[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 3982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01298]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: Pharmacore,
Inc.
ACTION: Notice of registration.
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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.
[FR Doc. 2015-01298 Filed 1-23-15; 8:45 am]
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