What is the primary focus of USP Chapter 797?

The primary focus of USP Chapter 797 is to prevent contamination and ensure the integrity of compounded sterile preparations. This chapter outlines the necessary guidelines and standards for sterile compounding practices in order to protect patients from the risks associated with contaminated or improperly prepared medications. It establishes requirements for the environment where compounding occurs, including cleanroom standards, personnel training, and the use of appropriate equipment. By adhering to these guidelines, practitioners can minimize the potential for microbial contamination, ensure the stability and efficacy of compounded products, and ultimately safeguard patient health. The focus on contamination prevention and compound integrity is crucial in settings such as hospitals and pharmacies where sterile medications are frequently prepared.