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.

Current Declarations

COVID-19 PREP Act Declarations

• Declaration and Amendments
• Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (March 17, 2020)
• First Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (April 15, 2020)
• Second Amendment to Declaration under the PREP Act for Medical Countermeasures against COVID-19 (June 8, 2020)
• Third Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (August 24, 2020)  
  
• Fourth Amendment to Declaration under the PREP Act for Medical Countermeasures Against COVID–19 (December 3, 2020) 
  


• Advisory Opinions of the General Counsel
• First Advisory Opinion on the PREP Act Declaration (May 19, 2020)
• Second Advisory Opinion on the PREP Act Declaration (May 19, 2020)
• Third Advisory Opinion on the PREP Act Declaration (October 23, 2020)
• Fourth Advisory Opinion on the PREP Act Declaration (October 23, 2020)


• HHS Guidance
• Guidance for Licensed Pharmacists and Pharmacy Interns Regarding COVID-19 Vaccines and Immunity under the PREP Act (September 3, 2020)
• Guidance for Licensed Pharmacists, COVID-19 Testing, and Immunity under the PREP Act (April 8. 2020)
• 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)

Marburgvirus and Marburg Disease

• Marburgvirus and/or Marburg Disease Countermeasures (effective November 25, 2020)
  

Ebola

• Ebola Disease Vaccines - Amendment (effective December 1, 2018)
• Ebola Disease Therapeutics - Amendment (effective December 1, 2018)

Nerve Agents and Insecticides

• Nerve Agents and Certain Insecticides (Organophosphorus and/or Carbamate) Countermeasures (effective April 11, 2017)

Zika Virus

• Zika Virus Vaccines (effective August 1, 2016)

Pandemic Influenza

• Pandemic Influenza Medical Countermeasures (amended effective January 1, 2016)

Anthrax

• Anthrax Medical Countermeasures (amended effective January 1, 2016)

Acute Radiation Syndrome

• Acute Radiation Syndrome Medical Countermeasures (amended effective January 1, 2016)

Botulinum Toxin

• Botulinum Toxin Medical Countermeasures (amended effective January 1, 2016)

Smallpox

• Smallpox Medical Countermeasures (amended effective January 1, 2016)