The U.S. Court of Appeals for the Fifth Circuit has upheld the FDA’s decisions removing semaglutide and tirzepatide injection products from the federal drug shortage list, rejecting challenges from compounding interests in two consolidated cases involving Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound.
The August 27 ruling affirms that compounding interests cannot challenge manufacturer supply determinations and that both 503A compounding pharmacies and 503B outsourcing facilities lose the shortage exception once a drug is delisted. The court found that manufacturer supply data outweighed evidence submitted by compounders.
The decision closes the primary legal pathway that compounders relied on to justify large-scale production of compounded versions of FDA-approved GLP-1 drugs. Businesses that expanded GLP-1 operations during the shortages must now review whether their products and practices satisfy requirements that apply when no shortage exception is available.
What happened
The Fifth Circuit issued companion rulings in two consolidated cases challenging the FDA’s removal of semaglutide and tirzepatide from the federal drug shortage list. The cases involved Novo Nordisk products (Ozempic, Wegovy) and Eli Lilly products (Mounjaro, Zepbound).
The court affirmed the FDA’s authority to make shortage determinations based on manufacturer supply data, which the court found outweighed evidence submitted by compounders. The ruling applies to both 503A compounding pharmacies and 503B outsourcing facilities, meaning both categories lose the ability to produce compounded versions of these drugs under the shortage exception once delisting takes effect.
Why it matters
This appellate decision effectively ends the primary legal basis that compounding pharmacies and outsourcing facilities used to produce compounded versions of semaglutide and tirzepatide at scale. During the GLP-1 shortage, numerous businesses expanded operations to meet patient demand through compounded products.
The ruling affects a broad ecosystem: 503A compounding pharmacies, 503B outsourcing facilities, telehealth platforms distributing compounded GLP-1s, and patients using compounded versions of these drugs. With the shortage exception no longer available, these businesses must determine whether their current products and practices can comply with requirements that apply outside the shortage context.
For Novo Nordisk and Eli Lilly, the decision limits compounded competition against their FDA-approved GLP-1 products, though it does not constitute a broader regulatory endorsement of those products.
What to watch next
- Whether compounding interests pursue further appellate review of the Fifth Circuit’s decision
- How 503A and 503B facilities adjust GLP-1 compounding operations in response to the ruling
- Whether telehealth platforms modify their compounded GLP-1 offerings given the narrowed legal basis
- Whether FDA pursues enforcement actions against facilities that continue compounding without the shortage exception
Sources
- Clark Hill: Fifth Circuit Upholds FDA GLP-1 Shortage Decisions
- PeptidesBeat: Compounded GLP-1 Ruling
Industry information only. Not medical or legal advice.
