Bulk Manufacturer of Controlled Substances Application: Specgx LLC, 43570-43571 [2017-19786]

Download as PDF 43570 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices Controlled substance Gamma Hydroxybutyric Acid ... Marihuana Extract .................... Marihuana ................................ Drug code 2010 7350 7360 Schedule Drug Enforcement Administration I I I [Docket No. DEA–392] The company plans to import finished dosage unit products containing gammahydroxybutryic acid and cannabis extracts for clinical trial studies. These cannabis extracts compounds are listed under drug code 7350. No other activity for these drug codes is authorized for this registration. 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 nonapproved finished dosage forms for commercial sale. Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19833 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Bulk Manufacturer of Controlled Substances Application: Specgx LLC 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 in accordance with 21 CFR 1301.33(a) on or before November 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: 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 DATES: 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 1301.33(a), this is notice that on August 9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: sradovich on DSKBBY8HB2PROD with NOTICES Controlled substance Drug code Gamma Hydroxybutyric Acid ........................................................................................................................................... Tetrahydrocannabinols .................................................................................................................................................... Codeine-N-oxide .............................................................................................................................................................. Dihydromorphine ............................................................................................................................................................. Difenoxin .......................................................................................................................................................................... Morphine-N-oxide ............................................................................................................................................................ Normorphine .................................................................................................................................................................... Norlevorphanol ................................................................................................................................................................ Acetyl Fentanyl (N-(1-phenethylpiperidin-4-yl)-N-phenylacetamide) ............................................................................... Butyryl Fentanyl ............................................................................................................................................................... Amphetamine ................................................................................................................................................................... Methamphetamine ........................................................................................................................................................... Lisdexamfetamine ............................................................................................................................................................ Methylphenidate .............................................................................................................................................................. Nabilone ........................................................................................................................................................................... 4-Anilino-N-phenethyl-4-piperidine (ANPP) ..................................................................................................................... Codeine ........................................................................................................................................................................... Dihydrocodeine ................................................................................................................................................................ Oxycodone ....................................................................................................................................................................... Hydromorphone ............................................................................................................................................................... Diphenoxylate .................................................................................................................................................................. Ecgonine .......................................................................................................................................................................... Hydrocodone ................................................................................................................................................................... Levorphanol ..................................................................................................................................................................... Meperidine ....................................................................................................................................................................... Methadone ....................................................................................................................................................................... Methadone intermediate .................................................................................................................................................. Dextropropoxyphene, bulk (non-dosage forms) .............................................................................................................. Morphine .......................................................................................................................................................................... Oripavine ......................................................................................................................................................................... Thebaine .......................................................................................................................................................................... Opium tincture ................................................................................................................................................................. Opium, powdered ............................................................................................................................................................ Oxymorphone .................................................................................................................................................................. Noroxymorphone ............................................................................................................................................................. Alfentanil .......................................................................................................................................................................... Remifentanil ..................................................................................................................................................................... Sufentanil ......................................................................................................................................................................... Tapentadol ....................................................................................................................................................................... Fentanyl ........................................................................................................................................................................... VerDate Sep<11>2014 16:54 Sep 15, 2017 Jkt 241001 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 E:\FR\FM\18SEN1.SGM 18SEN1 2010 7370 9053 9145 9168 9307 9313 9634 9821 9822 1100 1105 1205 1724 7379 8333 9050 9120 9143 9150 9170 9180 9193 9220 9230 9250 9254 9273 9300 9330 9333 9630 9639 9652 9668 9737 9739 9740 9780 9801 Schedule 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 II II II II II II II 43571 Federal Register / Vol. 82, No. 179 / Monday, September 18, 2017 / Notices The company plans to manufacture bulk active pharmaceutical ingredients (APIs) for distribution to its customers. Dated: September 13, 2017 Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19786 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration Marihuana ....................... Phenylacetone ................ Coca Leaves .................. Opium, raw ..................... Poppy Straw Concentrate. [Docket No. DEA–392] Importer of Controlled Substances Application: Specgx LLC 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 in accordance with 21 CFR 1301.34(a) on or before October 18, 2017. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before October 18, 2017. 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 sradovich on DSKBBY8HB2PROD with NOTICES DATES: VerDate Sep<11>2014 16:54 Sep 15, 2017 Drug code Controlled substance DEPARTMENT OF JUSTICE ACTION: 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 August 9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri 63147 applied to be registered as an importer of the following basic classes of controlled substances: Jkt 241001 Schedule 7360 8501 9040 9600 9670 I II II II II The company plans to import the listed controlled substances to bulk manufacture into Active Pharmaceutical Ingredients for distribution to its customers. In reference to drug code 7360 (marihuana) the company plans to import a synthetic cannabidiol. No other activity for this drug code is authorized for this registration. Placement of these drug codes onto the company’s registration does not translate into automatic approval of subsequent permit applications to import controlled substances. 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: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19784 Filed 9–15–17; 8:45 am] BILLING CODE 4410–09–P 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 1301.33(a), this is notice that on July 11, 2017, Halo Pharmaceutical, Inc., 30 North Jefferson Road, Whippany, New Jersey 07981 applied to be registered as a bulk manufacturer the following basic classes of controlled substances: Controlled substance Dihydromorphine .......... Hydromorphone ............ Drug code 9145 9150 Schedule I II The company plans to manufacture Hydromorphone (9150) for distribution to its customers. Dihydromorphine (9145) is an intermediate in the manufacture of Hydromorphone and is not for commercial distribution. Dated: September 11, 2017. Demetra Ashley, Acting Assistant Administrator. [FR Doc. 2017–19834 Filed 9–15–17; 8:45 am] BILLING CODE P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Bulk Manufacturer of Controlled Substances Application: Halo Pharmaceutical, Inc. 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 in accordance with 21 CFR 1301.33(a) on or before November 17, 2017. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal DATES: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 [Docket No. DEA–392] Importer of Controlled Substances Application: Unither Manufacturing LLC 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 in accordance with 21 CFR 1301.34(a) on or before October 18, 2017. Such persons may also file a written request DATES: E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 82, Number 179 (Monday, September 18, 2017)]
[Notices]
[Pages 43570-43571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-19786]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: Specgx 
LLC

ACTION: Notice of application.

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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 in accordance with 21 CFR 
1301.33(a) on or before November 17, 2017.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: 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 1301.33(a), this is notice that on August 
9, 2017, Specgx LLC, 3600 North Second Street, Saint Louis, Missouri 
63147 applied to be registered as a bulk manufacturer of the following 
basic classes of controlled substances:

------------------------------------------------------------------------
        Controlled substance            Drug code          Schedule
------------------------------------------------------------------------
Gamma Hydroxybutyric Acid..........            2010  I
Tetrahydrocannabinols..............            7370  I
Codeine-N-oxide....................            9053  I
Dihydromorphine....................            9145  I
Difenoxin..........................            9168  I
Morphine-N-oxide...................            9307  I
Normorphine........................            9313  I
Norlevorphanol.....................            9634  I
Acetyl Fentanyl (N-(1-                         9821  I
 phenethylpiperidin-4-yl)-N-
 phenylacetamide).
Butyryl Fentanyl...................            9822  I
Amphetamine........................            1100  II
Methamphetamine....................            1105  II
Lisdexamfetamine...................            1205  II
Methylphenidate....................            1724  II
Nabilone...........................            7379  II
4-Anilino-N-phenethyl-4-piperidine             8333  II
 (ANPP).
Codeine............................            9050  II
Dihydrocodeine.....................            9120  II
Oxycodone..........................            9143  II
Hydromorphone......................            9150  II
Diphenoxylate......................            9170  II
Ecgonine...........................            9180  II
Hydrocodone........................            9193  II
Levorphanol........................            9220  II
Meperidine.........................            9230  II
Methadone..........................            9250  II
Methadone intermediate.............            9254  II
Dextropropoxyphene, bulk (non-                 9273  II
 dosage forms).
Morphine...........................            9300  II
Oripavine..........................            9330  II
Thebaine...........................            9333  II
Opium tincture.....................            9630  II
Opium, powdered....................            9639  II
Oxymorphone........................            9652  II
Noroxymorphone.....................            9668  II
Alfentanil.........................            9737  II
Remifentanil.......................            9739  II
Sufentanil.........................            9740  II
Tapentadol.........................            9780  II
Fentanyl...........................            9801  II
------------------------------------------------------------------------


[[Page 43571]]

    The company plans to manufacture bulk active pharmaceutical 
ingredients (APIs) for distribution to its customers.

    Dated: September 13, 2017
Demetra Ashley,
Acting Assistant Administrator.
[FR Doc. 2017-19786 Filed 9-15-17; 8:45 am]
 BILLING CODE 4410-09-P