[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1888-1889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-00206]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Importer of Controlled Substances; Notice of Registration; Mylan
Pharmaceuticals, Inc.
By Notice dated June 18, 2013, and published in the Federal
Register on July 1, 2013, 78 FR 39336, Mylan Pharmaceuticals, Inc.,
3711 Collins Ferry Road, Morgantown, West Virginia 26505, made
application to the Drug Enforcement Administration (DEA) to be
registered as an importer of the following basic classes of controlled
substances:
[[Page 1889]]
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Drug Schedule
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Amphetamine (1100)......................... II
Lisdexamfetamine (1205).................... II
Methylphenidate (1724)..................... II
Pentobarbital (2270)....................... II
Oxycodone (9143)........................... II
Hydromorphone (9150)....................... II
Hydrocodone (9193)......................... II
Levorphanol (9220)......................... II
Morphine (9300)............................ II
Oxymorphone (9652)......................... II
Remifentanil (9739)........................ II
Fentanyl (9801)............................ 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. 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: December 31, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 2014-00206 Filed 1-9-14; 8:45 am]
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