Emergency Use Authorization

Emergency Use Authorization (pronunciation: e-mer-gen-cy use au-tho-ri-za-tion) is a legal tool that allows the Food and Drug Administration (FDA) to help strengthen public health protections by facilitating the availability and use of medical countermeasures needed during public health emergencies.

Etymology

The term "Emergency Use Authorization" is derived from its function. "Emergency" refers to a situation that poses an immediate risk to health, life, property, or environment. "Use" signifies the act of using something, and "Authorization" refers to the approval or permission given for something.

Definition

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN-related agents when there are no adequate, approved, and available alternatives.

Related Terms

Food and Drug Administration: The FDA is a federal agency of the United States Department of Health and Human Services, responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods & feed, and veterinary products.
Federal Food, Drug, and Cosmetic Act: The FD&C Act is a set of laws passed by Congress in 1938 giving authority to the FDA to oversee the safety of food, drugs, medical devices, and cosmetics.
Chemical, biological, radiological, and nuclear defense: CBRN defense refers to measures taken to protect against threats from chemical, biological, radiological, and nuclear weapons.