[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Page 12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4994]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Mylan 
Pharmaceuticals Inc.

    By Notice dated December 22, 2011, and published in the Federal 
Register on December 29, 2011, 76 FR 81978, 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
------------------------------------------------------------------------
Methylphenidate (1724).....................  II
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  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 allow the company 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: February 23, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2012-4994 Filed 2-29-12; 8:45 am]
BILLING CODE 4410-09-P