2016-00782. Manufacturer of Controlled Substances Registration: Cambridge Isotope Lab

ACTION:

Notice of registration.

SUMMARY:

Cambridge Isotope Lab applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Cambridge Isotope Lab registration as a manufacturer of this controlled substance.

SUPPLEMENTARY INFORMATION:

By notice dated October 2, 2015, and published in the Federal Register on October 13, 2015, 80 FR 61470, Cambridge Isotope Lab, 50 Frontage Road, Andover, Massachusetts 01810 applied to be registered as a manufacturer 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(a) and determined that the registration of Cambridge Isotope Lab to manufacture 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. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of morphine (9300), a basic class of controlled substance listed in schedule II.

The company plans to utilize small quantities of the listed controlled substance in the preparation of analytical standards.

Dated: January 11, 2016.

Louis J. Milione,

Deputy Assistant Administrator.