October 17, 2024
BREAKING: FDA allows renewed compounding of tirzepatide copies—for now
FDA clarifies: For now, pharmacies may prepare copies of tirzepatide injection
In a win for continued patient access to compounded versions of Eli Lilly’s Mounjaro and Zepbound, FDA clarified today that pharmacies may continue to prepare copies of those FDA-approved drugs, at least for now.
The news came in a late Thursday afternoon letter to APC from FDA Office of Compounding Quality and Compliance Director Gail Bormel, who indicated that FDA will not take enforcement action against pharmacies that prepare copies of tirzepatide injection during a court-approved period in which the agency is reevaluating its October 2 decision resolving the formal shortage of that FDA-approved GLP-1 drug.
Bormel’s letter was a response to APC’s emergency request last weekend for just such a clarification from the agency. The uncertainty stemmed from FDA’s response to a lawsuit filed against the agency by the Outsourcing Facilities Association and APC-member pharmacy Farmakeio. The lawsuit asserts that FDA was capricious in resolving the tirzepatide injection shortage, that it relied on incomplete data, and that it should have followed notice-and-comment rulemaking. On Friday, at FDA’s request, the court remanded that decision back to the agency for reconsideration and indicated that enforcement action would not be taken against the plaintiffs in the case.
Concerned about interruption of patients’ drug therapy, APC had asked the agency to take a broader view and apply that “enforcement discretion” to all sterile compounding pharmacies that might prepare tirzepatide copies.
“FDA intends to treat compounders consistently at this time, meaning that FDA does not intend to take action against compounders for violations arising from the conditions above, for the same duration of time and subject to all the same limitations as described in FDA’s motion and the court’s order,” Bormel said in the letter to APC’s CEO Scott Brunner.
“The abruptness of FDA’s resolution of the tirzepatide injection shortage left thousands and thousands of patients stranded with a prescription that could no longer be filled — and no speedy means of transitioning to the FDA-approved drug,” said APC’s Brunner. “For those patients and their providers, today’s clarification by FDA is wonderful news.
“I sincerely thank the agency for its responsiveness. I do want to make clear that what led to this outcome is the courage of the Outsourcing Facilities Association in challenging in court what was a too-hasty, poorly informed move by FDA to end the shortage in the first place. Patients may not know how this reversal came about, but we do, and it’s thanks to OFA and Farmakeio.”
Brunner cautioned that FDA’s clarification is not a checkered flag allowing unrestrained compounding of tirzepatide injection. “Just because FDA says it will not take enforcement action during this period of time when it’s re-evaluating its decision does not mean state boards of pharmacy will take the same approach. We would hope most states would follow FDA’s lead, but we strongly urge pharmacies to check with their state board of pharmacy before they recommence compounding copies of tirzepatide injection.”
