Enforcement discretion ends for 503A pharmacies compounding tirzepatide

The FDA's temporary hands-off policy for state-licensed pharmacies making compounded tirzepatide — the drug in Eli Lilly's Mounjaro and Zepbound — reached its stated February 18, 2025 end date. The agency had set that deadline in a December 19, 2024 order declaring the tirzepatide shortage resolved, and later tied the actual cutoff to a pending court ruling ^[1][2].

Here is how the timing worked. In the December 19, 2024 declaratory order, FDA said it did not intend to act against compounders for violations that hinge on tirzepatide being on the drug shortage list for 60 calendar days — until February 18, 2025 — for pharmacists and physicians compounding under section 503A, and 90 calendar days — until March 19, 2025 — for registered outsourcing facilities under section 503B ^[1].

On February 11, 2025, FDA clarified that it had not changed its plans, but that the 503A window would run until February 18, 2025, or until the district court ruled on the preliminary injunction motion in Outsourcing Facilities Association v. FDA (N.D. Tex.), whichever was longer ^[2]. The court denied that motion on March 5, 2025. In a March 10, 2025 update, FDA said that because of the ruling, the period of enforcement discretion for 503A pharmacies compounding tirzepatide "has ended," while outsourcing facilities had until March 19, 2025 ^[2].

The underlying dispute is about supply. FDA first listed tirzepatide injection as being in shortage on December 15, 2022, removed it on October 2, 2024, then reevaluated after the Outsourcing Facilities Association and a compounder sued in the Northern District of Texas on October 7, 2024 ^[1]. In the December 19, 2024 order, FDA again concluded the shortage was resolved, saying Lilly's data showed supply "is currently meeting or exceeding demand," with finished-product reserves, semi-finished units, and additional production scheduled ^[1].

FDA acknowledged it had received reports that some patients and pharmacists still could not get the approved drugs, and that "a substantial amount of tirzepatide compounding is occurring." The agency said those intermittent problems were most likely caused by distribution dynamics between Lilly, wholesalers and retailers rather than a continuing national shortage, and that patients using compounded product "can be expected to seek Lilly's approved products at a future point when compounding is curtailed" ^[1].

Why it matters for patients

Shortage status is the legal hook that allowed widespread compounding of tirzepatide copies. Under section 503A, pharmacies may not regularly compound drugs that are essentially copies of a commercially available product; under 503B, outsourcing facilities generally cannot use a bulk drug substance unless it is on the 503B bulks list or the compounded drug is on FDA's shortage list at the time of compounding, distribution and dispensing ^[1][2]. Once tirzepatide came off the shortage list and the grace periods lapsed, those exemptions no longer applied.

Practically, that meant telehealth companies and pharmacies that had been supplying compounded tirzepatide lost the legal basis for most of that business, and some patients faced a change in what their provider could offer. FDA also noted that even with the shortage resolved, patients and prescribers "may still see intermittent localized supply disruptions" as products move through the supply chain ^[1]. Pricing, insurance coverage and individual patients' options are not addressed in these FDA documents.

FDA repeated in each update that it can still act on other violations, "such as to address findings that a product may be of substandard quality or otherwise unsafe" ^[2].

What happens next

• March 19, 2025: end of the 503B outsourcing facility window for tirzepatide ^[1][2].
• February 21, 2025: FDA declared the semaglutide injection shortage resolved, with 503A discretion until April 22, 2025 and 503B until May 22, 2025 ^[2].
• April 24, 2025: the court denied a preliminary injunction in the semaglutide case, 4:25-cv-00174 (N.D. Tex.); FDA said the 503A period for semaglutide had ended ^[2].
• April 1, 2026: FDA reminded compounders that tirzepatide and semaglutide appear neither on the 503B bulks list nor on the shortage list, and said it does not intend to act when a compounder fills four or fewer prescriptions of an essentially-a-copy product in a calendar month ^[2].