[Federal Register Volume 64, Number 3 (Wednesday, January 6, 1999)]
[Notices]
[Pages 886-887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-154]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 887]]

     This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on February 4 and 5, 1999, 
8:30 a.m. to 5 p.m.
    Location: CDER Advisory Committee Conference Room 1066, 5630 
Fishers Lane, Rockville, MD.
    Contact Person: Igor Cerny, or Tony Slater, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, or by e-mail at 
[email protected], or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 12440. Please 
call the Information Line for up-to-date information on this meeting.
    Agenda: The committee will discuss and provide FDA with advice 
about the agency's development and publication of a list of bulk drug 
substances that may be used in pharmacy compounding that do not have a 
United States Pharmacopeia or National Formulary monograph and are not 
components of FDA-approved drugs. Specifically, the committee is likely 
to address the following drug substances as candidates for the bulk 
drugs list: 4-aminopyridine, 3,4-diaminopyridine, betahistine 
dihydrochloride, cyclandelate, dinitrochlorobenzene, 
diphenylcyclopropenone, hydrazine sulfate, mild silver protein, 
pentylenetetrazole, and squaric acid dibutyl ester. The committee may 
also review drug products to be included on a list which have been 
withdrawn or removed from the market for reasons of safety or efficacy 
which may not be used in compounding that qualifies for the applicable 
statutory exemptions.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by January 21, 
1999. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before January 21, 1999, and submit a brief 
statement of the general nature of the evidence or arguments they wish 
to present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 28, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-154 Filed 1-5-99; 8:45 am]
BILLING CODE 4160-01-F