U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Emergency Preparedness and Response
  3. Public Health Preparedness and Response
  4. Medical Countermeasures (MCMs)
  5. MCM Legal, Regulatory and Policy Framework
  6. Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
  1. MCM Legal, Regulatory and Policy Framework

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)

The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) contains key legal authorities to sustain and strengthen our Nation's preparedness for public health emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, as well as emerging infectious disease threats.

The law also recognizes the key role FDA plays in public health emergency preparedness and response. Its provisions further FDA’s mission of fostering the development and availability of  drugs, vaccines, and devices (also referred to as medical countermeasures, or MCMs) for use in these emergencies. PAHPRA also builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development.

Together, these authorities for FDA not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but also help to facilitate MCM development and the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat. FDA is implementing PAHPRA's MCM-related provisions to support our nation’s preparedness and response capabilities, and continues to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.

PAHPRA Legislative Information

Emergency Use of MCMs

PAHPRA Authorities Related to MCM Development

Related Links

Back to Top