Importer of Controlled Substances Registration: Almac Clinical Services Incorp (ACSI)

ACTION:

Notice of registration.

SUMMARY:

Almac Clinical Services Incorp (ACSI) applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Almac Clinical Services Incorp (ACSI) registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated December 15, 2015, and published in the Federal Register on December 24, 2015, 80 FR 80387, Almac Clinical Services Incorp (ACSI), 25 Fretz Road, Souderton, Pennsylvania 18964 applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice.

The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Almac Clinical Services Incorp (ACSI) 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. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing 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 Morphine (9300), a basic class of controlled substance listed in schedule II.

The company plans to import the listed controlled substance in dosage form for clinical trial only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.