[Federal Register Volume 63, Number 172 (Friday, September 4, 1998)]
[Notices]
[Page 47301]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23836]


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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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    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 October 14, 15, and 16, 
1998, 8:30 a.m. to 5:30 p.m.
    Location: Advisory Committee conference room, rm. 1066, Food and 
Drug Administration, 5630 Fishers Lane, Rockville, MD 20852.
    Contact Person: Kimberly L. Topper or John B. Schupp, Center for 
Drug Evaluation and Research (HFD-21), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857-1000, 301-827-7001, or e-mail 
T[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: (1) Address those bulk drug substances 
that are neither components of FDA approved products nor covered by a 
United States Pharmacopeia monograph for inclusion on a list of bulk 
drug substances that may be used in compounding that qualifies for the 
applicable statutory exemptions, and (2) review drug products to be 
included on a list that have been withdrawn or removed from the market 
for reasons of safety or efficacy that 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 September 30, 
1998. 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 September 30, 1998, 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: July 27, 1998.
Michael A. Friedman.
Deputy Commissioner for Operations.
[FR Doc. 98-23836 Filed 9-3-98; 8:45 am]
BILLING CODE 4160-01-F