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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 September 14, 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 — FDA says it does not intend to act against a pharmacy that fills four or fewer such prescriptions in a calendar month. FDA enforcement discretion for shortage-era 503A semaglutide compounding ended April 22, 2025. 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 (the same four-prescriptions-a-month line applies). Shortage-era 503A enforcement discretion for tirzepatide ended February 18, 2025. Patient-specific only — not a bulk supply channel.
Shortage resolved first; bulk compounding stopped earliest
FDA first declared the tirzepatide injection shortage resolved on October 2, 2024 and confirmed that decision on December 19, 2024 after re-evaluating it. 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.
In shortage right now — so 503B bulk compounding is currently permitted
Unlike the other two, liraglutide injection is currently on the FDA drug-shortage list (first posted July 18, 2023; still listed in September 2026). Federal law (21 U.S.C. 353b) lets 503B outsourcing facilities compound from bulk a drug that appears on that list. The April 30, 2026 proposal to leave liraglutide off the 503B bulks list would close only the separate bulks-list pathway, not the shortage pathway.
“Allowed (with limits)” = lawful only under specific conditions — patient-specific compounding for a documented clinical reason (503A), or bulk compounding while the drug is on FDA’s shortage list (503B). “No longer permitted at scale” = the shortage exemption that allowed bulk compounding has ended. “Proposed bulks-list exclusion” = the April 2026 503B-bulks proposal, not yet final.
The sequence that took compounded GLP-1 from shortage-driven mass supply to a proposed 503B bulks-list exclusion. Confirmed dates are stamped; the one undecided step is marked as such.
Tirzepatide shortage resolution confirmed
FDA confirmed, after re-evaluation, its October 2, 2024 determination that the tirzepatide injection shortage was resolved, starting the clock on winding down shortage-based compounding of Mounjaro/Zepbound copies (503A cover ended Feb 18, 2025).
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 announces action against non-approved GLP-1 drugs
FDA said it intends to take action against non-FDA-approved GLP-1 drugs, including limiting the GLP-1 active ingredients used to make unapproved compounded products.
Warning letters to 30 telehealth companies
FDA warned 30 telehealth companies over marketing of compounded GLP-1s, including claims implying their compounded products are the same as FDA-approved drugs.
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, it closes the bulks-list pathway for 503B; the separate shortage pathway in the law would still apply if one of these drugs went back on the official shortage list. Published in the Federal Register May 1, 2026 (91 Fed. Reg. 23431).
More warning letters over compounded semaglutide and tirzepatide
FDA issued another round of warning letters to telehealth sellers of compounded semaglutide and tirzepatide (Altru Telehealth among them), citing misbranding and reminding that "compounded drug products are not FDA-approved."
Public comment period closed (extended from June 30)
On June 26, 2026 FDA extended the comment deadline on the 503B proposal from June 30 to July 30, 2026 in response to a request for more time (91 Fed. Reg. 38719). The comment period is now closed.
Appeals court upholds FDA in both compounding lawsuits
The Fifth Circuit affirmed rulings for FDA in the challenges to its decisions that the tirzepatide and semaglutide shortages were over, finding any procedural error "harmless" and FDA’s action not "arbitrary or capricious" (unpublished opinions).
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 September 14, 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 original June 29 vs June 30 comment deadline, later extended to July 30) we cite both. Verify with primary sources and your prescriber before making decisions.