Importer of Controlled Substances; Notice of Registration; Mylan Technologies, Inc., 33441 [2013-13181]

Download as PDF 33441 Federal Register / Vol. 78, No. 107 / Tuesday, June 4, 2013 / Notices DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Technologies, Inc. Importer of Controlled Substances; Notice of Registration; Caraco Pharmaceutical Laboratories, LTD Manufacturer of Controlled Substances; Notice of Application; Agilent Technologies By Notice dated January 15, 2013, and published in the Federal Register on January 29, 2013, 78 FR 6131, Mylan Technologies, Inc., 110 Lake Street, Saint Albans, Vermont 05478, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as an importer of the following basic classes of controlled substances: The company plans to import the listed controlled substances in finished dosage form (FDF) from foreign sources for analytical testing and clinical trials in which the foreign FDF will be compared to the company’s own domestically-manufactured FDF. This analysis is required to afford the company the opportunity to export domestically-manufactured FDF to foreign markets. 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 Mylan Pharmaceuticals, Inc., 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 Mylan Pharmaceuticals, 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. By Notice dated February 8, 2013, and published in the Federal Register on February 21, 2013, 78 FR 12101, Caraco Pharmaceutical Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey 08512, made application to the Drug Enforcement Administration (DEA) to be registered as an importer of Fentanyl (9801), a basic class of controlled substance listed in schedule II. The company plans to import the listed controlled substance in finished dosage form for clinical trials, and research. The import of the above listed basic class of controlled substance is granted only for analytical testing and clinical trials. This authorization does not extend to the import of 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 Caraco Pharmaceutical Laboratories, Ltd., 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 Caraco Pharmaceutical Laboratories, Ltd., 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: May 24, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. Dated: May 24, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–13181 Filed 6–3–13; 8:45 am] [FR Doc. 2013–13183 Filed 6–3–13; 8:45 am] BILLING CODE 4410–09–P BILLING CODE 4410–09–P Drug Schedule tkelley on DSK3SPTVN1PROD with NOTICES Methylphenidate (1724) ................ Fentanyl (9801) ............................ VerDate Mar<15>2010 18:33 Jun 03, 2013 II II Jkt 229001 PO 00000 Frm 00117 Fmt 4703 Sfmt 4703 Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on March 27, 2013, Agilent Technologies, 25200 Commercentre Drive, Lake Forest, California 92630–8810, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the basic classes of controlled substances listed in schedule II: Drug 1-Piperidinocyclohexanecarbonitrile (8603). Benzoylecgonine (9180) ............... Schedule II II The company plans to manufacture small quantities of the listed controlled substances for use in diagnostic products. Any other such applicant, and any person who is presently registered with DEA to manufacture such substances, may file comments or objections to the issuance of the proposed registration pursuant to 21 CFR § 1301.33(a). Any such written comments or objections should be addressed, in quintuplicate, to the Drug Enforcement Administration, Office of Diversion Control, Federal Register Representative (ODL), 8701 Morrissette Drive, Springfield, Virginia 22152; and must be filed no later than August 5, 2013. Dated: May 24, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–13219 Filed 6–3–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Penick Corporation Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 23, 2013, Penick Corporation, 33 Industrial Park Road, Pennsville, New Jersey 08070, made application to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Opium Tincture (9630), a basic class of E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13181]



[[Page 33441]]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Mylan 
Technologies, Inc.

    By Notice dated January 15, 2013, and published in the Federal 
Register on January 29, 2013, 78 FR 6131, Mylan Technologies, Inc., 110 
Lake Street, Saint Albans, Vermont 05478, made application by renewal 
to the Drug Enforcement Administration (DEA) to be registered as an 
importer of the following basic classes of controlled substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances in 
finished dosage form (FDF) from foreign sources for analytical testing 
and clinical trials in which the foreign FDF will be compared to the 
company's own domestically-manufactured FDF. This analysis is required 
to afford the company the opportunity to export domestically-
manufactured FDF to foreign markets.
    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 Mylan Pharmaceuticals, Inc., 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 Mylan Pharmaceuticals, 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: May 24, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-13181 Filed 6-3-13; 8:45 am]
BILLING CODE 4410-09-P

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