The United States Pharmacopeia (USP) has issued a Notice of Intent to Revise the Carbachol monograph, specifically targeting the Assay acceptance criteria. The revision proposes widening the acceptable range from NMT 99.0% - 101.0% to NMT 98.0% - 102.0%. This change is being made to accommodate FDA-approved products that operate with wider specifications, addressing a compliance concern identified by the Small Molecules 4 Expert Committee.

This revision is anticipated to be published as a Revision Bulletin on May 29, 2026, with an official effective date of June 1, 2026. Pharmaceutical companies and drug manufacturers producing Carbachol should review their current testing protocols and product specifications to ensure alignment with the updated criteria. While this is a USP monograph revision and not a direct FDA mandate, adherence is critical for products seeking to meet USP standards. The USP is accepting comments with supporting data until the publication date.