USP General Chapter 800 (Hazardous Drugs — Handling in Healthcare Settings) became official in December 2019 but enforcement by state boards has been uneven.
What USP 800 requires
USP 800 establishes standards for receiving, storing, compounding, dispensing, and disposing of hazardous drugs (HDs). Key requirements include: designated HD areas with appropriate ventilation (C-PEC and C-SEC), personal protective equipment requirements, HD list maintenance, spill kits, training requirements, and HD disposal protocols.
State enforcement landscape
Most states have adopted USP 800 requirements by reference to USP standards in their pharmacy practice acts or compounding regulations. Pennsylvania finalized compounding regulations in 2025 that explicitly reference USP 800. California, Texas, and Florida have incorporated USP 800 into their inspection standards.
Key compliance areas
Hazardous drug list: Maintain a current list using NIOSH as a reference. Review annually and when new drugs are added to practice.
Facility requirements: C-PEC and C-SEC must meet USP 800 specifications. Verify your state’s current requirements for existing facilities.
Training: All personnel who handle HDs must receive documented training before working with HDs and at least annually thereafter.
Verify with your state board
USP 800 requirements are complex and state implementation has been incremental. For current compliance requirements specific to your state, contact your state board of pharmacy directly.