Still getting compounded semaglutide from a telehealth service in 2026? You are probably wondering whether that is legal. The answer is more specific than yes or no.
The route that made it widely available closed. A narrower one remains open, and the FDA has proposed closing that too.
Two stories, not one
Semaglutide and tirzepatide are usually discussed as one event. They were two determinations, four months apart, litigated in two separate court actions with different dates.
| Tirzepatide | Semaglutide | |
|---|---|---|
| Shortage declared resolved | 19 December 2024 | 21 February 2025 |
| 503A pharmacies had until | 19 February 2025 | 22 April 2025 |
| 503B facilities had until | 19 March 2025 | 22 May 2025 |
| Injunction denied | 5 March 2025 | 24 April 2025 |
If you are trying to work out whether something you were prescribed was legal at the time, the dates matter, and they are not the same dates.
What the shortage listing actually did
While a drug sits on the FDA shortage list, compounding pharmacies get room to make versions of it without that counting as an unlawful copy of a commercial product.
Two kinds of facility operate under different rules. A 503A pharmacy compounds for one named patient against a prescription. A 503B outsourcing facility compounds in batches without patient-specific prescriptions.
For roughly three years, the shortage listing is what allowed both to supply semaglutide at scale. The whole compounded GLP-1 market was built on that basis, and our guide on what peptide therapy actually costs covers what it did to prices.
When the FDA declared the shortages resolved, that basis disappeared.
What it did not do
Compounding semaglutide did not become illegal. What became unlawful was compounding something that is essentially a copy of the approved product.
A 503A pharmacy may still compound semaglutide for an individual patient under a prescription. The condition is that the preparation is genuinely different from the commercial drug in a way that patient needs. So the legal question moved from whether a shortage exists to whether the documentation supports a clinical reason for the difference.
What counts as more than a copy
The term carries the whole rule, and four routes are generally cited.
A dose that is not commercially available. If the approved product comes in fixed increments and a patient needs something between them, the preparation is not a copy of anything you could buy.
A different form or route, where the approved product exists in one presentation and the patient needs another.
Removal of an ingredient the patient reacts to. An excipient allergy is the textbook example and the clearest case.
A combination with something else, which is the basis for the semaglutide-with-B12 products, and the one most contested of the four.
What all of them share is that the difference has to be for that patient, documented, and clinically motivated. A difference introduced to make a product lawful, with no patient reason behind it, is what the rule exists to catch.
That is why telehealth services are still shipping it. Whether any particular preparation clears the bar comes down to its paperwork, which a patient never sees.
Where liraglutide fits
Liraglutide appears in the proposed rule alongside the other two and gets almost no coverage, which leaves people taking it unsure whether any of this applies.
Liraglutide is an older GLP-1, sold as Saxenda for weight and Victoza for diabetes, given daily instead of weekly. It has been off patent longer, and generic versions exist, which changes the compounding picture because a generic is a different thing from a compounded copy.
It is named in the proposed 503B bulks list exclusion. If you are on a compounded liraglutide preparation, the same questions apply to you as to anybody on compounded semaglutide, and the answers are less well covered because the audience is smaller.
The proposed rule that would close the rest
In 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list on a finding of no clinical need.
If that is finalised, outsourcing facilities could not compound these drugs from bulk substances at all, regardless of nomination. Neither drug is currently on the bulks list or the shortage list. So the proposal would formalise a position that already applies in practice, and remove the possibility of it changing quietly.
It has not been finalised, and its finalisation is the thing to watch here.
If your supply changed in 2025, this is why
Several hundred thousand people were receiving compounded semaglutide when the windows closed in April and May 2025. If you were one of them, what happened next followed a pattern, though it was probably not explained to you at the time.
Perhaps you were moved onto a personalised preparation, which is where a lot of the unusual dose numbers came from. That was not a downgrade. Your provider was moving you onto the only route that remained open.
The branded product was the other common destination, and there cost replaced availability as the obstacle. Our guide on what peptide therapy actually costs sets out how large that gap is.
Tirzepatide took some people, having gone through the same sequence four months earlier and settled already.
And some supplies simply stopped. If yours did and you came off it, that was a regulatory deadline rather than anything about you or your prescriber. Weight regain after discontinuation is documented, and our guide on how long peptides take to work covers what the trial extensions found.
None of that was communicated well at the time, largely because it happened quickly and providers were working it out alongside everybody else.
What this means if you are on it now
Nothing about your prescription became invalid, and nothing requires you to stop.
Your supply is legally narrower than it was
The service you use is operating on a different basis from the one it started on, and that basis is more fragile.
Personalised dosing has a purpose beyond convenience
A non-standard dose is part of what makes a preparation lawful now. That is not a reason to distrust it, and it does explain why compounded doses often look unusual.
Price differences have a reason
Our guide on what peptide therapy costs sets out how far apart the routes are, and part of that gap is regulatory rather than commercial.
This is not the same as research-labelled material
A compounded prescription from a licensed pharmacy is not the same category as a vial bought online, whatever the price similarity suggests. Our guide on whether peptides are legal covers that distinction.
What to watch
Finalisation of the 503B bulks list rule
The next thing that could change materially, and it would end bulk compounding of these drugs outright.
Further litigation
The Outsourcing Facilities Association lost both preliminary injunction attempts. The underlying cases and any appeals are the mechanism by which this could reverse.
Any new shortage determination
Supply problems could theoretically reopen the original route, and there is no current indication of that.
State-level action
Rules reach people at this level, and federal timelines do not capture it.
Pharmacy boards issue their own notices to licensees, and they did so through 2025 as the deadlines passed. Enforcement priorities differ between states, some boards have acted independently of the FDA position, and a pharmacy's licence is held at state level rather than federal.
So whether a given pharmacy is still compounding can depend on which state it operates in. Federal dates give you no visibility on that at all.
Where this stops being useful
Whether your specific prescription is lawful. That rests on documentation you cannot see, and your prescriber is the person who can.
What will happen to your access if the proposed rule is finalised, which depends on how your provider currently sources.
Anything about compounded tirzepatide specifically, which followed the same path on different dates and is worth checking separately.
Common questions
Is compounded semaglutide illegal now?
Not automatically. When the shortage ended, compounding a copy of Ozempic or Wegovy became unlawful. Compounding for an individual patient is still permitted. It needs a documented clinical reason for a genuinely different preparation.
When did the shortage end?
The FDA determined the semaglutide shortage resolved on 21 February 2025 and the tirzepatide shortage on 19 December 2024. The enforcement windows closed on 22 April and 22 May 2025 for semaglutide, and 19 February and 19 March 2025 for tirzepatide.
Why am I still able to get it?
Because a narrower route remains. A prescription for a personalised preparation, with documentation supporting why it differs from the commercial product, is a different legal basis from the shortage exemption.
Why is my compounded dose an unusual number?
A dose that is not commercially available is one of the ways a preparation is distinguished from a copy of the approved drug. It is part of what makes it lawful rather than an arbitrary choice.
Did the compounders win their lawsuit?
No. The Outsourcing Facilities Association sought preliminary injunctions over both drugs and was denied on both, in March and April 2025.
Could this change again?
Yes. The FDA has proposed excluding these drugs from the 503B bulks list, which would close bulk compounding entirely, and that proposal has not been finalised.
What counts as more than a copy?
Four routes are generally cited. A dose not commercially available. A different form or route. Removal of an ingredient the patient reacts to. Or a combination product. The difference has to be for that patient, documented and clinically motivated.
Does this apply to liraglutide?
It is named in the same proposed rule. Liraglutide is an older daily GLP-1 sold as Saxenda and Victoza, and generic versions exist, which makes its picture different from semaglutide's.
What happened to people when the deadlines passed?
Some moved to personalised preparations under the narrower route, some to the branded product where cost became the barrier, some to tirzepatide, and some stopped.
Is compounded semaglutide the same as buying it online?
No. One is a prescription from a licensed pharmacy under state oversight. The other is research-labelled material of unverified origin, and the similar price hides how far apart those two things are.
Should I switch to the branded product?
That is a conversation with your prescriber, and cost is usually the deciding factor. Our guide on what peptide therapy costs sets out what each route runs to.
Sources
[^1]: FDA declaratory orders resolving the tirzepatide and semaglutide shortages. Regulatory. The tirzepatide determination was issued 19 December 2024 and the semaglutide determination 21 February 2025. Enforcement discretion for 503A pharmacies ran to 19 February 2025 for tirzepatide and 22 April 2025 for semaglutide; for 503B outsourcing facilities, to 19 March 2025 and 22 May 2025 respectively. Compiled from five independent legal and pharmacy sources that agree on all dates, including a State of Nevada Board of Pharmacy notice to licensees dated 2 June 2025. The FDA declaratory orders themselves should be linked directly before publication.
[^2]: Outsourcing Facilities Association v. FDA, US District Court for the Northern District of Texas. Litigation record, reported consistently across sources. The Outsourcing Facilities Association filed suit over the tirzepatide determination in October 2024 and over the semaglutide determination on 24 February 2025. Preliminary injunctions were denied on 5 March 2025 and 24 April 2025 respectively. The dockets should be cited directly before publication.
[^3]: FDA proposed rule regarding the 503B bulks list. Reported in legal analysis dated 2026. The proposal would formally exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list on a finding of no clinical need, which would prevent outsourcing facilities from compounding these drugs from bulk substances regardless of nomination. Neither drug currently appears on the bulks list or the shortage list. The Federal Register notice should be located and linked, and its status checked, before this page publishes and at each status review.
[^4]: The distinction between shortage-based compounding and compounding that is not essentially a copy. Legal analysis, reported across three independent sources. A 503A pharmacy may compound semaglutide for an individual patient under a prescription provided the preparation is not essentially a copy of the approved product, with the lawfulness now resting on documentation of clinical need for the difference rather than on shortage status. Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act should be cited directly.