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

Federal Register, Volume 78 Issue 147 (Wednesday, July 31, 2013)

Federal Register Volume 78, Number 147 (Wednesday, July 31, 2013)

Notices

Pages 46371-46372

From the Federal Register Online via the Government Printing 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:

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Drug Schedule

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Oxycodone (9143)........................... II

Hydromorphone (9150)....................... II

Tapentadol (9780).......................... II

Fentanyl (9801)............................ II

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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

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