Is Compounded Semaglutide or Tirzepatide Legal in 2026?

Is compounded semaglutide still legal in 2026? The timeline that answers it

The legal status of compounded GLP-1 drugs turned on one fact: whether the approved products were in shortage. While Wegovy, Ozempic, Zepbound, and Mounjaro were on FDA's shortage list, compounders could prepare versions of them under a specific statutory exception. FDA removed tirzepatide from the list in 2024 and semaglutide on February 21, 2025, and gave compounders a wind-down period before enforcement resumed.

The table lays out the dates FDA published. After the last of them, the shortage exception no longer applies to either drug, and the only remaining basis for compounding is the ordinary 503A rule for individual prescriptions.

What changed when the shortages ended

FDA's April 2026 compounding update explains the current rule in one sentence: a 503A pharmacy qualifies for its exemptions only if it does not compound, regularly or in inordinate amounts, any drug products that are essentially copies of a commercially available drug product. That is the test every compounded semaglutide or tirzepatide prescription now has to pass. A shortage used to make the approved drug not commercially available, which switched the copy rule off. With the shortages resolved, the rule is back on.

FDA also published a benchmark for what it considers not regular. It does not intend to take action against a compounder for compounding essentially copies regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug during a calendar month. A pharmacy filling thousands of identical semaglutide prescriptions a month is on the wrong side of that line unless each prescription documents a real difference from the approved product for that patient.

Why 503B outsourcing facilities are out and 503A pharmacies are not

Compounding happens in two kinds of facilities. A 503A pharmacy is state-licensed, compounds for individual prescriptions, is overseen day to day by its state board of pharmacy, and is not subject to current good manufacturing practice. A 503B outsourcing facility registers with FDA, follows CGMP, and can make larger batches without patient-specific prescriptions. FDA's questions-and-answers page draws that distinction, and it is why the two lost their GLP-1 permissions on different dates.

A 503B facility may only compound from a bulk drug substance if the substance is on FDA's 503B bulks list or the drug is in shortage. Semaglutide and tirzepatide were never added to the list, and on April 30, 2026 FDA proposed formally not to add them, along with liraglutide, after finding insufficient evidence of clinical need. The Federal Register notice, docket FDA-2018-N-3240, took comments through the end of June 2026. Until FDA finalizes it, the practical effect is the same: no bulk-substance compounding of these drugs at outsourcing facilities.

Commissioner Marty Makary put the policy plainly in the press release: when FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need. The 503A route survives because it was never tied to the bulks list in the same way; it is tied to individual prescriptions and the copy rule.

Is compounded tirzepatide still legal if the telehealth company calls it personalized?

Telehealth programs that continue to sell compounded semaglutide or tirzepatide usually describe the product as personalized, or pair the drug with an additive such as vitamin B12, so that each prescription is not an exact copy of the approved product. FDA has not published a page approving or rejecting that approach by name. What it has done is warn the companies about how they describe the result.

On March 3, 2026 FDA announced warning letters to 30 telehealth companies for illegal marketing of compounded GLP-1s, the second group since September 2025. The letters cited claims implying sameness with FDA-approved products and advertising drugs under the telehealth company's own brand or trademark in a way that hides who compounded them. FDA's June 15, 2026 guidance to telehealth companies lists the prohibited claims: describing a compounded drug as a generic version of an FDA-approved drug or the same as a drug approved by FDA, claiming it has been FDA-approved or evaluated for safety and effectiveness, calling it clinically proven to produce the same result, claiming it is sourced from an FDA-approved or FDA-licensed pharmacy, and using branding that falsely implies the telehealth company is the compounder.

For a buyer, the legal question therefore has two parts. Is the pharmacy filling a patient-specific prescription that is not a routine copy? And is the company describing the product honestly? A program that fails the second test is already in FDA's sights, whatever its answer to the first.

Legal still means not FDA-approved

Every compounded GLP-1 product, however lawfully prepared, is unapproved. FDA's September 2026 statement says compounded drugs are not FDA approved, which means the agency does not review them for safety, effectiveness, or quality before they are marketed. The same page reports 990 adverse-event reports involving compounded semaglutide and more than 730 involving compounded tirzepatide as of May 31, 2026, including hospitalizations that may be related to dosing errors with multi-dose vials.

FDA also flags an ingredient problem that has nothing to do with legality. Some compounders use salt forms, including semaglutide sodium and semaglutide acetate, which FDA says are different active ingredients than are used in the approved drugs. A prescription can be perfectly lawful and still be for a product whose active ingredient has never been tested in people. The agency's advice is to obtain a prescription from a licensed doctor and fill it at a state-licensed pharmacy, and to be suspicious of any label naming a pharmacy that cannot be verified.

How to check that a compounded GLP-1 prescription is on the right side of the line

A telehealth program that is operating within the rules can answer each of these questions in writing before you pay. Vague answers are the signal.

• Which pharmacy fills the prescription, in which state is it licensed, and is it a 503A pharmacy or a 503B outsourcing facility? A 503B answer for semaglutide or tirzepatide in 2026 needs an explanation.
• What makes this prescription more than a copy of Wegovy, Zepbound, Ozempic, or Mounjaro for you specifically, and is that reason documented by the prescriber?
• Is the active ingredient base semaglutide or tirzepatide, or a salt form such as semaglutide sodium or acetate?
• Does the pharmacy named on the vial label exist, and can you confirm its license with the state board of pharmacy?
• Does the marketing avoid the claims FDA prohibits, including any statement that the product is the same as, or a generic of, an approved drug?

What could change next

Two decisions are pending. FDA has to finalize or withdraw its proposal to keep semaglutide, tirzepatide, and liraglutide off the 503B bulks list; a final notice would settle the outsourcing-facility question. Separately, FDA continues to send warning letters in waves, and each wave narrows the language telehealth companies can use. State boards of pharmacy, which oversee 503A pharmacies, can also act on their own.

The catalog on this site records which programs currently publish compounded semaglutide and tirzepatide prices and which pharmacy each program names. That list changes as programs withdraw products or switch pharmacies, so the price module above reflects the last verification date, not a permanent state of the market.