2013-15563. Manufacturer of Controlled Substances; Notice of Registration; Patheon Pharmaceuticals, Inc.

By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19016, Patheon Pharmaceutical, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I.

The company plans to manufacture the listed controlled substance for clinical trials and distribution to its customers.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Patheon Pharmaceuticals, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Patheon 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. 823(a), and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed.

Dated: June 18, 2013.

Joseph T. Rannazzisi,

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