July 13-14, 2000

Briefing Information


Cover Letter

Table of Contents

Tab 1 Proposed Rule entitled "Additions to the list of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness" (65FR256, January 4, 2000) pdf txt

Tab 2 Aminopyrine - All drug products containing Aminopyrine
Revocation of Requirements for Aminopyrine and Dipyrone (42FR53954, October 4, 1977)
-RX Study Bulletin #231 Drug Products containing Dipyrone

Tab 3 Astemizole - All drug products containing Astemizole
- Determination that Astemizole 10mg tablets Were Withdrawn From Sale for Safety Reasons (64FR 45973, August 23, 1999)
pdf txt
FDA Talk Paper, T99-29 (June 21, 1999) Janssen Pharmaceutica Announces the Withdrawal of Hismanal From the Market
"Dear Healthcare Provider" Letter from Janssen Pharmaceutica (June 18, 1999)

Tab 4 Cisapride - All drug products containing Cisapride
FDA Talk Paper, T00-14 (March 23, 2000) Janssen Pharmaceutica Stops Marketing Cisapride in the US
Janssen Pharmaceutica Press Release (March 23, 2000)
Washington Post article (March 24, 2000) "Heartburn Drug to Be Pulled"*
-"Dear Healthcare Provider" Letter from Janssen Pharmaceutica (April 12, 2000)

Tab 5 Grepafloxacin - All drug products containing Grepafloxacin
Glaxo Wellcome Press Release (October 27, 1999)
"Dear Healthcare Provider" Letter from Glaxo Wellcome (November 1, 1999)
Wall Street Journal article (October 28, 1999) "Glaxo Removes Raxar Antibiotic From Markets Due to Side Effects"*

Tab 6 Troglitazone - All drug products containing Troglitazone
-"Dear Pharmacist" Letter from Warner-Lambert Company (March 22, 2000)
Warner-Lambert Company Press Release (March 21, 2000)
HHS News Press Release (March 21, 2000) Rezulin to Be Withdrawn From the Market
Washington Post article (March 22, 2000) "Controversial Diabetes Drug Is Withdrawn"*


Demonstrably Difficult to Compound Drugs

A. Concept Paper pdf  wpd

Extension of Comment Period for Concept Paper pdf


B. Sterile Products

  1. United States Pharmacopeia (USP) 24, Chapter 1206 - Sterile Drug Products for Home Use, p. 2130-2143, 2000. *
  2. USP Chapter 1206 - Sterile Preparations – Pharmacy Practices (In-process revision) Pharmacopeial Forum, Vol. 26, p. 812, 2000.*
  3. National Association of Boards of Pharmacy Model Rules for Sterile Pharmaceuticals*
  4. American Society of Hospital Pharmacists (ASHP) Technical Assistance Bulletin on Quality Assurance for Pharmacy Prepared Sterile Products, September 24, 1993.*
  5. American Society of Health-Systems Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products," American Journal of Health-Systems Pharmacy 2000, 57:1150-69, 2000.*
  6. "Upgrading quality assurance for pharmacy-prepared sterile products," American Journal of Hospital Pharmacy, 48:2387-2388, 1991.*
  7. "ASHP Invitational Conference on Quality Assurance for Pharmacy Prepared Sterile Products," American Journal of Hospital Pharmacy, 48:2391-2397, 1991.*
  8. "National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals" American Journal of Hospital Pharmacy 48:2398-2413, 1991.*
  9. "Perspective on Sterile Compounding Practices and Draft Guidelines. By V. Tormo, American Journal of Hospital Pharmacy, 49:946-947, 1992.*
  10. "National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities – 1995" American Journal of Health System Pharmacy, 53:2591-2605, 1996*
  11. "Needed: Serious attention to sterile products" by C.E. Meyers, American Journal of Health System Pharmacy, 53:2582, 1996.*
  12. "Essential elements of quality control" by J.C. Boylan, American Journal of Hospital Pharmacy, 40:1936-1939, 1983.*
  13. "Sterility testing of antimicrobial-containing injectable solutions prepared in the pharmacy" by M.J. Akers, G.E. Wright, and K.A. Carlson, American Journal of Hospital Pharmacy, 48:2414-2418, 1991.*"
  14. "Membrane filtration of pharmaceutical solutions" by B.T. McKinnon and K.E. Avis, American Journal of Hospital Pharmacy, 50, 1921-1936, 1993.*
  15. "Unsafe Activities of Compounding Pharmacists" by J. Perrin, American Journal of Health-Systems Pharmacy, 52:2827-2828, 1995*
  16. "Compounding Sterile Products: What is Good Pharmacy Practice?" by J. Feinberg, Consultant Pharmacist, 7:1012-1014, 1992.*
  17. "Control of the aseptic processing environment" by W.R. Frieben, American Journal of Hospital Pharmacy, 40:1928-1935, 1983. *
  18. "FDA Safety Alert: Hazards of precipitation associated with parenteral nutrition" by B.T. McKinnon, Nutrition in Clinical Practice, 11:59-65, 1996.*
  19. Editorials "Caring about stability and compatibility," "Compounding our problems." and "The complexity of mixing calcium and phosphate," American Journal of Hospital Pharmacists, 51:1533-1536, 1994.*
  20. "Chapter 84 Parenteral Preparations" by K.E. Avis in Remington's Pharmaceutical Sciences, 18th ed., p. 1545-1569, 1990.*
  21. "Chapter 12 Parenteral Products in Hospital and Home Care Pharmacy Practice" by J.W. Levchuk, in Pharmaceutical Dosage Forms: Parenteral Medications Volume 1, 2nd ed., p. 513-568, 1992.*
  22. "Chapter 5 Extemporaneous Preparation," "Chapter 15 Ophthalmic Preparations," and "Appendix 4 Hazards Associated with Parenteral Therapy," in Sterile Dosage Forms Their Preparation and Clinical Application, by S.J. Turco, 4th ed., 1994.*
  23. Excerpts from "Quality Assurance for Sterile Drug Compounding An Educational Resource" United States Pharmacopeia, 1998.*.  


C. Transdermal Delivery Systems

  1. "Fundamentals of Controlled Drug Administration: Physicochemical Considerations" by J.L. Zatz, Drug Development and Industrial Pharmacy, 9:561-577, 1983.*
  2. "Transdermal Drug Delivery – Problems and Promises" by DC Monkhouse and AS Huq, Drug Development and Industrial Pharmacy, 14:183-209, 1988. *
  3. "The Four Transdermal System Design Configurations Utilized Within the Pharmaceutical Industry," Transdermal and Topical Drug Delivery Systems, edited by Tapash K. Ghosh, William R. Pfister, and Su II Yum, Interpharm Press, Inc., 1997.*
  4. "Nothing New Under the Sun or in Pharmacy" by S. Scheindlin, Pharmacy Times, 44-46, September 1994.*
  5. "Transdermal Drug Delivery" by G.W. Cleary, Cosmetics and Toiletries, 106:97-109, 1991.*
  6. "Workshop Report: Scale-up of Adhesion Transdermal Drug Delivery Systems" by G.A. Van Buskirk, M.A. Gonzalez, V.P. Shah, S. Barnhardt, C. Barrett, S. Berge, , Pharmaceutical Research, 14:846-853, 1997.*
  7. Premeation Enhancers Compatible with Transdermal Drug Delivery Systems: Part II System Design Considerations" by W.R. Pfister and D. Hsieh, Pharmaceutical Technology, p. 54-55, October 1990.*
  8. "Current Status and Future Prospects of Transdermal Drug Delivery" by R.H. Guy, Pharmaceutical Research, 13:1765-1769, 1996.*
  9. "Methods of Enhancement of Transdermal Drug Delivery Part 1, Physical and Biochemical Approaches" by T.K. Ghosh and A.K. Banga, Pharmaceutical Technology, p. 72, March 1993.*
  10. "Drug Delivery Systems. 6. Transdermal Drug Delivery," by V.V. Ranade, Journal of Clinical Pharmacology, 31:401-418, 1991.*
  11. "Chapter 87 Medicated Applications" by L.H. Block in Remington’s Pharmaceutical Sciences, 18th ed., p. 1596-1602, 1990.*

D. Metered Dose Inhalers and Dry Powder Inhalers

FDA Guidance for Industry - Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry Manufacturing and Controls Documentation Draft Guidance Food and Drug Administration, October 1998.

*The document contains copyrighted material.  You may view this document at: Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, Monday through Friday, 9:00 am to 4:00 pm, except for Federal Holidays.