Which chapter of USP pertains to sterile compounding?

Chapter 797 of the United States Pharmacopeia (USP) specifically addresses the standards for sterile compounding. This chapter outlines practices and procedures to ensure that sterile preparations are made consistently safe, effective, and of high quality. It establishes guidelines on various aspects, including the environment in which sterile compounding occurs, personnel training and competency, and the procedures for preparing sterile products.

In sterile compounding, the primary concern is to prevent contamination and ensure that the compounded products are free from harmful microorganisms and particles. Chapter 797 provides guidance on risk levels for compounding based on the degree of difficulty and potential hazards involved. This includes detailing the necessary cleaning and disinfection protocols for compounding areas, the use of appropriate protective gear, and the testing of compounded products to ensure their sterility.

The other chapters mentioned serve different purposes: Chapter 795 deals with non-sterile compounding, Chapter 800 focuses on handling hazardous drugs, and Chapter 500 does not exist within the context of compounding. Understanding the specific roles of these chapters is essential for pharmacy professionals to comply with regulations and ensure patient safety.