Manufacturers Notice of Registration - 2016
[Federal Register Volume 81, Number 6 (Monday, January 11, 2016)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-215]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-392]
Manufacturer of Controlled Substances Registration: IRIX Manufacturing, Inc.
ACTION: Notice of registration.
SUMMARY: IRIX Manufacturing, Inc. applied to be registered as a
manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants IRIX Manufacturing, Inc. registration as a manufacturer of those controlled substances.
SUPPLEMENTARY INFORMATION: By notice dated August 10, 2015, and published in the Federal Register on August 18, 2015, 80 FR 50035, IRIX Manufacturing, Inc., 309 Delaware Street, Building 1106, Greenville, South Carolina 29605 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 IRIX Manufacturing, 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:
The company plans to manufacture the above-listed controlled substances synthetically as Active Pharmaceutical Ingredients (API) for clinical trials.
Dated: January 4, 2016.
Louis J. Milione,
Deputy Assistant Administrator.
[FR Doc. 2016-215 Filed 1-8-16; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).