By Notice dated April 17, 2012, and published in the Federal Register on April 26, 2012, 77 FR 24985, 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.
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 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: August 7, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2012-20370 Filed 8-17-12; 8:45 am]
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