Manufacturer of Controlled Substances Registration: Johnson Matthey Pharmaceutical Materials, Inc.

Download PDF
Federal RegisterMay 16, 2016
81 Fed. Reg. 30343 (May. 16, 2016)

ACTION:

Notice of registration.

SUMMARY:

Johnson Matthey Pharmaceutical Materials, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey Pharmaceutical Materials, Inc. registration as a manufacturer of those controlled substances.

SUPPLEMENTARY INFORMATION:

By notice dated November 30, 2015, and published in the Federal Register on December 8, 2015, 80 FR 76311, Johnson Matthey Pharmaceutical Materials, Inc., 25 Patton Road, Devens, Massachusetts 01434 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 Johnson Matthey Pharmaceutical Materials, 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 following basic classes of controlled substances:

Controlled substance Schedule
Amphetamine (1100) II
Methylphenidate (1724) II
Nabilone (7379) II
Hydrocodone (9193) II
Alfentanil (9737) II
Remifentanil (9739) II
Sufentanil (9740) II

The company plans to utilize this facility to manufacture small quantities of the listed controlled substances in bulk and to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to its customers.

Dated: May 9, 2016.

Louis J. Milione,

Deputy Assistant Administrator.

[FR Doc. 2016-11394 Filed 5-13-16; 8:45 am]

BILLING CODE 4410-09-P