USP 800 Hazardous Drug Compounding Verification

Inspection template for verifying USP <800> hazardous drug compounding controls, including containment ventilation, PPE, spill preparedness, and disposal practices.

Inspection Details

• Inspection date and time recorded
• Compounding area and room(s) identified
• Inspector signature completed
• Scope includes hazardous drug handling, compounding, and waste areas

Containment Ventilation and Engineering Controls

• Primary engineering control in use is appropriate for hazardous drug compounding
• Containment secondary engineering control is present and operational
• Negative pressure differential maintained in hazardous drug compounding area
• Airflow indicators or monitoring devices functioning and visible
• Certification or maintenance status current for containment equipment

PPE and Personnel Practices

• Required PPE available at point of use
• Personnel don PPE before entering hazardous drug compounding area
• Glove and gown change practices observed or documented per procedure
• Hand hygiene supplies available and used at required transition points
• Training records current for personnel assigned to hazardous drug tasks

Spill Preparedness and Emergency Response

• Hazardous drug spill kit present in or near compounding area
• Spill kit contents complete and within expiration dates
• Written spill response procedure accessible to staff
• Staff can identify who to notify and how to isolate a spill area

Decontamination, Waste Segregation, and Disposal

• Hazardous drug waste containers properly labeled and closed
• Hazardous waste segregated from non-hazardous waste at point of generation
• Cleaning and decontamination supplies available for hazardous drug surfaces
• Disposal process follows approved hazardous waste procedure and local requirements