Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Manufacturers Notice of Registration - 2013

[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Page 69134]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27487]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals

By Notice dated July 23, 2013, and published in the Federal Register on July 31, 2013, 78 FR 46372, Apertus Pharmaceuticals, 331 Consort Drive, St Louis, Missouri 63011, made application by renewal to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of the following basic classes of controlled substances:

Drug Schedule
Alfentanil (9737) II
Remifentanil (9739) II
Sufentanil (9740) II
Fentanyl (9801) II

The company plans to manufacture small quantities of the listed controlled substances to make reference standards for distribution to their customers.

No comments or objections have been received. DEA has considered the factors in 21 U.S.C. 823(a), and determined that the registration of Apertus Pharmaceuticals to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time.

DEA has investigated Apertus Pharmaceuticals to ensure that the company's registration is consistent with the public interest. The investigation has included inspection and testing of the company's physical security systems, verification of the company's compliance with state and local laws, and a review of the company's background and history.

Therefore, pursuant to 21 U.S.C. 823, 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 listed.

Dated: November 5, 2013.

Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.

[FR Doc. 2013-27487 Filed 11-15-13; 8:45 am]

BILLING CODE 4410-09-P

 

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