Pharmacies and healthcare providers may no longer dispense Paxlovid labeled in accordance with the FDA's emergency use authorization, the agency said March 13.
All current and expired Paxlovid doses with an EUA label must be returned to the manufacturer or disposed of properly, according to the agency.
The revision comes nearly 10 months after the FDA approved Pfizer's new drug application for Paxlovid to treat COVID-19 in adults at high -risk of severe complications, including hospitalization or death. Pharmacies and healthcare providers may now only dispense the drug with this NDA labeling.
Paxlovid is still authorized for emergency use in pediatric patients 12 and up.
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