The effective date for USP 800 implementation is Dec. 1, 2019

MedTrainer in the News: To help protect employees, patients and the environment, the United States Pharmacopeia (USP) has developed comprehensive standards for the safe handling of hazardous drugs—USP <800>. According to the Centers for Disease Control and Prevention (CDC), over 8 million healthcare personnel in the United States are exposed to hazardous drugs each year. This exposure presents significant risks for acute and chronic health conditions, including skin rashes, hair loss, adverse reproductive health, vision problems, and even cancer.

Virtually all types of practices—from community health centers and ambulatory surgery centers, to skilled nursing facilities and hospitals—will have to meet the new compliance standards. The USP standards will initially be enforced by the state boards of pharmacy; however, enforcement may come from the Food and Drug Administration (FDA) due to the 2013 Drug Quality and Safety Act focused on patient safety. Accreditation organizations such as the Joint Commission and Accreditation Association for Ambulatory Health Care (AAAHC) may also enforce the standards during accreditation surveys. Further, OSHA already has enforcement authority wherever worker safety is concerned.

USP 800 is a direct evolution of USP 797, which describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. However, USP 797 only serves as a guideline for sterile compounding and contamination prevention. Going into effect Dec. 1, 2019, USP 800 will cover the complete end-to-end process, from receipt to disposal.

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