2015-01289. Manufacturer of Controlled Substances Registration: Boehringer Ingelheim Chemical, Inc.

ACTION:

Notice of registration.

SUMMARY:

Boehringer Ingelheim Chemical, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The DEA grants Boehringer Ingelheim Chemical, Inc. registration as a manufacturer of the controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated May 28, 2014, and published in the Federal Register on June 4, 2014, 79 FR 32321, Boehringer Ingelheim Chemical, Inc., 2820 N. Normandy Drive, Petersburg, Virginia 23805-9372, applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted to this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Boehringer Ingelheim Chemical, Inc. to manufacture 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. 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the basic classes of controlled substances:

Controlled substance	Schedule
Amphetamine (1100)	II
Methylphenidate (1724)	II
Methadone (9250)	II
Methadone Intermediate (9254)	II

The company plans to manufacture the listed controlled substances in bulk for sale to its customers for formulation into finished pharmaceuticals. In reference to methadone intermediate (9254) the company plans to produce methadone HCL active pharmaceutical ingredients (APIs) for sale to its customers.

Dated: January 9, 2015.

Joseph T. Rannazzisi,

Deputy Assistant Administrator.