Type of Posting: General Announcement
Posting Date: 28-Feb-2025
Targeted Official Date: 01-Aug-2025
Expert Committee: Complex Excipients
As mentioned in the previous General Announcement posted on October 7, 2024, in accordance with USP’s Rules and Procedures of the Council of Experts, Complex Excipients Expert Committee (CE EC) published the USP-NF Polyethylene Glycol (PEG) monograph revision proposal via an accelerated revision process – Interim Revision Announcement (IRA) in PF 50(3) [May – Jun. 2024] to include the Limit of Ethylene Glycol and Diethylene Glycol (EG/DEG) test in the Identification (ID) section of the PEG monograph.
Additionally, as described in another General Announcement posted on December 27, 2024, there are additional changes to the PEG PF 50(3) IRA, which are anticipated to become official on May 1, 2025. However, based on the latest feedback received by USP, stakeholders need additional time to implement the additional changes after the official version of monograph is published. To address this feedback, the CE EC anticipates postponing the official date of the PEG IRA from May 1, 2025 to August 1, 2025, providing stakeholders approximately three months to implement changes using the official version of the PEG monograph.
Consistent with General Notices 3.10. Applicability of Standards, stakeholders may exercise early adoption of the revised monograph in advance of the official date.
Should you have any questions, please contact Jenny Liu, Senior Principal Scientist (jyl@usp.org).