What is USP <800>?
United States Pharmacopeia chapter for handling hazardous drugs. Requires negative pressure HD rooms, containment primary engineering controls (C-PECs), exposure monitoring, and separate HVAC systems.
USP <800> applies to any facility handling hazardous drugs on the NIOSH list — not just compounders. Core requirements include an assessment of risk (or full containment), negative-pressure compounding rooms with 12+ air changes per hour and external exhaust, C-PECs, designated storage, personal protective equipment, deactivation/decontamination procedures, and medical surveillance considerations.
The chapter's documentation burden includes the hazardous drug list review, assessment of risk with periodic re-review, wipe sampling where performed, training records, and spill/exposure procedures.
See how CompliRx handles this in practice:
USP <800> compliance softwareRelated terms
Turn the standard into daily records
CompliRx helps compounding pharmacies keep environmental monitoring, qualifications, cleaning, documents, and CAPA evidence inspection-ready.