Public Readiness and Emergency Preparedness Act
The Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of the Department of Health and Human Services (Secretary) to issue a PREP Act declaration. The declaration provides immunity from liability (except for willful misconduct) for claims:
- of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions
- determined by the Secretary to constitute a present, or credible risk of a future public health emergency
- to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures
A PREP Act declaration is specifically for the purpose of providing immunity from liability, and is different from, and not dependent on, other emergency declarations.
COVID-19 PREP Act Declarations
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Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020)
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First Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (April 15, 2020)
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Second Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (June 8, 2020)
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Third Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (August 24, 2020)
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Fourth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (December 3, 2020)
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Fifth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (February 2, 2021)
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Sixth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (February 16, 2021)
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Technical Correction to Fifth and Sixth Amendments to the Declaration under the PREP Act for Medical Countermeasures Against COVID-19 (February 22, 2021)
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Seventh Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (March 11, 2021)
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Eighth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID–19 (August 4, 2021)
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Ninth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID–19 (Fact Sheet |
PDF Presentation)
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Technical Correction to Ninth Amendment to the Declaration under the PREP Act for Medical Countermeasures Against COVID-19 (October 4, 2021)
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Tenth Amendment to Declaration Under the PREP Act for Medical Countermeasures Against COVID-19 (January 7, 2022)
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Guidance for National Guard Personnel Regarding COVID-19 Vaccines and Immunity under the PREP Act (December 18, 2020)
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Guidance for Department of Defense Personnel, Contractors, and Volunteers Regarding COVID-19 Vaccines and Immunity under the PREP Act (February 2, 2021)
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PREP Act Authorization for Pharmacies Distributing and Administering Certain Covered Countermeasures (October 29, 2020)
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Guidance for PREP Act Coverage for Qualified Pharmacy Technicians and State-Authorized Pharmacy Interns for Childhood Vaccines, COVID-19 Vaccines, and COVID-19 Testing (October 20, 2020)
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Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act (September 3, 2020)
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Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act (April 8. 2020)
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Guidance for PREP Act Coverage for COVID-19 Screening Tests at Nursing Homes, Assisted-Living Facilities, Long-Term-Care Facilities, and other Congregate Facilities (August 31, 2020)
Other Current PREP Act Declarations