Importer of Controlled Substances Registration: CODY LABORATORIES, INC., 34552 [2014-14151]

Download as PDF 34552 Federal Register / Vol. 79, No. 116 / Tuesday, June 17, 2014 / Notices dispensers 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 sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.34(a), this is notice that on May 8, 2014, Alkermes Gainesville LLC, 1300 Gould Drive, Gainesville, Georgia 30504, applied to be registered as an importer of Noroxymorphone (9668), a basic class of controlled substance listed in schedule II. The company plans to import the above listed controlled substance for analytical research and testing. The import of the above listed basic class of controlled substance would be granted only for analytical testing and clinical testing. This authorization does not extend to the import of a finished Food and Drug Administration approved or non-approved dosage form for commercial distribution in the United States. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. 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 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 sec. 7(g) of 28 CFR pt. 0, subpt. R, App. In accordance with 21 CFR 1301.34(a), this is notice that on December 9, 2013, Meda Pharmaceuticals, Inc., 705 Eldorado Street, Decatur, Illinois 62523, applied to be registered as an importer of Nabilone (7379), a basic class of nonnarcotic controlled substance listed in schedule II. The company plans to import the FDA approved listed controlled substance as a finished drug product in dosage form for distribution to its customers. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–14145 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P [FR Doc. 2014–14150 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration DEPARTMENT OF JUSTICE [Docket No. DEA–392] Drug Enforcement Administration Importer of Controlled Substances Application: MEDA PHARMACEUTICALS, INC. [Docket No. DEA–392] ACTION: Importer of Controlled Substances Registration: CODY LABORATORIES, INC. Notice of Application. 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 1301.34(a) on or before July 17, 2014. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before July 17, 2014. DATES: Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. tkelley on DSK3SPTVN1PROD with NOTICES ADDRESS: The Attorney General has delegated his authority under the Controlled SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:43 Jun 16, 2014 Jkt 232001 ACTION: Notice of Registration. Cody Laboratories, Inc. applied to be registered as an importer of certain basic classes of narcotic or non-narcotic controlled substances. The DEA grants Cody Laboratories, Inc. registration as an importer of those controlled substances. SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1888, Cody Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414–9321, applied to be registered as an importer of certain basic classes of narcotic or non-narcotic controlled substances. The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and SUMMARY: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 958(a) and determined that the registration of Cody Laboratories, Inc. to import 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, verified the company’s compliance with state and local laws, and reviewed the company’s background and history. Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the basic classes of narcotic or non-narcotic controlled substances listed: Controlled substance Phenylacetone (8501) .................. Poppy Straw Concentrate (9670) Tapentadol (9780) ........................ Schedule II II II The company plans to import narcotic raw materials for manufacturing and further distribution to its customers. The company is registered with the DEA as a manufacturer of several controlled substances that are manufactured from poppy straw concentrate. The company plans to import an intermediate form of tapentadol (9780), to bulk manufacture tapentadol for distribution to its customers. Comments and request for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417 (2007). In reference to the non-narcotic raw material, no comments or objections have been received. Dated: June 10, 2014. Joseph T. Rannazzisi, Deputy Assistant Administrator. [FR Doc. 2014–14151 Filed 6–16–14; 8:45 am] BILLING CODE 4410–09–P DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA–392] Importer of Controlled Substances Registration: STEPAN COMPANY ACTION: Notice of registration. Stepan Company applied to be registered as an importer of a basic class of a narcotic controlled substance. The DEA grants Stepan Company SUMMARY: E:\FR\FM\17JNN1.SGM 17JNN1

Agencies

[Federal Register Volume 79, Number 116 (Tuesday, June 17, 2014)]
[Notices]
[Page 34552]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14151]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]


Importer of Controlled Substances Registration: CODY 
LABORATORIES, INC.

ACTION: Notice of Registration.

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SUMMARY: Cody Laboratories, Inc. applied to be registered as an 
importer of certain basic classes of narcotic or non-narcotic 
controlled substances. The DEA grants Cody Laboratories, Inc. 
registration as an importer of those controlled substances.

SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and 
published in the Federal Register on January 10, 2014, 79 FR 1888, Cody 
Laboratories, Inc., 601 Yellowstone Avenue, Cody, Wyoming 82414-9321, 
applied to be registered as an importer of certain basic classes of 
narcotic or non-narcotic controlled substances.
    The Drug Enforcement Administration (DEA) has considered the 
factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the 
registration of Cody Laboratories, Inc. to import 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, verified the company's 
compliance with state and local laws, and reviewed the company's 
background and history.
    Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in 
accordance with 21 CFR 1301.34, the above-named company is granted 
registration as an importer of the basic classes of narcotic or non-
narcotic controlled substances listed:

------------------------------------------------------------------------
            Controlled substance                       Schedule
------------------------------------------------------------------------
Phenylacetone (8501).......................  II
Poppy Straw Concentrate (9670).............  II
Tapentadol (9780)..........................  II
------------------------------------------------------------------------

    The company plans to import narcotic raw materials for 
manufacturing and further distribution to its customers. The company is 
registered with the DEA as a manufacturer of several controlled 
substances that are manufactured from poppy straw concentrate.
    The company plans to import an intermediate form of tapentadol 
(9780), to bulk manufacture tapentadol for distribution to its 
customers.
    Comments and request for hearings on applications to import 
narcotic raw material are not appropriate. 72 FR 3417 (2007).
    In reference to the non-narcotic raw material, no comments or 
objections have been received.

    Dated: June 10, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-14151 Filed 6-16-14; 8:45 am]
BILLING CODE 4410-09-P