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USP <800> Hazardous Drug Handling Requirements
USP Chapter <800> sets comprehensive standards for handling hazardous drugs (HDs) in healthcare settings — including hospitals, outpatient infusion centers, physician offices, and pharmacies. It covers receiving, storage, preparation, administration, and disposal of hazardous drugs.
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Scope of USP <800>
USP <800> applies to all healthcare personnel who handle hazardous drugs and all facilities where HDs are received, stored, compounded, dispensed, administered, or disposed of. The NIOSH Hazardous Drug list is the definitive reference for which drugs are covered.
Waste Segregation Requirements
PPE Requirements for HD Waste Handling
- Chemotherapy-rated gloves (double-gloving recommended)
- ASTM D6978-certified gown
- Eye/face protection when splash risk exists
- Respiratory protection when aerosol risk exists
Frequently Asked Questions
What is USP Chapter <800>?
USP <800> is a set of standards published by the United States Pharmacopeia that establishes requirements for handling hazardous drugs in healthcare settings. It became enforceable by most state boards of pharmacy in 2023 and applies to all personnel who handle HD drugs.
Which drugs are classified as hazardous under USP <800>?
The NIOSH Alert list identifies hazardous drugs including antineoplastics (chemotherapy), antivirals, hormones, immunosuppressants, and reproductive hazards. USP <800> adopts the NIOSH list as its reference.
What are the waste disposal requirements under USP <800>?
Hazardous drug waste (including trace-contaminated items) must be disposed of in clearly labeled, yellow or black containers (depending on waste type). Trace chemo waste goes to yellow containers as RCRA non-exempt; bulk chemo waste may go to black containers as RCRA hazardous waste.
Does USP <800> require separate ventilated areas for HD waste?
Yes. Hazardous drug waste must be stored in a separate, negative-pressure area until collection. Waste containers must be sealed to prevent contamination and labeled appropriately.
Who enforces USP <800>?
USP <800> is enforced primarily by state boards of pharmacy and nursing. OSHA may also use it as a reference for workplace safety. Joint Commission and other accreditation bodies may reference it in surveys.
Need Compliant Medical Waste Disposal?
MedWaste Solution serves healthcare facilities across Illinois, Indiana, Iowa, Missouri, Minnesota, and Wisconsin. Licensed, insured, and fully compliant with all federal and state regulations.
