Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends? Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Legal, Regulatory and Policy Framework
          Summary of PAHPRA's MCM ProvisionsMCM Legal, Regulatory and Policy Framework Summary of PAHPRA's MCM Provisions
  
  	
    Share
    Post
    Linkedin

    Email
    PrintImage
              VialsThe 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 emergency preparedness and response.  It has provisions that further FDA’s mission of fostering the development and availability of medical products, including drugs, vaccines, and devices, for use in these emergencies, also referred to as medical countermeasures (MCMs).

Specifically, PAHPRA clarified and added to FDA’s existing authority under Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) (21 USC 360bbb-3) to support preparedness efforts and rapid response capabilities for a range of stakeholders, such as federal partners like the Department of Defense and the Centers for Disease Control and Prevention, as well as state and local public health agencies, in the event of a CBRN or emerging infectious disease emergency.

PAHPRA amendments to section 564 included the following:

Refinements to existing Emergency Use Authorization (EUA) requirements
	Governmental pre-positioning
	Authorities for emergency use of medical products
	Expiration dating extensions
	Provisions focusing on FDA’s interactions with government and industry working to develop MCMsRefinements to existing Emergency Use Authorization (EUA) requirements, including:

Provided clearer authority for FDA to issue EUAs--before a CBRN emergency occurs--to enable stakeholders to prepare for use of unapproved medical products, or unapproved uses of approved products, if certain criteria are met *[Sec. 564(b)(1) of the FD&C Act]*
	Allowed FDA to issue an EUA based on the HHS Secretary’s determination that there is a potential for a public health emergency involving a CBRN threat agent (not only based on an actual emergency)*[Sec.564(b)(1)(C) of the FD&C Act]*
	Expanded the time period for collection and analysis of information about an MCM’s safety and effectiveness for a reasonable period beyond the effective period of the EUA *[Sec.564(e)(1)(B)(iii) of the FD&C Act]*
	Expressly permitted FDA, as part of issuance of an EUA, to categorize the complexity of an *in vitro* diagnostic device to indicate whether the test can be performed at a point-of-care setting or only in a more sophisticated laboratory*[Sec.564(m) of the FD&C Act]**back to top*

Governmental pre-positioning

Permitted federal, state, and local governments to pre-position MCMs in anticipation of FDA approval or clearance, or issuance of an EUA to enable them to better prepare for potential rapid deployment during an actual CBRN emergency *[Sec. 564B of the FD&C Act]*PAHPRA authorities for emergency use of medical products

Empowering FDA to extend the expiration dating/shelf-life of an eligible FDA-approved MCM stockpiled for use in a CBRN emergency, and to require appropriate conditions relating to such extensions, such as appropriate storage, sampling, and labeling*[Sec. 564A(b) of the FD&C Act]*
	Allowed the Centers for Disease Control and Prevention (CDC) to create and issue, and government stakeholders to disseminate, special emergency use instructions (EUI) (also referred to as fact sheets for recipients of an MCM and for health care professionals) about the FDA-approved conditions of use for such MCMs before a CBRN event occurs *[Sec. 564A(e) of the FD&C Act]*
	Permitted FDA to waive otherwise applicable manufacturing requirements (current Good Manufacturing Practices (cGMPs)), such as storage or handling, to accommodate emergency response needs *[Sec. 564A(c) of the FD&C Act]*
	Allowed emergency dispensing (including mass dispensing at a point of dispensing (POD)) of MCMs during an actual CBRN emergency, without requiring an individual prescription for each recipient of the MCM, if (1) permitted by state law or (2) in accordance with an order issued by FDA *[Sec. 564A(d) of the FD&C Act]*
	Expanded waiver authority for risk evaluation and mitigation strategies (REMS) to encompass any element for MCMs to mitigate the health effects of a CBRN emergency *[Sec. 505-1 of the FD&C Act]**back to top*

Expiration dating extensions

Empowered FDA to extend the expiration dating/shelf-life of an eligible FDA-approved MCM stockpiled for use in a CBRN emergency, and to require appropriate conditions relating to such extensions, such as appropriate storage, sampling, and labeling*[Sec. 564A(b) of the FD&C Act]*Together, these MCM authorities for FDA not only support and facilitate government partners’ pre-event planning efforts and pre-positioning of MCMs, but also facilitate the efficient and rapid deployment of these medical products in the event of a CBRN emergency or emerging disease health threat.

PAHPRA also codifies and builds on FDA’s ongoing efforts to enhance review processes and advance regulatory science for MCM development.

PAHPRA provisions focusing on FDA’s interactions with government and industry working to develop MCMs, including:

Expanded current Special Protocol Assessment authorities to require FDA to meet with sponsors on the design and size of pivotal animal studies supporting claims of efficacy*[Sec. 505(b)(5)(B) of the FD&C Act]  – also see Special Protocol Assessment Guidance for Industry (PDF, 182 KB)*
	Established a procedure whereby FDA will meet with MCM sponsors developing certain animal models*[Sec. 565(d) of the FD&C Act]*
	Ensures that FDA personnel are appropriately involved in interagency activities related to MCM advanced research and development, and that those who are involved in review of applications for MCMs have sufficient background information, training, and expertise*[Sec. 565(b)(3) of the FD&C Act]*
	Maintains teams with expertise on MCMs to help to identify and resolve scientific issues that may present obstacles to product development and approval *[Sec. 565(b)(4) of the FD&C Act]*
	Finalized guidance on the development of animal models for purposes of establishing claims of efficacy *[Sec. 565(c) of the FD&C Act] - - Note: the guidance was finalized in October 2015: Product Development Under the Animal Rule (PDF, 574 KB) - also see Animal Rule Information*
	Developed formal processes for sponsor interactions and the development of Regulatory Management Plans for certain high-priority MCMs*[Sec. 565(f) of the FD&C Act]*
	Ensures that pediatric experts are consulted and the needs of pediatric populations are appropriately considered in developing MCMs*[Sec. 307 of PAHPRA]**back to top*

FDA is implementing PAHPRA's MCM-related provisions to support our nation’s preparedness and response capabilities, and continuing to provide the highest quality and most timely guidance possible to all stakeholders engaged in MCM product development.

*For more information, visit our**main PAHPRA page**, or email**AskMCMi@fda.hhs.gov*

Related Links

Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
	Availability of Regulatory Management Plans
	MCM Emergency Use Authorities
	Emergency Use Authorization
	FDA PAHPRA Q&A for Public Health Preparedness and Response Stakeholders (Archived - PDF, 250 KB)
	HHS Public Health Emergency Information

                                                                                  Content current as of:
      04/28/2023
              
              
Topic(s)
			  Emergencies
				    				       				    				       Drug Shortage
				       				    				       Terrorism
				       				    				       Radiological
				       				    				       ChemicalLaw(s) & Regulation(s)
			  Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)MCM Legal, Regulatory and Policy Framework

          
                        Emergency Use Authorization
          Expiration Dating Extension
          MCM Emergency Use Authorities
          MCM-Related Counterterrorism Legislation
          MCM-Related Legal and Policy Presentations, Publications and Q&As
          State, Tribal, Local, and Territorial Public Health Preparedness
          Guidance and Other Information of Special Interest to MCM Stakeholders
          MCM-Related Cooperative Arrangements
          Availability of Regulatory Management Plans
          Vaccine EUA Questions and Answers for Stakeholders
          FAQs: What happens to EUAs when a public health emergency ends?
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop