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 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
          MCM Emergency Use AuthoritiesMCM Legal, Regulatory and Policy Framework MCM Emergency Use Authorities
  
  					FDA can allow the emergency use of MCMs through Emergency Use Authorization (EUA) and authorities related to emergency use of approved MCMs
	
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              Emergency sign on buildingDuring public health emergencies, medical countermeasures(MCMs) may be needed to prevent or treat diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) or emerging infectious disease threats, like pandemic influenza.  MCMs are medical products such as drugs, vaccines, diagnostic tests, and other medical equipment and supplies, needed to respond to emergencies involving such threats.

Depending on the emergency and public health need, MCMs may be provided by the Strategic National Stockpile (SNS), which is overseen by the Assistant Secretary for Preparedness and Response (ASPR), or through state and local stockpiles or other supplies.  When needed during a public health emergency, MCMs are usually dispensed or administered to impacted individuals by health care workers and public health responders under official federal, state, and/or local emergency response plans.

In some cases, MCMs might already be approved and will be used in approved ways during a response. In other cases, the best medical products available for a response might be unapproved or need to be used in unapproved ways.

Because of its role in regulating medical products, FDA may use specific authorities within the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow the use of such MCMs in impacted populations during or in anticipation of emergencies.  Mechanisms FDA can use to allow the emergency use of MCMs include the Emergency Use Authorization (EUA) authority, under section 564 of the FD&C Act, use of expanded access authorities for investigational products, and several authorities related to the emergency use of approved MCMs.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

More information in this section

Emergency Use Authorization (EUA) - more information and a list of current EUAs
	Emergency Use Authorization - archived information
	Summary of process for EUA issuance - graphic illustrating the process
	Emergency use of approved MCMs, including expiration dating extensions
	Emergency dispensing orders and Emergency Use Instructions (EUI)
	EUA information for *in vitro*diagnostic devices (IVDs), including how to submit a Pre-EUA for IVDs to FDA, and information for laboratories implementing IVD tests under EUA
	FAQs: What happens to EUAs when a public health emergency ends?Related Links

Vaccine EUA Questions and Answers for Stakeholders
	What is an EUA?(YouTube video, 1:45)
	Emergency Use Authorization for Vaccines Explained
	The Path for a COVID-19 Vaccine from Research to Emergency Use Authorization(PDF, 723KB)
	Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
	21st Century Cures Act (2016): MCM-Related Cures Provisions
	Public Readiness and Emergency Preparedness (PREP) Act (2005)
	Emergency Use of an Investigational Drug or Biologic - Information Sheet (Expanded Access IND)
	Expanded Access for Medical Devices
	HHS Public Health Emergency Information

                                                                                  Content current as of:
      04/05/2022
              
              
Topic(s)
			  Emergency Response
				    				       				    				       Terrorism
				       				    				       Outbreak
				       				    				       Chemical
				       				    				       BiologicalLaw(s) & Regulation(s)
			  21st Century Cures Act of 2016
			    			       			    			       Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
			       			    			       Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
			       			    			       Public Readiness and Emergency Preparedness Act of 2005 (PREP Act)
			       			    			       Federal Food, Drug & Cosmetic ActMCM 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?
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