USP <800> - Hazardous Drugs - Handling in Healthcare Settings

What it says

General Chapter <800> establishes requirements for safely handling hazardous drugs in healthcare settings to minimise exposure risk to personnel, patients and the environment, covering facility design, personal protective equipment, engineering controls, and procedures spanning receipt, storage, compounding, administration and disposal.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• This chapter's primary focus is occupational and environmental safety, protecting personnel who handle hazardous drugs, which is a distinct purpose from most other USP chapters that primarily address product quality or patient safety directly.
• Engineering controls, such as containment primary engineering controls for sterile hazardous drug compounding, are specific and non-negotiable for certain hazardous drug categories, not simply a recommended best practice.
• This chapter's requirements span the full hazardous drug lifecycle within a healthcare setting, from initial receipt through storage, compounding, administration and final disposal, treated as one connected safety system.

What inspectors look for

• Whether facility engineering controls for hazardous drug handling match what is required for the specific hazard category of drugs actually handled at that site.
• Whether personnel handling hazardous drugs have documented training and use appropriate personal protective equipment consistently, not just during observed audits.
• Whether hazardous drug disposal procedures are documented and followed, addressing the full lifecycle rather than only compounding and administration.

Related regulations