Which chapter outlines the requirements for sterility of Compounded Sterile Preparations (CSPs)?

The chapter that outlines the requirements for sterility of Compounded Sterile Preparations (CSPs) is Chapter 797. This chapter provides detailed guidelines and standards for the compounding of sterile medications, focusing on the critical aspects of sterility, including the necessary environments, equipment, and practices needed to minimize contamination risks.

Chapter 797 addresses various elements such as facility design, personnel training, and procedures required to ensure that sterile compounding is performed safely and effectively. This includes guidelines on the use of cleanroom environments, air filtration systems, and aseptic techniques, all of which are crucial for maintaining the sterility of compounded products and ensuring patient safety.

Other chapters like 795 and 800 deal with non-sterile compounding and hazardous drugs, respectively, while chapter 701 does not specifically address the compounding requirements for sterility. Understanding the context and specifics of Chapter 797 is essential for anyone involved in the preparation of sterile medications, as it sets the standard for practice in the field.