USP 800 is a set of practice standards, published by the U.S. Pharmacopeia, that addresses the handling of hazardous drugs throughout the pharmacy setting — from receiving and storage through compounding, dispensing, administration, and disposal. Unlike sterile or non-sterile compounding chapters that focus on preparation quality, USP 800 is built around personnel and environmental safety, aiming to reduce exposure risk for pharmacists, technicians, and others who come into contact with these medications during routine work.
The standard touches facility design (such as dedicated negative-pressure areas), engineering controls, personal protective equipment, and procedures for spill response and waste handling. It applies broadly across settings that handle drugs identified as hazardous, which means it can affect community pharmacies, hospitals, and compounding facilities alike, not just specialized cleanrooms.
Why it matters
Boards of pharmacy have taken varied approaches to adopting and enforcing USP 800, with some incorporating it directly into inspection checklists and others referencing it more loosely. A pharmacist working in or overseeing compounding operations typically needs to understand not just the general framework but how their specific state board has chosen to implement and inspect against it, since enforcement timelines and expectations differ. This standard frequently comes up alongside USP 795 and USP 797, since many facilities that compound hazardous non-sterile or sterile preparations must satisfy all three simultaneously.
RxByState tracks how USP 800 adoption and enforcement vary by state. Learn more at https://app.rxbystate.com/signup.