2016-06534. Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc.

ACTION:

Notice of registration.

SUMMARY:

Cody Laboratories, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated October 13, 2015, and published in the Federal Register on October 21, 2015, 80 FR 63835, Cody Laboratories, Inc., Steven Hartman—Vice President of Compliance, 601 Yellowstone Avenue, Cody, Wyoming 82414 applied to be registered as a manufacturer of certain basic classes of controlled substances. No comments or objections were submitted for this notice.

The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cody Laboratories, 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 methadone intermediate (9254), a basic class of controlled substance listed in schedule II.

The company plans to manufacture the listed controlled substance as an intermediate in the manufacture of an active pharmaceutical ingredient to sell to its customers.

Dated: March 14, 2016.

Louis J. Milione,

Deputy Assistant Administrator.