FDA tells compounders it will hold off on tirzepatide copy enforcement during review

The FDA's compounding office told the Alliance for Pharmacy Compounding on October 17, 2024 that it does not intend to take action against compounders for making products that copy tirzepatide, the active ingredient in Mounjaro and Zepbound, while the agency re-evaluates its removal of the drug from the national shortage list ^[1].

The letter came from Gail Bormel, director of the Office of Compounding Quality and Compliance at the FDA's Center for Drug Evaluation and Research, and was addressed to APC chief executive officer Scott Brunner ^[1]. Bormel wrote that the agency "intends to treat compounders consistently at this time," meaning it does not intend to act on violations tied to tirzepatide's place on the shortage list "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].

FDA was sued on October 7, 2024 by a compounder and a trade association over removal of tirzepatide injection from its shortage list. On October 11, upon FDA's motion, a court order remanded the decision to the agency for reevaluation (Outsourcing Facilities Ass'n v. FDA, No. 4:24-cv-953, ECF Nos. 27, 28, N.D. Tex.) ^[1]. FDA's policy page notes the agency had re-evaluated an earlier determination on the tirzepatide shortage dated October 2, 2024 ^[2].

The discretion described in the letter covers specific provisions of federal law: section 503A(b)(1)(D), which addresses compounded drugs that are essentially a copy of a commercially available product, and sections 503B(a)(2)(A) and (a)(5), which cover bulk drug substances used in compounding and compounded drugs that are essentially a copy of an FDA-approved product ^[1]. FDA said neither its statement nor the court's order prevents it from acting on other violations of statutory or regulatory requirements, such as findings that a product may be of substandard quality or otherwise unsafe ^[1].

The agency said the discretion runs during the reevaluation and until two weeks after it makes a decision. If the plaintiffs file a motion for a preliminary injunction, the period lasts until the court resolves that motion ^[1]. The letter does not say when the reevaluation will end.

Why it matters for patients

Compounded versions of tirzepatide, made by pharmacies rather than the brand manufacturers, became a common stopgap for patients when the injectable was scarce. The October 17 letter did not authorize compounding; it described when FDA would hold off on enforcing certain rules against compounders while the shortage decision is reconsidered ^[1].

The pause is narrow. It applies to the specific violations listed in FDA's court filing, and FDA said it can still act on substandard quality or unsafe products ^[1]. The letter addresses federal enforcement only. It does not change state pharmacy rules, and it does not address what patients pay for a compounded product or whether insurance covers one; those points have not been reported here.

The policy page also records later guidance. A compounded product may be considered essentially a copy if it uses the same active ingredient in the same, similar or easily substitutable strength and can be given by the same route as the commercial product, unless a prescriber determines and documents a change that produces a significant difference for an identified patient. Combining semaglutide with another ingredient such as vitamin B12 can also count as a copy when the two products go by the same route and the strengths are within 10% of the commercial products, FDA said. FDA stated it does not intend to act against a compounder that fills four or fewer prescriptions of such a product during a calendar month ^[2].

What happens next

• FDA has not disclosed when its reevaluation of the tirzepatide shortage decision will be complete ^[1].
• The policy page records that on December 19, 2024, FDA again determined the tirzepatide shortage was resolved, setting windows for enforcement discretion that ran until February 18, 2025 for state-licensed pharmacies and physicians compounding under section 503A and until March 19, 2025 for outsourcing facilities under section 503B ^[2].
• On March 5, 2025, a district court denied the plaintiffs' preliminary injunction motion in the tirzepatide case, so the 503A period ended and the 503B period ran to March 19, 2025 ^[2].
• On February 21, 2025, FDA determined the semaglutide injection shortage was resolved, with discretion running to April 22, 2025 for 503A compounders and May 22, 2025 for 503B facilities. After the court denied a preliminary injunction in the semaglutide case on April 24, 2025, the 503A period ended and the 503B period ran to May 22, 2025 ^[2].
• The page's most recent note, dated April 1, 2026, states that tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list ^[2]. Semaglutide is sold as Ozempic, Wegovy and Rybelsus; tirzepatide is sold as Mounjaro and Zepbound.