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

Draft Agenda

Advisory Committee Members

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

Federal Register Document (63 FR 17011): Bulk Drug Substances To Be Used in Pharmacy Compounding; Request for Nominations

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

 

Appendix I: Documentation Regarding Bulk Drugs Nominated for Proposed List, Arranged Alphabetically, with a Description of Documentation

Volume 3 - Products Withdrawn

or Removed From the Market

Documentation Regarding Products Withdrawn or Removed from the Market, Arranged Alphabetically, with a Description of Documentation