E9-15447. Manufacturer of Controlled Substances; Notice of Registration

By Notice dated September 22, 2008, and published in the Federal Register on September 29, 2008, (73 FR 56612), 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 Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I.

The company plans to produce sodium oxybate for sale to customers.

One objection was received; however, the objector is not registered with DEA as a bulk manufacturer of Gamma Hydroxybutyric Acid (GHB). DEA has determined that the objection received is without merit and does not warrant denial of the application. DEA has also determined that the Food and Drug Administration does not preclude the sale of GHB to other manufacturers for the development of generic GHB products.

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, 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: June 23, 2009.

Joseph T. Rannazzisi,

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