2014-20198. Manufacturer of Controlled Substances Registration: Patheon Pharmaceuticals, Inc.

ACTION:

Notice of registration.

SUMMARY:

Patheon Pharmaceuticals, Inc., applied to be registered as a manufacturer of a certain basic class of controlled substance. The DEA grants Patheon Pharmaceuticals, Inc., registration as a manufacturer of the controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated April 21, 2014, and published in the Federal Register on April 28, 2014, 79 FR 23373, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237, applied to be registered as a manufacturer of a certain basic class of non-narcotic controlled substance. No comments or objections have been received.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Patheon Pharmaceuticals, Inc., to manufacture the basic class of this controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing 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 Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I.

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

Dated: August 19, 2014.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.