, Philadelphia,
Pennsylvania 19114, applied to be
registered as an importer of the
following basic class of controlled
substance:
SUPPLEMENTARY INFORMATION:
Drug
code
Controlled substance
Dated: July 12, 2018
John J. Martin,
Assistant Administrator.
[FR Doc. 2018–15719 Filed 7–20–18; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–392]
Importer of Controlled Substances
Application: VHG Labs DBA LGC
Standards
ACTION:
Notice of application.
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
DATES:
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.
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:
SUPPLEMENTARY INFORMATION:
amozie on DSK3GDR082PROD with NOTICES1
Controlled substance
Drug code
3-Fluoro-N-methylcathinone (3-FMC) ......................................................................................................................
Cathinone ................................................................................................................................................................
Methcathinone .........................................................................................................................................................
4-Fluoro-N-methylcathinone (4-FMC) ......................................................................................................................
Pentedrone (a-methylaminovalerophenone) ...........................................................................................................
Mephedrone (4-Methyl-N-methylcathinone) ............................................................................................................
4-Methyl-N-ethylcathinone (4-MEC) ........................................................................................................................
Naphyrone ...............................................................................................................................................................
N-Ethylamphetamine ...............................................................................................................................................
4-Methylaminorex (cis isomer) ................................................................................................................................
Methaqualone ..........................................................................................................................................................
JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl) indole) ...........................................................................................
SR-18 (Also known as RCS–8) (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl) indole) ........................................
APINACA and AKB48 N-(1-Adamantyl)-1-pentyl-1H-indazole-3-carboxamide ......................................................
JWH-081 (1-Pentyl-3-(1-(4-methoxynaphthoyl) indole) ...........................................................................................
SR-19 (Also known as RCS–4) (1-Pentyl-3-[(4-methoxy)-benzoyl] indole .............................................................
JWH-018 (also known as AM678) (1-Pentyl-3-(1-naphthoyl)indole) ......................................................................
JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl) indole) ..............................................................................................
UR-144 (1-Pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone ..........................................................
AM2201 (1-(5-Fluoropentyl)-3-(1-naphthoyl) indole) ...............................................................................................
JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl) indole) ..............................................................................................
Ibogaine ...................................................................................................................................................................
Lysergic acid diethylamide ......................................................................................................................................
2,5-Dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) ........................................................................................
Marihuana ................................................................................................................................................................
Mescaline ................................................................................................................................................................
2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2 ) ....................................................................................
VerDate Sep<11>2014
19:07 Jul 20, 2018
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7008
7048
7081
7104
7118
7122
7144
7201
7203
7260
7315
7348
7360
7381
7385
Schedule
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34876
Federal Register / Vol. 83, No. 141 / Monday, July 23, 2018 / Notices
Controlled substance
Drug code
amozie on DSK3GDR082PROD with NOTICES1
4-Bromo-2,5-dimethoxyamphetamine .....................................................................................................................
4-Bromo-2,5-dimethoxyphenethylamine ..................................................................................................................
JWH–398 (1-Pentyl-3-(4-chloro-1-naphthoyl) indole) ..............................................................................................
3,4-Methylenedioxyamphetamine ............................................................................................................................
N-Hydroxy-3,4-methylenedioxyamphetamine ..........................................................................................................
3,4-Methylenedioxy-N-ethylamphetamine ...............................................................................................................
3,4-Methylenedioxymethamphetamine ....................................................................................................................
4-Methoxyamphetamine ..........................................................................................................................................
5-Methoxy-N–N-dimethyltryptamine ........................................................................................................................
Alpha-methyltryptamine ...........................................................................................................................................
Bufotenine ...............................................................................................................................................................
Dimethyltryptamine ..................................................................................................................................................
Psilocyn ...................................................................................................................................................................
N-Benzylpiperazine .................................................................................................................................................
4-Methyl-alphapyrrolidinopropiophenone (4-MePPP) .............................................................................................
2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E ) ............................................................................................
2-(4-iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) ................................................................................................
2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) ...........................................................................................
MDPV (3,4-Methylenedioxypyrovalerone) ...............................................................................................................
2-(4-chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl) ethanamine (25C-NBOMe) .............................................
Methylone (3,4-Methylenedioxy-N-methylcathinone) ..............................................................................................
Butylone ...................................................................................................................................................................
Pentylone .................................................................................................................................................................
alpha-pyrrolidinopentiophenone (a-PVP) ................................................................................................................
AM-694 (1-(5-Fluoropentyl)-3-(2-iodobenzoyl) indole) ............................................................................................
Codeine-N-oxide ......................................................................................................................................................
Desomorphine .........................................................................................................................................................
Dihydromorphine .....................................................................................................................................................
Heroin ......................................................................................................................................................................
Morphine-N-oxide ....................................................................................................................................................
Normorphine ............................................................................................................................................................
Pholcodine ...............................................................................................................................................................
Dipipanone ..............................................................................................................................................................
Properidine ..............................................................................................................................................................
Tilidine .....................................................................................................................................................................
Alpha-methylfentanyl ...............................................................................................................................................
Methamphetamine ...................................................................................................................................................
Phenmetrazine ........................................................................................................................................................
Amobarbital .............................................................................................................................................................
Pentobarbital ...........................................................................................................................................................
Secobarbital .............................................................................................................................................................
Glutethimide ............................................................................................................................................................
Phencyclidine ..........................................................................................................................................................
Phenylacetone .........................................................................................................................................................
Alphaprodine ...........................................................................................................................................................
Dihydrocodeine ........................................................................................................................................................
Diphenoxylate ..........................................................................................................................................................
Ecgonine ..................................................................................................................................................................
Ethylmorphine ..........................................................................................................................................................
Levorphanol .............................................................................................................................................................
Isomethadone ..........................................................................................................................................................
Meperidine ...............................................................................................................................................................
Meperidine intermediate-B ......................................................................................................................................
Meperidine intermediate-C ......................................................................................................................................
Dextropropoxyphene, bulk (non-dosage forms) ......................................................................................................
14-Hydroxmorphone ................................................................................................................................................
Noroxymorphone .....................................................................................................................................................
Remifentanil .............................................................................................................................................................
Sufentanil .................................................................................................................................................................
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
VerDate Sep<11>2014
17:59 Jul 20, 2018
Jkt 244001
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-
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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
Frm 00054
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7498
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7518
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9307
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23JYN1
Agencies
[Federal Register Volume 83, Number 141 (Monday, July 23, 2018)]
[Notices]
[Pages 34875-34876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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