Pharmacy
Compounding Advisory Committee
October 14, 15, and 16, 1998
Advisory Committee Conference Room, 1066
Food and Drug Administration
5630 Fishers Lane
Rockville,
MD 20852
Background
Materials - Table of Contents
Volume I - Introduction
Background
Tab 1 Food and Drug Administration Modernization Act of 1997,
Section 127, Application of Federal Law to Practice of Pharmacy Compounding
Tab 2 Conference Report 105-399 (to accompany S. 830), pp.
94-95
Tab 3 Senate Report 105-43 (to accompany S. 830), pp. 67-69,
99-100
Tab 4 Congressional
Record, 105th Cong., 1st Sess., Colloquy, pp. S9839-40
Tab 5 Pharmacy Compounding Practices, Chapter 1161, USP 23-NF
18, Supplement 5
Tab 6 FDA Organizational Chart
Tab 7 Center
for Drug Evaluation and Research Organizational Chart
Tab
8 Pharmacy
Compounding Steering Committee Members Federal Register Documents
Tab 9 Advisory Committees: Pharmacy Compounding Advisory
Committee; Establishment (63 FR 11596)
Tab 10 Pharmacy Compounding Advisory Committee: Notice of Meeting
(63 FR 47301)
Relevant Information Submitted to the Docket
Tab 11 Comments (by Pharmaceutical Research and Manufacturers of
America, received May 19, 1998)
Tab 12 Comments (by International Academy of Compounding
Pharmacists, received July 10, 1998)
Tab 13 Comments (by John H. Perrin, Ph.D., received September
17, 1998)
Volume 2 - Bulks
List
Responses to Request for Nominations
Tab 1 International Academy of Compounding Pharmacists
Tab 2 Scottsdale Skin & Cancer
Center, Ltd.
Tab
3 Mary T. Gidaro
Tab 4 Neil Brody, M.D., Ph.D, Dermatology and Dermatologic
and Laser Surgery
Tab 5 Abbott Laboratories
Tab 6 The University of Texas MD
Anderson Cancer Center
Tab 7 Texas Pharmacy Association
Tab 8 North Carolina Board of Pharmacy
Tab 9 Moss Pharmacy and Nutrition Center
Tab 10 Baxter Healthcare Corporation
Tab
11 Dermatology
Associates
Volume
3 - Products Withdrawn
or Removed From the Market