What are the requirements if a State chooses to extend the shelf-life of their KI stockpiles?
The decision to extend the shelf-life of potassium iodide tablets relies on the States. The FDA, in a February 15, 2007 letter to the NRC stated that the FDA does not have any regulation or policy regarding application of an extended expiration dating period to lots that were manufactured prior to the implementation of the extended expiration period. However, the FDA does not object to such a practice as long as adequate records are kept and doing so is scientifically sound. It would be considered to be scientifically sound if the lots having the expiration date extended had no significant difference in formulation, manufacturing process or packaging materials from current lots. The letter …to NRC from counsel to Anbex, Inc. dated January 23, 2007 indicates that this is the case. RECIP, the manufacturer of the 65 mg tablets, supplied lot numbers along with extended expiration dates. States must maintain records of current stockpiled lot number(s) and expiration date(s) as well as new
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