FDA and the Outsourcing Facilities Association filed a joint status report update in their case (Outsourcing Facilities Association v. United States Food and Drug Administration) regarding the status of the drug shortage for tirzapatine.
According to the status update, FDA stated that it "has made substantial progress reevaluating the challenged decision" and that "FDA is carefully assessing the challenged decision and continues to prioritize issuing a new decision on remand." However, FDA did not say it was changing its position regarding the shortage status of tirzapatine and so the current status of tirzepatide has not been changed.
The OFA stated that they "have continued to monitor market conditions for tirzepatide and that they, their members, and other interested persons have provided the agency with evidence that the drug remains in shortage." OFA provided further evidence of increased demand for tirzepatide and that the drug remains in shortage based on the data they acquired.
The parties plan to file a "further joint status report by the earlier of December 19, 2024, or within seven days of FDA's decision on remand."
If any party needs help with navigating the issues regarding compounding and drug shortages, Buchanan's attorneys can assist with these issues.
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