Ketorolac Tromethamine Ophthalmic Solution Revision Notice
Summary
The USP has issued a notice of intent to revise the Ketorolac Tromethamine Ophthalmic Solution monograph. The revision aims to extend the official date and adjust the pH limit from 6.8-7.9 to 6.2-7.9 to accommodate FDA-approved products.
What changed
The United States Pharmacopeia (USP) has issued a Notice of Intent to Revise for the Ketorolac Tromethamine Ophthalmic Solution monograph. This revision is prompted by comments received indicating a need for further consideration of the monograph's content. The USP intends to extend the official date of the monograph, which was originally scheduled for April 1, 2026, while the Small Molecules 2 Expert Committee reviews the comments and data. A key proposed change is the adjustment of the pH limit from 6.8-7.9 to 6.2-7.9 to align with specifications of FDA-approved products.
This revision means that the monograph will not become official on April 1, 2026, as initially planned. The proposed revision is anticipated to be published as a Revision Bulletin on November 20, 2026. Compliance officers at drug manufacturing and pharmaceutical companies should note the extended timeline and the proposed change to the pH specifications. The USP is seeking comments on this proposed revision, with the final official date to be determined after the review process.
What to do next
- Monitor for the Revision Bulletin on November 20, 2026.
- Review proposed changes to the pH limit (6.2-7.9) for Ketorolac Tromethamine Ophthalmic Solution.
- Submit comments to USP if additional data or concerns exist regarding the monograph revision.
Archived snapshot
Mar 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Ketorolac Tromethamine Ophthalmic Solution
Type of Posting: Notice of Intent to Revise
Posting Date: 27-Mar-2026
Targeted Official Date: 01-Dec-2026; Revision Bulletin
Expert Committee: Small Molecules Therapeutic Area 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Ketorolac Tromethamine Ophthalmic Solution monograph. This monograph was published on January 2, 2026, and is scheduled to become official on April 1, 2026.
Comments with supporting data were received indicating that additional consideration of the content of this monograph may be needed. USP intends to revise the monograph to extend the period of time before the monograph become official while additional review of the comments and data is conducted by the Small Molecules 2 Expert Committee. Additionally, the Expert Committee proposes to revise the Ketorolac Tromethamine Ophthalmic Solution monograph pH limit from 6.8 – 7.9 to 6.2 – 7.9 to accommodate FDA-approved products with wider specifications. It is anticipated that the proposed revision will be published as a Revision Bulletin on November 20, 2026.
Should you have any questions, please contact Andrea Carney, Senior Manager (afc@usp.org) and/or Sabrina Cusick, Senior Pharmacopeial Specialist (Sabrina.cusick@usp.org).
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