Update — October 14, 2026
In an October 2 letter responding to the district court's remand, FDA again concluded that retatrutide belongs under the drug pathway, rather than the biologic pathway. The letter was filed with the Seventh Circuit on October 8.
FDA counts retatrutide's qualifying chain at 39 amino acids, short of the more-than-40 needed to be treated as "analogous" to a protein, so the agency says a marketing application would need to use section 505—the drug approval pathway.
This is FDA's remand decision, not an appellate ruling. The Seventh Circuit has requested additional briefing on whether it has jurisdiction to hear the appeal at this stage. The decision does not approve retatrutide or determine its safety or effectiveness.
The classification decision does not approve retatrutide or determine its safety or effectiveness. FDA's published position remains that retatrutide cannot currently be used in compounding under federal law./
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