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 In this section:

        Medical Countermeasures Initiative (MCMi)

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 FrameworkMedical Countermeasures Initiative (MCMi) MCM Legal, Regulatory and Policy Framework
  	
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    PrintThe FDA Medical Countermeasures Initiative (MCMi) legal, regulatory, and policy framework ensures that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats.  We work with appropriate partners to assess how FDA can help MCM-related development, distribution, administration, post-administration assessment efforts, and where changes are needed to better protect public health, we develop and propose new approaches.
Sub-Topic Paragraphs
          In this sectionEmergency sign on building

                    MCM emergency use authorities
            FDA may need to use special authorities to allow the use of MCMs in impacted populations during or in anticipation of emergencies. More information about mechanisms FDA can use to allow the emergency use of MCMs, including EUA.
          
          Gavel and stethoscope, representing medical countermeasure-related counterterrorism legislation

                    MCM-related counterterrorism legislation
            Summary of federal legislation enacted to strengthen the nation's preparedness for responding to public health emergencies involving CBRN and emerging infectious disease threats.
          In this section (continued)Modular medical supply containers ready for shipment from the Strategic National Stockpile (credit: CDC)

                    State, tribal, local, and territorial public health preparedness
            FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs.
          
          Compass on wooden background, representing the concept of guidance

                    Guidance and other information of special interest to MCM stakeholders
            Guidance documents of special interest to existing or prospective MCM sponsors, and other stakeholders, including state, tribal, local, and territorial public health preparedness personnel.
          In this section (continued)Ball representing Earth

                    MCM-related cooperative arrangements
            FDA and MCMi use a variety of cooperative arrangements to further development and availability of MCMs, including Confidentiality Commitments and Memoranda of Understanding.
          
          Stethoscope with books

                    MCM-related legal and policy presentations, publications and Q&As
            Updates on FDA activities to support the MCM-related legal and policy framework, to better protect national health and security.
          Popular linksEmergency Use Authorization (EUA)
            The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.Expiration Dating Extension
            Information on various expiration dating extension activities, including the Shelf Life Extension Program (SLEP), emergency use authorities and enforcement discretion.21st Century Cures Act: MCM-related Cures provisions
            The Cures Act contains MCM-specific provisions, including two FDA-specific MCM provisions: amending FDA’s EUA authority, and creating a material threat MCM priority review voucher (PRV) program.Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA)
            PAHPRA contains key legal authorities to sustain and strengthen our nation's preparedness for public health emergencies involving CBRN agents, as well as emerging infectious disease threats.Unapproved uses of approved MCMs (Emergency use of approved MCMs)
            Overview of tools, which are applicable only to eligible FDA-approved medical products intended for use during a CBRN emergency under PAHPRA.Summary of process for EUA issuance
            Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. Flow chart depicting the process.Vaccine EUA Questions and Answers for Stakeholders
            Vaccine EUA Q&A for stakeholders, including industry; health care providers; pharmacists; and state, local, tribal, and territorial governments.FAQs: What happens to EUAs when a public health emergency ends?
            Answers to frequently asked questions about what happens to EUAs, and products available under EUA, when a public health emergency ends.
          Executive Order Information Related to Supply ChainsExecutive Order 13944 List of Essential Medicines, MCMs, and Critical Inputs
            Directed FDA to identify a list of essential medicines, medical countermeasures, and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms.Executive Order 14017 on America’s Supply Chains
            Launched an immediate 100-day review and strategy development process to identify and address vulnerabilities in supply chains of key product sectors, including pharmaceuticals and API, and required agencies to produce sectoral 1-year supply chain reports, including on public health and agri-food supply chains.
          EUA information for in vitro devices (IVDs)How to Submit a Pre-EUA for In vitro Diagnostics to FDA
            Pre-EUA information for manufacturers of IVD tests. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency.Information for Laboratories Implementing IVD Tests Under EUA
            Information to help labs using tests available under EUA learn more about the benefits and limitations of EUA tests, and answer frequently asked questions, including how to report problems with a EUA test to FDA during an emergency.

                                                                                  Content current as of:
      06/16/2023
                  
                   
Topic(s)
			  Rulemaking
				    				       				    				       Emergency Response
				       				    				       EmergenciesMCM 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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