Hazardous Drugs, Waste and Disposal Requirements

Hazardous Drug Classification and Facility Controls

In modern pharmacy practice, handling medications that pose toxic risks to healthcare personnel requires strict adherence to safety standards. The National Institute for Occupational Safety and Health (NIOSH) maintains a comprehensive list of antineoplastic and other hazardous drugs used across healthcare settings. NIOSH hazardous-drug criteria include carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, genotoxicity, and a structure and toxicity profile similar to those of an existing hazardous drug. The NIOSH list identifies antineoplastic and other hazardous drugs, including drugs that primarily pose reproductive risks; facilities should use the current list rather than assume a fixed three-category format.

Pharmacy technicians handle, prepare, and dispose of hazardous drugs under pharmacist supervision as required by applicable law and facility policy; the required form of supervision varies by jurisdiction and task. Clear boundaries define this collaborative relationship. A pharmacy technician may reconstitute or manipulate a hazardous compound, but the final verification of hazardous drug compounding and dispensing must be performed by a pharmacist. Furthermore, clinical evaluation of hazardous drug therapy and patient counseling are strictly the responsibility of the pharmacist. Technicians support safe handling but rely on the pharmacist for all clinical decision-making.

To protect healthcare personnel, patients, and the environment from hazardous drug exposure, USP General Chapter <800> sets detailed containment and engineering standards. Under these standards, every facility must maintain an entity-specific list of the hazardous drugs handled on site and review this list at least once every 12 months. Containment begins the moment items arrive at the pharmacy loading dock. Hazardous drugs must be unpacked in neutral/normal or negative pressure areas, and they must never be unpacked in positive pressure areas. Antineoplastic hazardous drugs requiring manipulation must subsequently be stored in an externally ventilated, negative-pressure room that provides at least 12 air changes per hour.

Compounding hazardous drugs requires specialized physical equipment known as engineering controls. Sterile hazardous drug compounding requires a containment secondary engineering control (C-SEC) that is externally vented and maintains negative pressure. Inside this containment room, sterile hazardous drugs are compounded in an appropriate containment primary engineering control (C-PEC), such as a Class II biological safety cabinet or a compounding aseptic containment isolator. When compounding nonsterile hazardous drugs, a containment ventilated enclosure may be used. To further prevent chemical release, closed-system drug-transfer devices (CSTDs) mechanically prohibit the transfer of environmental contaminants and the escape of hazardous drug aerosols. Under USP <800>, CSTDs should be used when compounding hazardous drugs and must be used when administering antineoplastic hazardous drugs if the dosage form allows.