And this:
Emergency Use Authorization (EUA)
An Emergency Use Authorization (EUA) under Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) allows for the special use of drugs and other medical products during certain types of emergencies. Specifically, an EUA permits the use of unapproved medical products (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]) or the use of approved medical products in unapproved ways to diagnose, treat, or prevent serious diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents. FD&C Act §564 requires: (1) the determination by any of the U.S. secretaries of Health and Human Services (HHS), Homeland Security, or Defense that an emergency exists; (2) the declaration by the HHS secretary of an emergency justifying the authorization under FD&C Act §564; and (3) the issuance of an EUA by the Food and Drug Administration (FDA) commissioner upon a finding by the FDA that specified criteria have been met.
If all criteria are met, the FDA commissioner can issue a letter that authorizes the EUA. The letter must state: (1) the diseases or conditions the product may be used to diagnose, prevent, or treat within the scope of the EUA; (2) the known and potential benefits of the product; (3) conclusions concerning the safety and potential effectiveness of the product; (4) an assessment of the available scientific evidence; and (5) additional conditions of authorization, such as requiring that fact sheets to be distributed to healthcare professionals and the public with the EUA-authorized product.
An EUA does not contain or confer any tort liability protections by itself; however, medical products authorized under an EUA qualify as countermeasures (e.g., vaccines, drugs, devices) covered under the Public Readiness and Emergency Preparedness (PREP) Act if these medical products are identified as covered countermeasures in a PREP Act declaration. Medical products used pursuant to an EUA must also be used and administered according to the terms of the EUA for PREP Act coverage to arise.
