The Outsourcing Facilities Association has appealed its case against the FDA, asking the Fifth Circuit Court of Appeals to reconsider the district court’s decision that denied a preliminary injunction and left compounded tirzepatide off the market. The move signals that OFA is not banking solely on summary judgment in the lower court and instead sees an opportunity to challenge the legal framework the FDA used to justify its crackdown on compounding.
The appeal comes days after the district court set a briefing schedule for summary judgment, a process that could lead to a final ruling in the case without a full trial. That schedule requires motions to be filed by March 21, responses by April 11, and replies by April 18. OFA’s decision to file an appeal introduces a second legal front, raising the possibility of an extended legal fight with no immediate relief for compounders or patients.
It is unclear whether the Fifth Circuit will agree to hear the case quickly or grant any emergency relief that would allow compounded tirzepatide to return while the case is under review. Appeals courts move at a slower pace than district courts, and even an expedited ruling could take months. In the meantime, the lower court continues its path toward a final decision, leaving 503B compounding facilities without a legal avenue to resume production.
With no clear timeline for resolution, patients who had relied on 503b compounded copies of tirzepatide are watching their hopes slowly fade. The FDA has not signaled any change in enforcement, which will give 503B pharmacies until March 19th, 2025 to hault their sales of compound Tirzepatide. The OFA’s appeal is a necessary step to keep legal pressure on the agency, but it does little to provide immediate relief to those who depended on lower-cost, more accessible alternatives.
Lilly and Novo maintain that their efforts to eliminate compounded tirzepatide are driven by patient safety concerns.
At the same time, telehealth companies like Mochi Health are transitioning patients to custom doses, while some providers have started offering untested custom formulations now that standard 503B compounded tirzepatide is off the table. These custom doses and formulations come from 503A pharmacies, which operate under different regulations than 503B outsourcing facilities and lack the same FDA oversight under Current Good Manufacturing Practices (CGMP).
Ironically, the uncertainty surrounding continuity of care has led former compound users to turn to grey market sources in droves, openly sharing on social media that they are purchasing imported and unregulated research-grade versions. These products are sold through online web stores, do not require a prescription, and are labeled “not for human consumption.” Restricting 503B copies may ultimately leave patients with fewer federally regulated options, pushing them toward riskier and unregulated alternatives.
Stay tuned to OnThePen.com for more updates as the case moves forward.
My colleagues know I’m in this space. Three of them are on branded versions. All three have told me their meds are backordered two-four weeks.