FDA Issues Nerve Agent Emergency Use Authorization Information

On April 11, 2017, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) to permit the emergency use of the 2 mg atropine auto-injector, manufactured by Rafa Laboratories, Ltd. On May 23, 2017, FDA amended the EUA to also permit the emergency use of pediatric strengths (i.e., 0.5 mg and 1 mg) of this atropine auto-injector. On January 24, 2018, FDA granted another EUA amendment to permit auto-injector administration through clothing. These products are included in CHEMPACK containers located across the United States. This specific atropine auto-injector is authorized for the initial treatment of symptoms of known or suspected poisoning in individuals exposed to nerve agents or certain insecticides (organophosphorus and/or carbamate).

The original letter of authorization describes the scope and conditions of EUA that apply to all three strengths (0.5 mg, 1 mg and 2 mg) of this atropine auto-injector; the amendment letters are addenda to the original letter of authorization. The amended fact sheets (version three) dated January 24, 2018, for healthcare providers and patients and caregivers are the current versions and available through FDA’s EUA website.

Note: this update was originally posted in the DSLR Friday Update. 

About Raymond Puerini

Raymond Puerini, MPH, is a Senior Program Analyst on the Environmental Health, Pandemic Preparedness, and Catastrophic Response team at NACCHO. His work includes sharing best practices for the distribution and dispensing of medical countermeasures and developing policy and guidance to support strategic national stockpile responses. Twitter: @Are_You_Ray_Dy

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