2016-10728. Importer of Controlled Substances Registration: Sharp Clinical Services, Inc.

ACTION:

Notice of registration.

SUMMARY:

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

SUPPLEMENTARY INFORMATION:

By notice dated January 4, 2016, and published in the Federal Register on January 11, 2016, 81 FR 1207, Sharp Clinical Services, Inc., 300 Kimberton Road, Phoenixville, Pennsylvania 19460 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 Sharp Clinical Services, Inc. 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 marihuana (7360), a basic class of controlled substance listed in schedule I.

The company plans to import finished pharmaceutical products containing cannabis extracts in dosage form for clinical trial studies.

This compound is listed under drug code 7360. No other activity for this drug code is authorized for this registration. Approval of permits 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.

Dated: April 29, 2016.

Louis J. Milione,

Deputy Assistant Administrator.