As of March 13, 2024, the EUA-labeled Paxlovid is no longer authorized for emergency use, regardless of the labeled or extended expiration date. This completes the transition to the FDA-approved Paxlovid after revision of the Paxlovid EUA (revised March 13, 2024).

Therefore, all EUA-labeled Paxlovid, including expired EUA-labeled Paxlovid, remaining in U.S. distribution must be returned to the manufacturer or disposed of in accordance with all federal, state, and local regulations. For both NDA-approved and EUA-authorized uses, only NDA-labeled Paxlovid may be dispensed. 

Authorizations under the revised EUA currently still in effect: 

• emergency use of NDA-labeled Paxlovid for the treatment of mild-to-moderate COVID-19 in pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death; and 
• Pharmacists can still prescribe Paxlovid for an individual patient for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death, subject to certain conditions. 

See FDA’s website for the Frequently Asked Questions on the Emergency Use Authorization for Paxlovid for Treatment of COVID-19 for additional information related to the dispensing of Paxlovid.