Manufacturers Notice of Registration - 2013
[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-01603]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey, Inc.
By Notice dated May 9, 2012, and published in the Federal Register on May 21, 2012, 77 FR 30026, Johnson Matthey, Inc., Custom Pharmaceuticals Department, 2003 Nolte Drive, West Deptford, New Jersey 08066-1742, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Tapentadol (9780), a basic class of controlled substance listed in schedule II.
The company plans to manufacture the listed controlled substance for sale to its customers.
One comment objecting to the granting of registration as a bulk manufacturer of the basic class of controlled substance listed to this applicant was received. However, after a thorough review of this matter, DEA has concluded that the issues raised in the comment and objection do not warrant the denial of this application.
DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Johnson Matthey, Inc., to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Johnson Matthey, Inc., 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(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: January 15, 2013.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2013-01603 Filed 1-24-13; 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).