8.3 Hazardous Drug Handling (USP <800>): Engineering Controls, PPE & Spill Protocols

Hazardous Drugs and USP <800>

USP <800> protects workers, patients, and the environment from hazardous-drug exposure. It applies throughout the drug lifecycle: receipt, unpacking, storage, transport, compounding, dispensing, administration support, cleaning, spill response, and disposal. Sterile hazardous compounding also follows USP <797>; nonsterile hazardous compounding also follows <795>.

Current NIOSH list

The NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 supersedes the 2016 list. It uses two tables, not the older three-group structure. The first addresses antineoplastic drugs meeting the current criteria; the second covers non-antineoplastic drugs meeting one or more hazardous-drug criteria. Reproductive risk and other hazards are identified within the current framework rather than taught as a standalone “Group 3” list.

A facility maintains its own hazardous-drug list based on NIOSH and products handled, reviews new drugs, and updates policies. Manufacturer labeling and safety data sheets inform but do not replace NIOSH evaluation.

Assessment of risk

For eligible final dosage forms and tasks, a documented assessment of risk may permit alternative containment strategies when <800> allows. It identifies dosage form, packaging, manipulation, exposure route, task, frequency, and controls. The assessment is reviewed regularly and when process or drug changes.

An assessment cannot exempt antineoplastic hazardous drugs that require manipulation from full containment. Crushing a tablet, opening a capsule, compounding, or manipulating a hazardous injectable presents exposure beyond handling an intact final dosage form.

Engineering controls

Hazardous sterile compounding occurs in a containment primary engineering control, such as a biological safety cabinet or compounding aseptic containment isolator, located in an externally vented negative-pressure containment secondary engineering control. The pressure, air changes, exhaust, certification, and placement meet the current chapters.

Nonsterile hazardous compounding uses a containment ventilated enclosure or other permitted externally vented control. A horizontal laminar-airflow workbench that blows air toward the operator is not hazardous-drug containment.

Hazardous drugs are stored to prevent breakage and exposure; antineoplastic hazardous drugs requiring manipulation are stored in a negative-pressure externally vented area as required. Refrigerated hazardous storage also maintains containment.

Work practices and PPE

Personnel receive training and demonstrate competence. Gloves are chemotherapy-tested when required and changed at the prescribed interval and after contamination. Gowns are disposable, resistant, and closed; eye, face, sleeve, respiratory, and shoe/hair protection depend on task and risk. A surgical mask does not protect against hazardous aerosols.

Use a closed-system drug-transfer device when required for administration and when the dosage form allows for compounding under the standard’s hierarchy. Prime tubing using a nonhazardous method when feasible. Label and transport preparations in leak-resistant secondary containment.

Cleaning, spills, and waste

The workflow distinguishes deactivation, decontamination, cleaning, and disinfection; one wipe does not automatically perform all four. Agents and sequence must be compatible with drug, surface, and sterility requirements.

Spill kits are accessible, and trained personnel isolate, don PPE, contain, clean, document, and seek medical evaluation as needed. Exposure and medical-surveillance programs address reproductive and other risks.

Hazardous pharmaceutical waste is classified under EPA, state, local, and facility requirements. Yellow, black, blue, or other container colors may be used by a vendor or institution, but color alone is not a universal legal determination of RCRA status. Never place trace chemotherapy, bulk chemotherapy, P-listed waste, and ordinary trash based solely on a memorized color.

Exam method

Identify the drug on the current list, dosage form, manipulation, and route of exposure. Decide whether assessment-of-risk alternatives are allowed, then apply containment, PPE, workflow, cleaning, spill, and waste rules.

Task-based examples

Receiving an intact manufacturer-sealed hazardous tablet bottle, counting intact tablets, crushing a tablet, and compounding a liquid are four different exposure tasks. An assessment of risk may support alternative controls for eligible intact final dosage forms, but crushing creates powder and requires containment. Document the exact task; a drug-level statement alone is incomplete.

For a spill outside containment, stop traffic, post the area, obtain the spill kit, don task-appropriate PPE, contain from the perimeter inward, collect contaminated material, clean through the required sequence, and document personnel and exposure. Consult safety and occupational-health procedures after skin, eye, inhalation, or needlestick exposure. Dispose based on the actual drug and federal/state waste category, not the nearest bin’s color.

Receiving staff need a procedure for damaged cartons before opening them. Move the package to a designated containment area, use appropriate PPE, evaluate leakage, and manage a spill without carrying contamination through ordinary receiving space.