USP Extends Implementation Date for Revised Talc Monograph

The United States Pharmacopeia (USP) has postponed the official date for its revised Talc monograph from 1 December 2025 to 1 June 2026. This extension adds six months to the previously announced two-year implementation period, giving stakeholders more time to comply with the updated requirements.

The revised Talc monograph, along with two general chapters—<901> Detection of Asbestos in Pharmaceutical Talc and <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc—originated from USP publications in 2022, following the FDA’s request to enhance the specificity of asbestos testing. Challenges in sourcing reference materials and implementing X-Ray Diffraction (XRD) and Polarized Light Microscopy (PLM) tests in standard quality control labs prompted the extension.

Stakeholders may still adopt the monograph early, in line with General Notices 3.10. The USP encourages users to plan for laboratory access and method implementation during this extended period to ensure smooth compliance. More details are available on USP’s Compendial Notices website.

01-12-2025