Questions and Answers on USP 797 Provided by American Society of Health-System Pharmacists, 7272 Wisconsin Avenue, Bethesda, MD 20814, 301–657-3000:

• A6 Question: Are enforceable sterile compounding standards necessary?
   
• A6 Answer: The FDA has long expressed concern about the quality of compounded preparations. Recent deaths caused by microbial contamination of injectable steroids have prompted several state boards of pharmacy to strengthen compounding regulations. Although ASHP published the profession's first sterile compounding standards in 1992, a 2002 survey of sterile compounding practices revealed low compliance with those voluntary standards. The lack of enforceable standards has allowed budget-driven health-system administrators to avoid making the investment necessary to construct and operate safe compounding facilities. ASHP believes that enforceable standards will improve compliance, enhance patient safety, and ultimately enrich the practice of pharmacy.

This answer provided by ASHP on www.Ashp.org. The subject of this question-and-answer session is constantly evolving because of ongoing research, changes in legal and regulatory requirements, and improvements in technology, and are subject to the professional judgment and interpretation of the practitioner due to the uniqueness of each pharmacy's role in compounding sterile preparations. The author, reviewers, editors, ASHP, and Baxter have made reasonable efforts to ensure the accuracy and appropriateness of the information presented. However, any reader of this information is advised that the author, reviewers, editors, ASHP, and/or Baxter are not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information in the interview in any and all practice settings. Any reader of this document is cautioned that ASHP and Baxter make no representation, guarantee, or warranty, express or implied as to the accuracy and appropriateness of the information contained in this interview, and will bear no responsibility or liability for the results or consequences of its use