USP extends Implementation of Revised Talc Monograph

The USP is changing the official date of the revised USP Talc monograph from 1 December 2025 to 1 June 2026. In addition to the previous two-year implementation period for this monograph, this will provide stakeholders with an additional six months to implement the changes.

Background

The USP published the revised Talc monograph as well as two general chapter proposals in PF 48(2) [Mar-Apr 2022]. According to the USP, these publications are consistent with a request from the U.S. Food and Drug Administration (FDA) to revise the current tests for asbestos to ensure adequate specificity. The FDA recently also proposed standardized testing for asbestos in talc-containing cosmetic products.

The USP Excipient Expert Committee addressed all comments received on the draft chapters and approved the two chapters <901> Detection of Asbestos in Pharmaceutical Talc and <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc (official since 1 December 2023). In addition, the revised Talc monograph was approved with a two-year implementation period with an anticipated official date of 1 December 2025.

Recently, the USP received a number of inquiries and requests that stakeholders are encountering difficulties in sourcing reference materials and implementing tests of X-Ray Diffraction (XRD) and Polarized Light Microscopy (PLM) because they are not routine analyses in a quality control lab setting. To address this feedback, The USP has approved extending the implementation period for the Talc monograph from 1 December 2025 to 1 June 2026, providing an additional six months to find appropriate contract laboratories to perform the tests.

However, according to the General Notices 3.10. Applicability of Standards, stakeholders may exercise early adoption of the revised monograph in advance of the official date. 

For more information please see the announcement on USP's Compendial Notices website.