USP General Chapter <797> is the U.S. Pharmacopeia standard for sterile compounding — applicable to sterile compounded preparations such as injectables, ophthalmics, and IV admixtures.
USP <797> governs the personnel, facilities, equipment, environmental controls, and quality assurance procedures required for sterile compounding. It sets requirements for clean-room classifications, garbing, gloved fingertip sampling, beyond-use dating, and sterility testing where applicable.
The most recent major revision was published in 2022 and became enforceable on November 1, 2023. Enforcement is the responsibility of state boards of pharmacy and, indirectly, of accreditation bodies that audit compounding facilities.
USP <797> is a pharmacy obligation, not a supplier obligation. When a 503A pharmacy compounds a sterile preparation from an API we supplied, the pharmacy is responsible for <797> compliance: clean-room maintenance, beyond-use dating, and sterility verification. A COA from us does not substitute for the pharmacy's own QC procedures.