FDA added Zepbound to its drug shortage list in April 2024

In April 2024, the FDA added Zepbound, the weight-management brand of tirzepatide, to its national drug shortage list because of high demand ^[2]. The step extended shortage status to the version of the drug sold for weight loss, not only the diabetes brand of the same molecule.

Zepbound pens were approved in November 2023 under application NDA 217806 and were added to the shortage list in April 2024 due to high demand, according to FDA's December 19, 2024 declaratory order on tirzepatide ^[2]. Tirzepatide injection products had first gone on the list on December 15, 2022; Mounjaro, the same molecule approved for type 2 diabetes, was added in December 2022 ^[2]. Both brands are sold as single-dose pens in strengths of 2.5, 5, 7.5, 10, 12.5 and 15 mg per 0.5 mL ^[2]. Zepbound single-dose vials were approved in March 2024, but only the 2.5 mg and 5 mg strengths are marketed, and the vials have never been on the shortage list ^[2].

Shortage status matters because of how compounding rules work. Under section 503A of the Food, Drug, and Cosmetic Act, a state-licensed pharmacy or physician may compound a drug for an individual patient who has a prescription, but generally may not regularly compound a product that is essentially a copy of a commercially available drug ^[1]. FDA considers a compounded product essentially a copy when it uses the same active ingredient at the same, similar or easily substitutable strength and is given the same way, unless a prescriber documents a significant difference for an identified patient ^[1]. For outsourcing facilities under section 503B, bulk drug substances can be used only if they appear on the 503B bulks list, or if the compounded drug is on FDA's shortage list at the time it is compounded, distributed and dispensed ^[1].

That shortage-based path narrowed later. On December 19, 2024, FDA issued a new decision replacing its October 2, 2024 determination and found the tirzepatide shortage resolved ^[2]. FDA said Eli Lilly's data showed its supply was meeting or exceeding demand, that the company held finished and semi-finished inventory, and that more production was scheduled ^[2]. FDA also said it had received reports from patients, pharmacists and compounders that some people could not get the approved drugs and that substantial tirzepatide compounding was occurring, but it concluded that information had important limitations and did not outweigh the company's data ^[2]. The agency said patients and prescribers may still see intermittent, localized supply disruptions as products move through distributors and pharmacies ^[2].

FDA said it would not take action against compounders for violations tied to the shortage listing for 60 days for 503A compounders, until February 18, 2025, and for 90 days for 503B outsourcing facilities, until March 19, 2025 ^[2]. On March 5, 2025, a federal district court denied a preliminary injunction in Outsourcing Facilities Association v. FDA, and FDA said the 503A discretion period had ended while the 503B period ran to March 19, 2025 ^[1]. For semaglutide injection products, FDA declared the shortage resolved on February 21, 2025, with discretion ending April 22, 2025 under 503A and May 22, 2025 under 503B; after an April 24, 2025 court ruling, FDA said the 503A period had ended and the 503B period ran to May 22, 2025 ^[1]. Neither tirzepatide nor semaglutide currently appears on the 503B bulks list or on FDA's shortage list ^[1].

Why it matters for patients

The listing changed what was legally available for a time. While tirzepatide and semaglutide were on the shortage list, compounders could make copies under the exemptions; with both drugs off the list, that route is closed ^[1]. FDA has said it may still act on violations of other requirements, including findings that a product is substandard or unsafe ^[1]. FDA also said it generally does not intend to act against a compounder that fills four or fewer prescriptions a month of a compounded product that is essentially a copy of a commercially available drug ^[1]. Access to the approved products was not guaranteed by the shortage determination either: FDA said some people still had trouble getting prescriptions filled, and that intermittent local supply problems can continue after a shortage is called resolved ^[2].

What happened next

• December 19, 2024: FDA declares the tirzepatide shortage resolved ^[2].
• February 18, 2025: enforcement discretion ends for 503A compounders of tirzepatide ^[2].
• February 21, 2025: FDA declares the semaglutide shortage resolved ^[1].
• March 5, 2025: the tirzepatide injunction is denied; 503A discretion ends ^[1].
• March 19, 2025: 503B discretion ends for tirzepatide ^[1].
• April 22 and May 22, 2025: semaglutide discretion periods end under 503A and 503B ^[1].