USP revised about thirty Ophthalmic Ointment Monographs
Recommendation

4/5 November 2026
How to avoid Mix-Ups, Contamination and labelling issues
On July 29, 2016, the United States Pharmacopeia (USP) posted a new Revision Bulletin regarding approximately thirty Ophthalmic Ointment Monographs.The revised monographs became official on August 1, 2016.
The USP Chemical Medicines Expert Committees 1 to 6 have revised the monographs following the revision of general chapter <771> which became official on May 1, 2016 (USP 39).
The purpose of the revision is to replace the requirement to comply with the entire content of the USP general chapter Ophthalmic Products—Quality Tests <771> (whose former title was Ophthalmic Ointments) with a requirement to comply only with the subsection for Particulate and Foreign Matter in Ophthalmic Products—Quality Tests <771>, and with the section for Container Content for those monographs where the requirement for Minimum Fill was deleted.
The Revision Bulletins for the respective monographs supersede the currently official version of these monographs. The Revision Bulletin will be incorporated in the First Supplement to USP 40–NF 35.
For more information please visit the USP Revision Bulletins website.
Related GMP News
03.09.2026USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc
02.09.2026USP Publishes Comments Received on Chapter <320>
26.08.2026New USP Requirements for Asbestos Testing in Pharmaceutical Talc
19.08.2026FDA Warning Letter: Averaging Data to Override OOS Findings
12.08.2026ECA's Analytical Control Group Publishes Detailed Report on OOS Survey
12.08.2026BP Publishes Key Insights on Limits in Chromatographic Tests

