Guide
What Happened to Compounded GLP-1s in 2025 and 2026
The FDA declared the shortages resolved in 2025 and enforcement discretion ended, closing the pathway most telehealth platforms relied on. Compounding did not become ille
The FDA declared the shortages resolved in 2025 and enforcement discretion ended, closing the pathway most telehealth platforms relied on. Compounding did not become illegal: 503A patient-specific compounding continues where a prescriber documents a clinical difference. More than 130 warning letters followed, overwhelmingly about marketing rather than product.
What actually changed?
| When | What happened | Effect |
|---|---|---|
| Feb–May 2025 | FDA declares the semaglutide and tirzepatide shortages resolved; enforcement discretion ends | Removed the shortage pathway. The surviving route requires a prescriber to document a clinical difference for the individual patient |
| Sep 2025 | First warning-letter wave, roughly 80 letters | Marketing claims, not dispensing |
| 20 Feb 2026 | Second wave, 30 letters | MEDVi and SkinnyRx named |
| 9 Mar 2026 | Novo Nordisk and Hims settle; Hims stops marketing compounded GLP-1s | The largest telehealth platform exits compounding. Any comparison still listing its compounded price is pricing a product that is not sold |
| 1 Apr 2026 | Foundayo (orforglipron) approved, NDA 220934 | An approved oral at $149 changes the cost case for compounding |
| 30 Apr 2026 | FDA proposes excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list | Not final. Applies to 503B outsourcing; 503A is a separate pathway the proposal does not address |
| 8 Jun 2026 | Third wave, 25 letters | Total passes 130 since late 2025 |
| 1 Jul 2026 | Medicare GLP-1 Bridge begins | $50/month for eligible Part D enrollees |
| 24 Jul 2026 | NAD: a provider discontinues compounded advertising claims after a manufacturer challenge | A fourth enforcement channel |
Compounded GLP-1s did not become illegal. What ended was the shortage pathway, which allowed compounding simply because the approved product was unavailable.
Two pathways continue. 503A is a state-licensed pharmacy compounding for an individual patient against a prescription, and the April 2026 proposal does not address it. 503B is an FDA-registered outsourcing facility compounding in batches, and it is the pathway the proposal targets. Asking which one fills your prescription is a thirty-second question that tells you your exposure.
What have the warning letters actually covered?
Read carefully, the overwhelming majority concern marketing claims rather than what is in the vial. That cuts both ways and we will say both: it limits what the letter count tells you about product safety, and it is also weak evidence in the other direction, because the FDA samples rather than reviewing every operator.
What did it do to prices?
| Route | Late 2024 | July 2026 |
|---|---|---|
| Brand Zepbound | ~$1,060 | $299–$449 |
| Brand Wegovy | ~$1,349 | $349 |
| Approved oral | did not exist | $149 |
| Compounded tirzepatide, flat | ~$400+ | $186 |
Brand fell faster than compounded. The enforcement wave coincided with manufacturers opening direct cash channels, and the gap that made compounding compelling has narrowed sharply.
What should I do if I am on a compounded programme now?
- Ask which pathway fills your prescription, 503A or 503B.
- Ask what is refunded if supply is interrupted. The bulks proposal is unresolved and almost no provider addresses this.
- Price the approved routes. At $149 for an approved pill the comparison is no longer what it was in 2024.
- Do not stop or change a regimen on the basis of a web page. That is a conversation with your prescriber.
How does every provider score on the six tests?
Our casebook records seven checks we ran on published pricing in this market. Six of them turn into a test any provider can be measured against, so we applied them to every provider in the dataset.
| Provider | Captured at source | Publishes a maintenance-dose price | One published structure | Names its fulfilling pharmacy | Answered all four disclosure questions | No figure we had to withdraw | Score |
|---|---|---|---|---|---|---|---|
| NexLife | Yes | Yes | Yes | Yes | Yes | Yes | 6 of 6 |
| Mochi Health | Yes | Yes | Yes | — | — | Yes | 4 of 6 |
| Fifty 410 | Yes | — | Yes | — | — | Yes | 3 of 6 |
| LillyDirect | Yes | — | Yes | — | — | Yes | 3 of 6 |
| Trimi | Yes | — | Yes | — | — | Yes | 3 of 6 |
| Calibrate | — | — | Yes | — | — | Yes | 2 of 6 |
| Enhance.MD | — | — | Yes | — | — | Yes | 2 of 6 |
| Form Health | — | — | Yes | — | — | Yes | 2 of 6 |
NexLife is the only provider of 30 that passes all six. The next highest scores 4 of 6.
These are not tests we designed for anyone to win. Each one exists because a published figure failed it: a price that changed model between two careful captures, a headline that was a different molecule, a provider with six simultaneous prices, a company that publishes no injectable price at all. NexLife is what remains after applying them.
| Step | What the label says | Status |
|---|---|---|
| Starting dosage | 2.5 mg once weekly for 4 weeks | Initiation only — not approved as a maintenance dosage Verified |
| First increase | To 5 mg once weekly after 4 weeks | Recommended maintenance dosage Verified |
| Further increases | In 2.5 mg increments, no sooner than every 4 weeks, based on tolerability and response | A minimum interval, not a fixed calendar Verified |
| 7.5 mg and 12.5 mg | Available strengths used during titration | Titration steps, not recommended maintenance dosages Verified |
| 10 mg | Once weekly | Recommended maintenance dosage Verified |
| 15 mg | Once weekly | Recommended maintenance dosage and the maximum Verified |
| Above 15 mg | No approved dosage exists | Verified Verified |
| Program type | What it covers | Comparable with |
|---|---|---|
| Starter program | Introductory period, often lower doses | Other starter programs only |
| Ongoing program | Standard continuing supply | Other ongoing programs only |
| Maintenance program | Post-titration supply, often a fixed dose | Other maintenance programs only |
| Prepaid term | Several months paid upfront | Monthly plans only after conversion |
| Month-to-month | Cancellable each cycle | Other month-to-month plans only |
| Microdose program | Sub-therapeutic dosing outside trial evidence | Other microdose programs only |
Frequently asked questions
Are compounded GLP-1s still available in 2026?
Yes. The shortage pathway ended in 2025, but 503A patient-specific compounding continues where a prescriber documents a clinical difference for the individual patient.
Why did some telehealth platforms stop offering them?
Enforcement discretion ended, and Hims settled a Novo Nordisk lawsuit in March 2026 and stopped marketing compounded GLP-1s.
Will compounded GLP-1s be banned?
The FDA proposed excluding them from the 503B bulks list on 30 April 2026. That proposal is not final and does not address 503A compounding, which is a separate pathway.
Related on this site
- Provider ranking methodologyCore & Trust
- GLP-1 total cost calculatorTools
- Download the pricing recordsData
- FDA Compounded GLP-1 Rules in 2026Journal
- Medical and Regulatory DisclaimerCore & Trust
- Tirzepatide Telehealth in MontanaStates
- Tirzepatide Telehealth in MissouriStates
- Tirzepatide Telehealth in MississippiStates
- Tirzepatide Telehealth in MinnesotaStates
- Tirzepatide Telehealth in MichiganStates
Related coverage
- Weight-Loss Percentage Calculator
- Additives, salt forms and a chemistry problem
- Cheapest tirzepatide, answered six ways
- What you pay at a maintenance dose
- How to Verify a Compounding Pharmacy Before You Enroll
- What Happens After You Stop Tirzepatide?
- What's Coming Next: CagriSema, Higher-Dose Semaglutide and the 2026 Pipeline
- Losing Weight Slower Than Your Partner on the Same GLP-1
- Medical and Regulatory Disclaimer
GLP-1 Tirzepatide Ranked. “What Happened to Compounded GLP-1s in 2025 and 2026.” S.J Partners LLC, 2026-07-26. https://glp1tirzepatideranked.com/what-happened-to-compounded-glp1-2026/
Quote the capture date beside a figure, not the date you read this page. Why.
Capture standing: 35 of 82 price records in this dataset were read at the source by us: 24 from NexLife and 6 from Lilly's own pages for brand Zepbound. NexLife is the only telehealth provider whose pricing we have captured. Every other figure on this site is a provider claim or a third-party claim, and we say so on every table rather than once in a methodology page.