USP 797 is a standard published by the United States Pharmacopeia focused on the compounding of sterile preparations — medications such as injectables, intravenous solutions, and eye drops that must be prepared in a way that avoids microbial or particulate contamination. The standard addresses topics like the design of cleanrooms and controlled environments, personnel garbing and hand hygiene, environmental monitoring, and the training and competency verification expected of staff who compound sterile products.
Because contamination in sterile preparations carries meaningful risk, the practices described in USP 797 tend to be more rigorous and detailed than those for nonsterile compounding. Many state boards of pharmacy reference or incorporate USP 797, or similar sterile compounding expectations, into their own regulations governing pharmacies that prepare these products.
Why it matters
Pharmacists working in hospital, infusion, or specialty pharmacy settings where sterile compounding occurs need to understand that facility design, staff training, and ongoing quality checks are often not just a matter of internal best practice but tied to what a state board expects for licensure and inspection purposes. Falling short of these expectations can affect a pharmacy’s ability to operate a sterile compounding service.
Because how states adopt and enforce sterile compounding standards varies, RxByState tracks these differences so pharmacists can understand what’s expected in the states where they practice. Learn more at https://app.rxbystate.com/signup.