What does USP 797 specifically govern?

The United States Pharmacopeia (USP) Chapter 797 specifically governs sterile compounding practices, which is critical for ensuring the safe preparation of medications that are intended to be sterile. This chapter sets forth guidelines to minimize the risk of contamination and ensure the quality of compounded sterile preparations (CSPs).

The standards outlined in USP 797 address various aspects of sterile compounding, including the criteria for the environment in which sterile preparations are compounded, the training and competencies required for personnel, proper cleaning and disinfecting procedures, and the protocols for the use of sterile equipment. By adhering to these guidelines, pharmacy professionals can help ensure patient safety and minimize the risk of infections or other complications associated with the administration of sterile products.

In contrast, the other options refer to areas that are not covered under USP 797: pharmaceutical pricing is typically regulated by economic policies, non-sterile compounding practices fall under different guidelines, and drug storage conditions are covered by distinct regulations outside USP 797.