USP 800 Hazardous Drug Handling: Pharmacy Tech Guide

What Is USP 800?

USP General Chapter 800 establishes standards for the safe handling of hazardous drugs (HDs) in healthcare settings, including pharmacies. Published by the United States Pharmacopeia, USP 800 outlines requirements for receiving, storing, compounding, dispensing, administering, and disposing of hazardous drugs. Pharmacy technicians who handle these medications must understand and follow these standards to protect themselves, their coworkers, and patients.

What Are Hazardous Drugs?

The National Institute for Occupational Safety and Health (NIOSH) publishes a list of hazardous drugs that is updated periodically. Hazardous drugs exhibit one or more of the following characteristics: carcinogenicity (cancer-causing), teratogenicity (harmful to fetal development), reproductive toxicity, organ toxicity at low doses, or genotoxicity (DNA damage). Common examples include chemotherapy agents like cyclophosphamide and methotrexate, certain antiviral drugs, and some hormonal medications.

It is important to note that not all hazardous drugs are chemotherapy agents. Some commonly dispensed medications like finasteride, warfarin, and certain hormone therapies are also classified as hazardous. Pharmacy technicians should consult the current NIOSH list and their facility's hazardous drug inventory to identify which medications require special handling.

NIOSH Hazardous Drug Groups

• Group 1: Antineoplastic (chemotherapy) drugs
• Group 2: Non-antineoplastic drugs that meet NIOSH hazardous criteria
• Group 3: Drugs with reproductive risk only (primarily a concern for handling by reproductive-age workers)

Engineering Controls Required by USP 800

USP 800 requires specific engineering controls to minimize worker exposure to hazardous drugs. For sterile compounding of hazardous drugs, a biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI) must be used. These devices provide both product sterility and worker protection through negative pressure airflow that prevents hazardous aerosols from escaping into the room.

The room where hazardous drug compounding occurs must have negative pressure relative to adjacent areas, with a minimum of 12 air changes per hour (ACPH) and externally vented HEPA-filtered air. This containment supplementary engineering control (C-SEC) prevents contamination from spreading to other pharmacy areas.

Non-Sterile Hazardous Drug Handling

For non-sterile compounding or manipulation of hazardous drugs, such as counting or repackaging tablets, USP 800 requires the use of a containment ventilated enclosure (CVE) or a BSC. Simple activities like dispensing intact tablets from a manufacturer bottle may not require a CVE if performed with appropriate PPE and procedures, but facilities should conduct a risk assessment to determine the level of containment needed.

Personal Protective Equipment (PPE)

Proper PPE is a cornerstone of USP 800 compliance. The type of PPE required depends on the activity being performed. At minimum, pharmacy technicians handling hazardous drugs should wear chemotherapy-tested gloves that meet ASTM D6978 standards. Two pairs of gloves are recommended for compounding activities.

PPE Requirements by Activity

• Receiving hazardous drugs: chemotherapy-tested gloves
• Storing hazardous drugs: chemotherapy-tested gloves
• Dispensing final dosage forms: chemotherapy-tested gloves (risk assessment may determine additional PPE)
• Compounding hazardous drugs: double gloving, protective gown, eye and face protection, respiratory protection as needed
• Spill cleanup: double gloving, protective gown, eye protection, respiratory protection

Gowns used for hazardous drug handling must be disposable, lint-free, and made of a material that is resistant to permeability by hazardous drugs. Standard pharmacy lab coats do not meet this requirement. Gowns should close in the back and have closed cuffs to prevent skin exposure.

Receiving and Storage Requirements

Hazardous drugs should be received in a designated area and unpacked by trained personnel wearing appropriate PPE. All hazardous drug shipments should be inspected for damage upon arrival. Damaged containers must be handled as spills and cleaned up according to the facility's spill management procedures.

Storage of hazardous drugs should be in a dedicated area with appropriate signage. Hazardous drugs that require refrigeration must be stored in a dedicated refrigerator or in a clearly marked, sealed container within a shared refrigerator. The storage area should have negative pressure or be adequately ventilated to prevent accumulation of drug vapors.

Spill Management

Every facility that handles hazardous drugs must have a written spill management policy and readily accessible spill kits. Spill kits should contain absorbent materials, chemotherapy-tested gloves, protective gowns, eye protection, respiratory protection, and waste disposal bags. Pharmacy technicians should know the location of spill kits and be trained on proper spill cleanup procedures.

Small spills can typically be cleaned up by trained pharmacy staff, while large spills may require involvement of environmental services or specialized cleanup teams. All spills must be documented, and exposed workers should receive appropriate medical evaluation.

Training and Medical Surveillance

USP 800 requires that all personnel who handle hazardous drugs receive initial training before working with these drugs and ongoing training at least every 12 months. Training must cover the facility's standard operating procedures, proper use of PPE, spill management, and waste disposal. Competency assessments should be documented.

Medical surveillance is recommended for workers who handle hazardous drugs. This may include baseline and periodic health assessments, reproductive counseling, and exposure monitoring. Workers who are pregnant, planning to become pregnant, or breastfeeding should be informed of the risks and given alternative work assignments when possible.

Waste Disposal

Hazardous drug waste must be disposed of in designated containers that are clearly labeled and meet EPA and state regulatory requirements. Trace-contaminated items such as used gloves, gowns, and empty vials go into yellow chemotherapy waste containers. Bulk hazardous drug waste requires special handling and disposal through a licensed hazardous waste contractor.