Type of Posting: Notice of Intent to Revise
Posting Date: 26–Apr–2024
Targeted Official Date: 01–Dec–2024
Expert Committee: Various
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that USP and its Expert Committees, as applicable, intend to revise multiple monographs in response to a revision of General Chapter <1031> The Biocompatibility of Materials Used in Drug Containers, Medical Devices, and Implants.
General Chapter <1031> was proposed for comment in PF 49(2) and is expected to become official on December 1, 2024. USP has identified other documentary standards referencing General Chapter <1031> impacted by the revisions in PF 49(2). These references are expected to be updated on June 3, 2024 and become official Decembe 1, 2024. A list of the monographs that will be modified can be found here.
Interested stakeholders are encouraged to alert USP staff to any impact they recognize related to the update of those monographs.
Should you have any questions or comments, please contact Desmond Hunt, Senior Principal Scientist (dgh@usp.org), or the affected monograph’s liaisons.