[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)]
[Rules and Regulations]
[Pages 11596-11597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6151]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14


Advisory Committees; Pharmacy Compounding Advisory Committee; 
Establishment

AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
establishment of the Pharmacy Compounding Advisory Committee in FDA's 
Center for Drug Evaluation and Research by the Commissioner of Food and 
Drugs (the Commissioner). Elsewhere in this issue of the Federal 
Register, FDA is publishing a notice requesting nominations for 
membership on this committee. This document adds the Pharmacy 
Compounding Advisory Committee to the agency's list of standing 
advisory committees.

DATES: This rule becomes effective March 10, 1998. Authority for the 
committee being established will end on February 3, 2000, unless the 
Commissioner formally determines that renewal is in the public 
interest.

FOR FURTHER INFORMATION CONTACT:  Donna M. Combs, Committee Management 
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-4820.

SUPPLEMENTARY INFORMATION:  Under the Federal Advisory Committee Act of 
October 6, 1972 (Pub. L. 92-463) (5 U.S.C. app. 2); section 904 of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 394), as 
amended by the Food and Drug Administration Revitalization Act (Pub. L. 
101-635); section 503A of the act (21 U.S.C. 353a) and 21 CFR 14.40(b), 
FDA is announcing the establishment of the Pharmacy Compounding 
Advisory Committee by the Commissioner. The committee shall provide 
advice on scientific, technical, and medical issues concerning drug 
compounding by pharmacists and licensed practitioners, and make 
appropriate recommendations to the Commissioner.
    Because establishment of this advisory committee is explicitly 
required by section 503A(d)(1) of the act (21 U.S.C. 353a(d)(1)), the 
Commissioner finds, under 21 CFR 10.40, that notice and public 
procedure in Sec. 10.40(b) are unnecessary and contrary to the public 
interest.
    Therefore, the agency is amending 21 CFR 14.100(c) as set forth 
below.

[[Page 11597]]

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

    1. The authority citation for 21 CFR part 14 continues to read as 
follows:

    Authority: 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 
1034; 42 U.S.C. 201, 262, 263b, 264; 15 U.S.C. 1451-1461; 5 U.S.C. 
app. 2; 28 U.S.C. 2112.
    2. Section 14.100 is amended by adding paragraph (c)(18) to read as 
follows:

Sec. 14.100  List of standing advisory committees.

* * * * *
     (c) * * *
     (18) Pharmacy Compounding Advisory Committee.
     (i) Date established: February 12, 1998.
     (ii) Function: Provides advice on scientific, technical, and 
medical issues concerning drug compounding by pharmacists and licensed 
practitioners.

    Dated: March 3, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-6151 Filed 3-9-98; 8:45 am]
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