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Guidance Issuing OfficeCenter for Drug Evaluation and Research
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 Agency has developed this document in response to several state inquiries on this topic. This guidance discusses FDA recommendations on testing for such 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 users2 about changes to batch shelf life once testing has been successfully conducted.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2003-D-0029.