Meetings: Pharmacy Compounding Advisory Committee,

[Federal Register: January 6, 1999 (Volume 64, Number 3)]

[Notices]

[Page 886-887]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr06ja99-69]

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.

[[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 CERNY@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 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 The committee may also review drug products to be included on a list which have been withdrawn or removed from the market for reasons of safety or efficacy which may not be used in compounding that qualifies for the applicable statutory exemptions.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. 99-154Filed1-5-99; 8:45 am]

BILLING CODE 4160-01-F