U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Public Health Preparedness and Response
  4. Medical Countermeasures (MCMs)
  5. MCM Legal, Regulatory and Policy Framework
  6. Vaccine EUA Questions and Answers for Stakeholders
  1. MCM Legal, Regulatory and Policy Framework

Vaccine EUA Questions and Answers for Stakeholders

Questions 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.

 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.  

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 amendment to 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:

Subscribe

Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases.
Back to Top