[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
Topperk@cder.fda.gov, 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included on a list that have been withdrawn or removed from the market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
