E9-25888. Importer of Controlled Substances; Notice of Registration

By Notice dated June 3, 2009, and published in the Federal Register on June 9, 2009 (74 FR 27349), Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Road, Morgantown, West Virginia 26505, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of the basic classes of controlled substances listed in schedule II:

Drug	Schedule
Methylphenidate (1724)	II
Fentanyl (9801)	II

The company plans to import the listed controlled substances for analytical research and clinical trials.

Two objections and one request for a hearing were received. The request for a hearing has been withdrawn. DEA has examined the other objections to the registration and has determined that the objections and comments received are not valid for this specific situation. The company will import finished dosage forms for clinical trials and analytical comparison only. They will not purchase raw material for the manufacture of finished goods and/or commercial distribution. No other use of the imported material in question will be allowed.

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: October 16, 2009.

Joseph T. Rannazzisi,

Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.