What a compounding pharmacy may and may not do with GLP-1s now

The shortage listings ended in December 2024 and February 2025. Compounded semaglutide and tirzepatide did not disappear. This page sets out, from FDA's own statements, what remained lawful, what did not, and how to tell the difference from the outside.

What a 503A pharmacy may still do

FDA's GLP-1 policy page lists three things a state-licensed pharmacy or physician may continue to do under section 503A:

1. Compound for an individual patient on a prescription where the prescriber has determined that a change made for that patient produces a significant difference from the approved product, and the pharmacy has a record of it. The essentially a copy page explains the test.
2. Fill four or fewer prescriptions a month for a product that is essentially identical to an approved one. This is FDA's reading of "regularly or in inordinate amounts."
3. Compound when the approved product is genuinely unavailable in the sense the guidance describes, for example a documented supply interruption affecting the patient, with the reason recorded. FDA notes that intermittent local supply problems after a shortage is resolved do not put the drug back on the list.

None of these depends on the drug being on the shortage list. All of them depend on a prescription for a named patient and a prescriber's documented judgement.

What a 503A pharmacy may not do

• Compound and dispense semaglutide or tirzepatide that is identical or nearly identical to Ozempic, Wegovy, Mounjaro or Zepbound regularly or in large volume, without a patient-specific difference.
• Dispense without a valid prescription from a licensed prescriber. This was never permitted, shortage or not.
• Use a salt form (semaglutide sodium, semaglutide acetate) as the active ingredient. FDA says it is not aware of a basis for compounding these under 503A; see salt forms.
• Market the product as FDA approved, generic, or the same as the brand. FDA's letters of September 2025, February 2026, March 2026 and June 2026 treat these claims as false or misleading. The enforcement timeline has the dates and links.

The tighter position for 503B facilities

An outsourcing facility may only compound from a bulk drug substance if the substance is on the 503B bulks list or the finished drug is on the shortage list. Semaglutide and tirzepatide are on neither. So, from March 19, 2025 (tirzepatide) and May 22, 2025 (semaglutide), an outsourcing facility compounding either from bulk API has no exemption to point to. On April 30, 2026 FDA went further and proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list outright, with comments due June 29, 2026. A final decision had not been published when this page was checked.

There is a narrow alternative: 503B facilities may compound from an approved finished product rather than from bulk (for example repackaging or diluting an approved vial). That route has its own conditions and is not what most GLP-1 telehealth programs describe.

How to tell which side of the line an offer is on

Ask the program these questions and write down the answers. The vetting checklist prints them for you.

• Which pharmacy will dispense, and is it a 503A pharmacy or a 503B outsourcing facility?
• What is the documented difference between this product and the approved one, for me? Who determined it? Can I see it?
• Is the active ingredient semaglutide or tirzepatide base, or a salt?
• Does any material call the product FDA approved, generic, equivalent, or the same as the brand?
• Will I receive a prescription record and a dispensed label with my name, the prescriber and the pharmacy?

A program that answers all five in writing may or may not be a good choice, but it is operating in the part of the map FDA has described. A program that answers none of them is asking you to take its word for it.

The numbers behind the concern

FDA's GLP-1 concerns page, current as of September 1, 2026, reports 990 adverse event reports involving compounded semaglutide and more than 730 involving compounded tirzepatide as of May 31, 2026, including reports of dosing errors where patients or clinicians drew up the wrong amount from a multi-dose vial. Those are reports, not confirmed causation, and the approved products have their own adverse event profile. But they are the reason FDA keeps saying the same three things: not approved, not interchangeable, and check who made it. If you are on compounded medication now, the dose unit converter on our calculator site exists for exactly the error FDA describes.