FDA ends enforcement discretion for state-licensed pharmacies compounding tirzepatide

The FDA's enforcement discretion for state-licensed pharmacies and physicians compounding tirzepatide injections ended February 18, 2025, the deadline the agency set when it declared the tirzepatide shortage resolved ^[1][2].

The December 19, 2024 declaratory order revoked and replaced FDA's October 2, 2024 decision and concluded that the shortage of tirzepatide injection products is resolved ^[1]. Tirzepatide injections were first added to the shortage list on December 15, 2022 ^[1]. The order gave compounders working under section 503A of the Food, Drug, and Cosmetic Act 60 calendar days — until February 18, 2025 — before the agency would treat compounded tirzepatide that is "essentially a copy" of an approved product as a violation. Outsourcing facilities under section 503B got 90 days, until March 19, 2025 ^[1].

FDA's February 11, 2025 update kept those dates but tied the 503A deadline to ongoing litigation: enforcement discretion would last until February 18, 2025, or until the district court ruled on a preliminary injunction motion in Outsourcing Facilities Association v. FDA, whichever was longer ^[2]. On March 5, 2025, the court denied that motion in case 4:24-cv-00953 (N.D. Tex.). FDA then said the 503A period of enforcement discretion has ended, and that for section 503B outsourcing facilities it does not intend to act on violations tied to the drug shortage list until March 19, 2025 ^[2].

FDA based the shortage determination on data from Eli Lilly, which makes Mounjaro and Zepbound, the only FDA-approved tirzepatide products ^[1]. FDA said those submissions showed Lilly's supply was meeting or exceeding demand nationally, that the company holds reserves in finished product inventory plus significant units of semi-finished product, and that it has scheduled substantial additional production ^[1]. FDA also said it received reports that some patients and pharmacists were not able to obtain the approved drugs and that "a substantial amount of tirzepatide compounding is occurring," but concluded that information had important limitations and did not outweigh Lilly's data ^[1]. The agency said patients and prescribers may still see intermittent, localized supply disruptions as products move from manufacturers through distributors to pharmacies ^[1].

Why it matters for patients

Compounded tirzepatide has been one source of the drug for patients who could not fill a prescription for Mounjaro or Zepbound, and FDA's shortage-based discretion let state-licensed pharmacies prepare copies without the agency acting on that specific violation. That discretion has now ended for those pharmacies ^[2]. Mounjaro and Zepbound are approved as single-dose pens in six strengths, from 2.5 mg/0.5 mL to 15 mg/0.5 mL; Zepbound is also approved in single-dose vials, with only the 2.5 mg and 5 mg strengths currently marketed in the United States ^[1]. FDA has said it may still take action on other statutory or regulatory violations, such as products that may be of substandard quality or otherwise unsafe ^[2]. It has not been reported how many patients were receiving compounded tirzepatide, how much they paid, or what individual compounding pharmacies plan to do now.

What happens next

• February 21, 2025: FDA said the shortage of semaglutide injection products is resolved, with 503A discretion running until April 22, 2025 and 503B discretion until May 22, 2025 ^[2].
• March 19, 2025: The section 503B window for outsourcing facilities compounding tirzepatide is set to close ^[2].
• April 24, 2025: A district court denied the preliminary injunction motion on compounded semaglutide. FDA said the 503A discretion period has ended and that for 503B facilities it does not intend to act until May 22, 2025 ^[2].