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Notice

Manufacturer of Controlled Substances Registration: Patheon Pharmaceuticals, Inc.

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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ACTION:

Notice of registration.

SUMMARY:

Patheon Pharmaceuticals, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Patheon Pharmaceuticals, Inc. registration as a manufacturer of this controlled substance.

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SUPPLEMENTARY INFORMATION:

By notice dated March 9, 2015, and published in the Federal Register on March 24, 2015, 80 FR 15632, Patheon Pharmaceuticals, Inc., 2110 E. Galbraith Road, Cincinnati, Ohio 45237 applied to be registered as a manufacturer of a certain basic class of controlled substance. No comments or objections were submitted for this notice.

The 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 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 manufacturer the listed controlled substance for distribution to its customers.

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Dated: July 29, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.

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[FR Doc. 2015-19173 Filed 8-4-15; 8:45 am]

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