What is USP <797>?
United States Pharmacopeia chapter for sterile compounding: the primary standard for cleanroom operations. Covers environmental monitoring, personnel training, garbing, cleaning, and beyond-use dating for sterile preparations.
The 2023 revision replaced the old low/medium/high risk levels with Categories 1, 2, and 3, each with its own beyond-use date limits, facility expectations, and personnel requalification frequencies (every 6 months for Categories 1 and 2; every 3 months for Category 3 competencies such as media fill and garbing evaluation).
Operationally, <797> drives most of a sterile compounding pharmacy's recurring evidence: temperature, humidity, and pressure monitoring; viable air and surface sampling; gloved fingertip sampling; cleaning documentation; certification records; and master formulation/compounding records with assigned BUDs.
See how CompliRx handles this in practice:
USP <797> compliance softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.