Type of Posting: Notice of Intent to Revise
Posting Date: 03-Feb-25
Targeted Official Date: 01-Jan-2026, Interim Revision Announcement
Expert Committee: Small Molecules 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Teriflunomide and Teriflunomide Tablets monographs.
Based on the supporting data received from the manufacturers and comments on the PF 48(5) proposals which could not be accommodated as part of balloting activities, the Expert Committee proposes to revise the acceptance criteria for Leflunomide Related Compound A from NMT 0.01% to NMT 107 ppm in the tests for Organic Impurities to accommodate FDA approved specifications.
It is anticipated that the proposed revisions will be published as Interim Revision Announcements in Pharmacopeial Forum 51(4) [July – August 2025] pursuant to the Rules and Procedures. The comment period for these revisions ends on September 30, 2025. In the absence of any adverse comments, the proposed IRAs will become official on January 1, 2026.
The Small Molecules 4 Expert Committee is delaying the implementation of the Teriflunomide and Teriflunomide Tablets monographs to allow the alignment with the official date of the proposed revisions, namely changing them from August 1, 2025 to January 1, 2026.
This would be implemented via Revision Bulletins (RBs) to be posted on February 28, 2025, and official on January 1, 2026. Below is the anticipated timeline for the changes described above:
- RBs posted February 28, 2025 (New implementation date: January 1, 2026)
- Proposed revisions posted in PF 51(4) on July 1, 2025
- End of comment period September 30, 2025
- Publication in USP-NF November 21, 2025
- Official January 1, 2026
If you have any questions or comments, please contact Simona Dragan, Senior Scientist II, simona.dragan@usp.org