USP 795 is a standard published by the United States Pharmacopeia that addresses the compounding of nonsterile preparations — that is, medications prepared or altered by a pharmacy that are not required to be sterile, such as many oral liquids, topical creams, ointments, and capsules made from bulk ingredients. The standard describes general expectations around the environment where compounding takes place, the equipment and ingredients used, staff training and competency, and documentation practices intended to support consistent, quality preparations.
Many state boards of pharmacy incorporate USP compounding standards, including USP 795, into their own regulations, either by direct reference or by building state-specific rules around similar concepts. As a result, a pharmacy’s compounding practices are often evaluated against both the professional standard and the state’s own adopted rules.
Why it matters
Pharmacists involved in nonsterile compounding need to understand that “USP 795” isn’t just an abstract quality guideline — it can carry direct regulatory weight depending on how a given state has adopted or referenced it. This affects everything from how a compounding area is set up to what training and recordkeeping a pharmacy needs to maintain to stay in good standing with its board.
Because adoption and enforcement of USP compounding standards differ from state to state, RxByState tracks how these requirements vary so pharmacists can understand what applies in the states where they practice. Learn more at https://app.rxbystate.com/signup.