Manufacturers Notice of Registration - 2012
[Federal Register Volume 77, Number 219 (Tuesday, November 13, 2012)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27567]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration; Nektar Therapeutics
By Notice dated July 17, 2012, and published in the Federal Register on July 26, 2012, 77 FR 43862, Nektar Therapeutics, 1112 Church Street, Huntsville, Alabama 35801, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Fentanyl (9801), a basic class of controlled substance listed in schedule II.
The company plans to manufacture the listed controlled substance in support of product development.
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 Nektar Therapeutics to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Nektar Therapeutics 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 review of 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 basic class of controlled substance listed.
Dated: November 5, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2012-27567 Filed 11-9-12; 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 Printing Office (GPO).