FDA extends enforcement discretion for compounded tirzepatide pending a court ruling

The FDA said on Feb. 11, 2025, that it would not enforce a planned cutoff for compounded tirzepatide until a federal district court rules on a preliminary injunction request from pharmacy groups ^[1][2]. The move extended a deadline that had originally been set for Feb. 18, 2025, for smaller 503A compounding pharmacies, and March 19, 2025, for larger 503B outsourcing facilities ^[1].

Tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound. The FDA had removed tirzepatide from its drug shortage list in October 2024, then reaffirmed that decision in a declaratory order on Dec. 19, 2024 ^[1]. That order set the enforcement discretion deadlines of Feb. 18 for 503A pharmacies and March 19 for 503B facilities ^[1][2]. Industry groups, including the Outsourcing Facilities Association, sued the FDA over the shortage determination in the case Outsourcing Facilities Association v. FDA, filed in the Northern District of Texas ^[1].

Rather than let the original deadlines pass while the lawsuit was pending, the FDA said on Feb. 11 that enforcement discretion would continue until either the original deadline or the date of the district court's ruling on the preliminary injunction motion, whichever came later ^[1][2]. If the court ruled before the original deadlines, the FDA said it would go back to those original dates ^[2].

The tirzepatide dispute followed a similar pattern with semaglutide, the ingredient in Novo Nordisk's Ozempic, Wegovy, and Rybelsus. On Feb. 21, 2025, the FDA marked the semaglutide shortage as resolved for all forms of the drug ^[1]. For semaglutide, the FDA set compounding wind-down deadlines of April 22, 2025, for 503A pharmacies and May 22, 2025, for 503B outsourcing facilities ^[1][2]. The Outsourcing Facilities Association filed a separate lawsuit challenging that semaglutide determination on Feb. 24, 2025, and as of early March 2025 the FDA had not said whether it would extend enforcement discretion again in response ^[1].

Separately, Eli Lilly and Novo Nordisk have each asked the FDA to add tirzepatide and semaglutide, respectively, to a list of drugs considered too difficult to compound safely ^[2]. If granted, those petitions would bar compounding of the drugs on safety grounds, independent of the shortage question ^[2].

Why it matters for patients

Patients who have been getting compounded tirzepatide from a 503A pharmacy or 503B outsourcing facility are affected directly by these deadlines, because compounders generally cannot keep making close copies of a commercial drug once the FDA says the shortage is over ^[1][2]. The Feb. 11 extension meant that patients relying on compounded tirzepatide did not face an immediate cutoff, since the FDA tied continued access to the outcome of ongoing litigation rather than a fixed calendar date ^[1][2].

Compounded products can still be dispensed in narrower circumstances, such as when a prescriber documents that a patient needs a different strength, dosage form, or route of administration that isn't available commercially ^[1]. Patients whose compounded prescriptions do not fit those exceptions may need to switch to the brand-name product or find another option once enforcement resumes.

Because the case was still pending in the Northern District of Texas, the sources do not say when or how the court will rule, so it is not yet known how long enforcement discretion for tirzepatide will actually last ^[1][2].

What happens next

The FDA's Feb. 11 enforcement pause for tirzepatide continues until the district court rules on the preliminary injunction motion in Outsourcing Facilities Association v. FDA, or until the original deadlines of Feb. 18, 2025 (503A) and March 19, 2025 (503B), whichever is later ^[1][2]. For semaglutide, wind-down deadlines of April 22, 2025 (503A) and May 22, 2025 (503B) were set after the FDA declared that shortage resolved on Feb. 21, 2025, though a separate lawsuit filed Feb. 24, 2025, could affect that timeline as well ^[1]. The sources do not indicate a ruling date for either case.