USP <797> & <800>: Updates in Standards & Strategies for Compliance

Revised standards for compounding sterile preparations (USP <797>), and a new USP chapter with standards addressing hazardous drugs in healthcare settings (USP <800>) were published June 1, 2019 with the intent to become official on December 1, 2019. In late September 2019, USP announced they are postponing the official date of the revised USP <797> due to pending appeals, and with no anticipated official date provided. To achieve compliance, ensure the quality of compounded sterile preparations, and promote the safety of healthcare workers potentially exposed to hazardous drugs, pharmacy leaders must implement processes aligned with USP standards. However, the postponing of several USP chapters has caused uncertainty, especially for facilities undergoing changes to address the updates made to USP standards. This program provides a high-level summary of key changes related to USP <797> and USP <800> chapters, and discuss strategies for implementing these standards within federal facilities to ensure compliance. The program discusses the current status of the USP chapters in light of the postponed official date, the specifics of the appeals currently pending, and strategies for deciding what actions to take based on the September USP announcement.