The United States Pharmacopeia (USP) Convention’s Chapter 800, “Hazardous Drugs — Handling in Healthcare Settings,” goes into effect Dec. 1. The new standards provide detailed specifications for the handling of hazardous drugs in order to protect pharmacy staff from health risks associated with harmful chemicals. Hazardous drugs, such as antineoplastic drugs used in chemotherapy, are identified by the National Institute for Occupational Safety and Health (NIOSH) based upon criteria that includes carcinogenicity and toxicity. Pharmacies that handle these hazardous drugs are primarily regulated by the State Boards of Pharmacy and may also be inspected by the U.S. Food & Drug Administration.
As a result of the imminent USP 800 Chapter, many pharmacies in hospitals and cancer clinic settings may require substantial modifications to comply with the safety requirements. The authoritative new standards address the sequence and types of spaces required; appropriate finishes for floors, counters, and ceilings; necessary components, such as a sink and an emergency eyewash station; and environmental controls, including negative pressure spaces for unpacking and compounding the drugs. In many cases, pharmacies will need to expand or reconfigure their space in order to accommodate the prescribed standard.