By Notice dated June 22, 2009, and published in the Federal Register on June 26, 2009, (74 FR 30621), Noramco, Inc., Division of Ortho-McNeil, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801, made application by letter to the Drug Enforcement Administration (DEA) to be registered as an importer of Tapentadol (9780), a basic class of controlled substance listed in schedule II.
The company plans to import an intermediate of the basic class listed for the bulk manufacture of Tapentadol which it will distribute to its customers.
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 Noramco, 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, at this time. DEA has investigated Noramco, Inc. 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 class of controlled substance listed.Start Signature
Dated: September 14, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. E9-22506 Filed 9-17-09; 8:45 am]
BILLING CODE 4410-09-M