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Last reviewed 2026-09-01 · FDA and Federal Register text read 2026-09-01
Compounded tirzepatide: what the FDA has published, as of September 2026
Compounded tirzepatide is tirzepatide made by a compounding pharmacy or an outsourcing facility rather than the FDA-approved product. The FDA declared the tirzepatide shortage resolved on December 19, 2024, and as of April 1, 2026 lists it on neither the shortage list nor the 503B bulks list. Below: the FDA's dated statements, the pending proposal, and the pharmacy lookup.
Status as reviewed 2026-09-01 · every line is the regulator's, with its date
- Is the FDA-approved tirzepatide product in shortage?
- No. On December 19, 2024 the FDA issued “a new decision determining the tirzepatide injection shortage is resolved”, replacing its October 2, 2024 decision after that decision was remanded in litigation. (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-01)
- Is tirzepatide on the 503B bulks list?
- No. FDA, April 1, 2026: “Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.” (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-01)
- Enforcement discretion for compounders after the shortage
- Ended. The FDA gave 503A pharmacies 60 days from December 19, 2024 (“until February 18, 2025”) and 503B facilities 90 days (“until March 19, 2025”). (FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, read 2026-09-01)
- Proposal to keep it off the 503B bulks list
- On May 1, 2026 the FDA published a notice proposing not to include tirzepatide on the 503B bulks list (91 FR 23431); the comment period was extended to July 30, 2026 (91 FR 38719). (91 FR 23431 (May 1, 2026), docket FDA-2018-N-3240, read 2026-09-01)
- Adverse-event reports the FDA has received
- As of May 31, 2026, the FDA says it has received “more than 730 reports of adverse events associated with compounded tirzepatide”. It adds that such reports are likely underreported and that “it is not always possible to determine if the adverse event directly resulted from use of the drug or if other factors may have contributed to these adverse events”. (FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, read 2026-09-01)
- Latest document on the 503B bulks-list docket (FDA-2018-N-3240)
- List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period, 91 FR 38719, published 2026-06-26. No final determination on tirzepatide had been published as of the build's docket check on 2026-09-02.
What this box does not say: whether any product is right for you, or what it costs. It says what the regulator has published, and when. The pharmacy on your label is the next thing to check: look it up.
What the FDA has said, in order
The FDA keeps a dated log of its compounding policy for GLP-1 drugs. These are its entries for tirzepatide, quoted with the FDA's own dates.
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
As part of litigation, the decision to remove tirzepatide from the FDA drug shortage list has been remanded to the agency for reevaluation.
FDA re-evaluated its determination from October 2, 2024, on the status of the tirzepatide shortage. Today, FDA has issued a new decision determining the tirzepatide injection shortage is resolved. FDA's determination is based on its analysis of all the information before the agency.
For a state-licensed pharmacy under section 503A of the FD&C Act compounding, distributing or dispensing tirzepatide injections within 60 calendar days from today's announcement, until February 18, 2025.
For outsourcing facilities under section 503B compounding, distributing or dispensing tirzepatide injections within 90 calendar days from today's announcement, until March 19, 2025.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list.
What the statute allows now, in the FDA's words
With the shortage resolved, the question for both kinds of compounder is the “essentially a copy” restriction. The FDA's April 1, 2026 entry states it for each:
Section 503A of the FD&C Act includes restrictions on compounding drugs that are essentially copies of a commercially available drug. When a drug shortage is resolved, FDA generally considers the drug to be commercially available. Certain amounts are permissible under the law as long as the compounding is not done “regularly or in inordinate amounts.”
Section 503B of the FD&C Act restricts outsourcing facilities from making compounded drugs that are essentially a copy of one or more FDA-approved drugs. Among other things, this means the compounded drug may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA's drug shortage list.
Whether a particular pharmacy's tirzepatide falls inside or outside those sentences is a determination for the FDA and the state board, not for this site. What this site can show you is which kind of compounder made yours, and its record. 503A vs 503B, in the statute's words explains the two.
How to read your label
A compounded prescription is labelled with the pharmacy or outsourcing facility that made it, which is often not the telehealth brand that sold it. Type that name below. If it matches, the maker is an FDA-registered 503B facility and its inspection record is on this site with the FDA's date. If it does not match, it is most likely a state-licensed 503A pharmacy, whose license lives at its state board of pharmacy.
What the FDA says about compounded GLP-1 drugs
A compounded drug might be appropriate if a patient's medical need cannot be met by an FDA-approved drug, or the FDA-approved drug is not commercially available. However, compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed.
FDA has received reports of adverse events related to compounded versions of semaglutide and tirzepatide. However, federal law does not require state-licensed pharmacies that are not outsourcing facilities to submit adverse events to FDA so it is likely that adverse events from compounded versions of these drugs are underreported. Many of the adverse events reported for compounded products appear to be consistent with adverse events related to the FDA-approved versions of these products.
The agency urges consumers to be vigilant when purchasing drugs online and only purchase from state-licensed pharmacies.
If you have had a problem with a compounded drug, the FDA's reporting channel is MedWatch; the pharmacy's state board takes complaints about the pharmacy itself.
Common questions
Is compounded tirzepatide legal?
This site does not make that call, and the FDA's published position is a set of conditions rather than a yes or no. With the shortage resolved, section 503A restricts a pharmacy from compounding drugs that are essentially copies of a commercially available drug, with the FDA noting that "certain amounts are permissible under the law as long as the compounding is not done regularly or in inordinate amounts"; section 503B restricts outsourcing facilities from compounding a drug that is essentially a copy of an FDA-approved drug unless the approved drug is on the shortage list. Whether a particular pharmacy is within those conditions is for the FDA and its state board.
Why can a pharmacy still offer compounded tirzepatide?
Because the restrictions above are conditional, and because a 503A pharmacy answers first to its state board rather than to the FDA. The FDA's own questions-and-answers page says it "does conduct surveillance and for-cause inspections of state-licensed pharmacies that are not registered as outsourcing facilities". A pharmacy offering it is not, by that fact alone, in or out of compliance; its record is what you can check.
Is compounded tirzepatide the same as the FDA-approved product?
The FDA's sentence is the one to keep: "compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed." This site does not compare the two beyond that.
What happens if the FDA finalises the bulks-list proposal?
The proposal concerns whether outsourcing facilities (503B) may compound tirzepatide from bulk drug substances. A final determination will be published in the Federal Register on the same docket, FDA-2018-N-3240. The status box on this page shows the newest document on that docket at every build, and the page's text will be re-reviewed when one appears.
How do I find out which pharmacy made mine?
It is printed on the label of the compounded product, and usually in the telehealth brand's paperwork. Type that name into the lookup on this page. A match means an FDA-registered 503B facility with its inspection record here; no match usually means a state-licensed 503A pharmacy, whose license the state board holds.
Sources, all read 2026-09-01: FDA, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize (content current as of 04/01/2026); FDA, FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss (content current as of 09/01/2026); FDA press release, April 30, 2026; 91 FR 23431 (May 1, 2026), docket FDA-2018-N-3240; 91 FR 38719 (June 26, 2026). The docket is re-queried from the Federal Register API at every build. Nothing on this page is medical advice; see methodology.