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

Manufacturers Notice of Registration - 2012

[Federal Register Volume 77, Number 191 (Tuesday, October 2, 2012)]
[Notices]
[Pages 60145-60146]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24194]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

Manufacturer of Controlled Substances; Notice of Registration; Apertus Pharmaceuticals, LLC

By Notice dated June 4, 2012, and published in the Federal Register on June 12, 2012, 77 FR 35058, Apertus Pharmaceuticals, LLC., 331 Consort Drive, St Louis, Missouri 63011, made application 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, LLC., to manufacture the listed basic classes of controlled substances is consistent with the public interest at this time.

DEA has investigated Apertus Pharmaceuticals, LLC., 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,

[[Page 60146]]

the above named company is granted registration as a bulk manufacturer of the basic classes of controlled substances listed.

Dated: September 25, 2012.

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

[FR Doc. 2012-24194 Filed 10-1-12; 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).

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