Draft Guidance for Federal Agencies and State and Local Governments; Potassium Iodide Shelf Life Extension; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for Federal agencies and State and local governments entitled "Potassium Iodide Shelf Life Extension." This document is intended to provide guidance to Federal agencies and to State and local governments on testing to extend the shelf life of stockpiled potassium iodide (KI) tablets. The draft guidance discusses FDA recommendations on the requisite testing for KI tablet shelf life extensions, the qualifications of laboratories suitable to conduct the tests, and issues regarding notification of holders of stockpiled KI tablets as well as end users about changes to batch shelf life once testing has been successfully conducted.