Type of Posting: Publication Announcement
Posting Date: 01-Feb-2024
Official Date: 01-Aug-2026
Expert Committee: Complex Excipients
Revisions to omit the Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 monographs, the documentary standards for carbomers manufactured with the use of benzene, were published in Pharmacopeial Forum 49(2) [Mar.– Apr. 2022] with a proposed official date of August 1, 2025.
On the basis of comments received and the recognition that these revisions represent significant changes for the pharmaceutical industry and may impact the availability of affected drug products, the Complex Excipients Expert Committee approved the omission of these monographs with an official date of August 1, 2026. These revisions are published in USP-NF 2024, Issue 2 on February 1, 2024.The two-year implementation period is intended to provide sufficient time for the drug product manufacturers to reformulate the affected drug products and to implement related changes in labeling and any regulatory documents.
Should you have any questions, please contact Galina Holloway, Senior Principal Scientist (gvh@usp.org).