Appearing in today’s pre-publication of the Federal Register (here), the FDA announced the issuance of an Emergency Use Authorization (EUA) for an atropine autoinjector that has not been FDA approved to date. An EUA is issued by the FDA once a series of requests have been made and cleared for a product for a potential domestic disaster, chemical weapon attack, organophosphate or insecticide poisoning, or some other specific health emergency.
In this case, the EUA was issued because of the potential for chemical weapons use against our troops overseas and a potential shortage of FDA approved atropine autoinjectors to replace those in the national stockpile. The product subject to this EUA is approved in at least one country (Israel) at the time this authorization was issued. The actual EUA is reprinted in its entirety in the FR Notice cited above.
This does not happen often, but it appears that there is sufficient worry about the chemical weapon attacks that have occurred in Syria that the US government acted to provide the greatest assurance that our troops will be protected in the event of exposure to such agents. Let’s hope they never have to use the product. The FR Notice and the actual EUA are very informative and give one a look into a seldom used process.