Type of Posting: General Announcement
Posting Date: 26-May-2023
Expert Committees: Simple Excipients, Excipients Test Methods
In accordance with the Rules and Procedures of the Council of Experts, Simple Excipients Expert Committee (SE EC) and Excipients Test Methods Expert Committee (ETM EC) published the USP Talc monograph revision proposal and proposals for two new chapters <901> Detection of Asbestos in Pharmaceutical Talc and <1901> Theory and Practice of Asbestos Detection in Pharmaceutical Talc in Pharmacopeial Forum 48(2) [Mar. – Apr. 2022] to update the asbestos testing methods in pharmaceutical talc. This is consistent with a request documented in a letter from the U.S. Food and Drug Administration to revise the current tests for asbestos to ensure adequate specificity.
The X-ray diffraction (XRD) and polarized light microscopy (PLM) testing methods in the PF 48(2) proposals are not routine analyses in quality control labs, and, as such, the revisions to the USP Talc monograph may require additional time for industry to adopt and prepare for compliance. Therefore, the SE EC approved an extended official date of December 1, 2025, with changes anticipated to be published in USP–NF 2023, Issue 3. The extended official date is intended to provide the time needed by manufacturers and users to implement the test methods and make necessary changes.
The ETM EC approved an official date of December 1, 2023, for the two general chapters <901> and <1901>.Though chapter <901> is anticipated to become official before the USP Talc monograph becomes official, the chapter will only become applicable when revisions to the USP Talc monograph (which references chapter <901>) becomes official. Chapter <1901> is for informational purpose only. The earlier official date for both chapters will help stakeholders in the adoption of the of the USP Talc monograph revisions that are anticipated to become official later.
In summary, below are the respective anticipated official dates for the USP Talc monograph and general chapters <901> and <1901>:
- The USP Talc monograph revision is anticipated to be published in USP-NF 2023, Issue 3 and become official on December 1, 2025.
- General chapters, <901> and <1901>, are anticipated to be published USP-NF 2023, Issue 3 and become official on December 1, 2023.
Please note that stakeholders may generally exercise early adoption of the revised monograph in advance of the official date. See General Notices 3.10. Applicability of Standards.
USP will also offer an educational course on June 14, 2023 on the XRD and PLM testing methods for detection of asbestos in pharmaceutical talc. You can register via the link here.
Should you have any questions, please contact Jenny Liu, Principal Scientist (jyl@usp.org).