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What is USP Chapter 800?

At LicenseTrak, we understand the difficulty of staying current with all of the latest regulation and rule changes when it comes to USP standards. For this reason, we offer you a guide and helpful information, contributing to the ability of your staff to maintain USP compliance and stay safe. LicenseTrak can help your pharmacy operations stay compliant with all of the latest USP 800 and other regulations.

USP 800 guidelines cover the duties and requirements of medical staff personnel, including pharmacists and pharmacy technicians, who handle hazardous drugs during the course of their duties. The various aspects covered by the guidelines include cleaning and decontamination, documentation, spill control, and deactivating procedures. The USP 800 standards apply to all workers who accept, conduct preparation with, ship, provide to patients or in any other way contact hazardous drugs. They also apply to locations in which these drugs are handled.

USP 800 Purpose

Hazardous drugs can have significant negative effects on health and safety. These include cancer drugs, certain hormone products, certain anticoagulants, and other drugs that have may pose a risk to patients and care givers. USP 800 establishes methods for proper handling of hazardous drugs involving worker, patient and environmental protection.

USP 800 describes the requirements for medical surveillance, engineering and facility controls, spill control, deactivation, decontamination, and cleaning related to hazardous drugs. They apply to all medical personnel coming into contact with or handling hazardous drugs. USP 800 explains the requirements for medical surveillance, medical surveillance, facility and engineering controls, contact with hazardous drugs, spill control, deactivating, decontaminating, and cleaning.

USP 800 Compliance Deadline

The USP Compounding Expert Committee developed the USB 800 chapter and set an initial compliance deadline of July 1, 2017. However, that date was extended until December 1, 2019 in order to accommodate the latest changes to USP 797. USP 800 rules now apply to all facilities that store or handle hazardous drugs, including retail, mail order, compounding, and infusion pharmacies, plus medical clinics and hospitals.

Differences Between USP 800 and USP 797

While USP 800 focuses on protecting patients and care givers from experiencing harm from hazardous drugs, USP 797 only includes guidelines for sterile compounding of drugs (hazardous and nonhazardous). USP 797 does not provide standards for handling hazardous drugs.

To learn how our LicenseTrak software can help you achieve and maintain compliance with USP 800 standards, call us today at (480) 500-6236 or fill out our contact form.