Importer of Controlled Substances Application: VHG Labs DBA LGC Standards, 34875-34876 [2018-15721]

Download as PDF 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 Jkt 244001 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 E:\FR\FM\23JYN1.SGM 23JYN1 1233 1235 1237 1238 1246 1248 1249 1258 1475 1590 2565 6250 7008 7048 7081 7104 7118 7122 7144 7201 7203 7260 7315 7348 7360 7381 7385 Schedule I I I I I I I I I I I I I I I I I I I I I I I I I I I 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- PO 00000 Fmt 4703 Sfmt 4703 I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I I II II II II II II II II II II II II II II II II II II II II II II II 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 7391 7392 7398 7400 7402 7404 7405 7411 7431 7432 7433 7435 7438 7493 7498 7509 7518 7519 7535 7537 7540 7541 7542 7545 7694 9053 9055 9145 9200 9307 9313 9314 9622 9644 9750 9814 1105 1631 2125 2270 2315 2550 7471 8501 9010 9120 9170 9180 9190 9220 9226 9230 9233 9234 9273 9665 9668 9739 9740 Schedule E:\FR\FM\23JYN1.SGM 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