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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
          State, Tribal, Local, and Territorial Public Health PreparednessMCM Legal, Regulatory and Policy Framework State, Tribal, Local, and Territorial Public Health Preparedness
  
  	
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FDA Roles | Legal Mechansims | Latest Updates | Contact

FDA Roles

FDA has many medical countermeasure (MCM) roles. MCMs include drugs, vaccines, diagnostic tests, and other medical products used in public health emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions resulting from chemical, biological, radiological, and nuclear (CBRN) threats. This includes emerging infectious diseases, such as pandemic influenza.

Among FDA’s MCM roles, FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs. Stakeholders’ MCM preparedness and response efforts include activities such as stockpiling, distributing, and dispensing or administering MCMs (e.g., antimicrobials) during or in anticipation of a public health emergency (e.g., an anthrax attack or influenza pandemic).

Legal Mechanisms

Through certain legal mechanisms, FDA can help make available safe and effective MCMs for use in emergencies by state and local partners. One of these tools is an Emergency Use Authorization (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Through an EUA, in certain situations FDA may authorize the use of an unapproved medical product—or an unapproved use of an approved medical product—to counter CBRN and emerging infectious disease threats.

In March 2013, the President signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). Among other things, this law amended the EUA authority. It also created new FDA authorities related to the emergency use of MCMs, including for expiration dating extensions, emergency dispensing orders, and cGMP requirement waivers, when appropriate. These changes resulting from PAHPRA will further facilitate state and local preparedness for emergencies that involve the use of MCMs.

The latest updates and additional information for stakeholders are available on these pages:

EUA
	Expiration dating extensions
	PAHPRA
	Summary of PAHPRA's MCM provisions
	MCM-related legal and policy presentations, publications and Q &A
	Guidance and other information of special interest to MCM stakeholders
	Vaccine EUA Questions and Answers for Stakeholders
	FAQs: What happens to EUAs when a public health emergency ends?For more information on these topics, please contact: AskMCMi@fda.hhs.gov.

Related Links

FDA Information for Federal, State, Local, Tribal, and Territorial Officials
	HHS Response and Recovery Resources Compendium
	Public Readiness and Emergency Preparedness (PREP) Act
	HHS Public Health Emergency Information
	CDC Center for Preparedness and Response
	CDC State, Tribal, Local and Territorial Public Health Professionals Gateway

                                                                                  Content current as of:
      02/24/2023
              
              
Topic(s)
			  Biological
				    				       				    				       Emergency ResponseLaw(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?
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