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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

Whether a person (e.g., a pharmacist) can prescribe a “covered countermeasure” as a treatment for COVID-19 is governed by the terms of the Emergency Use Authorization for an authorized product. Covered countermeasures, including therapeutics, are defined in the PREP Act as products that are authorized, approved, licensed, or cleared by FDA. 42 U.S.C. 247d-6d(i)(1),(7). Section V(i) of the Secretary’s PREP Act Declaration for COVID-19 Countermeasures, added in the Ninth Amendment to the Declaration at 86 FR 51160 (September 14, 2021), authorizes pharmacists to order (i.e., prescribe) and administer COVID-19 therapeutics that fall within the definition of “covered countermeasure” under the Act, including countermeasures that are authorized by FDA. The same amendment also authorizes pharmacists, pharmacy technicians, and pharmacy interns to administer (but not order) authorized COVID-19 therapeutics under certain conditions. Importantly, the declaration also specifies that the ordering and administration of authorized therapeutics must be done in accordance with the FDA authorization of the product.

Specifically, section V(i) of the declaration provides that the following persons are qualified persons to order and administer COVID-19 therapeutics that are authorized, approved, licensed, or cleared by FDA, provided certain conditions are met, including:

  1. The COVID-19 therapeutic must be authorized, approved, licensed, or cleared by the FDA;
  2. In the case of a licensed pharmacist ordering a COVID-19 therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;
  3. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the COVID-19 therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing;…” Ninth Amendment to the Secretary’s PREP Act Declaration for COVID-19 Countermeasures, 86 FR 51160 (September 14, 2021).

Accordingly, under the Ninth Amendment to the Secretary’s PREP Act Declaration, a pharmacist is only allowed to order COVID-19 therapeutics (and pharmacists, pharmacy technicians, and interns are only allowed to administer COVID-19 therapeutics) under the terms of the FDA Emergency Use Authorization issued for that product. For example, if the Emergency Use Authorization includes a condition that the product may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the belongs, the Ninth Amendment to the Secretary’s PREP Act Declaration would not permit pharmacists to order the product.  Additionally, if the Emergency Use Authorization specifies conditions under which a product may be prescribed by pharmacists, then the Ninth Amendment to the Secretary’s PREP Act Declaration would only permit pharmacists to order the product when the conditions specified in the Emergency Use Authorization are met.  

Immunity

Immunity under the PREP Act becomes available when HHS issues a Declaration, beginning on the effective date or other triggering event stated in the Declaration.  For example, the Declaration may specify that activities such as manufacture and testing are covered on the effective date of the Declaration, but emergency uses such as mass dispensing are covered following a declared public health or other emergency.

Claims and Compensation

If no funds have been appropriated to the compensation program, or the Secretary does not make a final determination on the individual’s request within 240 days, or the individual decides not to accept the compensation, the injured individual or his representative may pursue a tort claim in the United States District Court for the District of Columbia, but only if the claim involves willful misconduct and meets the other requirements for suit under the PREP Act. If the individual accepts compensation from the CICP, or if there is no willful misconduct, the individual does not have a tort claim that can be filed in a United States Federal or a State court.

Any award is reduced by public or private insurance or worker’s compensation available to the injured individual. Awards for non-economic damages, such as pain, suffering, physical impairment, mental anguish, and loss of consortium are also limited.

Litigation