Healthcare Facility Compliance 14 items
Pharmacy Sterile Compounding USP <797>/<800> Audit
Audit of pharmacy sterile and hazardous drug compounding operations against USP <797> and <800> for facilities, engineering controls, and personnel practices.
USP <797>USP <800>CMS 42 CFR 482.25
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Facilities & Engineering Controls
- Is sterile compounding performed in an ISO Class 5 primary engineering control (PEC) within an ISO Class 7 buffer area? *
- Is certification of PECs, SECs, and cleanrooms performed at least every 6 months? *
- Are pressure differentials between the buffer, ante-area, and general pharmacy monitored and documented? *
- Is viable and non-viable air/surface environmental sampling performed at the required frequency? *
Personnel Training & Garbing
- Do compounding personnel complete initial and periodic competency including gloved fingertip and media-fill testing? *
- Is hand hygiene and garbing performed in the correct order and re-donned when exiting the ante-area? *
- Is aseptic technique observed and documented during compounding? *
Compounding & Beyond-Use Dating
- Are beyond-use dates (BUDs) assigned based on category, sterility testing, and storage conditions? *
- Are master formulation and compounding records maintained for compounded sterile preparations? *
- Is a final visual inspection and verification performed before release of each preparation? *
Hazardous Drug Handling (USP <800>)
- Is an assessment of risk maintained and hazardous drugs on the NIOSH list identified? *
- Are hazardous drugs compounded in a containment primary engineering control within a negative-pressure C-SEC? *
- Is hazardous drug receipt, storage, and spill response managed with appropriate PPE and a spill kit? *
- Is environmental wipe sampling for hazardous drug surface contamination performed periodically?
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