Justia Regulation Tracker

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[Federal Register: June 30, 2009 (Volume 74, Number 124)]
[Notices]               
[Page 31314]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jn09-100]                         

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

 
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.
[FR Doc. E9-15447 Filed 6-29-09; 8:45 am]

BILLING CODE 4410-09-P