Notice of Registration - 2012
[Federal Register Volume 77, Number 41 (Thursday, March 1, 2012)]
[Notices]
[Page 12621]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4994]
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
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
