USP 800 & USP 797 – Explained

USP 800 Modular Clean Room
USP 800 Modular Clean Room

The USP 800 guidelines developed by the United States Pharmacopeia were created to protect the working environment of pharmacists and technicians when dealing with compounding Hazardous Drugs. This was first published in 9/29/2019, becoming official on 7/1/2018. USP 800 guidelines and standards can vary by State. USP 800 is specific for compounding Hazardous Drugs, while the USP 797 is specialized for Non-Hazardous Drugs. The United States Pharmacopeia (USP) published standards in 2016 to protect workers who handle hazardous drugs. The requirements go into effect in December 2019.
The changes reflected in the USP regulations follow more than three decades of research in the safety the pharmacy and healthcare workers.