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KI guidance

This article was originally published in The Tan Sheet

Executive Summary

Color and appearance of potassium iodide (KI) tablets in federal agency, state and local emergency stockpiles should be monitored to assess stability, FDA states in a 1guidance on KI shelf life extension slated for publication in the Federal Register March 8. Although numerous studies have proven the supplements do not degrade significantly over time, FDA suggests "samples of three batches of KI tablets from each manufacturer be selected and stored under controlled conditions of temperature and humidity and that the samples be tested periodically for compliance with [U.S. Pharmacopeia] assay and dissolution specifications." The guidance, which updates a similar release from April 2002, has been revised to recommend confirmatory testing after two years...

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