Can you still sell compounded semaglutide or tirzepatide?

What actually changed?

Compounding a copy of an approved drug is normally prohibited. The exception is a shortage: while a drug is on the FDA shortage list, pharmacies may compound it, which is why thousands of brands could sell compounded semaglutide at all.

The FDA declared the tirzepatide shortage resolved on 19 December 2024 and the semaglutide shortage resolved on 21 February 2025. The exception closed with them.

What survives is the ordinary 503A rule, which is about one patient rather than a catalogue. A prescriber has to document a clinically significant difference from the commercially available product for that specific person, and the pharmacy has to be filling a handful of such prescriptions rather than running a production line.

What did the FDA actually object to?

Three waves of warning letters have gone to telehealth sellers since September 2025, and reading what they cite is more useful than reading the rule, because the letters are about the storefront rather than the pharmacy.

Saying it is the same drug. Describing a compounded product as generic, identical or equivalent to Ozempic, Wegovy, Mounjaro or Zepbound, or quoting those drugs' trial results on a page selling a compounded one.

Borrowing the word approved. One letter cites a site claiming its product contained an "FDA approved active ingredient" and that its pharmacies were "FDA approved". The agency's answer is worth memorising: compounding pharmacies and outsourcing facilities are not FDA approved or FDA licensed, and a compounded drug does not become approved because its active ingredient matches one that is.

Adding an ingredient to justify the copy. Pages advertising semaglutide combined with "a body safe vitamin such as B12". Adding B12 does not create a clinically significant difference, and the FDA has said so.

Hiding who made it. Selling under the telehealth brand's own name and trademark without naming the pharmacy that compounded the product.

Does documenting a difference protect you?

Only if the difference is real. An FDA inspection of a Houston compounding facility in September 2026 found the documented differences were, in the agency's reading, pretextual: the same significant-difference wording repeated word for word across patient records, at production volumes that did not match a one-patient-at-a-time story.

That is the trap worth naming plainly. A template sentence in an intake, applied to everyone, is not a clinical judgement. It is a paper trail that proves the opposite of what it was meant to prove, and it sits in your records rather than the pharmacy's.

Whether any particular arrangement is lawful is a question for a healthcare lawyer who can see your contracts, and it is worth the hour.

So what should a weight-loss brand sell now?

The approved products, through the normal channel. Semaglutide and tirzepatide are available and no longer in shortage, which is the entire reason the exception closed. A brand that prescribes the approved drug has no compounding exposure at all.

The margin question changes with it, and the answer is not another molecule. Weight loss built on a cheap compounded vial and nothing else was always a thin business, and it is thinner now that the drug makers sell direct. The brands holding patients are pairing the medication with labs, side-effect management and a reason to stay past month three.

If the appeal of compounding was price, the honest comparison is your real cost per patient per month against a retail price, which is the arithmetic on our pricing page rather than a molecule decision.