Compounded GLP-1 regulatory timeline
How the compounding landscape for tirzepatide and semaglutide has shifted with FDA shortage and bulks-list designations. Educational only — not legal advice.
How we got here
Tirzepatide approved and in high demand
The FDA approved tirzepatide as Mounjaro (2022) and Zepbound (2023), both made by Eli Lilly. Surging demand led to supply constraints.
Tirzepatide on the FDA shortage list
During the supply constraints, tirzepatide appeared on the FDA drug shortage list. Under federal law, licensed pharmacies may compound versions of a drug under specific conditions, and shortage status is one factor affecting when that is permitted.
FDA reports the tirzepatide shortage resolved
The FDA reported the tirzepatide shortage resolved and removed it from the shortage list, which began a wind-down of broad compounding of copies, subject to FDA's stated enforcement timelines. (Confirm exact dates with the FDA.)
Transition period for compounders
Following resolution, the conditions under which compounded copies could be produced narrowed. Compounding may still occur in specific circumstances — for example, patient-specific 503A preparations a clinician deems clinically necessary — but the broad shortage-based allowance no longer applied.
Current status (verify with FDA)
The FDA states that tirzepatide and semaglutide do not currently appear on the FDA drug shortage list or the 503B bulks list, and the agency has proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list. Because compounding rules depend on these designations, the landscape continues to evolve.
Two compounding pathways
Two regulated pathways matter here. A 503A pharmacy compounds for an individually identified patient pursuant to a prescription. A 503B outsourcing facility is FDA-registered and may compound larger batches under stricter cGMP standards. The 503B bulks list governs which bulk substances 503B facilities may use; the FDA has proposed excluding tirzepatide, semaglutide and liraglutide from it. See 503A vs 503B and our glossary.
Practical takeaways
If you're comparing compounded providers, treat the regulatory picture as live: confirm that a provider names its pharmacy and pathway, can supply a certificate of analysis, and is operating lawfully in your state. Because the basis for compounding can shift with FDA designations, what's available may change. None of this is legal advice; for your situation, rely on the FDA and a licensed clinician or pharmacist.
Common questions
Is compounded tirzepatide still legal in 2026?
It's nuanced and evolving. As of mid-2026 the FDA states tirzepatide is not on the drug shortage list or the 503B bulks list, which narrows the basis for broad compounding of copies. Some compounding may continue in specific circumstances. This is educational, not legal advice — verify current status with the FDA and a licensed clinician or pharmacist.
Is compounded tirzepatide FDA-approved?
No. Only brand-name Mounjaro and Zepbound (Eli Lilly) are FDA-approved. Compounded tirzepatide is prepared by licensed pharmacies and is not FDA-approved.
Why does the FDA shortage list matter for compounding?
Federal law lets pharmacies compound versions of a drug only under specific conditions. A drug's shortage status and 503B bulks-list status are among the factors that affect when compounding is permitted, so changes to those designations change the compounding landscape.