USP Delays General Chapter 800

October 3, 2017

On September 29, the U.S. Pharmacopeial Convention (USP) announced it will postpone the official date of General Chapter 800, “Hazardous Drugs – Handling in Healthcare Settings,” (USP 800) to Dec. 1, 2019. USP 800 was originally scheduled to become official on July 1, 2018, but USP now plans to align the official date of General Chapter 800 with the release of a final version of General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations,” which is currently undergoing revision.

Some state and national enforcement agencies and other entities may require adherence to USP 800 before its official implementation date. Since USP plays no role in enforcement of its standards, the organization’s decision to postpone implementation will have no impact on existing requirements unless the appropriate enforcement agencies take additional action.

ASCO previously submitted comments on the second draft of General Chapter 800, recognizing a number of positive changes (compared to the initial draft of the chapter) but also listing clarifications and revisions needed to create standards that are practical and appropriate for ensuring the safe handling of chemotherapy drugs community-based oncology practices.

In 2014, the society convened a Task Force on Safe Handling of Chemotherapy to develop recommendations for updating safety standards and to work with other stakeholders to promote clear, evidence-based approaches to safety standards for the handling of hazardous drugs. ASCO will continue to develop evidence-based recommendations, collaborate with stakeholders, and educate policymakers and ASCO members on the safe handling of hazardous drugs.

Please stay tuned to ASCO in Action for more information and analysis on the impact of USP 800 on the oncology community.