Among community oncology practices, the US Pharmacopeia (USP) Convention’s General Chapter <800> draft guidelines have already raised the bar for hazardous drug (HD) management and imposed costs for compliance.
In the community practice setting, readiness for enforcement of USP <800> varies from full compliance (rare) to no compliance decision having been made (also rare). Although not all are in conformance, most community oncology practices intend to comply.
USP <800> was intended to be enforceable starting on July 1, 2018. However, the final document release has been postponed to coordinate with the scheduled December 1, 2019, publication of the USP <797> revision. These guidelines cover pharmaceutical compounding and sterile preparations. The intent is to provide a unified approach to compounding practices that is safe for both patients and employees. USP <797> describes responsibilities of drug compounding personnel, training, facilities, environmental monitoring, and storage and testing of finished preparations. USP <800> describes requirements for HDs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.
Preparing for USP <800>
Many oncology practices have been preparing for USP <800> for a long time and are well on their way to compliance. However, for those just getting started, the following steps may make the process more manageable:
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