FDA 发布碘化钾片 shelf life 延长检测指南（FDA-2003-D-0029）
Potassium Iodide Tablets—Shelf Life Extension
美国 FDA 发布指南文件 FDA-2003-D-0029，面向联邦机构及州和地方政府，说明如何通过检测延长储备碘化钾（KI）片的 shelf life。指南涵盖延长 shelf life 的检测建议、可承担检测的实验室资质，以及检测成功后通知储备 KI 片持有者和终端用户批次 shelf life 变更的相关事项。该指南为建议性文件，不构成法律强制义务。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2003-D-0029
- Issued by:
-
Guidance Issuing Office
Center 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.
Submit Comments
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:
Dockets Management
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.
来源：FDA Pharmaceutical Quality Documents · fda.gov