By Notice dated June 23, 2011, and published in the Federal Register on July 5, 2011, 76 FR 39127, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceuticals Service, 25 Patton Road, Devens, Massachusetts 01434, made application by letter to the Drug Enforcement Administration (DEA) to be registered as a bulk manufacturer of Remifentanil (9739), the basic class of controlled substance in schedule II.
The company plans to utilize this facility to manufacture small quantities of the listed controlled substance in bulk and to conduct analytical testing in support of the company's primary manufacturing facility in West Deptford, New Jersey. The controlled substances manufactured in bulk at this facility will be distributed to the company's 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 Johnson Matthey Pharmaceutical Materials, Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Johnson Matthey Pharmaceutical Materials, 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 27, 2012.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration.
[FR Doc. 2012-2568 Filed 2-3-12; 8:45 am]
BILLING CODE 4410-09-P