Judge denies compounding groups' request to pause FDA tirzepatide shortage ruling

A federal judge in Texas denied a request on March 5, 2025, to block the Food and Drug Administration's finding that tirzepatide injection products are no longer in shortage, a ruling that clears the way for a March 19 deadline for one group of compounders ^[1][2].

The decision came in Outsourcing Facilities Association v. FDA, 4:24-cv-00953 (N.D. Tex.) ^[1]. The plaintiffs were the Outsourcing Facilities Association and North American Custom Laboratories, which does business as FarmaKeio Custom Compounding ^[2]. They had asked for a preliminary injunction to keep the FDA from taking action against them while they made compounded versions of Mounjaro and Zepbound, the two FDA-approved tirzepatide products ^[2].

The FDA first declared the tirzepatide shortage resolved on Oct. 2, 2024 ^[2][4]. After the compounders sued, the agency agreed to a remand and reevaluated, then reaffirmed on Dec. 19, 2024 that the shortage was over ^[1][2][4]. The agency said Eli Lilly's supply would "meet or exceed projected demand," based on the company's expanded manufacturing capacity and information submitted by Eli Lilly, patients, health care providers and compounders ^[2].

The FDA set two different transition periods. For state-licensed pharmacies and physicians compounding under section 503A of the Food, Drug and Cosmetic Act, the period of enforcement discretion ended Feb. 18, 2025 ^[1]. For outsourcing facilities under section 503B, the agency said it did not intend to take action for violations that depend on tirzepatide's former place on the shortage list until March 19, 2025 ^[1]. Because the district court denied the injunction, those dates stand ^[1].

The FDA added Mounjaro to its shortage list in December 2022 and Zepbound in April 2024, which allowed compounders to make copies under the shortage exception ^[2]. Lilly received FDA approval for Mounjaro in May 2022 and Zepbound in November 2023, and its exclusive right to make tirzepatide products runs to 2027 ^[2]. Lilly spent about $23 billion to expand manufacturing in the United States and Europe, and Becker's Hospital Review reported that the company's supply data showed an 11.6 million-dose surplus by November 2024 ^[2][4].

The compounders argued the FDA should have used formal notice-and-comment rulemaking and that its shortage determination was arbitrary and capricious ^[2][4]. The district court concluded they were unlikely to succeed on the merits ^[2].

Why it matters for patients

Compounded drugs are not FDA-approved, meaning the agency does not review them for safety, effectiveness or quality before they reach patients ^[2]. While tirzepatide was on the shortage list, some federal restrictions on compounding copies were suspended; that exception no longer applies ^[1][2].

The FDA said tirzepatide and semaglutide do not currently appear on its 503B bulk drug substances list or on its drug shortage list ^[1]. The agency has said it does not intend to act against a compounder that fills four or fewer prescriptions a month of a product that is essentially a copy of a commercially available drug ^[1]. It also said it may still act on violations of other requirements, such as products found to be substandard or unsafe ^[1].

The FDA said patients and prescribers may still see "intermittent and limited localized supply disruptions" as products move from manufacturers and distributors to local pharmacies, even though the agency confirmed with the manufacturer that its stated availability and capacity can meet present and projected national demand ^[1]. Mounjaro and Zepbound were both approved as single-dose pens, and Lilly later won approval to sell single-dose vials as well ^[2].

What patients using compounded tirzepatide would pay if they move to approved products, and how insurers would handle those switches, has not been disclosed in these materials. Becker's Hospital Review described compounded versions as cheaper and unapproved ^[4].

What happens next

• March 19, 2025: the FDA's period of enforcement discretion ends for outsourcing facilities compounding tirzepatide injections ^[1].
• For semaglutide injection products, the FDA set discretion periods of April 22, 2025 for state-licensed pharmacies and physicians, and May 22, 2025 for outsourcing facilities, or the date a court ruled on a preliminary injunction motion in a related case, whichever was later ^[1]. That motion was denied on April 24, 2025, so the 503A period ended and the May 22, 2025 date applied to 503B facilities ^[1].
• The tirzepatide case continued. The district court granted summary judgment for the FDA on May 7, 2025 ^[3], and the Fifth Circuit affirmed on Aug. 27, 2026, rejecting the compounders' procedural and merits arguments ^[2][4]. A parallel appeal over semaglutide is pending before the same panel ^[4].