Type of Posting: General Announcement
Posting Date: December 16, 2022
Targeted Official Date: August 1, 2023
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, are updating the style of section “Uniformity of Dosage Units <905>” in drug product monographs when the “acceptance criteria” subsection is located after the “Procedure for Content Uniformity” subsection.
To address the comments received, the statement “meet the requirements” will be placed directly after the section title, indicating that uniformity of dosage units can be demonstrated by either weight variation or content uniformity procedures, as directed in General Chapter <905>. No changes will be made to the monographs which do not contain a procedure for content uniformity.
A list of the monographs to be modified can be found here.
All modifications will become official on August 1, 2023.
Should you have any questions or comments, please contact Yanyin Yang, Senior Scientist II (email@example.com), or the affected monograph’s documentary standard scientist.