FDA ·
In February 2026 the FDA released an updated guidance document consolidating its position on compounded GLP-1 and GIP agonists. The document reiterates that the resolution of the tirzepatide shortage in October 2024 ended the statutory basis for broad enforcement discretion, clarifies the 503A and 503B bulks list requirements, and lays out the agency's enforcement priorities. Among the prioritized concerns are API sourcing from unregistered foreign suppliers, essential copying of commercially available products, and the use of cosmetic additives to assert clinical differentiation. The guidance is non-binding but represents the clearest single articulation of FDA's current posture on compounded GLP-1s.
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