Manufacturer of Controlled Substances; Notice of Application; Patheon Pharmaceuticals, Inc., 19016 [2013-07138]

Download as PDF 19016 Federal Register / Vol. 78, No. 60 / Thursday, March 28, 2013 / Notices Diversion Control, Drug Enforcement Administration, that the requirements for such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied. Dated: March 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. CFR § 1301.34, the above named company is granted registration as an importer of the basic classes of controlled substances listed. Dated: March 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–07150 Filed 3–27–13; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2013–07152 Filed 3–27–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE Drug Enforcement Administration Drug Enforcement Administration Importer of Controlled Substances; Notice of Registration; Mylan Pharmaceuticals, Inc. Importer of Controlled Substances; Notice of Registration; Johnson Matthey, Inc. By Notice dated November 19, 2012, and published in the Federal Register on November 27, 2012, 77 FR 70824, Johnson Matthey, Inc., Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, New Jersey 08066–1742, 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 mstockstill on DSK4VPTVN1PROD with NOTICES Coca Leaves (9040) ..................... Thebaine (9333) ........................... Opium, raw (9600) ....................... Noroxymorphone (9668) .............. Poppy Straw Concentrate (9670) II II II II II The company plans to import the listed controlled substances as raw materials, to be used in the manufacture of bulk controlled substances, for distribution to its customers. 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 Johnson Matthey, 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, at this time. DEA has investigated Johnson Matthey, 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 VerDate Mar<15>2010 20:20 Mar 27, 2013 Jkt 229001 By Notice dated November 27, 2012, and published in the Federal Register on December 5, 2012, 77 FR 72409, Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, 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 Amphetamine (1100) .................... Methylphenidate (1724) ................ Oxycodone (9143) ........................ Hydromorphone (9150) ................ Methadone (9250) ........................ Morphine (9300) ........................... Fentanyl (9801) ............................ II II II II II II 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 allow the company to export domesticallymanufactured 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 PO 00000 Frm 00063 Fmt 4703 Sfmt 9990 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: March 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–07143 Filed 3–27–13; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Patheon Pharmaceuticals, Inc. Pursuant to § 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on February 22, 2013, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I. The company plans to manufacture the listed controlled substance for distribution to its customers. Any other such applicant, and any person who is presently registered with DEA to manufacture such substance, 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 May 28, 2013. Dated: March 20, 2013. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. [FR Doc. 2013–07138 Filed 3–27–13; 8:45 am] BILLING CODE 4410–09–P E:\FR\FM\28MRN1.SGM 28MRN1

Agencies

[Federal Register Volume 78, Number 60 (Thursday, March 28, 2013)]
[Notices]
[Page 19016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07138]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Manufacturer of Controlled Substances; Notice of Application; 
Patheon Pharmaceuticals, Inc.

    Pursuant to Sec.  1301.33(a), Title 21 of the Code of Federal 
Regulations (CFR), this is notice that on February 22, 2013, Patheon 
Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, 
made application by renewal to the Drug Enforcement Administration 
(DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric 
Acid (2010), a basic class of controlled substance listed in schedule 
I.
    The company plans to manufacture the listed controlled substance 
for distribution to its customers.
    Any other such applicant, and any person who is presently 
registered with DEA to manufacture such substance, 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 May 28, 2013.

    Dated: March 20, 2013.
 Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-07138 Filed 3-27-13; 8:45 am]
BILLING CODE 4410-09-P

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