Manufacturer of Controlled Substances Registration: Pharmacore, Inc., 3982 [2015-01298]

Download as PDF 3982 Federal Register / Vol. 80, No. 16 / Monday, January 26, 2015 / Notices (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 pt. 0, subpt. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on August 14, 2014, IRIX Manufacturing, Inc., 309 Delaware Street, Building 1106, Greenville, South Carolina 29605, applied 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 API for clinical trials. Dated: January 9, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. 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 pt. 0, subpart. R, App. In accordance with 21 CFR 1301.33(a), this is notice that on November 19, 2014, Siemens Healthcare Diagnostics, Inc., Attn: RA, 100 GBC Drive, Mailstop 514, Newark, Delaware 19702, applied to be registered as a bulk manufacturer of the following basic classes of controlled substances: Controlled substance Schedule Tetrahydrocannabinols (7370) ...... Ecgonine (9180) ........................... Morphine (9300) ........................... Thebaine (9333) ........................... I II II II [Docket No. DEA–392] The company plans to produce the listed controlled substances in bulk to be used in the manufacture of reagents and drug calibrator controls which are DEA exempt products. In reference to drug code 7370 the company plans to bulk manufacture a synthetic tetrahydrocannabinol. No other activity for this drug code is authorized for this registration. Bulk Manufacturer of Controlled Substances Application: Siemens Healthcare Diagnostics, Inc. Dated: January 9, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2015–01314 Filed 1–23–15; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration ACTION: BILLING CODE P 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 March 27, 2015. ADDRESSES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Request for hearings should be sent to: Drug Enforcement Administration, Attention: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152. SUPPLEMENTARY INFORMATION: The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of 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, and dispensers of controlled substances (other than final orders in connection emcdonald on DSK67QTVN1PROD with NOTICES 18:48 Jan 23, 2015 Jkt 235001 [FR Doc. 2015–01298 Filed 1–23–15; 8:45 am] BILLING CODE P Drug Enforcement Administration [Docket No. DEA–392] DATES: VerDate Sep<11>2014 Dated: January 9, 2015. Joseph T. Rannazzisi, Deputy Assistant Administrator. DEPARTMENT OF JUSTICE [FR Doc. 2015–01315 Filed 1–23–15; 8:45 am] Notice of application. 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. DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances Registration: Lin Zhi International, Inc. [Docket No. DEA–392] ACTION: Manufacturer of Controlled Substances Registration: Pharmacore, Inc. SUMMARY: ACTION: Notice of registration. 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 SUMMARY: PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 Notice of registration. Lin Zhi International, Inc., applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Lin Zhi International, Inc. registration as a manufacturer of those controlled substances. By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32321, Lin Zhi International, Inc., 670 Almanor Avenue, Sunnyvale, California 94085, applied to be registered as a manufacturer of certain basic classes of controlled substances. 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 Lin Zhi International, Inc. to manufacture the basic classes of controlled SUPPLEMENTARY INFORMATION: E:\FR\FM\26JAN1.SGM 26JAN1

Agencies

[Federal Register Volume 80, Number 16 (Monday, January 26, 2015)]
[Notices]
[Page 3982]
From the Federal Register Online via the Government Printing 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]
BILLING CODE P

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