Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Importers Notice of Registration - 2014

[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Notices]
[Pages 1888-1889]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00206]


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]]

Drug Schedule
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

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]

BILLING CODE 4410-09-P

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

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