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

• A4 Question: What is a "compounded sterile preparation" according to USP Chapter 797?
   
• A4 Answer: A "compounded sterile preparation" (CSP) is defined in USP Chapter 797 as a dosage unit that 1) is prepared according to manufacturer's labeled instructions; 2) contain nonsterile ingredients or employ nonsterile components and devices that must be sterilized before administration; or 3) is biologic, diagnostic, drug, nutrient, or pharmaceutical that possesses either of the two previous characteristics and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powder for injection, irrigations, metered sprays, and ophthalmic and otic preparations. For more information, see the ASHP Discussion Guide on USP Chapter 797.

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