The short answer. Tirzepatide is FDA-approved as Mounjaro and Zepbound, and FDA found the shortage resolved on December 19, 2024. As of September 25, 2026, a 503A pharmacy may compound it only for a named patient inside the essentially-a-copy limits, and outsourcing facilities have no bulk pathway.
| FDA approved | Yes. Mounjaro (May 13, 2022), Zepbound (Nov 8, 2023; obstructive sleep apnea added Dec 20, 2024). |
|---|---|
| Shortage | Resolved Dec 19, 2024. |
| 503A pharmacy | Eligible as a component of an approved drug, restricted by the essentially-a-copy rules. |
| 503B outsourcing facility | No bulk pathway. Exclusion proposed at 91 FR 23431; no final action. |
| Latest FDA action | Warning letters to 30 telehealth companies, Mar 3, 2026. |
| MDside position | Our providers prescribe the approved products. A compounded preparation is used only where the prescriber documents a patient-specific difference. |
| Last verified | 2026-09-25 |
The shortage ended twice
The dates matter because much of the market still quotes the first one.
| Date | What happened |
|---|---|
| Dec 15, 2022 | Tirzepatide added to the shortage list. |
| Oct 2, 2024 | FDA removed it from the list. |
| Oct 22, 2024 | The removal was sent back to FDA for reevaluation during litigation. |
| Dec 19, 2024 | A new FDA order found the shortage resolved, revoking and replacing the October decision. |
| Mar 5, 2025 | 503A grace period effectively ended when the court denied a preliminary injunction. |
| Mar 19, 2025 | 503B grace period ended. |
The same three copy tests apply
A 503A pharmacy must answer three separate questions: whether the product is essentially a copy of Mounjaro or Zepbound, whether the prescriber documented a significant difference for the identified patient, and whether copies are being made regularly or in inordinate amounts, where FDA’s policy is not to act at four or fewer in a calendar month. The semaglutide page walks through each one, and they apply to tirzepatide identically.
The 503B pathway is being closed formally
FDA’s May 1, 2026 proposal (91 FR 23431) would exclude tirzepatide, semaglutide and liraglutide from the 503B bulks list. Comments closed July 30, 2026, and as of September 2026 no final action has been published.
Orforglipron is a different question
FDA approved orforglipron as Foundayo on April 1, 2026 for chronic weight management. It is an oral small molecule, so it sits outside a peptide tracker, but it matters to your menu: an approved oral option now exists alongside the injectables.
What this means for you
If a supplier’s paperwork still cites October 2024 as the end of the shortage, their compliance file has not been updated in almost two years. Default to the approved products, document any patient-specific difference on the prescription, and retire marketing written during the shortage. Our weight management program runs on that basis.
Read next
Frequently asked questions
Is compounded tirzepatide still legal?
Only in narrow circumstances. A 503A pharmacy may compound it for a named patient where the prescriber documents a significant difference, or in small numbers under FDA’s four-a-month enforcement policy. Outsourcing facilities have no bulk pathway, and FDA has proposed making that exclusion formal.
When did the tirzepatide shortage end?
FDA’s December 19, 2024 order found it resolved. An earlier October 2, 2024 removal was sent back for reevaluation, so that date is superseded. The 503A grace period effectively ended March 5, 2025 and the 503B grace period ended March 19, 2025.
Is Foundayo a compounded tirzepatide alternative?
No. Foundayo is orforglipron, a separate molecule approved by FDA on April 1, 2026 as an oral tablet for chronic weight management. It is an approved drug with its own label, and it is not a version of tirzepatide. It is also not a peptide, which is why it has no page on this tracker.
Primary sources. Last verified September 25, 2026. Corrections are welcome: contact us.
- FDA declaratory order, tirzepatide shortage resolved (Dec 19, 2024)
- FDA approval letter, Zepbound obstructive sleep apnea, NDA 217806 S-013 (Dec 20, 2024)
- FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA guidance, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A (Jan 2018)
- 91 FR 23431 (May 1, 2026), proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, Docket FDA-2018-N-3240
- 91 FR 38719 (June 26, 2026), comment period extended to July 30, 2026
- FDA, FDA warns 30 telehealth companies against illegal marketing of compounded GLP-1s (Mar 3, 2026)
- FDA approval letter, Foundayo (orforglipron), NDA 220934 (Apr 1, 2026)
This is general information, not legal advice. Rules vary by state and change. Confirm your own facts with counsel.