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A dated, plain-English status board for compounded GLP‑1s. We split it the way the law does — 503A patient-specific vs 503B outsourcing/bulk — per molecule, each with an FDA source and what it means for you. This area is changing; every status carries a verified date.
“Compounded” means a pharmacy mixes the drug itself rather than dispensing an FDA-approved Ozempic / Wegovy / Mounjaro / Zepbound pen. Whether that is legal turns entirely on which kind of pharmacy and why — which is what the board below tracks.
Each cell is a current legality verdict for that molecule in that pharmacy lane, with the FDA source and a one-line "what this means for patients." Verified June 2026.
Ozempic · Wegovy · Rybelsus (brand) — compounded versions are not FDA-approved
Still legal for a specific patient, not as a routine copy
A 503A pharmacy may compound semaglutide for an individual patient with a valid prescription when there is a documented clinical reason (e.g. an allergy to an inactive ingredient, or a dose the FDA-approved product does not make). It may NOT compound it "regularly or in inordinate amounts" as essentially a copy of commercially available Ozempic/Wegovy. So population-scale "compounded semaglutide for everyone" is not a lawful 503A model.
Shortage exemption ended; large-scale bulk compounding stopped
Semaglutide injection was removed from the FDA drug-shortage list on February 21, 2025. FDA enforcement discretion for 503B outsourcing facilities compounding from bulk semaglutide ended May 22, 2025. With no shortage and semaglutide not on the 503B bulks list, outsourcing facilities can no longer mass-compound it. This is the route that supplied most telehealth "compounded semaglutide."
Mounjaro · Zepbound (brand) — compounded versions are not FDA-approved
Still legal for a specific patient, not as a routine copy
Same framework as semaglutide: a 503A pharmacy may compound tirzepatide for an individual patient with a genuine clinical need, but not as a routine essentially-a-copy of Mounjaro/Zepbound. Patient-specific only — not a bulk supply channel.
Shortage resolved first; bulk compounding stopped earliest
The tirzepatide injection shortage was declared resolved December 19, 2024. FDA enforcement discretion for 503B outsourcing facilities ended March 19, 2025 — earlier than semaglutide. Tirzepatide is not on the 503B bulks list, so outsourcing facilities cannot mass-compound it.
Saxenda · Victoza (brand) — lower-volume in the compounded market
Patient-specific compounding follows the same rules
Liraglutide is far less common in the compounded market, but the same 503A logic applies: patient-specific with a documented clinical reason, not a routine copy of Saxenda/Victoza.
Named in the April 2026 proposal alongside the other two
Liraglutide is the third molecule named in the April 30, 2026 FDA proposal to leave these GLP-1s off the 503B bulks list. Like the others, it is not available for routine 503B bulk compounding now, and the proposal would make that permanent.
“Allowed (with limits)” = lawful only as patient-specific compounding for a documented clinical reason, not a routine copy. “No longer permitted at scale” = the shortage exemption that allowed bulk compounding has ended. “Proposed permanent bar” = the April 2026 503B-bulks proposal, not yet final.
The sequence that took compounded GLP-1 from shortage-driven mass supply to a proposed permanent 503B bar. Confirmed dates are stamped; the one undecided step is marked as such.
Tirzepatide shortage declared resolved
FDA determined the tirzepatide injection shortage was resolved, starting the clock on winding down shortage-based compounding of Mounjaro/Zepbound copies.
Semaglutide removed from the drug-shortage list
FDA removed semaglutide injection from its drug-shortage list, removing the shortage basis for mass-compounding Ozempic/Wegovy copies.
503B tirzepatide enforcement discretion ends
The date through which FDA said it would not act against 503B outsourcing facilities for shortage-dependent tirzepatide compounding. After this, bulk 503B tirzepatide compounding lost its cover.
503B semaglutide enforcement discretion ends
The corresponding cutoff for 503B outsourcing facilities compounding semaglutide. This is the practical end of large-scale compounded semaglutide supply through the outsourcing-facility channel.
FDA proposes to leave all three GLP-1s off the 503B bulks list
FDA proposed NOT to add semaglutide, tirzepatide, or liraglutide to the 503B bulks list, finding "no clinical need" for outsourcing facilities to compound them from bulk substance. If finalized, this permanently bars 503B bulk compounding of these molecules even if a future shortage occurs. Published in the Federal Register May 1, 2026 (91 Fed. Reg. 23431).
Public comment period closes
The Federal Register notice sets the formal deadline for written/electronic comments as June 30, 2026 (FDA’s own announcement framed it as "by June 29, 2026"). Patients, prescribers, and pharmacies can comment via Regulations.gov before FDA makes a final determination.
Final determination — no date announced
FDA will review comments before issuing a final decision. As of this writing FDA has NOT announced a finalization date. Until a final rule issues, the 503B bulks status is "proposed," not settled. Treat any specific finalization date you see elsewhere as speculation unless FDA publishes it.
No status on this page forces an overnight cutoff. But the bulk-compounded supply is contracting, so plan ahead.
This changes. Compounded-GLP-1 law is moving — a shortage relisting, a final 503B rule, or new enforcement could shift any status above. This tracker was last verified June 2026. Before you act, confirm with the FDA primary sources linked throughout, on FDA.gov, and with your prescriber.
Editorial summary of FDA actions and a proposed rule — not legal or medical advice. A proposal is not a final rule; allegations and proposals can change. Dates are taken from the cited FDA and Federal Register sources; where a date is contested (e.g. the June 29 vs June 30 comment deadline) we cite both. Verify with primary sources and your prescriber before making decisions.