[Federal Register Volume 78, Number 107 (Tuesday, June 4, 2013)]
[Notices]
[Page 33441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13183]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Caraco 
Pharmaceutical Laboratories, LTD

    By Notice dated February 8, 2013, and published in the Federal 
Register on February 21, 2013, 78 FR 12101, Caraco Pharmaceutical 
Laboratories, Ltd., 270 Prospect Plains Road, Cranbury, New Jersey 
08512, made application to the Drug Enforcement Administration (DEA) to 
be registered as an importer of Fentanyl (9801), a basic class of 
controlled substance listed in schedule II.
    The company plans to import the listed controlled substance in 
finished dosage form for clinical trials, and research.
    The import of the above listed basic class of controlled substance 
is granted only for analytical testing and clinical trials. This 
authorization does not extend to the import of finished FDA approved or 
non-approved dosage form for commercial distribution in the United 
States.
    No comments or objections have been received. DEA has considered 
the factors in 21 U.S.C. 823(a) and 952(a), and determined that the 
registration of Caraco Pharmaceutical Laboratories, Ltd., to import the 
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. DEA has 
investigated Caraco Pharmaceutical Laboratories, Ltd., 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. 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 class of controlled substance 
listed.

    Dated: May 24, 2013.
 Joseph T. Rannazzisi,
 Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-13183 Filed 6-3-13; 8:45 am]
BILLING CODE 4410-09-P