USP 800: Hazardous Drug Compounding Standards

What Is USP 800?

USP Chapter 800 describes standards for handling hazardous drugs (HDs) throughout the healthcare system, from receiving to disposal. It applies to all healthcare personnel who handle HDs, including pharmacy technicians. The chapter became enforceable and is critical for safe pharmacy operations.

Hazardous drugs are identified by the NIOSH (National Institute for Occupational Safety and Health) list, which categorizes drugs as antineoplastic (cancer drugs), non-antineoplastic that meet hazardous criteria, and reproductive hazards.

Engineering Controls and PPE

HD compounding requires a negative-pressure room with externally vented biological safety cabinets (BSCs) or containment aseptic isolators (CASIs). Chemotherapy-rated gloves (tested to ASTM D6978 standards) must be double-gloved and changed every 30 minutes during compounding.

Additional PPE includes a chemotherapy-tested gown, eye protection, and respiratory protection when appropriate. Spill kits must be readily available in all areas where HDs are handled.

PTCB Exam Tips

USP 800 questions are increasingly common on the PTCB exam. Review with our flashcards and take practice exams on compounding safety.