Can you still get compounded semaglutide?
Last reviewed 2026-Aug-20 · 6 min read
Yes, it is still being sold. But it is being sold on a narrower and more contested legal basis than it was in 2024, and that basis is under active pressure. If you are buying it now, it is worth understanding what changed rather than assuming nothing did.
What the permission was
Compounding a medicine that is essentially a copy of a commercially available FDA approved drug is not allowed under either compounding pathway. That restriction exists so compounding fills genuine individual needs rather than producing cheaper versions of approved medicines.
The exception is drug shortages. While an approved product sits on the FDA's official shortage list, the restriction is relaxed, because the alternative is patients going without.
Semaglutide and tirzepatide were in shortage for a long stretch. That is what allowed a compounded GLP-1 industry to appear, and it was entirely lawful while it lasted.
When it ended
| Molecule | Shortage resolved | 503A pharmacies | 503B facilities |
|---|---|---|---|
| Tirzepatide | 19 December 2024 | 18 February 2025 | 19 March 2025 |
| Semaglutide | 21 February 2025 | 22 April 2025 | 22 May 2025 |
Those are the FDA's own dates. After them, the shortage based permission was gone.
So why is it still on sale?
Because of a second, narrower argument written into the same law.
A compounded product is not essentially a copy if a change is made for an identified individual patient and that change produces a significant difference for that patient, as judged by the prescriber.
This is why you will see compounded GLP-1s described as personalised, or combined with something like vitamin B12, or offered at doses and schedules that do not match the approved product. Each of those is intended to be the "significant difference" that takes the product outside the copy rule.
Whether that argument survives when a product is mass marketed to thousands of people, with the same formulation and the same additive, is the open question. A rule written around one prescriber making a judgement about one patient is doing very different work when applied at scale.
What the FDA has done since
Warning letters. The FDA has issued warning letters to telehealth companies over how compounded GLP-1 products are advertised, in September 2025, February 2026 and June 2026. The letters focus on marketing claims, including describing a compounded product as having the "same active ingredient as" a named brand.
A proposed rule. On 1 May 2026 the FDA proposed removing semaglutide, tirzepatide and liraglutide from the list of bulk substances that registered outsourcing facilities may compound from, on the basis that there is no clinical need. The comment period closed 29 June 2026. If finalised, that would close the large scale route for these molecules specifically.
A hard limit on two others. Retatrutide and cagrilintide have never been FDA approved, so there is no lawful route to compound them at all.
What this means for you
It does not mean your prescription is illegal or that you should stop taking it. That is a conversation for you and a licensed clinician.
It does mean three practical things.
Supply is less predictable than it was. A business model resting on a contested legal argument can change faster than a business model resting on an approved product.
The personalisation should be explainable. If your product is "personalised," a prescriber should be able to tell you what the personalisation is and why it applies to you specifically. If the answer is that everyone gets the same formulation, that is worth noticing.
The price advantage shrank. The approved products got substantially cheaper in 2026 through federal pricing and a Medicare demonstration. The reason most people chose compounded is less compelling than it was.
What to ask
- What is the legal basis on which this product is being compounded for me?
- What specifically is personalised about my prescription, and why does it apply to me?
- Which facility compounds it, and are they registered with the FDA?
- What happens to my supply if the proposed rule is finalised?
- What would the approved product cost me now?
Sources
- Federal Food, Drug, and Cosmetic Act sections 503A and 503B, 21 U.S.C. 353a and 353b
- The "essentially a copy" restriction, 21 U.S.C. 353a(b)(1)(D) and 21 U.S.C. 353b(a)(5)
- FDA, "FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize"
- FDA, "FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List"; Federal Register document 2026-08552, comments closed 29 June 2026
- FDA warning letters to telehealth companies, September 2025, February 2026 and June 2026
- FDA, "FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss"
How we verify: see /how-we-verify.
Keep reading
The two kinds of compounding pharmacy and why the deadlines differed, at /guides/503a-vs-503b.
What compounded GLP-1s cost now, at /guides/compounded-glp1-cost.