[Federal Register Volume 66, Number 65 (Wednesday, April 4, 2001)]
[Notices]
[Page 17930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8180]


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DEPARTMENT OF JUSTICE

DRUG ENFORCEMENT ADMINISTRATION


Manufacturer of Controlled Substances; Notice of Registration

    By Notice dated September 28, 2000, and published in the Federal 
Register on October 13, 2000, (65 FR 60978), Irix Pharmaceuticals, 
Inc., 101 Technology Place, Florence, South Carolina 29501, made 
application by renewal to the Drug Enforcement Administration (DEA) to 
be registered as a bulk manufacturer of methylphenidate (1724), a basic 
class of controlled substance listed in Schedule II.
    The firm plans to manufacture methylphenidate for demonstration 
purposes and for dosage form development and stability studies.
    No comments or objections have been received. DEA has considered 
the factors in Title 21, United States Code, Section 823(a) and 
determined that the registration of Irix Pharmaceuticals, Inc. to 
manufacture methylphenidate is consistent with the public interest at 
this time. DEA has investigated the firm on a regular basis to ensure 
that the company's continued registration is consistent with the public 
interest. These investigations have included inspection and testing of 
the company's physical security systems, audits of the company's 
records, 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 28 CFR 0.100 and 0.104, the Deputy 
Assistant Administrator, Office of Diversion Control, hereby orders 
that the application submitted by the above firm for registration as a 
bulk manufacturer of the basic class of controlled substance listed 
above is granted.

    Dated: March 26, 2001.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. 01-8180 Filed 4-3-01; 8:45 am]
BILLING CODE 4410-09-M