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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

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About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize 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 threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

Information on terminated and revoked EUAs can be found in archived information.

Public Readiness and Emergency Preparedness Act (PREP Act) 

Information on the PREP Act can be found here.

The PREP Act amended the Public Health Service Act (PHS Act) to add section 319F-3 (42 U.S.C. 247d-6d).  The HHS Secretary has issued several Declarations pursuant to section 319F-3 of the PHS Act to provide liability immunity for activities related to medical countermeasures against COVID-19. 

PREP Act - COVID-19 Related Information

Guidance

In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.

Printable PDF (288 KB)

In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.

 


Coronavirus Disease 2019 (COVID-19) EUA Information

Vaccines

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

For additional information about COVID-19 vaccines, see:

Date of First EUA Issuance Most Recent Letter of Authorization (PDF) Authorized Use Fact Sheets and Manufacturer Instructions/Package Insert (PDF) Additional Information and Decision Memoranda (PDF) Federal Register Notice for EUA
02/27/2021

Janssen COVID-19 Vaccine (439KB) (Reissued June 10, October 20 and November 19, 2021)

Letter Granting EUA Amendment (March 29, 2021) (152KB)

Letter Granting EUA Amendment (April 23, 2021) (229KB)

Concurrence Letter (June 10, 2021) (26KB)

Concurrence Letter (June 15, 2021) (57KB)

Concurrence Letter (June 16, 2021) (70KB)

Concurrence Letter (July 2, 2021) (317.7KB)

Letter Granting EUA Amendment (July 12, 2021) (210KB)

Concurrence Letter (July 13, 2021)  (213KB)

Concurrence Letter (July 28, 2021) (63KB)

Letter Granting EUA Amendment (August 30, 2021) (80KB)

Concurrence Letter (September 8, 2021) (353KB)

Concurrence Letter (September 14, 2021) (253KB)

Concurrence Letter (September 29, 2021) (28KB)

Concurrence Letter (November 5, 2021) (212KB)

Letter Granting EUA Amendment (December 14, 2021) (253KB)

Letter Granting EUA Amendment (January 11, 2022) (439KB)

For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older

Healthcare Providers (1.54MB)

Recipients and Caregivers (776KB)

More information about the Janssen COVID-19 Vaccine

Frequently Asked Questions on the Janssen COVID-19 Vaccine

COVID-19 Vaccine Expiration Dating Extensions

Decision Memorandum (974KB, February 2021 initial EUA issuance)

Decision Memorandum (362KB, June 2021 EUA reissuance)

Decision Memorandum Addendum (59KB, June 2021 EUA reissuance)

Decision Memorandum Addendum (61KB, July 1, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum Addendum (58KB, July 13, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum Addendum (60KB, September 8, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum Addendum (55KB, September 14, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum Addendum (57KB, September 29, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum (605KB, October 20, 2021 EUA reissuance)

Memorandum to the File (940KB, October 20, 2021 EUA amendment to support use of a Janssen COVID-19 Vaccine heterologous booster dose following primary vaccination with other authorized COVID-19 vaccines)

Decision Memorandum Addendum (59KB, November 5, 2021 Assessment of Certain Janssen COVID-19 Vaccine Batches)

Decision Memorandum Addendum (64KB, November 18, 2021)

Review Memorandum (86KB, December 22, 2021)

Addendum to Dec. 22, 2021 Review Memorandum (398KB, December 22, 2021)

Decision Memorandum Addendum (87KB, December 30, 2021)

Decision Memorandum Addendum (87KB, January 6, 2022)

Review Memorandum (84KB, January 7, 2022)

Addendum to Jan 7, 2022 Review Memorandum (81KB, January 7, 2022)

 
12/18/2020

Moderna COVID-19 Vaccine (432KB) (Reissued February 25, July 7, August 12, October 20, November 19, 2021 and January 7, 2022)

Letter Granting EUA Amendment (April 1, 2021) (193KB)

Letter Granting EUA Amendment (June 25, 2021) (90KB)

Letter Granting EUA Amendment (August 30, 2021) (58KB)

Letter Granting EUA Amendment (December 9, 2021) (192KB)

For the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older

Healthcare Providers (398KB)

Recipients and Caregivers (110KB)

More information about the Moderna COVID-19 Vaccine

Frequently Asked Questions on the Moderna COVID-19 Vaccine

Decision Memorandum (769KB)

Decision Memorandum (65KB, August 12, 2021 EUA reissuance)

Decision Memorandum (606KB, October 20, 2021 EUA reissuance)

Memorandum to the File (605KB, October 20, 2021 EUA amendment to support use of a Moderna COVID-19 Vaccine heterologous booster dose following primary vaccination with other authorized COVID-19 vaccines)

Decision Memorandum Addendum (89KB, November 18, 2021)

Decision Memorandum (85KB, November 19, 2021)

Decision Memorandum Addendum (101KB, November 19, 2021)

Decision Memorandum Addendum (92KB, December 30, 2021)

Decision Memorandum (112KB, January 6, 2022)

12/11/2020

Pfizer-BioNTech COVID-19 Vaccine (493KB) (Reissued February 25, May 10, June 25, August 12, August 23, September 22, October 20, 2021, October 29, 2021, November 19, 2021, December 9, 2021, December 16, 2021 and January 3, 2022)

Letter Granting EUA Amendment (January 6, 2021) (164KB)

Letter Granting EUA Amendment (January 22, 2021) (190KB)

Letter Granting EUA Amendment (April 6, 2021) (166KB)

Letter Granting EUA Amendment (May 19, 2021) (184KB)

Concurrence Letter (August 22, 2021) (68KB)

Letter Granting EUA Amendment (September 1, 2021) (98KB)

For the prevention of 2019 coronavirus disease (COVID-19) in people 5 and older

On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, now known as Comirnaty, for the prevention of COVID-19.

Healthcare Providers (1.33MB) – for 12 years of age and older, purple cap (must dilute)

Healthcare Providers (1.07MB) – for 12 years of age and older, gray cap (no dilution) - This formulation is not yet available in the United States.

Healthcare Providers (1.34MB) – for 5-11 years of age, orange cap (must dilute)

Recipients and Caregivers (212KB) –12 years of age and older

Recipients and Caregivers (202KB) – 5-11 years of age

More information about the Pfizer-BioNTech COVID-19 Vaccine

Frequently Asked Questions on the Pfizer-BioNTech COVID-19 Vaccine

COVID-19 Vaccine Expiration Dating Extensions

Decision Memorandum (709KB, December 2020 initial EUA issuance)

Decision Memorandum (868KB, May 2021 EUA reissuance)

Decision Memorandum (93KB, August 12, 2021 EUA reissuance)

Decision Memorandum (362KB, September 24, 2021)

Decision Memorandum (630KB, October 20, 2021 EUA reissuance)

Decision Memorandum (508KB, October 29, 2021)

Decision Memorandum (135KB, November 19, 2021)

Decision Memorandum Addendum (96KB, November 19, 2021)

Decision Memorandum (135KB, December 8, 2021)

Decision Memorandum (140KB, December 30, 2021)

Decision Memorandum Addendum (87KB, January 6, 2022)

Drugs and Non-Vaccine Biological Products

The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Related information: FDA Combating COVID-19 With Therapeutics (PDF, 610 KB)

Office of the Assistant Secretary for Preparedness and Response (ASPR) Important Updates: COVID-19 Therapeutics

Date of First EUA Issuance Most Recent Letter of Authorization (PDF) Authorized Use 1 Fact Sheets and Manufacturer Instructions/ Package Insert (PDF) Federal Register Notice for EUA
12/23/2021

Molnupiravir (411KB)

Molnupiravir is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

Healthcare Providers (578KB)

Patients, Parents, and Caregivers (144KB)

Dear Healthcare Provider Letter (166KB)

Frequently Asked Questions on the Emergency Use Authorization of Molnupiravir (227KB)

Prescriber Checklist for Molnupiravir (180KB)

CDER Scientific Review Documents Supporting EUA

None currently
12/22/2021

Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) (359KB)

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Healthcare Providers (613KB)

Patients, Parents, and Caregivers (231KB)

Dear Healthcare Provider Letter (560KB)

Important Dispensing Information for Patients with Moderate Renal Impairment (476KB)

Frequently Asked Questions on the Emergency Use Authorization for Paxlovid (203KB)

CDER Scientific Review Documents Supporting EUA

None currently
12/08/2021

Evusheld (tixagevimab co-packaged with cilgavimab) (287KB) (reissued December 20, 2021)

For emergency use as pre-exposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):
  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
    • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
    • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s) and/or COVID-19 vaccine component(s).

Healthcare Providers (640KB)

Patients, Parents, and Caregivers (165KB)

Frequently Asked Questions on the Emergency Use Authorization for Evusheld (324KB)

CDER Scientific Review Documents Supporting EUA

None currently
06/24/2021 Actemra (Tocilizumab) (107KB) For the treatment of COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Healthcare Providers (231KB)

Patients, Parents, and Caregivers (47KB)

Frequently Asked Questions on the Emergency Use Authorization of Actemra (Tocilizumab) (128KB)

CDER Scientific Review Documents Supporting EUA

None currently
05/26/2021

Sotrovimab (386KB) (reissued October 8, 2021 and December 16, 2021)

Letter Granting EUA Amendment (December 22, 2021) (161KB)

For the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Healthcare Providers (493KB) (updated December 22, 2021)

Patients, Parents, and Caregivers (134KB) (updated November 3, 2021)

Frequently Asked Questions on the Emergency Use Authorization of Sotrovimab (288KB) (updated October 19, 2021)

CDER Scientific Review Documents Supporting EUA

None currently
03/12/2021

Propofol‐Lipuro 1% (344KB)

Letter Granting EUA Amendment (December 16, 2021) (188KB)

To maintain sedation via continuous infusion in patients greater than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting. 2

Healthcare Providers (446KB)

Patients, Parents, and Caregivers (190KB)

None currently
02/09/2021

Bamlanivimab and Etesevimab (900KB) (Reissued February 25, 2021, August 27, 2021, September 16, 2021, December 3, 2021, December 22, 2021 and January 24, 2022)

ASPR and FDA Statement on Shelf-Life Extension of Bamlanivimab and Etesevimab (December 21, 2021)

Important updates about bamlanivimab/etesevimab (ASPR)

Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region.  Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

Bamlanivimab and etesevimab administered together for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Healthcare Providers (1.75MB) (updated January 24, 2022)

Patients, Parents, and Caregivers (157KB) (updated December 3, 2021)

  • Spanish (158KB) (updated September 16, 2021)

Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab (312KB) (updated December 23, 2021)

CDER Scientific Review Documents Supporting EUA

None currently
11/21/2020 REGEN-COV (Casirivimab and Imdevimab) (1.03MB) (Reissued February 3, 2021, February 25, 2021, June 3, 2021, July 30, 2021, September 9, 2021, November 17, 2021 and January 24, 2022)

Due to the high frequency of the Omicron variant, REGEN-COV is not currently authorized in any U.S. region.  Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency.

Casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Healthcare Providers (1.74MB) (updated January 24, 2022)

Patients, Parents, and Caregivers (147KB) (updated July 30, 2021)

Dear Healthcare Provider Letter (435KB) (updated September 16, 2021)

Statement on Post-Exposure Prophylaxis (July 30, 2021)

Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab) (311KB) (updated October 19, 2021)

CDER Scientific Review Documents Supporting EUA

Quick Reference Guide for Co-Packaged REGEN-COV (38KB) (September 16, 2021)

11/19/2020 Baricitinib (Olumiant) (Revised December 20, 2021) For emergency use by healthcare providers for the treatment COVID-19 in hospitalized adults and pediatric patients 2 years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Healthcare Providers (Updated December 20, 2021)(321KB)

Patients, Parents, and Caregivers (Updated July 28, 2021) (55KB)

Frequently Asked Questions on the Emergency Use Authorization for Olumiant (baricitinib) for Treatment COVID-19 (270KB) (Updated July 28, 2021)

CDER Scientific Review Documents Supporting EUA

08/23/2020

COVID-19 convalescent plasma (365KB) (Reissued February 23, 2021, March 9, 2021 and December 28, 2021)

Letter Granting EUA Amendment (June 2, 2021) (107KB)

COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies is authorized for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment, in inpatient or outpatient settings.

Healthcare Providers (Updated December 28, 2021) (192KB)

Patients and Parents/ Caregivers (Updated December 28, 2021) (151KB)

Decision Memorandum (166KB)

Decision Memorandum (December 27, 2021) (242KB)

08/13/2020 REGIOCIT replacement solution that contains citrate for regional citrate anticoagulation (RCA) of the extracorporeal circuit (92KB) To be used as a replacement solution only in adult patients treated with continuous renal replacement therapy (CRRT), and for whom regional citrate anticoagulation is appropriate, in a critical care setting Healthcare Providers (108KB)

Patients and Caregivers (52KB)

REGIOCIT package insert for EUA (140KB)
05/08/2020 Fresenius Kabi Propoven 2% (209KB) To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2  Healthcare Providers (288KB)

Patients and Parent/Caregivers (39KB)

Propoven 2% Wall Chart (2.4MB)
05/01/2020 Remdesivir for Certain COVID-19 Patients (991KB) (Reissued August 28, 2020, October 1, 2020, October 22, 2020, and January 21, 2022)

Authorized for emergency use for the treatment of COVID-19 in pediatric patients weighing 3.5 kg to less than 40 kg or pediatric patients less than 12 years of age and weighing at least 3.5 kg with positive results of direct SARS-CoV-2 viral testing and who 1) are hospitalized, or 2) are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Approved for the treatment of COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) and who 1) are hospitalized, or 2) are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

For additional information, also see: FDA’s approval of Veklury (remdesivir) for the treatment of COVID-19 — The Science of Safety and Effectiveness

Healthcare Providers (1.49MB)

Parents and Caregivers (441KB)

Dear Healthcare Provider Letter (1.25MB) (updated January 21, 2022)

Frequently Asked Questions for Veklury (remdesivir) (839KB) (Updated January 21, 2022)

04/30/2020 Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171KB) 3
[also listed under Medical Device EUAs]
To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic.

Healthcare Providers (135KB)

Patients (125KB)

Instructions for Use, Bloodline/ Tubing (83KB)

Instructions for Use, UltraFlux (147KB)

Instructions for Use, multiFiltratePRO (15.07MB)

Summary of Product Characteristics (SmPC) (308KB)

Instructions for Use, MultiPlus (110KB)

1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as  with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved  drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients.  

2 In the circumstances of this public health emergency, it would not be feasible to require healthcare providers to seek to limit Fresenius Propoven 2% Emulsion or Propofol-Lipuro 1% only to be used for patients with suspected or confirmed COVID-19; therefore, this authorization does not limit use to such patients.

3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.

Information About COVID-19 EUAs for Medical Devices

Information about COVID-19 EUAs for medical devices can be found below and at: Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices.

On February 4, 2020, the Secretary determined pursuant to section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV).

On the basis of this determination, the HHS Secretary issued three declarations related to medical devices:

  • Determination of Public Health Emergency (effective February 4, 2020), and declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19
  • Emergency Use Declaration (effective March 2, 2020), that circumstances exist justifying the authorization of emergency use of personal respiratory protective devices during the COVID-19 outbreak
  • Emergency Use Authorization Declaration (effective March 24, 2020), that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak

For identification of the applicable declaration for each EUA, please see each EUA letter of authorization and/or the corresponding Federal Register notice.

Related information: FDA Combating COVID-19 With Medical Devices (PDF, 708 KB)

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Other Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

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