[Federal Register Volume 64, Number 77 (Thursday, April 22, 1999)]
[Notices]
[Pages 19791-19792]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10076]


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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 May 6 and 7, 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, chloramine-T, cyclandelate, dinitrochlorobenzene, 
diphenylcyclopropenone, hydrazine sulfate, mild silver protein, 
monosodium asparate, pentylenetetrazole, peruvian balsam, and squaric 
acid dibutyl ester.
    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 April 23, 
1999. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. to 11 a.m. for dinitrochlorobenzene, 
diphenylcyclopropenone, and squaric acid dibutyl ester, and between 
approximately 2:45 p.m. and 3:15 p.m. for 4-aminopyridine, 3,4-
diaminopyridine, and betahistine dihydrochloride on May 6, 1999; and 
between approximately 10:15 a.m. and 10:45 a.m. for mild silver 
protein, cyclandelate, and monosodium asparate, and between 
approximately

[[Page 19792]]

2:45 p.m. and 3:15 p.m. for hydrazine sulfate on May 7, 1999. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before April 
23, 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: April 16, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-10076 Filed 4-19-99; 11:05 am]
BILLING CODE 4160-01-F