USP Compendial Notices

Technetium Tc 99m Albumin Aggregated Injection Revision

USP's Small Molecules 4 Expert Committee has issued a Notice of Intent to Revise the Technetium Tc 99m Albumin Aggregated Injection monograph due to a compliance concern with the Appearance acceptance criterion. Comments with supporting data prompted this action. The proposed revision is targeted for an August 1, 2026 official date and is expected to be published as a Revision Bulletin on July 31, 2026.

Ketorolac Tromethamine Ophthalmic Solution Revision Notice

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.

General Chapter Prospectus for LG Polymer Implant Drug Products

The USP has issued a General Chapter Prospectus for <1158> LG Polymer Implant Drug Products – Characterization Methods. This proposed chapter aims to provide a compendial framework for product quality and performance testing of LG polymer implant drug products, focusing on specific characterization needs for these long-acting dosage forms. Stakeholders are invited to provide input.

Levocarnitine Monograph Revision: Proposed Direct Chiral HPLC Method

The USP has proposed a direct chiral HPLC method to revise the Enantiomeric Purity test in the Levocarnitine monograph due to the temporary unavailability of the required derivatization reagent (+)-FLEC. This proposed method is currently open for public comment.

USP Revises Select Chemical Standards

The USP has announced revisions to the chemical information of select standards, with updates becoming official on October 1, 2026. These changes affect specific USP monographs for various drug substances and formulations, including Candesartan Cilexetil and Hydrochlorothiazide Tablets, Dronabinol, and several Verapamil Hydrochloride products.

USP-NF Changes: Redesign-Only Standards Official Date Policy

The United States Pharmacopeia (USP) has updated its policy regarding the official date for "redesign-only" documentary standards in the USP-NF Online platform. Previously, these standards retained their original publication date, but now they will have a "To Be Official" status and become official six months after posting, effective March 27, 2026.

USP Notice: Revision to Guaifenesin, Pseudoephedrine HCL, Dextromethorphan Capsules Monograph

The United States Pharmacopeia (USP) has issued a notice of intent to revise the monograph for Guaifenesin, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Capsules. The revision aims to update a cross-reference to an omitted monograph and incorporate the full text of a previously official assay procedure.

Carbachol Monograph Revision - Assay Criteria

The United States Pharmacopeia (USP) is revising the Carbachol monograph to widen the acceptance criteria for Assay from NMT 99.0%-101.0% to NMT 98.0%-102.0%. This change aims to accommodate FDA-approved products with wider specifications and is targeted for publication on May 29, 2026, with an official date of June 1, 2026.

USP Notice: Revision to Sennosides Tablets Monograph Testing Method

The USP has issued a Notice of Intent to Revise the Sennosides Tablets monograph testing method. This revision aims to align the testing procedure with recent changes made to the general sennosides monograph, using sennosides A and B as marker compounds. The targeted official date for this revision is August 1, 2027.

Dapagliflozin Tablets Monograph Revision Notice

The USP is issuing a notice of intent to revise the Dapagliflozin Tablets monograph, with a targeted official date of June 1, 2026. This revision is being made in response to comments received, aiming to incorporate feedback into the monograph.

Adapalene Monograph Revision Proposed for Solubility Issue

The USP Small Molecules 3 Expert Committee intends to revise the Adapalene monograph to address a potential solubility issue in the Organic Impurities test. The proposed changes include allowing a larger volume of tetrahydrofuran for the standard stock solution, introducing a two-table format for retention times, and deleting the Limit of Triethylamine test.