Are Compounded GLP-1s Going Away? Where Things Stand Now (Updated Sept 2026)
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Nothing has been banned, and the ground has still moved considerably. A federal appeals court backed the FDA in August, a compounding pharmacy received a detailed warning letter in September, and the shortage-based legal route closed in 2025. What remains is narrower and more specific than most coverage suggests.
Who This Helps
This is for you if you're taking a compounded GLP-1 and want to know whether your supply is at risk, or you're deciding whether to start one. If you want the underlying rules, our 503A and 503B explainer covers how the two pathways differ.
The shortage pathway closed, and a court has now upheld that
The shortage provisions were the route that allowed compounding of these drugs at scale. FDA resolved both, tirzepatide in October 2024 and again by declaratory order that December after a remand, and semaglutide in February 2025. Grace periods ran out by May 2025 (FDA).
Compounders challenged that. On August 27, 2026 the Fifth Circuit ruled for FDA in both cases. In the semaglutide opinion the court wrote that any error in the FDA not proceeding through the APA’s notice and comment procedures "was harmless, and the FDA's ultimate action was not arbitrary or capricious" (United States Court of Appeals). The tirzepatide opinion reached the same result, concluding that "the FDA engaged in reasoned decision-making" (United States Court of Appeals) in ending the shortage.
Two things about that are often misunderstood. The court didn't rule only on procedure; it reviewed the substance too and found the decision reasoned. And both opinions are unpublished and per curiam, so neither sets binding precedent. Nothing changed on the ground either, since the restrictions had already applied for over a year.
What still allows compounding
One statutory route and one enforcement posture, which aren't the same thing. A 503A pharmacy can compound what would otherwise count as a copy if the prescribing practitioner determines and documents a change producing a significant difference for an identified individual patient. Separately, FDA has said that at this time it doesn't intend to act against a compounder filling four or fewer prescriptions of a given product in a calendar month (FDA). That second one is a nonbinding statement of enforcement discretion, not permission.
FDA also addressed the B12 question directly, saying it may consider a semaglutide and B12 combination a copy where the route matches and the amounts of both ingredients fall within 10% of the strengths of the respective approved products. That's an example in a position statement rather than a rule. On documentation, FDA's 2018 guidance says the determination should be recorded on the prescription, naming the change and the difference it produces, and that listing only the patient and the formulation isn't enough. A lower price doesn't count (FDA guidance). Essentially, if compounding pharmacies don’t make enough of a change to the medication they are producing to warrant the compounding and document it, it’s in violation of the FDA decision.
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The September warning letter is the clearest signal yet
On September 18, 2026 FDA sent a warning letter to Empower Pharmacy, a 503A facility in Houston (FDA). Most of the letter concerns sterile processing and manufacturing practice, including failed smoke studies and media fill discrepancies. One section addresses combination products, saying tirzepatide with niacinamide and semaglutide with cyanocobalamin appear to be essentially copies, and that the volume of products being produced suggests the differences are pretextual.
FDA also said some orders lacked any prescriber determination at all, and that others appeared repeated verbatim across many records, suggesting they may have been pre-generated. It separately described third-party platforms offering prescribers pre-selected menu options as something that could undermine such determinations, without finding that this firm used them.
The 503B route is narrowing separately
Outsourcing facilities can compound from a bulk substance when it sits on the 503B bulks list, or when the compounded drug is on FDA's shortage list. Neither applies to these drugs now. In April 2026 FDA proposed not adding semaglutide, tirzepatide and liraglutide to that list (FDA). The comment period was extended once and closed on July 30, 2026 (Federal Register). FDA says those comments "will inform FDA's final determination whether to include these substances on the 503B Bulks List." As of September 29, 2026 the docket carried no such determination (Federal Register docket).
This is an enforcement position on one firm's records rather than a court ruling, and it doesn't make every compounded product unlawful. It does show how FDA is reading the significant-difference provision when combination products are filled in volume.
What FDA says about the products themselves
FDA updated its GLP-1 safety page on September 1, 2026. Adverse event reports as of May 31, 2026 stood at 990 for compounded semaglutide and more than 730 for compounded tirzepatide, and FDA notes these are likely undercounted because pharmacies outside the 503B category aren't required to report (FDA).
Those are report counts rather than rates, and FDA notes it isn't always possible to tell whether an adverse event resulted from the drug. The page also carries three specific warnings:
- FDA recommends discarding a multi-dose vial 28 days after first use, even if the compounder's instructions say longer. The clock runs from first use, not from delivery.
- Retatrutide and cagrilintide cannot be used in compounding under federal law, and on salt forms FDA says it isn't aware of any lawful basis for their use.
- FDA flags products that arrive warm and anything labeled for research use, which isn't intended for people at all.
What this means for you
In a survey fielded in late spring 2026, roughly 18% of people currently taking a GLP-1 for weight loss reported using a compounded or custom-mixed version, described in the question as not approved by FDA. That's self-reported, with a margin of error running as high as ten points on that subgroup (Gallup). What has changed since then is the legal footing, which is narrower than it was.
Reasonable questions to ask: which pharmacy actually fills this, is it licensed in your state, and why is a compounded product clinically right for you specifically. Compounded drugs aren't reviewed by the FDA for safety, effectiveness or quality, and the same active ingredient doesn't mean the same product.
Final Takeaway
The honest picture is a narrowing pathway under active review rather than a settled status quo, and a mass-marketed combination product is the model FDA is testing. FDA notes patients may still see intermittent, localized supply disruptions. If something goes wrong, MedWatch is where it gets reported (FDA), and your state board of pharmacy is where a pharmacy's license can be checked (state boards directory).
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Frequently Asked Questions
Did the court make compounded GLP-1s illegal?
No. It upheld FDA's decision to remove both drugs from the shortage list, on both procedural and substantive grounds, in unpublished opinions that set no binding precedent. The practical restrictions had already applied since 2025.
Does adding B12 make it legal?
FDA has said it may treat that as a copy when the route matches and both ingredient amounts are within 10% of the respective approved products. The statute defers to the prescribing practitioner's determination of a significant difference for an identified patient, and FDA's September letter questioned whether repeated, apparently pre-generated language meets that.
Should I stock up?
That's a question for your prescriber rather than for us. Either way, FDA's 28-day recommendation runs from the first use of a multi-dose vial, not from when it arrives, so an unopened vial and an opened one are on different clocks.
What's changed since we first published this
We first covered this in April 2026, and the picture has moved steadily since, most of it in the last two months. Updated September 29, 2026. Four things are new:
- A federal appeals court ruled. The Fifth Circuit upheld FDA's shortage delisting on August 27, on both procedural and substantive grounds. This is the central litigation on the question, and it was undecided when we first wrote.
- FDA issued a detailed warning letter on September 18, the clearest published statement so far of how the agency reads the significant-difference provision when combination products are filled in volume.
- The 503B bulks list proposal closed for comment on July 30 and remains undecided. Which way it lands will matter more to outsourcing facilities than anything else on this list.
- FDA updated its safety page on September 1 with current adverse event counts and guidance on vial dating, salt forms and research-use products.
We've also rewritten the section on what still allows compounding, since FDA has published considerably more detail on that since April. We'll keep this current as the 503B decision and any further enforcement land. Next scheduled review: December 2026, or sooner if FDA issues a final determination.
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Written by
Lauren PescarusLauren Pescarus is a team member with GLP Winner where she works on marketing, content creation, and operations. She has over 10 years experience in the content creation space, including in the GLP-1 space where she works to stay on top of access news, research updates, and lifestyle tips guided by science.