2015-01298. Manufacturer of Controlled Substances Registration: Pharmacore, Inc.

ACTION:

Notice of registration.

SUMMARY:

Pharmacore, Inc. applied to be registered as a manufacturer of a basic class of controlled substance. The DEA grants Pharmacore, Inc. registration as a manufacturer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 3, 2014, 79 FR 31987, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265, applied to be registered as a manufacturer of a certain basic class of controlled substance. No comments or objections were submitted to this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Pharmacore, Inc. to manufacture this 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 Noroxymorphone (9668), a basic class of controlled substance listed in schedule II.

The company plans to manufacture the listed controlled substance as an active pharmaceutical ingredient (API) for clinical trials.

Dated: January 9, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.