What is the focus of Chapter 797 of the USP?

Chapter 797 of the United States Pharmacopeia (USP) specifically addresses guidelines for preparing sterile pharmaceuticals. Its primary focus is on ensuring that compounded sterile preparations are made safely and effectively to minimize the risk of contamination, infection, and other patient safety concerns.

This chapter outlines the standards for various aspects of sterile compounding, including the environment in which compounding occurs, personnel training and competencies, and the necessary procedures to guarantee sterility throughout the compounding process. By adhering to these guidelines, healthcare facilities can improve patient outcomes by providing high-quality, sterile medications that are free from harmful microorganisms.

The emphasis on preparation rather than manufacturing large batches, work hours, or storage requirements underscores the importance of maintaining stringent protocols in a sterile environment to ensure patient safety and the efficacy of the therapies provided.