ACTION:
Notice of registration.
SUMMARY:
Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION:
By notice dated January 27, 2016, and published in the Federal Register on February 4, 2016, 81 FR 6044, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265 applied to be registered as a manufacturer of certain basic classes of controlled substances. 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 Pharmacore, Inc. to manufacture 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. 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 the following basic classes of controlled substances:
| Controlled substance | Schedule |
|---|---|
| Oxymorphone (9652) | II |
| Noroxymorphone (9668) | II |
The company plans to manufacture the listed controlled substances as active pharmaceutical ingredients (APIs) for clinical trials.
Dated: May 16, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-11939 Filed 5-19-16; 8:45 am]
BILLING CODE 4410-09-P