HHS Reminds Providers About Paxlovid Transition

The Department of Health and Human Services (HHS) is reminding providers that emergency use authorization (EUA) labeled Paxlovid cannot be dispensed after March 8, 2024. HHS also indicated that providers should return EUA-labeled Paxlovid to manufacturers as soon as possible or dispose of it in accordance with applicable guidelines.

To ensure an adequate supply of Paxlovid for patients, HHS is urging providers to place orders for commercially available Paxlovid (e.g., the NDA-labeled Paxlovid) as soon as possible. The agency cautioned that failure to order NDA-labeled Paxlovid in advance of the March 8 deadline could result in pharmacies not having sufficient stock on hand to meet patient needs. HHS also stated that there are no current supply or distribution disruptions that would otherwise limit commercial Paxlovid availability.

Pharmacists can continue to prescribe NDA-labeled Paxlovid. The Food and Drug Administration’s Paxlovid Frequently Asked Questions document states that “The EUA does not place any limitation on the presentation of Paxlovid to be dispensed (EUA-labeled Paxlovid or NDA-labeled Paxlovid) when pharmacist prescribing is consistent with the conditions above.” The Administration for Strategic Preparedness and Response recently reiterated in its own document that pharmacists can continue to prescribe NDA-labeled Paxlovid provided they meet the requisite conditions. Providers should be directing uninsured or underinsured patients receiving Paxlovid to the Paxcess program to ensure that patients are not confronted with avoidable out-of-pocket costs for Paxlovid.

ASHP will continue to update members throughout the transition to commercially-available Paxlovid. Questions or concerns should be directed to Jillanne Schulte Wall, senior director for health and regulatory policy, at [email protected].