On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration's (FDA) favor in the case, Outsourcing Facilities Ass'n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op., 2025 WL 746028, at *15 (N.D. Tex. Mar. 5, 2025), denying plaintiffs' motion for (1) a preliminary injunction (PI) prohibiting the FDA from taking action against Outsourcing Facilities Association (OFA) members and FarmaKeio based on their compounding of the drug ingredient tirzepatide pending final judgment in the case and (2) a stay pending conclusion of the review proceedings in response to the FDA's declaration that the shortage of the diabetes and weight-loss tirzepatide products has been resolved.
Background
Based on unprecedented demand and Eli Lilly's inability to meet this demand, the tirzepatide products at issue, Mounjaro® and Zepbound®, whose marketing applications were approved in 2022 and 2023 respectively, were placed on the drug shortage list in December 2022.
The Food Drug, and Cosmetic Act (FDCA) defines "shortage" as "a period of time when the demand or projected demand for the drug within the United States exceeds the supply of the drug." 21 U.S.C.§ 356c. When a drug is placed on the FDA's shortage list, Congress permits 503A compounders, those operating under state board of pharmacy oversight and issuing patient specific prescriptions, to compound copies of the drug and 503B outsourcing facilities which are those compounders who are registered and regulated by the FDA and who manufacture large batches of sterile compounded medications for health care entities, to compound from that drug's active ingredient — which is otherwise prohibited — including by compounding drugs that are "essentially a copy" of an approved drug. See 21 U.S.C.§§ 353b(a)(2)(A)(ii), (a)(5), (d)(2)(A). Thus, compounding copies of a drug is only permitted while a shortage exists.
Current Status for Compounders
Consistent with the FDA's February 11, 2025 update, which remains in effect given the Court's denial of the PI and stay, the FDA's approach to compounders is as follows:
- For a state-licensed pharmacy or physician compounding under section 503A of the FDCA, the period of enforcement discretion described below has ended.
- For outsourcing facilities under section 503B, the FDA does not intend to take action against compounders for violations of the FDCA arising from conditions that depend on tirzepatide injection products' inclusion on the FDA's drug shortage list until March 19, 2025.
Future State
On March 10, 2025, OFA filed a notice of interlocutory appeal signaling their intention to appeal the March 5, 2025 decision in the FDA's favor to the United States Court of Appeals for the Fifth Circuit. The appeal notwithstanding, we will watch for developments on certain GLP-1 products that continue to be compounded by 503A pharmacies under the rationale that certain compounded products are required to meet the individual needs of patients. There are a number of different strengths, different dosage forms, and combination of ingredients being compounded or contemplated. While the FDA has not yet taken a position with respect to these types of modified compounded products, it will be interesting to see whether the FDA agrees that such modifications are determined to be needed to meet the individual needs of patients and are clinically relevant or whether such products are considered to be essentially a copy of a commercially available product. If so and barring judicial intervention, 503A pharmacies must stop compounding tirzepatide, and 503B pharmacies may only continue compounding tirzepatide until March 19, 2025.
Want To Learn More? See our prior blogs.
- FDA Targets GLP-1 Providers with Warning Letters
- GLP-1 Drugs: FDA Removes Lilly's Zepbound® and Mounjaro® (semaglutide injection) from its Drug Shortage List
- GLP-1 Drugs: Brand Companies Push FDA to Limit Compounding
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