FDA confirms the tirzepatide compounding timeline after the ruling

The FDA posted a timeline update on March 10, 2025, confirming that the window for compounded tirzepatide was closing. The agency said the enforcement discretion period for state-licensed pharmacies and physicians compounding under section 503A had ended, and that outsourcing facilities compounding under section 503B had until March 19, 2025 ^[1].

The trigger was a court decision. On March 5, 2025, a district court denied the plaintiffs' preliminary injunction motion in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) ^[1]. That motion had asked the court to block the FDA's handling of the tirzepatide shortage decision. Because the court did not grant it, the deadlines the FDA had already laid out took effect ^[1].

How the deadlines were set

The sequence started on December 19, 2024, when the FDA re-evaluated an earlier determination from October 2, 2024, and issued a new decision finding that the tirzepatide injection shortage was resolved ^[1]. Tirzepatide is the active ingredient in Mounjaro and Zepbound.

To avoid what the agency called unnecessary disruption to patient treatment, the FDA gave compounders a grace period rather than cutting them off immediately. State-licensed pharmacies under 503A got 60 calendar days, until February 18, 2025. Outsourcing facilities under 503B got 90 calendar days, until March 19, 2025 ^[1].

On February 11, 2025, the FDA clarified that those dates would run until the deadline or until the district court ruled on the preliminary injunction motion, whichever was longer ^[1]. The March 5 ruling resolved that question, and the March 10 update stated plainly that the 503A period had ended and the 503B period would close on March 19 ^[1].

The same March 10 notice laid out a separate, later set of dates for semaglutide, the ingredient in Ozempic, Wegovy and Rybelsus. The FDA had determined on February 21, 2025, that the semaglutide injection shortage was resolved ^[1]. Compounding under 503A was covered until April 22, 2025, and under 503B until May 22, 2025 — or until the district court decided a forthcoming preliminary injunction motion in a separate case, OFA v. FDA, 4:25-cv-00174 (N.D. Tex.), whichever was later ^[1].

Why it matters for patients

Many people had been getting compounded tirzepatide from telehealth platforms, med spas and compounding pharmacies while the drug was officially in shortage. Compounded versions are not FDA-approved, and the legal basis for making copies of an approved drug largely depends on that drug being on the FDA's shortage list. Once the shortage was declared resolved, that basis went away ^[1].

In practice, the March 10 update meant that the supply of legally compounded tirzepatide copies was set to stop. Pharmacies compounding under 503A were already past their deadline, and outsourcing facilities had about nine days left ^[1].

The FDA also noted that even during these grace periods, it could still take action over other violations — for example, if a product was found to be of substandard quality or otherwise unsafe ^[1].

What happens next

• March 19, 2025: The 503B outsourcing facility period for tirzepatide injection products ends ^[1].
• April 22, 2025: The 503A period for semaglutide injection products ends, or the date of the district court's decision in OFA v. FDA, 4:25-cv-00174, whichever is later ^[1].
• May 22, 2025: The 503B period for semaglutide ends, under the same "whichever is later" condition ^[1].

The sources do not say how individual compounders or telehealth sellers responded, or what happened to patients mid-treatment. That is not yet known from this material.