Type of Posting: General Announcement
Posting Date: 29–Sept–2023
Targeted Official Date: 1–May–2024
Expert Committee: Various
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that USP intends to revise the Description and Relative Solubility of USP and NF Articles Reference Table. Please see the Notice of Intent to Revise that posted on June 24, 2022, and the Notice of Intent to Revise that posted on September 22, 2022 for background information.
In USP–NF 2024, Issue 1, USP intends to further revise the Reference Table to remove the entries for drug substances and legacy entries for drug products and provide external links where description and solubility information for drug substances can be obtained as a part of FDA-approved labels. Because there are no external sources of information for Excipients and Dietary Ingredients which are comparable to the sources of description and solubility information in FDA-approved labels, USP will continue to update and publish description and solubility information for these types of substances.
The proposal was presented in PF 49(2) for public comments. It is anticipated that the updated Reference Table will be published on November 1, 2023, and become official on May 1, 2024. A list of entries planned for deletion can be found here.
Should you have any questions, please contact Sujatha Ramakrishna, Senior Principal Scientist (sxr@usp.org).