FDA added tirzepatide to its drug shortage list on Dec. 15, 2022

The FDA first added tirzepatide injection products to its drug shortage list on Dec. 15, 2022, when demand for Mounjaro outstripped supply ^[3]. Under federal law, that listing is what allowed compounding pharmacies and outsourcing facilities to make copies of an FDA-approved GLP-1 drug ^[2].

What the shortage listing changed

The FDA defines a shortage as a period when demand or projected demand for a drug in the United States exceeds supply, measured nationwide rather than locally ^[3]. When an approved drug is on that list, some federal restrictions on compounding do not apply, including the limit on making drugs that are essentially copies of approved products ^[2].

Two kinds of compounders were affected. State-licensed pharmacies and physicians working under section 503A may compound a copy of a drug on the shortage list, as long as the work is not done "regularly or in inordinate amounts" and each batch is based on a valid prescription for an individual patient ^[2]. FDA guidance says the agency does not intend to act against a compounder that fills four or fewer prescriptions of that compounded product in a calendar month ^[1]. Outsourcing facilities under section 503B, which make larger volumes without patient-specific prescriptions, are normally barred from making essentially a copy of an approved drug; that limit also did not apply while the drug was in shortage, and they could use bulk drug substances to make it ^[2].

The tirzepatide supply picture

Mounjaro (tirzepatide) injection was approved in May 2022 and added to the shortage list that December because of high demand ^[3]. Zepbound was approved in November 2023 and added to the list in April 2024 ^[3]. Both are approved as single-dose pens in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg strengths per 0.5 mL ^[3].

The FDA determined the tirzepatide shortage was resolved and removed it from the list on Oct. 2, 2024 ^[3]. The Outsourcing Facilities Association and North American Custom Laboratories, doing business as Farmakeio Custom Compounding, sued over that removal on Oct. 7, 2024; on Oct. 11, 2024, a court remanded the decision to the agency for reevaluation ^[3]. On Dec. 19, 2024, the FDA issued a new order again determining the shortage resolved, based on Eli Lilly data showing supply was meeting or exceeding demand ^[3]. The agency acknowledged reports that some patients and pharmacists still could not get the approved drugs, but concluded those intermittent problems most likely reflected the supply chain between the manufacturer and local pharmacies, not a continuing national shortage ^[3].

That order set wind-down dates: enforcement discretion for 503A compounders ran 60 days, until Feb. 18, 2025, and for 503B outsourcing facilities 90 days, until March 19, 2025 ^[3]. On March 5, 2025, a district court denied a preliminary injunction in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 ^[1]. The FDA then said the 503A discretion period had ended and that it would not act against 503B facilities for shortage-dependent violations until March 19, 2025 ^[1].

Semaglutide injection products were declared resolved on Feb. 21, 2025, after being in shortage since 2022, with discretion running until April 22, 2025 for 503A and May 22, 2025 for 503B; a preliminary injunction motion in a separate case was denied April 24, 2025 ^[1].

Why it matters for patients

The practical consequence is that the legal basis for large-scale compounded copies of tirzepatide and semaglutide is gone. As of the FDA's April 1, 2026 update, neither tirzepatide nor semaglutide appears on the 503B bulks list or on the agency's drug shortage list ^[1]. A compounded product is considered essentially a copy of a commercially available drug when it uses the same active ingredient in the same, similar or easily substitutable strength and the same route of administration, unless a prescriber documents a significant difference for an individual patient ^[1].

The FDA states that compounded drugs pose a higher risk than approved drugs because they do not undergo FDA review for safety, effectiveness or quality before marketing, and it recommends patients be prescribed an FDA-approved drug when one is available and appropriate ^[2]. The agency also notes that patients and prescribers may still see intermittent, localized supply disruptions even after a shortage is resolved, as products move from manufacturers and distributors to local pharmacies ^[1][3].

What happens next

The FDA says it will keep monitoring supply and demand and whether any tirzepatide injection products should be returned to the shortage list in the future ^[3]. It has also said it may still act on other statutory or regulatory violations, such as products found to be substandard quality or unsafe ^[1]. No further shortage-list changes for tirzepatide or semaglutide have been reported since the April 1, 2026 update ^[1].