USP Standards
USP Chapter 797
USP <797>
The USP general chapter governing sterile compounding, including environmental controls, beyond-use dating, and personnel training to prevent contamination.
In depth
USP <797> applies whenever a pharmacy prepares compounded sterile preparations. It addresses air quality and engineering controls, garbing and hand hygiene, competency testing (including media-fill and gloved-fingertip testing), microbiological monitoring, and risk-based beyond-use dating. Conformance is demonstrated through documented procedures, environmental monitoring records, and personnel qualification logs - all common inspection focal points for pharmacies that compound sterile products.