USP 797 is an important publication issued by the United States Pharmacopeia. It helps improve the safety of the compounding environment and the products produced in that environment. Sterile compounding environments designed, built, and operated in compliance with USP 797 are considered by most pharmaceutical professionals as state-of-the-art.
USP 797 is mandated by some state boards of pharmacy and recommended by others.
USP 797 is a far-reaching regulation that governs a wide range of pharmacy policies and procedures. It is designed both to cut down on infections transmitted to patients through pharmaceutical products and to better protect staff working in pharmacies in the course of their exposure to pharmaceuticals.
It is “to prevent patient harm and fatality from microbial contamination (non-sterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in compounded sterile preparations.”