Fifth Circuit upholds FDA decision to delist GLP-1 medicines from shortage list, tightening compounding rules

The Fifth Circuit has upheld the FDA’s decision to remove semaglutide and tirzepatide from the federal shortage list, limiting mass compounding of popular diabetes and weight-loss drugs and reinforcing manufacturer supply data as decisive.

The Fifth Circuit has upheld the Food and Drug Administration’s decisions to take semaglutide and tirzepatide off the federal shortage list, strengthening the agency’s position against large-scale compounding of the GLP-1 medicines sold as Ozempic, Wegovy, Mounjaro and Zepbound. According to legal reporting on the case, the court rejected industry claims that the FDA should have kept the drugs on the list because compounders and other market participants believed supply constraints were still affecting access.

The dispute matters because federal law sharply limits compounding when a drug is commercially available, but those limits are relaxed while the medicine is listed as being in shortage. Once the FDA said the shortages had ended, the broader shortage-based route for copying the drugs narrowed sharply. The agency had relied on manufacturer production data, inventories and projected demand in concluding that supply from Novo Nordisk and Eli Lilly could meet national needs. A later FDA proposal, issued on 30 April 2026, went further by seeking to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, saying there was no clinical need for outsourcing facilities to compound them from bulk substances.

The Fifth Circuit also found the FDA acted reasonably in weighing evidence submitted by compounders against the manufacturers’ figures. In the tirzepatide case, the agency gave limited weight to reports gathered through a Hims & Hers website because they did not reliably show when access problems occurred, where users were located or whether the same person had filed more than one report. The court accepted the FDA’s view that manufacturer supply data was more persuasive. Industry summaries say the ruling, issued on 27 August 2026, ends the compounding sector’s challenge to the delisting of the products.

The decision does not eliminate lawful patient-specific compounding, but it does mean pharmacies, telehealth companies, prescribers and weight-loss businesses can no longer lean on the old shortage exception for routine mass production of near-identical GLP-1 products. Section 503A compounding for an identified patient remains available where statutory requirements are met, yet the FDA can still scrutinise whether a programme is truly patient-specific or instead amounts to standardised production dressed up as compounding. For businesses that built operations around the shortage period, the ruling is likely to force a review of prescribing, marketing, sourcing and regulatory risk.