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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
          Emergency Use of Approved MCMsMCM Legal, Regulatory and Policy Framework Emergency Use of Approved MCMs
  
  	
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              Emergency sign on buildingThe 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, and recognizes the key role FDA plays in emergency preparedness and response.

PAHPRA 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).

FDA Authorities for the Emergency Use of Approved Medical Products

In addition to clarifying FDA’s existing Emergency Use Authorization (EUA) authority under section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) to support preparedness efforts and rapid response capabilities for a range of stakeholders, the following streamlined mechanisms—applicable only to eligible FDA-approved medical products intended for use during a CBRN emergency—facilitate certain MCM preparedness and response activities without FDA having to issue an EUA (which can be a time- and resource-intensive process).

FDA has the authority 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]*
	The Centers for Disease Control and Prevention (CDC) has been delegated the authority 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, FDA and CDC entered into a Memorandum of Understanding to facilitate creation of EUI. *[Sec. 564A(e) of the FD&C Act and HHS Delegation of Authority of section 564A(e) of the FD&C Act (PDF, 46 KB), December 16, 2013]*
	FDA has the authority 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]*
	FDA has the authority to allow 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]*
	FDA has the authority to expand the current 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]*

                                                                                  Content current as of:
      11/17/2021
              
              
Topic(s)
			  Emergency Response
				    				       				    				       Emergencies
				       				    				       Radiological
				       				    				       Outbreak
				       				    				       Chemical
				       				    				       BiologicalLaw(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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