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PREP Act Questions and Answers

The following is intended to address an overview of the PREP Act and frequently asked questions from the manufacturing industry, the healthcare community, and state and local government officials.  It is not an exhaustive review of the PREP Act’s provisions in all contexts or a protocol for the HHS’s implementation of the PREP Act.  In addition, other legal protections may be available at the federal, state, and local government level.

The Public Readiness and Emergency Preparedness Act (PREP Act):

  • adds new legal authorities to the Public Health Service (PHS) Act
  • provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics
  • adds authority to establish a program to compensate eligible individuals who suffer injuries from administration or use of products covered by the PREP Act’s immunity provisions

The PREP Act authorizes the Secretary of the Department of Health and Human Services (Secretary) (HHS) to issue a PREP Act Declaration (“Declaration”) that provides immunity from liability for any loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined in the Declaration to constitute a present or credible risk of a future public health emergency.

Liability Immunity and Compensation

In general, the liability immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures described in a Declaration. The only statutory exception to this immunity is for actions or failures to act that constitute willful misconduct.

The PREP Act also authorizes a United States Treasury fund that compensates eligible individuals for serious physical injuries or deaths directly caused by administration or use of a countermeasure covered by the Declaration.

PREP Declaration

A Declaration includes:

  • A determination that a disease or health condition or threat to health constitutes a public health emergency, or that there is a credible risk that it will in the future constitute an emergency;
  • The category of diseases, health conditions, or health threats for which administration and use of the countermeasure is recommended. During the time period covered by the Declaration, it is presumed that the recommended countermeasure;
  • The effective time period (the Secretary may specify an extended time period for manufacturers to dispose of the countermeasure and for others to cease administration and use of the countermeasure);
  • The population of individuals receiving the countermeasure and the geographic area of administration and use of the countermeasure for which immunity from liability is in effect for program planners and qualified persons (manufacturers and distributors are provided liability immunity regardless of who receives the countermeasure or where it is administered or used);
  • Limitations (if any) on the geographic area or areas for which immunity is in effect with respect to administration or use of the countermeasure;
  • Limitations (if any) on the means of distribution;
  • Any additional persons identified as qualified to prescribe, dispense, or administer the countermeasure; and
  • Any other limitations or conditions.


Claims and Compensation