FDA letter signals enforcement discretion during the remand
On Oct. 17, 2024, FDA told a compounding trade group it would hold off on enforcement against all compounders of tirzepatide while a court sent its shortage decision back for review [1].
The FDA's compounding office sent a letter on Oct. 17, 2024, telling the Alliance for Pharmacy Compounding that the agency did not intend to take enforcement action against compounders for making copies of tirzepatide while a federal court's remand played out [1]. The letter effectively extended to the whole compounding industry a promise FDA had already made to the plaintiffs in a lawsuit [1].
The background: On Oct. 7, 2024, a compounder and a trade association sued FDA over its removal of tirzepatide injection from the agency's drug shortage list [1]. On Oct. 11, at FDA's own request, the court sent the decision back to the agency for reevaluation in Outsourcing Facilities Ass'n v. FDA, No. 4:24-cv-953 (N.D. Tex.) [1]. Tirzepatide is the active ingredient in Eli Lilly's Mounjaro and Zepbound.
What the letter actually said
In its court motion, FDA stated that during the reevaluation — and until two weeks after the agency made its new decision, or, if the plaintiffs filed for a preliminary injunction, until the court ruled on that motion — it did not intend to take action against the plaintiffs for violations that hinge on tirzepatide being on the shortage list [1].
Those provisions are specific. Section 503A(b)(1)(D) of the Federal Food, Drug, and Cosmetic Act covers compounded drugs that are "essentially a copy" of a commercially available product, and sections 503B(a)(2)(A) and (a)(5) cover bulk drug substances used by outsourcing facilities and copies of FDA-approved products [1]. Whether a drug is in shortage under section 506E is what unlocks those exemptions [1].
The key sentence for everyone not named in the lawsuit: "FDA intends to treat compounders consistently at this time, meaning that FDA does not intend to take action against compounders for violations arising from the conditions above, for the same duration of time and subject to all the same limitations as described in FDA's motion and the court's order" [1]. The letter was signed by Gail Bormel, Office Director of the Office of Compounding Quality and Compliance in the Center for Drug Evaluation and Research, and addressed to APC Chief Executive Officer Scott Brunner [1].
FDA drew a clear boundary. Neither its statement nor the court's order stopped the agency from acting on "violations of any other statutory or regulatory requirements, such as to address findings that the product may be of substandard quality or otherwise unsafe" [1].
Why it matters for patients
Millions of people had been getting compounded tirzepatide and semaglutide from telehealth companies and pharmacies while the brand-name products were in shortage. That pipeline is legal only under narrow conditions, and shortage-list status is the main one [1]. When FDA declared tirzepatide's shortage over on Oct. 2, 2024, that legal basis started to close — and the October remand temporarily reopened it [1][2].
The practical effect of the Oct. 17 letter was that compounded tirzepatide could keep flowing for a while longer without FDA action tied to the copy and bulk-substance rules [1]. But the letter did not make compounded versions FDA-approved, and it explicitly preserved FDA's ability to act on quality and safety problems [1]. The agency also gave no end date — the clock depended on litigation and on FDA's own reevaluation [1].
What happens next
FDA posted the letter publicly in an Oct. 22, 2024 update [2]. On Dec. 19, 2024, the agency reissued its decision and again determined the tirzepatide shortage was resolved, with enforcement discretion running until Feb. 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities [2]. On Feb. 21, 2025, FDA determined the semaglutide injection shortage — in place since 2022 — was resolved, with parallel dates of April 22 and May 22, 2025 [2].
The courts then sided with FDA. The district court denied the plaintiffs' preliminary injunction motion on tirzepatide on March 5, 2025, and on semaglutide on April 24, 2025 [2]. As of FDA's April 1, 2026 guidance, neither tirzepatide nor semaglutide appears on the 503B bulks list or the drug shortage list [2].
Sources
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