GUIDANCE DOCUMENT
Potassium Iodide as a Thyroid Blocking Agent in Radiation Emergencies December 2001
- Docket Number:
- FDA-2000-D-1403
- Issued by:
-
Guidance Issuing OfficeCenter for Drug Evaluation and Research
The objective of this document is to provide guidance to other Federal agencies, including the Environmental Protection Agency (EPA) and the Nuclear Regulatory Commission (NRC), and to state and local governments regarding the safe and effective use of potassium iodide (KI) as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment. The adoption and implementation of these recommendations are at the discretion of the state and local governments responsible for developing regional emergencyresponse plans related to radiation emergencies.
This guidance updates the Food and Drug Administration (FDA) 1982 recommendations for the use of KI to reduce the risk of thyroid cancer in radiation emergencies involving the release of radioactive iodine. The recommendations in this guidance address KI dosage and the projected radiation exposure at which the drug should be used.
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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
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Dockets Management
Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2000-D-1403.