USP revised about thirty Ophthalmic Ointment Monographs

Recommendation

7/8 October 2021

Live Online Training: Serialization/Aggregation - Dealing with different global requirements

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.