[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withdrawn or removed from the market for reasons of safety or efficacy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
