As last reported on this matter, on December 19, 2024, in the midst of the ongoing lawsuit between the Outsourcing Facility Association and the FDA, the FDA determined (ostensibly once and for all) that the tirzepatide shortage was over. In announcing this determination, the FDA extended its pause on enforcement against compounders of tirzepatide for a limited time depending on the type of entity, giving:
- 503A pharmacies a 60-day period in which it does not intend to take enforcement action for compounding “essentially a copy” of tirzepatide brand products (this period expires on February 18, 2025); and
- 503B outsourcing facilities a 90-day period in which it does not intend to take enforcement action for compounding “essentially a copy” of tirzepatide brand products (this period expires on March 19, 2025).
Since then, several developments have taken place. First, Eli Lilly filed a motion to intervene in the federal court lawsuit, arguing that its interests are not adequately represented in the matter. Though initially opposed by the plaintiffs, that opposition was later withdrawn, and the court granted Lilly’s motion to intervene.
Second, the plaintiffs and FDA jointly moved to lift the stay and reopen the case (the case had been administratively closed following entry of the stay). Though the court has yet to officially grant this motion, based on the briefing schedule discussed below, the case has essentially been reopened.
Third, on January 14, 2025, the district court held a hearing on the pending preliminary injunction motion filed by the Outsourcing Facility Association. After the hearing, the court declined to convert the pending preliminary injunction motion to a motion for summary judgment; instead, the court entered a new briefing schedule centered around the plaintiffs receiving the FDA’s Decision Memorandum (“Resolution of Tirzepatide Injection Product Shortage and Supply Status,” dated December 19, 2024). The new briefing schedule suggests that it may be more than six weeks before any decision is rendered (at the earliest). Interestingly, in a footnote, the court noted that the FDA had represented during the hearing that it could compile the administrative record within three weeks, which would make for interesting information once produced but will be subject to a protective order.
Based on this timeline, if all the parties take the maximum allotted time to comply with the court’s order, then the hearing will not be fully briefed until March 18, 2025. This date is not insignificant because it is a month after the FDA’s announced grace period ends for 503A compounders and a day before the announced end date of the grace period for 503B compounders.
This, however, is not the end of the story for those affected by the previously announced dates. When the court entered the stay on October 11, 2024, it made sure to note that its decision to enter the stay took into account the FDA’s representation that it “will not take action against Plaintiffs and their members for violations of the [FDCA]” related to “tirzepatide’s inclusion on the drug shortage list . . . from the date of this order through two weeks beyond the new decision on remand and, if Plaintiffs file a motion for preliminary injunction regarding the new decision, through the Court’s resolution of that motion.”
Thus, 503A compounders will likely be able to continue compounding tirzepatide beyond February 18, 2025. How far beyond that remains to be seen.
It is vital that pharmacies and outsourcing facilities impacted by this case stay abreast of the latest developments as they happen. Even though the window to compound tirzepatide remains open for the time being, compounders may nevertheless face other compliance considerations and liability from third parties. As such, experienced legal guidance is critical.
How Frier Levitt Can Help
Contact us if you are contemplating or currently compounding GLP-1s, if you need a detailed review of the regulatory aspects of compounding, or a particular scenario. GLP-1 compounding presents a myriad of regulatory compliance issues for clinicians. We develop policies and procedures, conduct mock compounding inspections, assist with the VPP process, review labeling and advertising, and assist many clients in meeting full regulatory compliance in the GLP-1 503A and 503B compounding space.
