What does the USP 797 focus on?

The focus of USP 797 is on the sterility and stability of sterile compounded preparations (CSP). This section of the United States Pharmacopeia establishes practices to ensure that compounded sterile preparations are made in a way that minimizes the risk of contamination and maintains their integrity for patient safety.

One of the main goals of USP 797 is to provide guidelines that help ensure that these preparations are free from viable microorganisms, particulate matter, and other contaminants. It outlines the standards for the environment in which compounding occurs, the processes that should be followed, and the monitoring methods that need to be in place to confirm the sterility and stability of these formulations.

While quality assurance in non-sterile compounding, testing for contaminants in water, and waste disposal in pharmaceuticals are all important aspects of pharmacy practice, they do not fall under the specific guidelines set forth by USP 797. Instead, USP 797 is specifically tailored to the critical processes involved in the preparation of sterile products to ensure patient safety and efficacy.