USP Headquarters recently published the intend to revise the Description and relative solubility of USP and NF Articles reference table.
USP performed an analysis of over 2000 entries currently listed in the Reference Table to assess the value of the information provided. It was found that description and solubility information for many articles is readily available from other sources, reducing the value of USP recreating and maintaining this information separately. For drugs substances, the description and solubility information is typically available as a part of the FDA-approved labels of the products, in the ‘Description” section of the Drug label Information. FDA-approved labels are available at several sources, including the DailyMed searchable database (provided by National Library of Medicines) and Prescription Drug Labeling Resources (provided by the FDA). The information submitted by monograph sponsors for inclusion in the Reference Table is usually based on the Description section of the FDA-approved label. These resources are free for users and employ the same terminology for approximate solubility information as in General Notices 5.30, Description and Solubility.
In USP-NF 2023 Issue 1 that will be published on November 1st 2022, USP is planning to start the process of updating the Reference Table and:
- remove all entries pertaining to omitted monographs or those with no monograph association from the Reference Table. A list of entries planned for deletion can be found here;
- further revise the Reference Table to remove the entries for drug substances and legacy entries for drug products (beginning with Pharmacopeial Forum 46(6); November – December 2022). Because there are no external sources of information for Excipients and Dietary Ingredients which are comparable to the sources of D&S information in FDA-approved labels, USP will continue to update and publish description and solubility information for these types of substances at this time. The updated table is targeted to appear in USP-NF 2024 Issue 1 with an official date of May 1st 2024.
- USP plans to update the Introduction section of the Reference Table to outline the new approach and include external links to where description and solubility information for drug substances can be obtained from non-USP sources. After the revision becomes official, all legacy description and solubility information can still be accessed in the USP-NF Online by viewing the “Older Versions” of this document.