[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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] BILLING CODE 4160-01-F