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Public Health Emergency Determinations to Support an Emergency Use Authorization

The Pandemic and All Hazards Preparedness Reauthorization Act amended section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act, 21 U.S.C. 360bbb-3, to provide more flexibility to the Health and Human Services Secretary to authorize the U.S. Food and Drug Administration (FDA) to issue an Emergency Use Authorization (EUA). The Secretary is no longer required to make a formal determination of a public health emergency under section 319 of the Public Health Service Act, 42 U.S.C. 247d before declaring that circumstances justify issuing an EUA. Under section 564 of the FFD&C Act, as amended, the Secretary now may determine that there is a public health emergency or significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent or disease or condition that may be attributable to such agent(s). The Secretary may then declare that the circumstances justify emergency authorization of a product, enabling the FDA to issue an EUA  before the emergency occurs. This is only one mechanism for initiating an EUA. 

The following list summarizes these determinations and resulting EUAs that have been issued to date. 

For a full list of EUAs, see Emergency Use Authorization.