On this page
"Compounded tirzepatide" is a preparation made by a pharmacy or an outsourcing facility. FDA does not approve it, and the agency does not review its safety, effectiveness, or quality before sale. That sentence is the same one FDA used for compounded GLP-1 drugs in the March 3, 2026 warning-letter announcement. The semaglutide version of this file is compounded semaglutide vs Ozempic. The brand-by-brand approval table is the GLP-1 drugs list.
What the approved products are
Mounjaro was approved May 13, 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Zepbound was approved November 8, 2023 for chronic weight management in adults with obesity, or overweight with a weight-related condition. On December 20, 2024 FDA approved Zepbound for moderate to severe obstructive sleep apnea in adults with obesity. The trial behind that sleep apnea use is tirzepatide and sleep apnea.
Those are specific products, reviewed under new-drug applications, supplied in the devices the labels describe. A compounded copy is not reviewed that way. FDA has also said compounded drugs are not generic drugs. Generics go through their own approval.
In Canada, Health Canada issued a notice of compliance for Mounjaro on November 24, 2022. The Zepbound product monograph prints an authorization date of June 11, 2026. Canada does not run the US 503A and 503B lists. An authorized Canadian product has a Drug Identification Number. A compounded or online product that borrows the name does not become Mounjaro because the name matches.
The shortage, and the dates that closed it
| Date | What FDA said | What it changed for copies |
|---|---|---|
| Dec 15, 2022 | What FDA saidTirzepatide injection went on the shortage list. | What it changed for copiesThe shortage condition that 503A and 503B compounding rules refer to was in effect. |
| Oct 2, 2024 | What FDA saidFDA determined the shortage was resolved and removed the products. | What it changed for copiesCompounders sued. On October 11, 2024 a court remanded the decision for reevaluation. |
| Dec 19, 2024 | What FDA saidFDA reaffirmed that the shortage is resolved. The declaratory order revokes and replaces the October 2 decision. | What it changed for copies503A discretion announced through February 18, 2025. 503B discretion announced through March 19, 2025. |
| Feb 11, 2025 | What FDA saidFDA restated the dates. | What it changed for copies503A until February 18, 2025, or the court's decision, whichever was longer. 503B until March 19, 2025, or the court's decision, whichever was longer. |
| Mar 5, 2025 | What FDA saidThe district court denied the preliminary injunction in Outsourcing Facilities Association v. FDA, No. 4:24-cv-00953 (N.D. Tex.). | What it changed for copiesMarch 5 is later than February 18. |
| Mar 10, 2025 | What FDA saidFDA said the 503A period of enforcement discretion had ended. | What it changed for copiesState-licensed pharmacies and physicians no longer had that shortage discretion. 503B discretion still ran to March 19, 2025. |
| Mar 19, 2025 | What FDA saidThe 503B date arrived, and it was later than the court date. | What it changed for copiesOutsourcing-facility discretion tied to the shortage ended. |
| May 1, 2026 | What FDA saidFederal Register notice. | What it changed for copiesProposal not to include tirzepatide, semaglutide, or liraglutide on the 503B Bulks List. The notice says approved tirzepatide products were not on the shortage list. |
| Jun 26, 2026 | What FDA saidComment period extended. | What it changed for copiesComments due July 30, 2026. |
| Oct 23, 2026 | What FDA saidThis page checked. | What it changed for copiesNo final 503B determination found. |
The December 19, 2024 declaratory order is the shortage decision to cite. It says Lilly's supply was meeting or exceeding demand, and it says patients and prescribers may still see intermittent local gaps as product moves through wholesalers. A local gap is not the same thing as FDA putting the drug back on the shortage list.
FDA's February 11, 2025 update is the "whichever is longer" rule. The March 5 court denial is later than February 18, so that is the 503A end. FDA's March 10 update said the 503A discretion had ended. For 503B outsourcing facilities, March 19, 2025 was later than the court date, so that is the date FDA had set. The same page says FDA may still act on other violations, including a product that is substandard or otherwise unsafe, including during a discretion window. The window is over.
What "still allowed" means after those dates
Mounjaro and Zepbound remain legal to prescribe and dispense as the approved products, in the United States under their FDA approvals and in Canada under the authorizations above. That is the ordinary prescription path. It is not a compounding path.
Read this next Compounded semaglutide vs Ozempic
The shortage-based enforcement discretion for copies is over. FDA's April 1, 2026 update on the same compounding page, quoted on our semaglutide comparison, says tirzepatide and semaglutide do not appear on the 503B Bulks List or on the drug-shortage list. Outsourcing facilities cannot use a bulk substance for this kind of compounding unless the substance is on the 503B Bulks List or the drug made from it is on the shortage list at the time of compounding, distribution, and dispensing. Tirzepatide injection is on neither, according to that FDA statement and the May 1, 2026 notice.
On April 30, 2026 FDA announced a proposal not to include tirzepatide, semaglutide, and liraglutide on the 503B Bulks List, finding no clinical need for outsourcing facilities to compound them from bulk substance. The notice was published May 1, 2026. Comments first due June 30, 2026 were extended to July 30, 2026. A proposal is not a final determination. We did not find a later Federal Register notice that finishes it. The last notice in that docket we reviewed is the June 26, 2026 extension.
This page does not describe how a pharmacy might still compound a non-copy for one patient. FDA's copy rules are their own document, and a website that walks through them starts to look like instructions. The fact that matters for the shortage question is the one FDA already printed: the discretion tied to the shortage has ended.
Reports, salts, and sameness claims
As of May 31, 2026, FDA had received more than 730 reports of adverse events associated with compounded tirzepatide, and 990 associated with compounded semaglutide. Federal law does not require state-licensed pharmacies that are not outsourcing facilities to send adverse events to FDA, so the agency says the compounded totals are likely undercounts. Many of the reported events look like events already known from the approved products. A report count does not, by itself, prove that a compounded product caused the event, and it is not a rate. The source is FDA's page on unapproved GLP-1 drugs used for weight loss.
On March 3, 2026 FDA announced 30 warning letters to telehealth companies over compounded GLP-1 products. The agency said the main problems were claims implying sameness with FDA-approved products, and branding that hid the compounder. A letter is not a new statute. It says a specific claim was false or misleading. "Same as Mounjaro" is the kind of claim those letters were about. The two approved products, and why the labels do not swap, are Mounjaro vs Zepbound. The buying context is on the safety and buying page.
The May 2026 semaglutide file on this site goes into salt forms because FDA has said semaglutide sodium and semaglutide acetate are different active ingredients from the approved base. This page does not copy that sentence onto tirzepatide. We did not re-review a tirzepatide salt finding in the sources opened for this check.
What would change the answer
A final Federal Register determination on the 503B proposal would change the outsourcing-facility half of this page. It would not, by itself, approve a compounded product. An FDA decision to put tirzepatide injection back on the shortage list would reopen the shortage condition the statute talks about. We did not find that decision.
A new Health Canada notice would change the Canadian column. The June 11, 2026 Zepbound monograph and the November 24, 2022 Mounjaro notice of compliance are the authorizations this page is using.
The weight trial that compared tirzepatide with semaglutide is semaglutide vs tirzepatide. It studied the approved-drug doses in that trial. It is not evidence about a compounded vial.
Common questions
Is compounded tirzepatide still allowed because of the shortage?
No. FDA resolved the tirzepatide injection shortage on October 2, 2024 and reaffirmed that on December 19, 2024. On March 10, 2025 FDA said 503A enforcement discretion had ended after the March 5 court order. 503B discretion ran through March 19, 2025.
Is compounded tirzepatide the same as Mounjaro or Zepbound?
No. Mounjaro and Zepbound are FDA-approved products. FDA says compounded drugs are not FDA-approved, and the agency does not review them for safety, effectiveness, or quality before they are marketed. Compounded drugs are also not generics.
Did FDA ban compounded tirzepatide in 2026?
FDA proposed, on May 1, 2026, not to add tirzepatide to the 503B Bulks List. The comment period closed July 30, 2026. We did not find a final rule as of October 23, 2026. The shortage discretion had already ended in March 2025.
What is still allowed?
The approved products. Mounjaro and Zepbound in the United States, and the Health Canada authorizations for Mounjaro (November 24, 2022) and Zepbound (monograph dated June 11, 2026). The shortage exception for copies is not still open.
How many adverse event reports has FDA counted?
More than 730 reports associated with compounded tirzepatide as of May 31, 2026. FDA says the count is likely low, that many events resemble those of the approved drugs, and that a report is not a rate.
Does Canada use the same 503A rules?
No. Canada authorizes specific products. Mounjaro and Zepbound have those authorizations. A US shortage decision does not create a Canadian compounding category.
Sources
Methodology. Status checked October 23, 2026 against FDA's compounding updates (including the March 10, 2025 and April 1, 2026 entries on the GLP-1 supply page), the December 19, 2024 declaratory order and decision memorandum, the Federal Register notices of May 1 and June 26, 2026, FDA's unapproved GLP-1 page, the March 3, 2026 warning-letter announcement, the Mounjaro and Zepbound approval records, Health Canada's Mounjaro summary basis of decision, and the Canadian Zepbound monograph.
Primary sources.
- FDA, policies for compounders as GLP-1 supply stabilized: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- FDA declaratory order, December 19, 2024: https://www.fda.gov/files/drugs/published/2024.12.19_tirzepatide_declaratory_order.pdf
- FDA decision memorandum, December 19, 2024: https://www.fda.gov/media/185577/download
- FDA, concerns with unapproved GLP-1 drugs used for weight loss: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- FDA, 30 warning letters, March 3, 2026: https://www.fda.gov/news-events/press-announcements/fda-warns-30-telehealth-companies-against-illegal-marketing-compounded-glp-1s
- FDA, proposal to exclude semaglutide, tirzepatide, and liraglutide, April 30, 2026: https://www.fda.gov/news-events/press-announcements/fda-proposes-exclude-semaglutide-tirzepatide-and-liraglutide-503b-bulks-list
- Federal Register, May 1, 2026: https://www.federalregister.gov/documents/2026/05/01/2026-08552/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
- Federal Register, June 26, 2026, comments extended to July 30, 2026: https://www.federalregister.gov/documents/2026/06/26/2026-12937/list-of-bulk-drug-substances-for-which-there-is-a-clinical-need-under-section-503b-of-the-federal
- Mounjaro approval package, May 13, 2022: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215866Orig1s000Approv.pdf
- FDA, Zepbound, November 8, 2023: https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management
- FDA, Zepbound sleep apnea, December 20, 2024: https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
- Health Canada, Mounjaro summary basis of decision: https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD00629
- Zepbound Canadian product monograph: https://pi.lilly.com/ca/zepbound-ca-pm.pdf
Changes. October 23, 2026: first published. The 503A end is the March 10, 2025 FDA statement that discretion had ended after the March 5 court order, not a flat February 18 close. The 503B date is March 19, 2025, which was later than that court date.
