The ongoing legal battle between the Outsourcing Facilities Association and the FDA over compounded tirzepatide has taken a significant turn with a new statement from the FDA that clarifies its stance on enforcement. Previously, the Alliance for Pharmacy Compounding had framed its communication with the FDA in a way that suggested enforcement against compounders was off the table until the end of the trial. That language led to confusion in the industry about what the FDA actually intended. Now, the agency has set a definitive timeline for enforcement discretion, adding more emphasis on the importance of the upcoming (OFA vs FDA) court decision on a preliminary injunction.
The FDA has now stated that for state-licensed pharmacies and physicians compounding under section 503A, it does not intend to take enforcement action until February 18, 2025, or until the district court issues a decision on the preliminary injunction motion, whichever is longer. For outsourcing facilities operating under section 503B, the enforcement discretion extends until March 19, 2025, or until the preliminary injunction ruling, whichever date is further out. While this guidance does not eliminate all enforcement risks, it provides a temporary buffer for compounders and the patients who rely on them.
This clarification shifts the immediate stakes of the lawsuit. The preliminary injunction, which was meant to protect compounders from enforcement while the case is ongoing, now carries more urgency since the FDA has clarified the limited period of enforcement discretion. The ruling on the injunction will be a critical moment in the case.
The Alliance for Pharmacy Compounding’s initial messaging (corrected in later communications per APC CEO Scott Brunner) created an inaccurate impression that compounding would be left untouched for the duration of the trial. In reality, the FDA has provided only a limited window in which it will not take enforcement action, and that window is directly tied to the timing of the court’s decision. This means that the ruling on the preliminary injunction still holds weight, particularly if it is delayed beyond the current enforcement discretion deadlines.
This clarification does not resolve the broader dispute over compounded tirzepatide, but it does reshape the immediate legal landscape. The case will continue to be watched closely, as the final outcome will determine whether these temporary enforcement pauses translate into long-term access for patients.