At this time, the FDA is not aware of any request from Japan to the U.S. manufacturers of FDA -approved potassium iodide. In addition, there is not a public health event requiring anyone in the U.S. to be taking KI because of the ongoing situation in Japan.
Drugs shipped to a foreign country, including as part of a humanitarian relief effort, are considered exports, and therefore, need to meet certain legal requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). If a drug is approved and is otherwise in compliance with the FFDCA’s requirements, there are no additional restrictions by FDA on its exportation. Drugs that are not approved or that otherwise are not in compliance with the FFDCA’s requirements may be exported if the exportation meets certain conditions and requirements.
