81 FR 6044 - Bulk Manufacturer of Controlled Substances Application: Pharmacore, Inc.

DEPARTMENT OF JUSTICE
Drug Enforcement Administration

Federal Register Volume 81, Issue 23 (February 4, 2016)

[Federal Register Volume 81, Number 23 (Thursday, February 4, 2016)]
[Notices]
[Pages 6044-6045]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-02128]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Bulk Manufacturer of Controlled Substances Application: 
Pharmacore, Inc.

ACTION: Notice of application.

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DATES: Registered bulk manufacturers of the affected basic classes, and 
applicants therefore, may file written comments on or objections to the 
issuance of the proposed registration in accordance with 21 CFR 
1301.33(a) on or before April 4, 2016.

ADDRESSES: Written comments should be sent to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.

SUPPLEMENTARY INFORMATION: The Attorney General has delegated her 
authority under the Controlled Substances Act to the Administrator of

[[Page 6045]]

the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority 
to exercise all necessary functions with respect to the promulgation 
and implementation of 21 CFR part 1301, incident to the registration of 
manufacturers, distributors, dispensers, importers, and exporters of 
controlled substances (other than final orders in connection with 
suspension, denial, or revocation of registration) has been redelegated 
to the Deputy Assistant Administrator of the DEA Office of Diversion 
Control (``Deputy Assistant Administrator'') pursuant to section 7 of 
28 CFR part 0, appendix to subpart R.
    In accordance with 21 CFR 1301.33(a), this is notice that on 
December 3, 2015, Pharmacore, Inc., 4180 Mendenhall Oaks Parkway, High 
Point, North Carolina 27265 applied to be registered as a bulk 
manufacturer of the following basic classes of controlled substances:

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            Controlled substance                       Schedule
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Oxymorphone (9652).........................  II
Noroxymorphone (9668)......................  II
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    The company plans to manufacture the listed controlled substances 
as active pharmaceutical ingredients (APIs) for clinical trials.

    Dated: January 27, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-02128 Filed 2-3-16; 8:45 am]
 BILLING CODE 4410-09-P