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The US Food and Drug Administration (FDA) has stood by an earlier decision confirming that the tirzepatide shortage is over.
The end of the shortage means that pharmacies making compounded versions of the drug will have to stop production. FDA-approved drugs can be compounded under certain conditions such as if the original approved drug is in shortage and unavailable.
Many patients seeking glucagon-like peptide-1 receptor agonists (GLP-1RAs) turned to compound pharmacies as demand for Eli Lilly’s tirzepatide, branded as Ozempic and Mounjaro, far-outpaced supply, leading to shortages of the FDA-approved products.
The FDA declared the tirzepatide shortage over in October 2023, but a lawsuit by Outsourcing Facilities Association, a trade group for compounding pharmacists, pushed the FDA to reconsider. In a letter sent to Eli Lilly on 19 December, the agency confirmed the same October outcome had been reached after a re-evaluation.
Explaining its decision, the FDA said that Eli Lilly’s supply is meeting or exceeding demand for tirzepatide products and has taken additional production measures to meet or exceed projected demand in the future. The agency partly blamed the “practical dynamics of the portion of the supply chain between Lilly and the individual customers, including wholesale distributors and retailers”.
With the tirzepatide shortage resolved, the FDA has now clarified policies for compounders. The agency started by saying it would not take action against compounders who made their versions of Eli Lilly’s treatments, as tirzepatide injection products were included on the shortage list. State-licensed pharmacies will be required however to stop manufacturing compounded products by 18 February. Outsourcing facilities meanwhile will have a little longer to stop production, with a deadline of 19 March.
An Eli Lilly spokesperson told Pharmaceutical Technology that the FDA's decision "reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them."
The spokesperson added that "anyone marketing or selling unapproved tirzepatide knockoffs must stop," and that "compounders must immediately begin transitioning patients taking compounded tirzepatide knockoffs to FDA-approved tirzepatide medicines."
Scott Brunner, CEO of Alliance for Pharmacy Compounding said in a statement: “I’m just not persuaded that the data on which FDA is relying in this doubling-down on its shortage resolution decision is complete enough to say the shortage is really over.”