Type of Posting: Pre-posting
Posting Date: 02–Dec–2024
Expert Committee: Packaging and Distribution Expert Committee
The United States Pharmacopeia (USP) is issuing this pre-posting notice to inform stakeholders of the upcoming anticipated publication of General Chapter <1079.2> in USP-NF 2025, Issue 2. This pre-posting provides early access to the chapter due to strong regulatory interest in several Climatic Zone IVb countries.
Background and Proposed Revision:
General Chapter <1079.2> outlines the use of Mean Kinetic Temperature (MKT) to evaluate temperature excursions during the storage and transportation of drug products. While MKT cannot be used to normalize uncontrolled storage conditions, it serves as a valuable tool for assessing short-term excursions. The chapter currently includes temperature excursion limits for Climatic Zone II. The revised chapter will add temperature excursion limits for Climatic Zone IVb. A Stimuli Article titled The Use of Mean Kinetic Temperature and the Need for Allowable Excursion Limits for Climatic Zone IVb explains the rationale for this update.
Access and Inquiries:
The chapter and accompanying Stimuli Article can be accessed here. For questions or more information, please contact Desmond Hunt, Senior Principal Scientist, General Chapters, at dgh@usp.org.