Since late 2022, a surge in demand for GLP-1 medications like Eli Lilly's tirzepatide (Mounjaro/Zepbound) has led to a nationwide drug shortage. This situation provided compounding pharmacies an opportunity to create cheaper alternatives under FDA permission during shortages. However, in December 2024, the FDA declared the shortage resolved, ending the compounding pharmacies' rights to produce these alternatives. Facing criticism on pricing, the FDA's position has shifted towards supporting patent holders, complicating legal conflicts sparked by plaintiffs suing the FDA for permission to continue compounding.
Since late 2022, the extraordinary demand for glucagon-like peptide-1 receptor agonists (GLP-1s) like Eli Lilly's tirzepatide has created a persistent nationwide shortage.
The FDA abruptly determined that the tirzepatide shortage had resolved and removed these products from its shortage list, terminating compounders' legal authority to produce these drugs.
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