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

Importers Notice of Registration - 2014

[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Page 43782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17681]


DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-392]

Importer of Controlled Substances Registration: Fresenius Kabi USA, LLC

ACTION: Notice of registration.


SUMMARY: Fresenius Kabi USA, LLC applied to be registered as an importer of a basic class of narcotic controlled substance. The Drug Enforcement Administration grants Fresenius Kabi USA, LLC registration as an importer of this controlled substance.

SUPPLEMENTARY INFORMATION: By notice dated December 31, 2013, and published in the Federal Register on January 10, 2014, 79 FR 1888, Fresenius Kabi USA, LLC, 3159 Staley Road, Grand Island, New York 14072, applied to be registered as an importer of a certain basic class of controlled substance. No comments or objections were submitted for this notice.

The Drug Enforcement Administration (DEA) has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Fresenius Kabi USA, LLC to import the basic class of controlled substance 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. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of remifentanil (9739), a basic class of narcotic controlled substance listed in schedule II.

The company plans to import remifentanil for product development and preparation of stability batches.

Dated: July 21, 2014.

Joseph T. Rannazzisi,
Deputy Assistant Administrator.

[FR Doc. 2014-17681 Filed 7-25-14; 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).

Emergency Disaster Relief
National Prescription Drug Take Back Day. Turn in your unused or expired medication for safe disposal here.
RX Abuse Online

U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Diversion Control Division  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539

DOJ Legal Policies and Disclaimers    |    DOJ Privacy Policy    |    FOIA    |    Section 508 Accessibility