The decision by the US Food and Drug Administration (FDA) to remove tirzepatide from the drug shortage list triggered a complicated chain of legal, regulatory, and market factors. Tirzepatide was once deemed a serious scarcity due to high demand; however, it has been certified widely available since October 2, 2024. However, this judgment was not without controversy, resulting in legal challenges and an uncertain regulatory future for compounders.
In October 2024, the FDA declared that the tirzepatide shortage had been resolved after confirming with the producer, Eli Lilly and Company, that supply levels could match national demand. However, isolated supply disruptions remain prevalent as the product passes through the supply chain.
The agency’s judgment prompted legal action from the Outsourcing Facilities Association (OFA) and North American Custom Laboratories (a 503B outsourcing facility). The plaintiffs claim that the FDA acted arbitrarily by failing to address recurring supply chain problems and patient complaints about access. The lawsuit also says that the FDA violated the Administrative Procedures Act (APA) by issuing a substantial rule without following proper procedures.
The FDA filed a Motion for Voluntary Remand, seeking to reconsider the decision. During this reevaluation, 503B are allowed to compound tirzepatide until at least November 21, 2024.
Implications on 503A and 503B Compounders
Removing tirzepatide from the FDA’s shortage list has had a substantial impact on 503A and 503B compounding pharmacies.
503A Compounding Pharmacies
503A compounders are only permitted to prepare pharmaceuticals for particular patients based on a specific prescription. They cannot produce drugs identical to FDA-approved goods unless certain requirements allow it. While the FDA reaffirmed that enforcement discretion will apply to all sterile compounders, 503A pharmacies risk ongoing uncertainty regarding their standing throughout the reevaluation period.
503b Outsourcing Facilities
503B establishments, which generate higher volumes of compounded pharmaceuticals, are subject to tougher regulation. They are not allowed to compound pharmaceuticals identical or nearly identical to FDA-approved goods unless those drugs are still on the shortage list. The FDA’s interim non-enforcement policy allows 503B facilities some breathing room, but it might end soon when the agency’s reconsideration is completed.
Litigation and Industry Pushback
The case brought against the FDA by OFA and North American Custom Laboratories highlights the stakes. The plaintiffs claim that the FDA relied too heavily on manufacturer opinion without properly examining current difficulties, including supply chain delays. This litigation underscores broader pharmaceutical industry worries about how the FDA handles medicine shortages and strikes a balance between patient access and regulatory supervision.
Manufacturers such as Eli Lilly and Novo Nordisk are increasing measures to limit the compounding of GLP-1 medications. Novo Nordisk has petitioned the FDA to include semaglutide on the Difficult to Compound list, citing safety concerns due to the drug’s complexity. Brand-name medicine producers are putting pressure on compounding pharmacies to lower their market share.
The Broader Battle Over GLP-1 Drug Compounding
Tirzepatide is not the only GLP-1 medication under fire. Semaglutide has been on the FDA’s shortage list, and efforts are underway to completely stop its compounding entirely. Manufacturers claim that GLP-1 medications are too complex for safe compounding, while critics regard these actions as an attempt to limit competition.
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