Technetium Tc 99m Albumin Aggregated Injection Revision
Summary
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.
What changed
The Small Molecules 4 Expert Committee intends to revise the Technetium Tc 99m Albumin Aggregated Injection monograph based on stakeholder comments indicating the Appearance acceptance criterion presents a compliance concern. USP will incorporate the submitted comments as appropriate. The proposed revision will be published on July 31, 2026, as a Revision Bulletin with a Targeted Official Date of August 1, 2026.
No immediate action is required at this time since this is a notice of intent rather than a final revision. Affected parties should monitor for the July 31, 2026 publication of the proposed Revision Bulletin. Stakeholders with relevant data or compliance concerns related to the Appearance criterion may contact Brice Wagner at USP (brice.wagner@usp.org) before the publication date. The actual compliance impact will be assessed when the final revision becomes official.
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Apr 3, 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.
Technetium Tc 99m Albumin Aggregated Injection
Type of Posting: Notice of Intent to Revise
Posting Date: 02-Apr-2026
Targeted Official Date: 01-Aug-2026
Revision Vehicle: Revision Bulletin ****
Expert Committee: Small Molecules Therapeutic Area 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Technetium Tc 99m Albumin Aggregated Injection monograph.
Comments with supporting data were received that indicate the acceptance criterion for Appearance presents a compliance concern. USP intends to revise this monograph to incorporate the comments, as appropriate.
It is anticipated that the proposed revision will be published on July 31, 2026, as a Revision Bulletin pursuant to the Rules and Procedures.
Should you have any questions, please contact Brice Wagner, Scientist IV (brice.wagner@usp.org)
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