USP General Chapters 795 (non-sterile), 797 (sterile), and 800 (hazardous drugs) set enforceable cleaning and environmental standards for pharmacy compounding. Non-compliance is a Board of Pharmacy issue that can shut a facility down.
USP 797 Cleaning Frequency
- ISO 5 primary engineering control (hood): clean at start of every shift and every 30 minutes during compounding.
- ISO 7 buffer area: clean daily.
- ISO 8 ante-area: clean daily.
- Walls, ceilings, and shelves: monthly.
Approved Chemistry
Sterile 70% IPA for ISO 5 surfaces. EPA-registered sporicidal disinfectant (typically hydrogen peroxide-based) monthly for ISO 7/8 areas. Standard quaternary disinfectant is not sufficient for sterile compounding.
Documentation
Every cleaning event must be documented: date, time, cleaner initials, chemistry, and area cleaned. Records held for the retention period specified by state Board of Pharmacy.
USP 800 for Hazardous Drug Areas
Additional decontamination step using approved deactivation agent (typically sodium hypochlorite followed by thiosulfate neutralizer or specific commercial products). PPE requirements more stringent.
Pharmacy-Aware Cleaning Support
We support pharmacies with ante-area and general cleaning while your team handles USP-critical zones.