FDA Tracker newsroom · GLP-1 / 503B

GLP-1 503B exclusion: the comment window closes June 29.

May 20, 2026 · Last reviewed Jun 16, 2026

The FDA has proposed excluding semaglutide, tirzepatide and liraglutide from 503B bulk compounding. Public comments close June 29, 2026. The approved branded products remain available; the proposal targets compounded supply.

On April 30, 2026, the FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulk-compounding list. The public-comment window closes June 29, 2026.

The proposal targets compounded supply, not the approved branded products, which remain available by prescription. If finalized, it would constrain the compounded GLP-1 market that expanded during the shortage period.

Our verdict dots for these stay green, they are available now, while the regulatory pill flags the proposed exclusion, so the regulatory flux is visible without implying the approved drug is gone.

Molecules in this update

• Semaglutide — FDA status
• Tirzepatide — FDA status
• Liraglutide — FDA status

Primary sources

• 503B bulks proposal docket
• FDA compounding, 503B outsourcing facilities

Reviewed by the Peptós.LIFE clinical team · Medical & regulatory review.

Compounded medications are not FDA-approved. PCAC is an advisory committee: a favorable vote leads to FDA rulemaking, not authorization and not next-day availability. Nothing here is medical advice, and no peptide is offered for sale on this page.

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