Federal Register #HHS-ASPR-2026-0199

HHS Announces Termination of Emergency Use Authorization for COVID-19 Drugs and Biological Products

This notice from the Department of Health and Human Services (HHS), Office of the Secretary, announces the termination of the emergency use authorization (EUA) for COVID-19 drugs and biological products. - Government Buyer: - Department of Health and Human Services (HHS) - Office of the Secretary - No OEMs or vendors are named in this notice - No products or services are being requested or procured - Key Details: - The EUA for COVID-19 drugs and biological products is being terminated - A 12-month transition period is provided for the disposition of authorized products and completion of data generation for potential traditional FDA approval - The FDA will not review new EUA requests for COVID-19 drugs or biological products during this period, but will review amendments necessary for public health protection - This is an informational notice, not a procurement opportunity or solicitation

Description

The Secretary of Health and Human Services is issuing a notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act. Initially declared on March 27, 2020, the emergency use authorization for drugs and biological products during the COVID-19 pandemic is being terminated. This decision follows a determination on June 29, 2026, that circumstances no longer justify the emergency use authorization. The termination will be effective on June 29, 2027, with a 12-month transition period for disposition of products and data generation for potential traditional approval pathways.

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