USP 800 Hazardous Drug Handling for Pharmacy Technicians
Learn USP 800 requirements for handling hazardous drugs in the pharmacy, including PPE, engineering controls, spill procedures, and waste disposal for PTCE prep.
What Is USP 800?
USP chapter 800 describes standards for handling hazardous drugs (HDs) to protect healthcare workers, patients, and the environment. It applies to all healthcare settings where HDs are received, stored, compounded, dispensed, administered, or disposed of. Pharmacy technicians who handle hazardous drugs must understand and follow these requirements.
What Makes a Drug Hazardous?
The National Institute for Occupational Safety and Health (NIOSH) publishes a list of hazardous drugs. A drug is considered hazardous if it exhibits one or more of these characteristics: carcinogenicity, teratogenicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or similarity in structure or toxicity to existing hazardous drugs. Common examples include chemotherapy agents, certain antivirals, hormones, and some immunosuppressants.
Engineering Controls
- Biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) - Required for sterile compounding of HDs
- Closed-system transfer devices (CSTDs) - Required for administration of antineoplastic HDs and recommended for compounding
- Negative pressure room - The HD compounding area should be at negative pressure relative to surrounding areas to contain vapors
Personal Protective Equipment (PPE)
At minimum, handling HDs requires chemotherapy-tested gloves (ASTM D6978 tested). For compounding, full PPE includes double gloving, a protective gown, eye and face protection, and respiratory protection when not using a ventilated cabinet. Gloves must be changed every 30 minutes during continuous compounding or immediately if torn or contaminated.
Spill Management
Spill kits must be available in all areas where HDs are handled. The kit should contain absorbent materials, PPE, disposal bags, and a spill sign. Small spills can be cleaned by trained personnel. Large spills may require specialized cleanup teams.
Waste Disposal
HD waste must be disposed of in designated yellow chemotherapy waste containers. Trace-contaminated items (gloves, gowns, empty vials) go in yellow containers. Bulk HD waste follows RCRA hazardous waste regulations when applicable.
USP 800 knowledge is tested within the patient safety domain of the PTCE.
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