<901> Detection of Asbestos in Pharmaceutical Talc and <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc became official on December 1, 2023.

USP understands that the revised USP Talc monograph is raising important implementation questions for stakeholders, including drug manufacturers, excipient suppliers, and contract laboratories. Expectations around asbestos detection, specialized testing capabilities, laboratory readiness, and documentation are creating a need for practical discussion and shared understanding.

We invite you to join a free, focused, virtual Stakeholder Forum on the USP Talc standards, with special attention to the testing  questions that are most relevant to drug manufacturers, suppliers, quality control and quality assurance teams, regulatory affairs teams, and contract testing laboratories.

Background and Resources/Pre-reads

To make the most of the stakeholder forum, we encourage registrants to review the background materials in advance so they can come prepared for a focused and productive discussion.

The revisions to the USP Talc monograph, 〈901〉 Detection of Asbestos in Pharmaceutical Talc and 〈1901〉 Theory and Practice of Asbestos Detection in Pharmaceutical Talc were first proposed in PF 48(2) on March 01, 2023.

Upon review and incorporation of comments from PF, the Expert Committees (Simple Excipients Expert Committee and the Excipients Test Methods Expert Committee) balloted the Talc monograph and two general chapters (<901> and <1901>) that were to become official on December 01, 2023. Chapters <901> and <1901> became official as scheduled, however, understanding the complexity and additional time required to implement changes, a General Announcement was posted to announce an extension of the official date for the revised USP Talc monograph to December 1. 2025. The intent was to provide two more years for manufacturers and users to implement the test methods and make necessary changes. 

Based on additional feedback from stakeholders in 2025, the USP Excipients Monograph 1 Expert Committee approved providing an additional six months for stakeholders to implement the revised USP Talc monograph with an official date on June 1, 2026. See Talc General Announcement on Oct. 31. 2025.

Recently, USP has posted additional information through Talc General Announcements and FAQ to help address questions raised by stakeholders:

· Talc | USP-NF

· Updates Regarding USP Talc Monograph | USP-NF

· Talc FAQ | USP-NF

Please take a moment to visit the above information prior to the event on August 11, 2026.