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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
          Vaccine EUA Questions and Answers for StakeholdersMCM Legal, Regulatory and Policy Framework Vaccine EUA Questions and Answers for Stakeholders
  
  	
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    PrintQuestions and answers on this page are specific to vaccine Emergency Use Authorizations (EUAs), and are intended for stakeholders, including industry, health care providers, pharmacists, and state, local, tribal, and territorial governments. For additional information, including consumer information, please see COVID-19 Vaccines, and Emergency Use Authorization for Vaccines Explained.

Q: FDA has issued a number of Emergency Use Authorizations (EUAs), including for vaccines. If state laws impose different or additional requirements on the medical product covered by an EUA, are those state laws preempted?
	****A: As stated in FDA’s emergency response guidance:  “FDA believes that the terms and conditions of an EUA issued under section 564 preempt state or local law, both legislative requirements and common-law duties, that impose different or additional requirements on the medical product for which the EUA was issued in the context of the emergency declared under section 564.” See Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders (January 2017), page 40,  https://www.fda.gov/media/97321/download. The guidance explains the basis for FDA’s views on this subject.

Q: In the COVID-19 Vaccine EUAs, is FDA’s reference to pharmacists who may be acting pursuant to state law under a standing order intended to suggest that standing orders are required for pharmacists to administer COVID-19 vaccine?
	A: No. When FDA issues an EUA, it is providing an access mechanism to a medical countermeasure needed for an emergency response. Under the EUAs for COVID-19 vaccines, FDA provides maximum flexibility to emergency response stakeholders (e.g., local, state, and federal public health and response partners, as defined in the EUAs) by authorizing them to identify or authorize the types of personnel and responders that would be the most appropriate to administer the product to specific populations and identify the mechanism for authorizing such (e.g., standing order, executive order, declaration, etc.) in accordance with applicable official response plans and HHS authorizations.



Under the plain terms of the EUAs, “vaccination provider” refers to certain persons including those who are acting under a “standing order issued by the state health officer,” and ***“also”***to persons “authorized by the U.S. Department of Health and Human Services (e.g., under the [Public Readiness and Emergency Preparedness Act] PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist).”

FDA’s reference to standing orders in the COVID-19 vaccine EUAs is not intended to supplant any preemptive legal or operational effect of any applicable HHS authorizations, such as the authorization of certain pharmacists, pharmacy interns, and pharmacy technicians who order or administer certain vaccines, as described in the 4th amendmentto the COVID-19 PREP Act Declaration and September 3, 2020 (PDF, 257 KB), and October 20, 2020 (PDF, 216 KB), HHS issuances. States might issue standing orders (or similar mechanisms) to authorize healthcare providers if the standing orders (or similar mechanisms) are consistent with, and not more restrictive than, the HHS authorization and also to authorize other types of health care providers that HHS has not specifically authorized under the PREP Act to administer COVID-19 vaccines.

*Additional Q&A will be added to this page as available.*

Related links:

FAQs: What happens to EUAs when a public health emergency ends?

                                                                                  Content current as of:
      04/06/2022
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  VaccinesTopic(s)
			  BiologicalHealth Topic(s)
			  CoronavirusMCM 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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