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USP 800 Compliance for Compounding Pharmacies & Labratories

January 14, 2020 / STEVE CARTER

If you’re reading this now, chances are you’re doing so with a bit of anxiety … and your anxiety is justified by the December 1, 2019 deadline for United States Pharmacopeia (USP) Chapter <800>.  You’re not alone. Other compounding facilities are in a rush to make physical and policy changes to ensure that they comply with USP 800 and can stay in business. The good news is that we can help. USP 800 details the regulations for handling of hazardous drugs. This could be in compounding pharmacies, hospital pharmacies, and medical centers. USP 800 augments USP 797 and the mandates are intended to provide additional protection to pharmacists and workers to ensure safe handling of chemotherapy and other hazardous drugs. But the requirements extend beyond the act of physically handling these drugs and extend to the design of the facility itself, as well as the engineering controls for the facility.