The Food and Drug Administration (FDA) reaffirmed its decision that the shortage of tirzepatide is over. Tirzepatide is the active ingredient in Eli Lilly’s GLP-1 weightloss drugs Mounjaro and Zepbound. This announcement provides clarity following recent concerns regarding the availability of the medications and a call for the FDA to reconsider their decision. In a statement released in October, the FDA declared the tirzepatide shortage resolved. The FDA’s recent announcement means that it believes that the supply of tirzepatide has stabilized, alleviating the need for compounded versions of the medication.
With the FDA sticking by the decision, Compounding pharmacies that have been producing compounded versions of tirzepatide will have until February 18, 2025, to distribute their remaining supply. This grace period allows for the transition back to reliance on FDA-approved versions of the drug.
Additionally, 503B compounding facilities, which are bulk compounding pharmacies, are granted a slightly longer timeline. These facilities will have until March 19, 2025, to distribute any compounded tirzepatide in their inventories.
Implications for Health Care Providers
- Shift Back to FDA-Approved Products: Health care providers should anticipate a transition to prescribing and dispensing FDA-approved Mounjaro and Zepbound. Patients currently using compounded tirzepatide should be counseled on this change.
- Compliance with Deadlines: Clinics and pharmacies utilizing compounded tirzepatide must ensure compliance with the February and March deadlines, as applicable, to avoid potential violation of regulatory and board rules.
- Availability and Cost Considerations: Providers should monitor patient access to these medications and prepare for potential price differences between compounded and FDA-approved versions.
Our previous articles, “Alert: Tirzepatide No Longer on FDA’s Drug Shortage List” and “Alert: Tirzepatide and Semaglutide Still on the Drug Shortage List”, provide valuable insights into the evolving situation and the steps taken to address the shortages. As of publication, there is no ruling as it relates to Outsourcing Facilities Association, a trade group for compounding pharmacists, lawsuit against the FDA. This lawsuit alleged that Tirzepatide should remain on the shortage list.
Contact ByrdAdatto for the Impact of this Ruling on Your Medical Practice
Physicians and other practitioners should stay informed about potential updates and remain vigilant in guiding patients through this transition period. Contact ByrdAdatto for guidance on navigating these changes.
