Nonsterile compounding is a core function of the practice of pharmacy; all pharmacies are expected to follow USP and state regulations to ensure high quality and patient safety. Pharmacies compounding nonsterile medications have been required to follow USP <795> requirements since 2000. Many State Boards of Pharmacy have laws governing the act of compounding and more recently have adopted the USP <795> standards directly.
For the last twenty years, the Chapter has undergone multiple revisions incorporating new science and evidence-based guidance and best practices. However, enforcement of the Chapter standards has been inconsistent, drawing little attention from regulatory agencies and pharmacy leaders alike while other USP compounding chapters have taken precedence.
Because of these ongoing revisions and lack of regulatory scrutiny, many pharmacies have not yet developed a robust USP <795> compliance program. This guide, developed by Simplifi 797 compounding compliance expert Annie Lambert, PharmD, BCSCP, explains the USP <795> standards in detail, and provides actionable steps your facility can take to meet best practices and ensure successful regulatory inspection outcomes.