USP 800 Hazardous Drug Handling
What this clause says
Where Vendor handles drugs designated hazardous by NIOSH, Vendor shall maintain compliance with USP General Chapter <800> covering containment, ventilation, PPE, and waste disposal, with documentation available for Sponsor audit.
What this means in plain English
USP 800 governs handling of hazardous drugs (NIOSH list) — chemotherapy, hormones, antivirals, immunosuppressants. Compliance affects facility design, PPE, environmental controls, and training, with insurance implications for workers comp, products, and pollution.
What it means for a CDMO program
Pharmacies handling hazardous drugs without USP 800 compliance face workers comp surcharges, products liability exclusions, and potential pollution liability gaps. State boards have made USP 800 enforcement a focus since 2022.
How this evaluates
The Decoder applies these rules in order; the first match wins.
- usp800 › applies is set → Borderline: Hazardous drugs handled — USP 800 documentation must be current.
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