FDA reaffirms tirzepatide shortage is over and sets deadlines for compounded copies

On Dec. 19, 2024, the FDA again determined that the shortage of tirzepatide injection products is resolved, revoking and replacing its Oct. 2, 2024, decision and naming the dates when it will stop holding back enforcement against compounders ^[1][3]. The decision covers Mounjaro, approved for type 2 diabetes, and Zepbound, approved for obesity or overweight with at least one weight-related condition ^[1].

FDA added tirzepatide injections to its drug shortage list on Dec. 15, 2022, and removed them on Oct. 2, 2024 ^[1]. On Oct. 7, 2024, the Outsourcing Facilities Association and North American Custom Laboratories, doing business as Farmakeio Custom Compounding, sued the agency in the U.S. District Court for the Northern District of Texas over the removal ^[1]. On Oct. 11, 2024, a court order sent the decision back to FDA for reevaluation ^[1]. The Dec. 19 order replaces the October decision ^[1].

FDA said the determination rests on Eli Lilly's production and inventory data, including stock reports showing quantities supplied and demanded for all strengths, cumulative 2024 supply and demand, projected future supply and demand, and wholesaler inventory data ^[1]. The agency concluded that Lilly's supply is "currently meeting or exceeding demand" and that reserves of finished and semi-finished product, plus scheduled additional production, mean supply will meet or exceed projected demand ^[1].

FDA also weighed reports from patients, health care providers, and compounders that some people could not fill prescriptions and that a substantial amount of tirzepatide compounding was occurring. It said that information "has important limitations" and did not outweigh Lilly's data, and that intermittent trouble filling prescriptions is most likely explained by the part of the supply chain between Lilly and individual customers, such as wholesalers and retailers ^[1]. Even with the shortage resolved, FDA said patients and prescribers may still see "intermittent localized supply disruptions" ^[1].

Compounding copies are allowed under shortage conditions; FiercePharma described the rule as letting pharmacies produce copies to fill the void while a drug is listed as short ^[4]. Under the Dec. 19 order, FDA does not intend to take action against state-licensed pharmacies or physicians compounding under section 503A for violations that depend on tirzepatide's place on the shortage list for 60 days, until Feb. 18, 2025, or against outsourcing facilities under section 503B for 90 days, until March 19, 2025 ^[1][3]. FiercePharma and STAT reported the same dates ^[4][5].

Reaction was split. Patrizia Cavazzoni, M.D., director of FDA's Center for Drug Evaluation and Research, wrote that supply "meets or exceeds current demand" and, based on the agency's best judgment, "will also meet or exceed projected demand" ^[4]. Scott Brunner, chief executive of the Alliance for Pharmacy Compounding, called the decision "not necessarily the end of the story" and said he was not "persuaded" FDA had the data to conclude the shortage is really over; pharmacies, he said, report that FDA-approved tirzepatide is "not attainable from wholesalers in quantities needed to meet demand" as patients move from compounded to commercial products ^[4]. Brunner also said the FDA statement "is not a decision by a court" ^[4].

As of Dec. 19, 2024, semaglutide injection products, sold as Ozempic and Wegovy, remained on the shortage list, along with dulaglutide and liraglutide ^[3]. About 2 million Americans were taking compounded versions of GLP-1 drugs, according to an estimate from the Kaiser Family Foundation cited by FiercePharma ^[4].

Why it matters for patients

People who get tirzepatide from a compounding pharmacy face a supply that is scheduled to shrink. The order gives those pharmacies until Feb. 18, 2025, and 503B outsourcing facilities until March 19, 2025, before the enforcement discretion tied to the shortage ends ^[1][3]. How prices will change after those dates has not been reported; compounders had been selling lower-cost copies that undercut branded prices ^[4].

FDA-approved Mounjaro and Zepbound remain the only FDA-approved tirzepatide products ^[1]. FDA has said local, intermittent difficulty getting them may continue even though national supply meets demand ^[1].

Compounded drugs are not FDA-approved, and Lilly cites the FDA's caution that "compounded drugs pose a higher risk to patients than FDA-approved drugs" ^[2]. Lilly also says its own testing found significant levels of an impurity formed when tirzepatide is mixed with vitamin B12 in the same solution, and that the short- and long-term effects of that impurity in humans are unknown ^[2]. Lilly states that a federal court confirmed compounders "must cease production" of copies of its tirzepatide medicines ^[2].

What happens next

The near-term milestones are the Feb. 18, 2025, date for state-licensed pharmacies and physicians and the March 19, 2025, date for outsourcing facilities ^[1][3]. Brunner said the FDA action informs the compounders' litigation but is not a court ruling ^[4]. FDA said it will keep monitoring supply and demand and whether any tirzepatide product should go back on the shortage list ^[1].

FDA's own policy page records later steps: it determined the semaglutide injection shortage resolved on Feb. 21, 2025, with enforcement discretion until April 22, 2025, for 503A compounders and May 22, 2025, for 503B facilities ^[3]. On April 24, 2025, a district court denied a preliminary injunction motion in Outsourcing Facilities Association v. FDA over compounded semaglutide, and FDA said the 503A enforcement discretion period for semaglutide had ended ^[3]. In an April 1, 2026 update, FDA said tirzepatide and semaglutide do not appear on the 503B bulks list or on the drug shortage list ^[3].