[Federal Register Volume 65, Number 126 (Thursday, June 29, 2000)]
[Notices]
[Page 40104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16397]


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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 July 13 and 14, 2000, 
8:30 a.m. to 5 p.m.
    Location: CDER Advisory Committee conference room 1066, 5630 
Fishers Lane, Rockville, MD.
    Contact Person: Jayne E. Peterson or Tony A. Slater, Jr., Center 
for Drug Evaluation and Research (CDER) (HFD-21), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, 
e-mail: [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: On July 13, 2000, the committee will review five drug 
products for inclusion on a list of drug products that cannot be 
compounded because they have been withdrawn or removed from the market 
because such drug products or components of such drug products have 
been found to be unsafe or not effective (see 21 CFR 216.24 (64 FR 
10944, March 8, 1999)) whereby FDA amended its regulations to include 
such a list of drug products). In the Federal Register of January 4, 
2000 (65 FR 256), FDA published a proposed rule amending these 
regulations to add two drug products to the list: (1) Aminopyrine (all 
drug products containing aminopyrine) and (2) astemizole (all drug 
products containing astemizole). In addition to these two drug 
products, the committee will review the following three drug products: 
(1) Grepafloxacin (all drug products containing grepafloxacin), (2) 
troglitazone (all drug products containing troglitazone), and (3) 
cisapride (all drug products containing cisapride). Beginning at 
approximately 10 a.m., and continuing on July 14, 2000, at 
approximately 8:30 a.m., the committee will discuss and provide FDA 
with advice about drug products that present demonstrable difficulties 
for compounding that reasonably demonstrate an adverse effect on the 
safety or effectiveness of those drug products.
    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 July 3, 2000. 
On July 13, 2000, oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. On July 14, 2000, oral 
presentations from the public will be scheduled between approximately 
8:30 a.m. and 9:30 a.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before July 3, 2000, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the July 13 and 14, 2000, Pharmacy Compounding Advisory Committee 
meeting. Because the agency believes there is some urgency to bring 
these issues to public discussion and qualified members of the Pharmacy 
Compounding Advisory Compounding Advisory Committee meeting were 
available at this time, the Commissioner of Food and Drugs concluded 
that it was in the public interest to hold this meeting even if there 
was not sufficient time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 20, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16397 Filed 6-28-00; 8:45 am]
BILLING CODE 4160-01-F