Manufacturer of Controlled Substances Registration: Austin Pharma, LLC, 60865 [2014-24018]

Download as PDF 60865 Federal Register / Vol. 79, No. 195 / Wednesday, October 8, 2014 / Notices the factors in 21 U.S.C. 823,952(a) and 958(a) and determined that the registration of Alkermes Gainesville LLC to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for analytical research and testing. The import of the above listed basic class of controlled substance would be granted only for analytical testing and clinical testing. This authorization does not extend to the import of a finished FDA approved or non-approved dosage form for commercial distribution in the United States. Dated: October 1, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24032 Filed 10–7–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Austin Pharma, LLC ACTION: No comments or objections were submitted to this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Austin Pharma, LLC to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances: Controlled substance Marihuana (7360) ......................... Tetrahydrocannabinols (7370) ..... Schedule I I The company plans to manufacture bulk synthetic active pharmaceutical ingredients (APIs) for distribution and new product development to its customers. The company plans to bulk manufacture a synthetic tetrahydrocannabinol. In reference to drug code 7360, the company plans to manufacture a synthetic cannabinol in bulk for sale to its customers. The controlled substance will be further synthesized to bulk manufacture a synthetic tetrahydrocannabinol (7370). No other activity for this drug code is authorized for this registration. Dated: October 2, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24018 Filed 10–7–14; 8:45 am] Notice of registration. BILLING CODE 4410–09–P Austin Pharma, LLC applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Austin Pharma, LLC registration as a manufacturer of those controlled substances. asabaliauskas on DSK5VPTVN1PROD with NOTICES SUMMARY: By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32322, Austin Pharma, LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665–2402, applied to be registered as a manufacturer of certain basic classes of controlled substances. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 17:27 Oct 07, 2014 Jkt 235001 DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Manufacturer of Controlled Substances Registration: Siemens Healthcare Diagnostics, Inc. ACTION: Siemens Healthcare Diagnostics, Inc., applied to be registered as a manufacturer of certain PO 00000 Frm 00062 Fmt 4703 Sfmt 9990 By notice dated May 2, 2014, and published in the Federal Register on May 15, 2014, 79 FR 27936, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Siemens Healthcare Diagnostics, Inc., to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company’s maintenance of effective controls against diversion by inspecting and testing the company’s physical security systems, verifying the company’s compliance with state and local laws, and reviewing the company’s background and history. Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed: SUPPLEMENTARY INFORMATION: Controlled substance Tetrahydrocannabinols (7370) ..... Ecgonine (9180) ........................... Morphine (9300) ........................... Schedule I II II The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products. In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Dated: October 1, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–24035 Filed 10–7–14; 8:45 am] Notice of registration. SUMMARY: basic classes of controlled substances. The DEA grants Siemens Healthcare Diagnostics, Inc. registration as a manufacturer of those controlled substances. BILLING CODE 4410–09–P E:\FR\FM\08OCN1.SGM 08OCN1

Agencies

[Federal Register Volume 79, Number 195 (Wednesday, October 8, 2014)]
[Notices]
[Page 60865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24018]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Manufacturer of Controlled Substances Registration: Austin 
Pharma, LLC

ACTION: Notice of registration.

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SUMMARY: Austin Pharma, LLC applied to be registered as a manufacturer 
of certain basic classes of controlled substances. The DEA grants 
Austin Pharma, LLC registration as a manufacturer of those controlled 
substances.

SUPPLEMENTARY INFORMATION: By notice dated May 28, 2014, and published 
in the Federal Register on June 4, 2014, 79 FR 32322, Austin Pharma, 
LLC, 811 Paloma Drive, Suite C, Round Rock, Texas 78665-2402, applied 
to be registered as a manufacturer of certain basic classes of 
controlled substances. No comments or objections were submitted to this 
notice.
    The Drug Enforcement Administration (DEA) has considered the 
factors in 21 U.S.C. 823(a) and determined that the registration of 
Austin Pharma, LLC to manufacture the basic classes of controlled 
substances is consistent with the public interest and with United 
States obligations under international treaties, conventions, or 
protocols in effect on May 1, 1971. The DEA investigated the company's 
maintenance of effective controls against diversion by inspecting and 
testing the company's physical security systems, verifying the 
company's compliance with state and local laws, and reviewing the 
company's background and history.
    Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 
CFR 1301.33, the above-named company is granted registration as a bulk 
manufacturer of the basic classes of controlled substances:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Marihuana (7360)...........................  I
Tetrahydrocannabinols (7370)...............  I
------------------------------------------------------------------------

    The company plans to manufacture bulk synthetic active 
pharmaceutical ingredients (APIs) for distribution and new product 
development to its customers. The company plans to bulk manufacture a 
synthetic tetrahydrocannabinol.
    In reference to drug code 7360, the company plans to manufacture a 
synthetic cannabinol in bulk for sale to its customers. The controlled 
substance will be further synthesized to bulk manufacture a synthetic 
tetrahydrocannabinol (7370). No other activity for this drug code is 
authorized for this registration.

    Dated: October 2, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-24018 Filed 10-7-14; 8:45 am]
BILLING CODE 4410-09-P

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