Notice2025-19270
Revocation of Emergency Use of a Biological Product; Availability
Primary source
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Published
October 2, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (ASPR/HHS) for COVID-19 convalescent plasma. FDA revoked the Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 90 Issue 189 (Thursday, October 2, 2025)</title>
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[Federal Register Volume 90, Number 189 (Thursday, October 2, 2025)]
[Notices]
[Pages 47774-47776]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-19270]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2305]
Revocation of Emergency Use of a Biological Product; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services (ASPR/HHS)
for COVID-19 convalescent plasma. FDA revoked the Authorization under
the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation,
which includes an explanation of the reasons for the revocation, is
reprinted in this document.
DATES: The Authorization is revoked as of August 27, 2025.
ADDRESSES: Submit written requests for single copies of the revocation
to the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3103, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The revocation may also be obtained by mail
by calling CBER at 1-800-835-4709 or 240-402-8010 or emailing
<a href="/cdn-cgi/l/email-protection#b6dfd8d2c3c5c2c4cf98d4dfd9dad9d1dfd5c5f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="8ce5e2e8f9fff8fef5a2eee5e3e0e3ebe5efffcceae8eda2e4e4ffa2ebe3fa">[email protected]</span></a>. See the SUPPLEMENTARY INFORMATION
section for electronic access to the revocation.
FOR FURTHER INFORMATION CONTACT: Andrew C. Harvan, Center for Biologics
Evaluation and Research, Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to
strengthen the public health protections against biological, chemical,
nuclear, and radiological agents. Among other things, section 564 of
the FD&C Act allows FDA to authorize the use of an unapproved medical
product or an unapproved use of an approved medical product in certain
situations.
On August 23, 2020, FDA issued an EUA to ASPR/HHS for COVID-19
convalescent plasma, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on February 19, 2021 (86 FR 10290), as required by section
564(h)(1) of the FD&C Act. Subsequent updates to the Authorization were
made available on FDA's website.
The authorization of a biological product for emergency use under
section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the
FD&C Act, be revoked when the criteria under section 564(c) of the FD&C
Act for issuance of such authorization are no longer met (section
564(g)(2)(B) of the FD&C Act), or other circumstances make such
revocation appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. EUA Revocation Request
In a request received by FDA on August 13, 2025, ASPR/HHS requested
revocation of the Authorization of COVID-19 convalescent plasma. On
August 27, 2025, FDA revoked the Authorization. In determining that
there are circumstances that make revocation of this EUA appropriate to
protect the public health or safety, FDA also considered that, as of
December 10, 2024, there is licensed COVID-19 convalescent plasma for
the same use that is described in the EUA, that current use of COVID-19
convalescent plasma under the EUA is limited to a small number of
patients, and that the supply of licensed COVID-19 convalescent plasma
is expected to meet clinical need. Due to all of these circumstances,
FDA has determined that revoking this EUA is appropriate to protect the
public health or safety.
III. The Revocation
Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA for COVID-19 convalescent plasma. The revocation in
its entirety follows and provides explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
IV. Electronic Access
An electronic version of this document and the full text of the
Authorization and revocation are available on the internet at <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-19270 Filed 10-1-25; 8:45 am]
BILLING CODE 4164-01-C
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