By Notice dated September 27, 2013, and published in the Federal Register on October 25, 2013, 78 FR 64017, PharmaCore, Inc., 4180 Mendenhall Oaks Parkway, High Point, North Carolina 27265, made application by letter to the Drug Enforcement Administration (DEA) to be registered 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 active pharmaceutical ingredients (API) for clinical trials.
No comments or objections have been received. The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of PharmaCore, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. The DEA has investigated PharmaCore, Inc., to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history.
Therefore, pursuant to 21 U.S.C. 823, and in accordance with 21 CFR 1301.33, the above named company is granted registration as a bulk manufacturer of the basic class of controlled substance listed.
Dated: February 19, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2014-05504 Filed 3-12-14; 8:45 am]
BILLING CODE 4410-09-P