FDA Issues Draft Guidance on Potassium Iodide Shelf-Life Extension

WASHINGTON -- The Food and Drug Administration (FDA) has issued a guidance titled, "Guidance for Federal Agencies, and State and Local Governments - Potassium Iodide Tablets Shelf Life Extension" on how to conduct drug testing to determine the shelf life of stockpiled potassium iodide (KI) tablets. These methods could verify the continued viability of these drugs when stored under controlled conditions. KI is a treatment for radiation poisoning after a nuclear attack.

A number of state and local governments maintain stockpiles of KI tablets for use in a radiation emergency involving the release of radioactive iodine. Several states have asked the FDA how to determine whether stockpiled KI tablets have retained their original quality after passing the expiration date.

The FDA, working with other federal agencies, state and local governments who stockpile KI tablets for use in the event of a radiation emergency, is providing guidance on how to conduct shelf life testing and how to identify laboratories that are suitable for conducting shelf life extension testing. The FDA guidance document also provides information on how to notify holders of stockpiled KI tablets about changes in shelf life, and how to distinguish stockpiled batches with different shelf lives.

The FDA has been actively working with other federal, state, and local governments to prepare our country for possible bioterrorism attacks. In November 2002, the FDA provided guidance on the safe and effective use of KI tablets as an adjunct to other public health protective measures in the event that radioactive iodine is released into the environment.

Anyone wishing to submit comments on this latest document may do so within 60 days of the publication date by sending them to http://www.fda.gov/dockets/ecomments, or by mailing them to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852.

Source: FDA