Importer of Controlled Substances; Notice of Registration; Alkermes Gainesville, LLC, 39338 [2013-15589]

Download as PDF 39338 Federal Register / Vol. 78, No. 126 / Monday, July 1, 2013 / Notices Drug Schedule Phenylacetone (8501) .................. Coca Leaves (9040) ..................... Opium, raw (9600) ....................... Poppy Straw Concentrate (9670) II II II II The company plans to import the listed controlled substances for the manufacture of controlled substances in bulk for distribution to its customers. Comments and requests for hearings on applications to import narcotic raw material are not appropriate, 72 FR 3417 (2007). Regarding Phenylacetone (8501), a basic class of controlled substance, no comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and § 952(a), and determined that the registration of Mallinckrodt, LLC., to import 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. DEA has investigated Mallinckrodt, LLC., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 the basic classes of controlled substances listed. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. The company plans to import the 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 trials. 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. No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(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. DEA has investigated Alkermes Gainesville, LLC, to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 the basic class of controlled substance listed. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15589 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P The company plans to import a finished pharmaceutical product containing cannabis extracts in dosage form, to package for a clinical trial study. In addition, the company also plans to import an ointment for the treatment of wounds, which contains trace amounts of the controlled substance normally found in poppy straw concentrate for packaging and labeling for clinical trials. Comments and requests for any hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417(2007). No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and 952(a) and determined that the registration of Catalent CTS., Inc., to import the basic classes 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. DEA has investigated Catalent CTS., Inc., to ensure that the company’s registration is consistent with the public interest. The investigation has included inspection and testing of the company’s physical security systems, verification of the company’s compliance with state and local laws, and a review of 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 the basic classes of controlled substances listed. Dated: June 18, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–15588 Filed 6–28–13; 8:45 am] DEPARTMENT OF JUSTICE BILLING CODE 4410–09–P [FR Doc. 2013–15603 Filed 6–28–13; 8:45 am] BILLING CODE 4410–09–P Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Catalent CTS., Inc. DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE By Notice dated April 10, 2013, and published in the Federal Register on April 19, 2013, 78 FR 23594, Catalent CTS., Inc., 10245 Hickman Mills Drive, Kansas City, Missouri 64137, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Importer of Controlled Substances; Notice of Registration; Lipomed Drug Enforcement Administration mstockstill on DSK4VPTVN1PROD with NOTICES Importer of Controlled Substances; Notice of Registration; Alkermes Gainesville, LLC By Notice dated January 16, 2013, and published in the Federal Register on January 29, 2013, 78 FR 6132, Alkermes Gainesville, LLC, 1300 Gould Drive, Gainesville, Georgia 30504, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. VerDate Mar<15>2010 21:38 Jun 28, 2013 Jkt 229001 Drug Schedule Marihuana (7360) ......................... Poppy Straw Concentrate (9670) PO 00000 Frm 00088 Fmt 4703 Sfmt 4703 I II Drug Enforcement Administration By Notice dated April 16, 2013, and published in the Federal Register on April 23, 2013, 78 FR 23957, Lipomed, One Broadway, Cambridge, Massachusetts 02142, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: Drug JWH–250 (6250) .......................... E:\FR\FM\01JYN1.SGM 01JYN1 Schedule I

Agencies

[Federal Register Volume 78, Number 126 (Monday, July 1, 2013)]
[Notices]
[Page 39338]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15589]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; 
Alkermes Gainesville, LLC

    By Notice dated January 16, 2013, and published in the Federal 
Register on January 29, 2013, 78 FR 6132, Alkermes Gainesville, LLC, 
1300 Gould Drive, Gainesville, Georgia 30504, made application to the 
Drug Enforcement Administration (DEA) to be registered as an importer 
of Noroxymorphone (9668), a basic class of controlled substance listed 
in schedule II.
    The company plans to import the 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 trials. 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.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and 952(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.
    DEA has investigated Alkermes Gainesville, LLC, to ensure that the 
company's registration is consistent with the public interest. The 
investigation has included inspection and testing of the company's 
physical security systems, verification of the company's compliance 
with state and local laws, and a review of 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 the basic class of controlled substance 
listed.

    Dated: June 18, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-15589 Filed 6-28-13; 8:45 am]
BILLING CODE 4410-09-P