FDA Reconsiders Tirzepatide Shortage Status, Allowing Continued Compounding

Reversal of Decision:
The FDA has reconsidered its earlier decision to remove tirzepatide from the drug shortage list, allowing compounding pharmacies to continue producing compounded versions of the drug.

Legal Action:
The Outsourcing Facilities Association (OFA) sued the FDA over the sudden removal of tirzepatide from the shortage list, alleging that the action was taken without proper notice and despite ongoing shortages.

Continued Shortage:
Despite the FDA's initial declaration that the shortage was resolved, patients and pharmacists continue to report difficulties in accessing tirzepatide, leading to the reconsideration.

Impact on Patients:
The decision to allow continued compounding of tirzepatide provides relief for patients who rely on these more affordable and accessible alternatives to branded medications.

Regulatory Clarity:
The Alliance for Pharmacy Compounding (APC) is seeking clarification on whether the FDA's latest filing implies that enforcement actions will not be taken against all compounding pharmacies producing tirzepatide or just those involved in the lawsuit.