Updated 14 September 2026: adds the structural point behind the enforcement record - the consumer-facing telehealth brand is generally not the manufacturer, and a brand can change compounding pharmacy without the customer knowing. Notes for completeness that the "55 warning letters to GLP-1 compounders in H1 2026" figure now circulating is the sum of the two waves already itemised on this page (30 in March, 25 in June), not a third, separate wave.

Updated 13 September 2026: two figures on this page were wrong and have been corrected. The adverse-event count was badly stale - the FDA had logged over 1,700 reports across compounded semaglutide and tirzepatide as of 31 May 2026, roughly double the 455+/320+ this page carried. And the first enforcement wave was more than 50 letters in September 2025, not "over 100 during 2025"; that figure was not supported by the record. Both are now sourced and dated in the references.

Updated September 2026: adds the 2026 enforcement record with corrected dates (30 warning letters to telehealth companies in March 2026 and a further 25 in the week of 15 June 2026, following the September 2025 opening wave) and states precisely what was alleged, which is a marketing claim about equivalence to the approved drugs rather than a finding about the compounded product itself. Adds the parallel litigation in one paragraph.

For two years, compounded semaglutide and tirzepatide were everywhere - roughly $150–400 a month versus $1,000+ for the brands. That market existed because of a specific legal hook: when a drug is on the FDA's shortage list, pharmacies may compound copies. Both drugs came off that list - tirzepatide in December 2024, semaglutide in February 2025 - and with the shortage gone, so did the legal basis for mass compounding. As of 2026, broadly available compounded GLP-1s are no longer legal, enforcement is active, and the sourcing risk is the real headline. Here's the honest picture.

What changed, and when

The wind-down happened on a clear timeline:

• Shortages resolved - tirzepatide (Dec 2024), semaglutide (Feb 2025).
• Grace periods ended - for state-licensed (503A) pharmacies and larger (503B) outsourcing facilities, the enforcement-discretion windows closed by May 2025. After that, "essentially a copy" compounding of these drugs is impermissible.
• Courts sided with the FDA - industry lawsuits (the Outsourcing Facilities Association cases) failed to secure injunctions, so the deadlines held.
• April 2026 - the door closes further - the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B "bulks list" entirely, on the basis that there's no clinical need to compound them from bulk when approved products exist. The comment period, first set to close in June 2026, was extended to 30 July 2026. As of 26 October 2026 no final decision had been announced, so it is still a proposal. If finalized, it forecloses bulk compounding even if a future shortage returns. The proposal concerns 503B outsourcing facilities; it does not directly change the narrow 503A exception below.

Is there any legal compounding left?

Yes - but it's narrow. 503A patient-specific compounding remains legal when a licensed pharmacy prepares a drug for an individual patient with a documented clinical need - for example, a genuine dose the approved products can't provide, or an allergy to an ingredient. What's not legal is routine, anticipated-demand "copycat" production of standard doses. If a pharmacy or telehealth site is still offering standard compounded semaglutide cheaply and at scale, that's the part under enforcement.

The 2026 enforcement record - and what was actually alleged

Enforcement stopped being theoretical in 2026, and the shape of it is more specific than the headlines suggest.

• September 2025 - the opening wave: more than 50 warning letters to compounders, telehealth providers and manufacturers, with a batch of over 55 published on 16 September 2025 targeting online sellers. (You will see figures of 80 or 100+ quoted for this wave; the contemporaneous record supports "more than 50," and we have corrected our own earlier figure accordingly.)
• 3 March 2026 - 30 warning letters to telehealth companies over compounded GLP-1 marketing.
• Week of 15 June 2026 - a further 25 letters, issued 16 June.

Those two 2026 waves are the source of the 55 warning letters to GLP-1 compounders in H1 2026 figure now circulating in summaries of the year. It is a total, not a third wave: 30 in March plus 25 in June. Anyone presenting it as a separate event is double-counting.

What was alleged matters more than the count. The violation identified in these letters is a marketing one: promotional material suggesting that a compounded version is equivalent to, or is, the FDA-approved drug - Wegovy, Ozempic, Zepbound, Mounjaro. That is a claim about sameness. It is not, in itself, a finding that a particular compounded product was contaminated, mislabelled or subpotent. The two get conflated constantly, and the conflation cuts both ways: people read the letters as proof that all compounded product is dangerous, or dismiss them as "just advertising rules." Neither is right. The agency's position is that a compounded copy marketed as though it were the approved drug misleads patients about what they are receiving and about the evidence behind it.

The FDA has named seizures and injunctions as possible escalations from here, and has stated that direct-to-consumer telehealth marketing is a top enforcement priority. That is a stated direction of travel, not a prediction about any particular company.

September 2026: adding a vitamin does not make it a different drug

A warning letter dated 18 September 2026 to a large 503A compounding pharmacy addressed a tactic that had become common: compounding semaglutide or tirzepatide with an added ingredient, such as vitamin B12 (cyanocobalamin) or niacinamide, and treating the combination as clinically different from the approved drug. According to law-firm analysis of the letter, the FDA concluded these combinations were still "essentially copies" of the approved products, so the compounding fell outside the 503A exemption, and it pointed to high production volumes as evidence that the claimed clinical differences were pretextual. We are not naming the pharmacy; the point is the theory, not the company. An added vitamin is not, on its own, the documented individual clinical need that the narrow exception requires.

October 2026: a sterility recall, which is a different question from legality

Two statements need to stay separate here, because the news invites people to merge them.

1. Narrow compounding can still be lawful under the conditions described above.
2. Specific batches from one facility failed a sterility-assurance standard. "Sterility assurance" means the maker can show its process reliably keeps a sterile product free of germs. A failure is a finding about the process, not a lab result showing any particular vial was contaminated.

The facts: Apothecary Pharma, a North Carolina firm registered with the FDA as a 503B outsourcing facility (not a 503A pharmacy), voluntarily recalled 22 lots of compounded tirzepatide injection and one lot of NAD+ injection because it could not assure they were sterile. The recall began on 24 September 2026, and on 8 October 2026 the FDA classified it Class II, meaning use may cause temporary or medically reversible health problems and serious harm is unlikely. The FDA notice reported no illnesses or injuries. The FDA had sent the same firm a warning letter dated 1 December 2025 about insanitary conditions in sterile production; the agency has not linked that letter to this recall. FDA's enforcement report separately lists a Class II recall of compounded semaglutide syringes from Carolina Infusion, LLC, also over sterility assurance.

Keep 503A and 503B apart when reading this. The 503B bulks-list proposal above is about outsourcing facilities; this recall also came from an outsourcing facility; neither is a statement about 503A pharmacies. A recall also does not make an approved medicine unsafe: it concerns specific compounded batches. If a product you use appears on a recall list, that is a conversation with your own prescriber, today.

August 2026: a different kind of letter

One batch from later in the year belongs on this page even though it is not a compounding action, because the drugs overlap and the two get merged in coverage. On 24 August 2026 the FDA issued warning letters to five online sellers of injectable peptides. The letters were published on 1 September 2026, with trade coverage following on 8 September 2026. The sites listed retatrutide, semaglutide, tirzepatide, elamipretide and tesamorelin.

The reasoning is not the compounding reasoning. The agency established the products' intended use under section 201(g)(1) of the FD&C Act from the sellers' own labelling and marketing claims, which made them drugs; lacking approval for those uses, they were unapproved new drugs under section 505(a). The bacteriostatic water sold on the same sites was cited as a drug in its own right, on the basis that it was marketed together with the injectable peptides and so fell inside the same intended-use finding.

We are not naming the sellers. Two distinctions are worth carrying away. First, this is not a 503A or 503B question: these were online sellers, not licensed compounding pharmacies, and nothing in the narrow patient-specific exception described above applies to them. Second, the alleged violation is again about what was claimed, not about what was in any particular vial - the same shape as the compounder letters, arrived at through a different section of the statute.

The pharmacy you never chose

One structural feature of this market explains a lot of the enforcement pattern, and almost nobody buying into it is aware of it: the brand you picked is usually not the entity that made your medication. A direct-to-consumer telehealth company is a prescribing and fulfilment front end. The actual preparation is done by a compounding pharmacy the customer typically never sees named, never selected, and cannot easily identify.

That separation has a consequence. When a compounding pharmacy accumulates regulatory problems, the telehealth brand can change suppliers and carry on trading under the same name, the same website and the same subscription. Nothing in the customer-facing experience necessarily changes. Reporting through 2026 has described exactly that pattern - telehealth firms continuing to work with, or rotate between, compounding pharmacies after repeated regulatory findings.

We are describing a structure, not accusing a named company, and the practical implication is not "avoid telehealth." It is narrower and more useful: a brand's reputation is not evidence about the pharmacy that filled your vial, because those are two different organisations and only one of them is accountable for what is in it. The question worth asking a prescriber - who compounds this, and are they licensed to - is one a legitimate service can answer.

The parallel litigation

Running alongside the regulatory action is a set of private disputes that shape the same market. Novo Nordisk sued Hims & Hers on 9 February 2026 in a patent action over compounded semaglutide. Pointing the other way, Strive Specialties has brought a claim against Novo Nordisk and Eli Lilly alleging anti-competitive conduct - the argument being that the wind-down of compounding has been used to foreclose competition rather than purely to protect patients. Both sides of that are live and unresolved. The relevant point for a patient is not who wins: it is that the commercial incentives on every side of this market are strong enough to fund litigation, which is a reason to weight regulatory primaries over anybody's press release, including ours.

We are not going to hand you a scorecard. No list of which named companies are fine and which aren't, and no "how to tell whether the vial you already have is legitimate" checklist. Those exercises put the burden of pharmaceutical quality assurance on the patient, which is exactly backwards, and they go stale faster than anyone updates them. The functional answer is the boring one: get the question in front of a prescriber who can take clinical responsibility for what you have been supplied and, if it is not defensible, move you onto something that is.

The October 2026 peptide policy is a separate track

In October 2026 you will see headlines that the government is about to let pharmacies compound "peptides" again. That story is not about GLP-1s. On 14 October 2026 HHS and the FDA submitted a document titled "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget for review. As of 19 October 2026 it has not been issued and its text is not public, so which substances, routes and conditions it covers is unknown. Reporting and legal commentary connect it to the peptides the FDA's Pharmacy Compounding Advisory Committee reviewed in July 2026, such as BPC-157, and law firms expect it to take the form of temporary enforcement discretion rather than approval of anything.

Semaglutide and tirzepatide sit on a different legal footing entirely. They are FDA-approved drugs whose shortages have ended, so the question for them is the "essentially a copy" rule and the proposed 503B bulks exclusion described above, not the advisory committee process. Nothing public suggests the interim peptide policy reopens GLP-1 compounding, and readers should not treat it as doing so.

Why this matters more for safety than for cost

The compounding story isn't only regulatory - it's a safety one, and the numbers have moved sharply. As of 31 May 2026, the FDA had received 990 adverse-event reports associated with compounded semaglutide and more than 730 associated with compounded tirzepatide - over 1,700 in total. That is roughly double the figure this page carried a year ago.

Three caveats belong with that number, and they pull in opposite directions. These are passive surveillance reports: anyone can file one, and a report is not a finding of causation. At the same time, the agency notes the totals are likely undercounts, because state-licensed pharmacies are not generally required to report adverse events at all. And the reports skew toward a specific, avoidable failure mode - dosing errors from multi-dose vials, including ten-fold mistakes traced to confusion over syringe measurement units, some requiring hospitalisation. Counterfeit product entering through online channels is a separate and continuing concern. Compounded drugs are not FDA-approved, and their quality depends entirely on the pharmacy. That's the same unverified-source problem we flag across peptide sourcing: the danger often isn't the molecule, it's what's actually in the vial.

What to do if you're on a compounded GLP-1

• Don't stop abruptly - stopping a GLP-1 suddenly can cause rapid weight regain. Talk to your prescriber first.
• Ask your provider the direct question - "What's the legal basis for this prescription today?" A legitimate 503A exception has a documented clinical reason.
• Move toward verified supply - approved products (with savings programs), or a supervised plan, remove the sourcing risk entirely.

A note on scope: this framework is US-specific, but the lesson is universal. Across markets - including Malaysia and the rest of Southeast Asia - the safe path is a licensed prescription through regulated channels under supervision, not a grey-market or "research-use-only" vial.

The bottom line - and where to start

Compounded semaglutide and tirzepatide are no longer broadly legal in the US: the shortages that justified them are resolved, grace periods ended in 2025, enforcement is active, and a 2026 proposal would close the bulk pathway for good. A narrow patient-specific exception survives, but the durable point is safety - unverified compounded and grey-market product is where the real harm happens. The dependable route is verified medication under a clinician who can manage the transition.

Where Vivre Labs fits. If you are currently on a compounded GLP-1 and unsure of its legal basis, that question belongs with your own prescriber, who can answer it and manage any transition. Vivre Labs offers semaglutide and tirzepatide, both prescription medicines approved for type 2 diabetes and weight management, and we recommend starting with baseline bloodwork.

Frequently asked questions

Is compounded semaglutide still legal in 2026? Not for routine dispensing. The shortage was resolved in February 2025 and enforcement grace periods ended in May 2025, so broad "copycat" compounding is no longer permitted. Narrow 503A patient-specific compounding with a documented clinical need can still be legal.

Can I still get compounded tirzepatide? Not routinely - its shortage resolved in late 2024 and the same wind-down applies. Only limited, documented patient-specific exceptions remain, and a 2026 FDA proposal would further restrict bulk compounding.

Is compounded GLP-1 safe? Compounded drugs aren't FDA-approved, and quality depends on the pharmacy. As of 31 May 2026 the FDA had logged over 1,700 adverse-event reports across compounded semaglutide and tirzepatide, many from dosing errors with multi-dose vials, plus counterfeit concerns. A prescriber taking clinical responsibility for what you are supplied is the thing that reduces that risk.

What were the FDA warning letters actually about? Marketing. The letters - 30 in March 2026, a further 25 in the week of 15 June 2026, after more than 50 in September 2025 - allege that promotional material presented compounded versions as equivalent to, or as, the approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro). That is an allegation about a claim of sameness, not in itself a finding about the contents of any particular vial. The FDA has named seizures and injunctions as possible escalations and direct-to-consumer telehealth marketing as a top enforcement priority. The "55 letters to GLP-1 compounders in H1 2026" figure you will see quoted is the March and June waves added together, not an additional batch. A separate action on 24 August 2026, published 1 September, warned five online sellers of injectable peptides - semaglutide and tirzepatide were among the products listed, but those letters turn on intended use under the FD&C Act rather than on compounding rules.

Is my provider in trouble if they got a letter? That is not a question this page can answer, and we deliberately don't publish a company-by-company assessment. Ask your prescriber directly what the legal basis for your current prescription is. A legitimate 503A exception has a documented clinical reason behind it, and a clinician should be able to state it.

Related reading

• Mounjaro vs Wegovy vs Ozempic · Do you need a doctor for weight-loss injections? · What is 503A compounding? · The honest peptide side-effects guide
• Part of The Complete Guide to GLP-1s

Educational content, not medical advice. Compounding rules are US-specific and evolving; verify current status. Claims for the Malaysian market are subject to MAB requirements.

References

• FDA: tirzepatide shortage resolved Dec 2024; semaglutide resolved Feb 2025; enforcement-discretion periods ended (503A/503B) by May 2025; "essentially a copy" compounding impermissible post-shortage. · FDA proposed excluding semaglutide, tirzepatide, liraglutide from the 503B bulks list (Apr 30, 2026; 91 Fed. Reg. 23431, 1 May 2026); comment period extended to 30 July 2026 (Federal Register, 26 June 2026, https://www.govinfo.gov/content/pkg/FR-2026-06-26/html/2026-12937.htm); no final decision announced as of 26 October 2026. · 503A patient-specific compounding with documented clinical need remains permissible. · Safety, as of 31 May 2026: 990 adverse-event reports associated with compounded semaglutide and 730+ with compounded tirzepatide - >1,700 combined. Passive surveillance; no causation established; FDA notes likely undercount because state-licensed pharmacies are largely not required to report. Many involve dosing errors with multi-dose vials, including ten-fold errors from syringe-unit confusion; counterfeit concerns separate. Supersedes the earlier 455+/320+ figures carried on this page. · Outsourcing Facilities Association v. FDA litigation denied injunctions. · Enforcement record: September 2025 - more than 50 warning letters to compounders, telehealth providers and manufacturers, including 55+ published 16 September 2025; 30 warning letters to telehealth companies 3 March 2026; a further 25 letters in the week of 15 June 2026 (issued 16 June). An earlier figure of "over 100 during 2025" carried on this page is not supported by the contemporaneous record and has been corrected; figures in the thousands that circulate online are not supported either. The alleged violation is marketing - promotional material suggesting compounded versions are equivalent to, or are, the FDA-approved drugs (Wegovy, Ozempic, Zepbound, Mounjaro); it is a claim about sameness, not a finding about the compound itself. Seizures and injunctions named as possible escalations; DTC telehealth marketing is a stated top enforcement priority. The 55 warning letters to GLP-1 compounders in H1 2026 figure is the sum of the 3 March (30) and week-of-15-June (25) waves, not a separate third wave. Sources: Foley & Lardner; Telehealth.org; Patient Care Online; Sheppard Mullin; National Law Review. · Separate action - online peptide sellers: FDA warning letters dated 24 August 2026, published 1 September 2026 (trade coverage 8 September 2026), to five online sellers of injectable peptides for selling them as unapproved new drugs. Listed products: retatrutide, semaglutide, tirzepatide, elamipretide, tesamorelin. Intended use established under FD&C Act s.201(g)(1) from labelling and marketing claims; products therefore unapproved new drugs under s.505(a). Bacteriostatic water sold on the same sites cited as a drug on the same intended-use basis. Not a compounding action; sellers not named here. · Litigation: Novo Nordisk v. Hims & Hers (patent, filed 9 February 2026); Strive Specialties v. Novo Nordisk and Eli Lilly (alleged anti-competitive conduct). Both unresolved.
• Added-ingredient combinations: FDA warning letter dated 18 September 2026 to a 503A compounding pharmacy citing semaglutide/cyanocobalamin and tirzepatide/niacinamide combinations as "essentially copies" of approved products; high production volumes cited as evidence the claimed differences were pretextual. Source: Frier Levitt, "FDA Warning Letter Signals New Enforcement Theory for Compounded GLP-1 Combination Products" (25 September 2026) https://www.frierlevitt.com/articles/fda-warning-letter-compounded-glp-1-products/
• October 2026 recall: Apothecary Pharma voluntary recall of 22 lots of compounded tirzepatide injection and one lot of NAD+ injection, lack of sterility assurance; began 24 September 2026; FDA Class II, 8 October 2026; no illnesses or injuries reported. Becker's Hospital Review, 20 October 2026 (https://www.beckershospitalreview.com/glp-1s/compounded-glp-1-injections-recalled-nationwide-4-notes/); BioPharma Dive, 22 October 2026 (https://www.biopharmadive.com/news/glp1-obesity-drug-recall-apothecary-tirzepatide-zepbound/833712/). FDA warning letter 717972 to Apothecary Pharma LLC, 1 December 2025: registered 503B outsourcing facility, insanitary conditions (fda.gov). Carolina Infusion, LLC: Class II recall of compounded semaglutide syringes, lack of sterility assurance, per FDA Enforcement Report as read by Peptide Briefs, 25 October 2026 (https://peptidebriefs.substack.com/p/a-sterility-recall-a-regulatory-signal).
• Separate track - peptide interim policy: HHS/FDA submitted "Interim Access Policy for Compounding Using Certain Peptides" to OIRA/OMB for review on 14 October 2026; not issued, text not public as of 19 October 2026; concerns the peptides reviewed by the PCAC, not semaglutide or tirzepatide. Sources: Buchanan Ingersoll & Rooney (16 October 2026) https://www.bipc.com/fda-submits-interim-peptide-compounding-policy-for-white-house-review-what-pharmacies-should-know · Holland & Knight, "Peptides at a Crossroads" (October 2026) https://www.hklaw.com/en/insights/publications/2026/10/peptides-at-a-crossroads-what-wellness-providers-need-to-know