E9-15446. Manufacturer of Controlled Substances; Notice of Registration

By Notice dated June 19, 2008, and published in the Federal Register on June 27, 2008, (73 FR 36573), Norac Inc., 405 S. Motor Avenue, P.O. Box 577, Azusa, California 91702-3232, made application by letter to the Drug Enforcement Administration (DEA) for registration as a bulk manufacturer of Gamma Hydroxybutyric Acid (2010), a basic class of controlled substance listed in schedule I.

The company plans to manufacture the listed controlled substance in bulk for sale to its 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 & 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 Norac Inc. to manufacture the listed basic class of controlled substance is consistent with the public interest at this time. DEA has investigated Norac Inc. to ensure that the company's registration is consistent with the public interest. The investigation included the 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.