FDA clarifies the tirzepatide compounding deadlines

The Food and Drug Administration said on February 11, 2025, that it had not changed its plans for enforcement discretion on compounded tirzepatide, but it clarified exactly when that discretion would end ^[1]. For state-licensed pharmacies and physicians compounding under section 503A of the Food, Drug and Cosmetic Act, the window ran until February 18, 2025, or until a federal district court ruled on a pending preliminary injunction motion, whichever came later ^[1]. For outsourcing facilities compounding under section 503B, the window ran until March 19, 2025, under the same either-or condition ^[1].

The case behind the injunction was Outsourcing Facilities Association v. FDA, filed in the Northern District of Texas ^[1]. The FDA had already declared the tirzepatide injection shortage resolved on December 19, 2024, reevaluating an earlier determination from October 2, 2024 ^[1]. That resolution meant tirzepatide, sold as Mounjaro and Zepbound, no longer qualified compounders for shortage-based exceptions once the grace periods lapsed ^[1]. The agency set those original 60-day and 90-day windows from the December 19 announcement, landing on February 18 for 503A compounders and March 19 for 503B outsourcing facilities ^[1].

The court eventually ruled. On March 5, 2025, the district court denied the plaintiffs' preliminary injunction motion in the tirzepatide case ^[1]. Following that decision, the FDA said 503A enforcement discretion had ended for state-licensed pharmacies and physicians, while 503B outsourcing facilities were given a slightly extended window, with the agency saying it would not act on shortage-related violations until March 19, 2025 ^[1]. Throughout, the FDA noted it could still act against compounders for other problems, such as substandard quality or unsafe products, regardless of the shortage timeline ^[1].

A similar pattern later played out for semaglutide, used in Ozempic, Wegovy and Rybelsus. The FDA declared that shortage resolved on February 21, 2025, and set comparable 60-day and 90-day grace periods, tied to a separate court case, 4:25-cv-00174 in the same Texas district ^[1]. That court denied a preliminary injunction motion on April 24, 2025, after which the FDA said 503A discretion for semaglutide had ended, while 503B outsourcing facilities retained a narrower allowance through May 22, 2025 ^[1].

Why it matters for patients

Patients who had been getting compounded tirzepatide from a pharmacy or physician under 503A lost that legal pathway once the court ruled and the grace period ended in March 2025 ^[1]. Outsourcing facilities operating under 503B had a bit more time, but the FDA made clear that once tirzepatide was off the shortage list, the main legal basis for large-scale compounding using bulk drug substances was gone unless other conditions applied ^[1]. The agency separately noted that tirzepatide and semaglutide do not currently appear on the FDA's 503B bulks list, which lists substances outsourcing facilities may use even without a shortage ^[1]. That means patients relying on compounded versions for cost or access reasons may need to look at brand-name Mounjaro, Zepbound, Ozempic, Wegovy or Rybelsus, or confirm with their pharmacy whether any compounding option remains legally available under narrower exceptions, such as documented patient-specific formulation changes ^[1].

What happens next

The FDA continues to monitor supply for other GLP-1 drugs. As of February 21, 2025, dulaglutide and liraglutide injections remained listed as in shortage, though manufacturers reported most presentations available ^[1]. The agency said it was still working to determine whether demand for those drugs exceeds supply ^[1]. Litigation over compounding rules continued in the same Texas court system tracking both the tirzepatide and semaglutide cases ^[1].