[Federal Register Volume 75, Number 144 (Wednesday, July 28, 2010)]
[Notices]
[Pages 44284-44285]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-18486]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration
By Notice dated April 20, 2010, and published in the Federal
Register on April 26, 2010, (75 FR 21660), 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 basic classes of controlled
substances listed in schedule II:
[[Page 44285]]
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Drug Schedule
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Methylphenidate (1724)..................... II
Fentanyl (9801)............................ II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
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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, at this time. 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: July 19, 2010.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2010-18486 Filed 7-27-10; 8:45 am]
BILLING CODE 4410-09-P