In late 2019, the United States Pharmacopeia (USP) Convention’s Chapter <800>, Hazardous Drugs—Handling in Healthcare Settings, took effect.
The chapter describes practice and quality standards for handling hazardous drugs to promote patient safety, worker safety, and environmental protection. The new standard mainly affects compounding and hospital pharmacies and cancer clinic settings. For many organizations, it required substantial modifications to comply.
USP <800> applies to handling of hazardous drugs (HDs) where there is a risk of exposure to patients, healthcare workers, and the environment. The future intent is for USP <800> to become applicable to compounding activities through reference in USP <795> and <797>, for nonsterile and sterile compounding. In keeping with this intent, this means that only when a practitioner is engaged in compounding (as that term is defined in USP <795> and <797>) would USP <800> be applicable.
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings Context for Implementation
USP <800> details process sequences, environmental controls, and the types of materials and finishes that can be used for floors, ceilings, and fixtures/furniture. Also included are components such as sinks and emergency eyewash stations.
Despite its coming online in 2019, some pharmacies either were unaware the new standards existed or struggled to comply with the changes necessary to meet the standard because of limited space. Fair enough, as the USP is not an enforcement agency.
However, some state agencies, as well as OSHA and Joint Commission, may require compliance with the standards. And further, the pharmacy building code was updated to USP <800>.
This code requires an anteroom for compounding pharmacies:
A sink must be available for hand washing. An eyewash station and/or other emergency or safety precautions that meet applicable laws and regulations must be readily available. Care must be taken to locate water sources and drains in areas where their presence will not interfere with required ISO classifications. Water sources and drains must be located at least 1 meter away from the C-PEC.
USP General Chapter <800> Hazardous Drugs—Handling in Healthcare Settings
As you can imagine, making these changes may require some creative reconfiguring of already limited space. Our One-Station Compact Wash-Up Sink with eye/face wash option has seen a surge in demand due to its smaller footprint. Also available in an ADA-compliant model, it is designed to offer increased infection control.
It’s best not to wait for OSHA or Joint Commission to come knocking on your door. Contact us today to learn more about these products to help you adhere to USP <800>.