USP 800 was first published in February 2016. “USP General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment. USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.” (https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare)
At ChemoGLO, we are seeing many healthcare organizations (cancer centers, pharmacies, hospitals) preparing for the impending November 1, 2023 deadline when the hazardous drug compounding and safe handling standards (USP 800) become official and enforceable. Our work with healthcare organizations around the country is focusing primarily on two sections of USP 800: Section 6 (wipe sampling for HD surface residue) and Section 15 (deactivation, decontamination, and cleaning of contaminated surfaces). Using the ChemoGLO Wipe Kit and HDClean daily cleaning wipes are two easy ways to establish and maintain compliance with USP 800.
Below are some of the key elements of each section:
Section 6 USP 800: Environmental Quality & Control
• Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment).
• Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area.
• Wipe sampling should be repeated to validate that the deactivation/decontamination and cleaning steps have been effective.
The ChemoGLO Wipe Kit is the most widely used wipe contamination kit in the United States. A single kit can measure 24 separate drugs (17 hazardous and 7 hormone drugs) at the same time and provide quantitative results within 3-5 business days.
Section 15 USP 800: Deactivating, Decontaminating, Cleaning, and Disinfecting
• All areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned.
• Agents used for deactivation, decontamination, and cleaning should be applied through the use of wipes wetted with appropriate solution and not delivered by a spray bottle to avoid spreading HD residue.
HDClean wipes are sterile, pre-moistened towelettes that are laboratory tested and proven to deactivate, decontaminate, and clean hazardous drugs from surfaces.
Many healthcare organizations have already been working on establishing best practices and protocols to meet USP 800 standards. If your organization isn’t ready for the November 1, 2023 deadline, now is the time to take the appropriate steps toward compliance. The founders of ChemoGLO are experts in their fields and understand the issues and concerns with chemotherapy formulations, pharmacy operations, and monitoring. We would be happy to consult with your team and share information about how our surface wipe sampling kits and HDClean Wipes can help you achieve and maintain compliance with USP 800.