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.
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?
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?
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.