FDA comment window on excluding compounded GLP-1s closes June 29
The FDA’s public comment window on whether to keep three popular GLP-1 medicines off the 503B bulk drug substances list closes June 29, 2026.
In an April 30, 2026 proposal, the FDA said it found no clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances, given that FDA-approved versions of these drugs are available. The 503B bulks list governs which bulk substances registered outsourcing facilities may use in compounding; in most cases a substance has to appear on that list (or the finished drug has to be on FDA’s shortage list) for bulk compounding to be permitted.
The agency is accepting comments through the public docket until June 29, 2026, and says it will weigh them before issuing a final determination. For anyone tracking the research and supply landscape around these compounds, this is the near-term milestone to watch: a final exclusion would further narrow the bulk-compounding pathway for the GLP-1 class. This summary is procedural and regulatory only and is not guidance on obtaining or using any medication.
Primary source: FDA — “FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List” (April 30, 2026)
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For informational and educational use only — not medical advice. Intended for adults 21+.