[Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)]
[Notices]
[Pages 46371-46372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18331]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Registration; Almac 
Clinical Services, Inc.

    By Notice dated April 10, 2013, and published in the Federal 
Register on April 19, 2013, 78 FR 23594, Almac Clinical Services, Inc., 
(ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964, made application 
by renewal to the Drug Enforcement Administration (DEA) to be 
registered as an importer of the following basic classes of controlled 
substances:

------------------------------------------------------------------------
                    Drug                               Schedule
------------------------------------------------------------------------
Oxycodone (9143)...........................  II
Hydromorphone (9150).......................  II
Tapentadol (9780)..........................  II
Fentanyl (9801)............................  II
------------------------------------------------------------------------

    The company plans to import small quantities of the listed 
controlled substances in dosage form to conduct clinical trials.
    The import of the above listed basic classes of controlled 
substances will be granted only for analytical testing and clinical 
trials. This authorization does not extend to the import of a finished 
FDA approved or non-approved dosage forms 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 Almac Clinical Services, Inc., (ACSI) 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. DEA has 
investigated Almac Clinical Services, Inc., (ACSI) 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

[[Page 46372]]

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 classes of controlled substances listed.

    Dated: July 23, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 2013-18331 Filed 7-30-13; 8:45 am]
BILLING CODE 4410-09-P