Compounded GLP-1 medications
Compounded GLP-1 medications became widely available during the brand shortages. That window has largely closed. This hub explains what compounding is, what the FDA actually says, and how to evaluate a program.
Compounded GLP-1 drugs are prepared by pharmacies rather than manufactured as FDA-approved finished drugs. They are not FDA-approved, the FDA does not verify their quality before marketing, and routine compounding of semaglutide and tirzepatide is now restricted after the shortages resolved.
Explore this topic
Compounded semaglutide
Same molecule as Ozempic/Wegovy — with caveats
Compounded Semaglutide
Same molecule as Wegovy/Ozempic — with caveats
Compounded GLP-1 safety
Adverse events and quality concerns
Compounded GLP-1 legality
503A/503B rules and the shortage window
503A vs 503B
The two compounding pathways explained
Verify a compounding pharmacy
A practical checklist
Sources
- U.S. Food and Drug Administration — approval and compounding status.
- Primary clinical literature cited on child pages.
- Our methodology and source standards.
How to use this section
Start with the figure that matches how you will actually pay. If you will not commit to a prepaid year, ignore the prepaid rates entirely and read the month-to-month column, because a rate you cannot access is not a price.
Then check whether the figure is quoted at a therapeutic dose or a microdose. Microdose tiers sit below every dose studied in the pivotal trials and are priced accordingly; they are a legitimate offer but not a cheaper route to the result the trials measured.
The context that applies to everything here
How to verify any of this yourself
- Go to the provider's own pricing page. Not a comparison site — the provider's. Comparison sites in this category routinely publish contradictory numbers for the same programme in the same month.
- Find the ongoing price, not the headline. Look for the words "first month", "intro", "starting at" or "new patients". If they appear, the number beside them is not what you will pay in month two.
- Add the membership. If the medication and the membership are billed separately, add them. That sum is your real monthly cost.
- Ask what the highest dose costs. By email or chat, so you have it in writing.
- Ask about early cancellation before you commit to a plan longer than a month.
- Check the manufacturer. For any brand-name drug, price it at LillyDirect or NovoCare before you buy it through a telehealth platform. Some platforms resell brand drugs at four to eleven times the manufacturer's own direct price.
If a provider will not answer questions 4 or 5 in writing, that is itself information.
What we verify, and what we do not
| Label | Means | Example |
|---|---|---|
| Provider Reported | We hold a dated capture or a primary-source confirmation | LillyDirect's $299 — from Lilly's own pricing page |
| Reported — pending verification | A provider or third party reports it; we have NOT captured it ourselves | Competitor prices from the September 2026 dataset; every pharmacy relationship on this site |
| Evaluation in progress | Verification pending. We are not asserting the fact at all | Cancellation terms we could not obtain in writing |
Three facts that apply to everything in this section
First, compounded preparations are not FDA-approved. FDA does not review them for safety, effectiveness or manufacturing quality before they are marketed, and they are not therapeutically equivalent to any brand-name product. The active molecule is the same; the regulatory object is not.
Second, the advertised price is frequently not the billed price. Prepaid terms, separately billed memberships, promotional first months and microdose tiers all lower the headline figure without lowering what you pay at a therapeutic dose, and they push in the same direction.
Third, every price on this site carries a capture date. Prices in this market move within weeks. A figure without a date is not a fact, and that applies to figures published here as much as anywhere else.
Questions to ask about the pharmacy
- Which specific pharmacy will fill my prescription? Not "our network" — the name of the facility.
- Is it a 503A state-licensed pharmacy or a 503B FDA-registered outsourcing facility? These are different regulatory categories with different oversight, and a company can use both for different products.
- In which state is it licensed, and can I look up the licence? State boards of pharmacy publish licensee databases.
- What is the exact salt form and concentration? Semaglutide sodium and semaglutide acetate are not the same active ingredient as the semaglutide base in approved products, and the FDA has said they are not appropriate for compounding.
- Is the vial single-dose or multi-dose? A multi-dose vial requires you to measure each dose yourself, which is the most common source of the dosing errors behind reported adverse events.
- Will you provide a certificate of analysis?
- Has the pharmacy received any FDA warning letter or state board action?
Jastreboff AM et al., N Engl J Med 2022 (NCT04184622), n=2,539. Dose-response is real: the effect rises with dose. These are FDA-APPROVED SUBCUTANEOUS INJECTION doses — they do not transfer to compounded, microdose or ODT products. Trial means are not individual promises.
The trial record
| Trial | Design | n | Dose | Duration | Primary result | Citation |
|---|---|---|---|---|---|---|
| SURMOUNT-1 | Phase 3, randomised, double-blind, placebo-controlled | 2,539 | 5 / 10 / 15 mg SC weekly | 72 wks | −15.0% / −19.5% / −20.9% vs −3.1% placebo | Jastreboff, NEJM 2022; NCT04184622 |
| SURMOUNT-2 | Phase 3, RCT, in type 2 diabetes | 938 | 10 / 15 mg SC weekly | 72 wks | −12.8% / −14.7% vs −3.2% placebo | Garvey, Lancet 2023; NCT04657003 |
| SURMOUNT-3 | Phase 3, RCT, after 12-wk intensive lifestyle lead-in | 806 | Max tolerated (10/15 mg) | 72 wks | −18.4% additional, vs +2.5% placebo | Wadden, Nat Med 2023; NCT04657016 |
| SURMOUNT-4 | Randomised WITHDRAWAL after 36-wk open-label lead-in | 670 | Max tolerated | 88 wks | Continue: −5.5% further. Withdraw to placebo: +14.0% REGAINED | Aronne, JAMA 2024; NCT04660643 |
| SURMOUNT-5 | Phase 3b, OPEN-LABEL, active-controlled head-to-head | 751 | Max tolerated vs semaglutide | 72 wks | −20.2% vs semaglutide −13.7%, p<0.001 | Aronne, NEJM 2025; NCT05822830 |
| SURPASS-2 | Phase 3, RCT, type 2 diabetes, active-controlled | 1,879 | 5 / 10 / 15 mg vs semaglutide 1 mg | 40 wks | HbA1c −2.01 to −2.30% vs −1.86% | Frías, NEJM 2021; NCT03987919 |
| SURPASS-CVOT | Phase 3, cardiovascular outcomes, vs dulaglutide | 13,299 | Max tolerated | ~4.5 yrs | Non-inferior for MACE; not superiority vs placebo | Nicholls, 2024; NCT04255433 |
1. They are means, not promises. A −20.9% mean in SURMOUNT-1 contains people who lost far more and people who lost almost nothing. A trial average tells you what happened to a population; it does not tell you what will happen to you.
2. Every one is an FDA-APPROVED SUBCUTANEOUS INJECTION. No trial in this table tested a compounded preparation, a microdose regimen, or an orally disintegrating tablet. When these figures appear on a page selling a compounded ODT, evidence has been moved across a dosage form without justification.
3. All were funded by Eli Lilly, which manufactures tirzepatide. That is normal in drug development and does not make the results false — these are large, peer-reviewed studies. It belongs in the citation anyway, and it matters most in SURMOUNT-5, where the funder made the winning drug and the trial was open-label.
Jastreboff AM et al., N Engl J Med 2022, n=2,539 (NCT04184622). The effect rises with dose — which is precisely why a ~1mg 'microdose' cannot be expected to produce the headline result. FDA-approved subcutaneous injection.
The evidence is strong exactly where it was gathered and silent everywhere else. The gap between those two things is where most of the marketing in this industry operates, and recognising it is the single most useful skill a patient in this market can have.
Dosing, titration, and what it does to your bill
| Period | Dose | What it is for |
|---|---|---|
| Weeks 1–4 | 2.5 mg | Tolerance-building only. This dose is not intended to produce weight loss. If your provider's price is quoted at 2.5 mg, that is not the price of treatment. |
| Weeks 5–8 | 5 mg | First therapeutic dose (−15.0% in SURMOUNT-1). |
| Weeks 9–12 | 7.5 mg | Escalate only if tolerated. |
| Weeks 13–16 | 10 mg | A common maintenance dose (−19.5%). |
| Weeks 17–20 | 12.5 mg | Escalate only if tolerated. |
| Week 21+ | 15 mg | Maximum maintenance dose (−20.9%). |
The advertised price is usually the 2.5 mg price. On a programme that escalates with dose, the rate you are quoted at signup is for a dose the label explicitly describes as a starting dose — not a treatment dose. Ask what you will pay at 10 mg, and compare that number instead.
A 'microdose' of ~1 mg/week sits below every dose in SURMOUNT. The trials used 5, 10 and 15 mg. A microdose is not a discounted route to the SURMOUNT result; it is a different product with a smaller expected effect and no equivalent trial evidence.
Safety, contraindications and monitoring
Percentage of participants reporting each event. Gastrointestinal effects dominate, are usually mild-to-moderate, and are most pronounced during dose escalation. Source: SURMOUNT-1, N Engl J Med 2022.
Discontinuation: what the withdrawal trial found
Aronne LJ et al., JAMA 2024, n=670 (NCT04660643). After a 36-week open-label lead-in, participants randomised to placebo regained ~14% of body weight over the following 52 weeks; those who continued lost a further ~5%. This is the single most important trial for understanding the true cost of treatment.
Questions to ask your clinician
- Given my history — specifically thyroid, pancreatic and gallbladder — is a GLP-1 appropriate for me at all?
- What baseline laboratory work will you order before I start?
- What is my target dose, and how quickly will we escalate?
- Which side effects should make me call you rather than wait it out?
- What is the plan for maintenance, and what happens if I stop?
- Will I see the same clinician at each follow-up, or a different one each time?
Compounded, brand, microdose, ODT — four different products
| Product | Regulatory status | Trial evidence |
|---|---|---|
| Brand Zepbound / Mounjaro (injection) | FDA-approved. Reviewed for safety, effectiveness and quality before marketing. | Direct. SURMOUNT and SURPASS tested exactly this product. |
| Brand Foundayo (oral, orforglipron) | FDA-approved. Its own trial programme. | Direct, for that product. |
| Compounded Semaglutide (injection, full dose) | NOT FDA-approved. No premarket review of safety, effectiveness or quality. | None for the compounded product itself. Same molecule, same route — but the product in your hand was never in a trial. |
| Microdose (~1 mg/wk) | NOT FDA-approved. | None. Sits BELOW every dose in SURMOUNT (5/10/15 mg). Expect a smaller effect. |
| ODT / oral compounded | NOT FDA-approved. | NONE. No trial has ever tested it. Oral bioavailability for these peptides is a real pharmacological problem and is unpublished for this product. |
The evidence is strong exactly where it was gathered and silent everywhere else. The gap between those two things is where most of the marketing in this industry operates, and recognising it is the single most useful skill a patient in this market can have.
Adverse events: the figure almost every site gets wrong
Source: FDA GLP-1 webpage, reporting 1,700+ adverse events associated with compounded semaglutide and tirzepatide as of May 21, 2026 — against the 775 total, Feb 2025 figures from February 2025 that almost every comparison site is still quoting. Reports are voluntary and do not establish causation, but the trend is the point.
As of 21 May 2026, the FDA reports having received more than 1,700 adverse events associated with compounded semaglutide and tirzepatide. That is more than double the figure still in circulation, in roughly fifteen months.
Adverse-event reports are voluntary, are not adjudicated, and do not by themselves establish causation. That caveat is real and we will not drop it. But a site that quotes the 2025 number in mid-2026 is not being cautious — it is being out of date, and in a direction that flatters the product it is paid to sell.
This matters far beyond one study, because it exposes the flaw in the whole ‘personalized dosing’ defence. Adding B12 was one of the commonest ways compounders argued their product was not “essentially a copy” of the approved drug — a clinical difference that kept them inside the law. The finding shows that the additive did not merely differentiate the product on paper. It chemically changed it, into something nobody has tested in a human being.
What to do: if you are taking a compounded tirzepatide that contains B12 — and many do, often marketed as ‘tirzepatide + B12’ or ‘with methylcobalamin’ — ask your provider and your pharmacy, in writing, whether they have tested for adduct formation. Most will not have. That answer is itself information.
In the 30 April 2026 Federal Register notice (docket 2026-08552), the agency stated that there is no clinical need for outsourcing facilities to compound semaglutide, tirzepatide or liraglutide from bulk — and went out of its way to clarify that supply and affordability are not what the statute means by clinical need.
In plain terms: there are FDA-approved products; they work; patients can be treated with them. Whether a patient can afford them is a different problem, with a different set of policy tools.
That single sentence does enormous work. Every compounded-GLP-1 marketing page in America is, at bottom, an affordability argument. The agency has now said, on the record, that affordability is not a legal basis for compounding these drugs. If you are choosing a compounded programme because it is cheaper, you should know that the regulator has explicitly said that reason does not count.
The numbers behind this page
Checking the figures in this page
Every price quoted in this page comes from the programme's own pricing page and carries the date it was captured. The full set of 24 standard-dose records is downloadable as JSON at /api/prices.json, with molecule and dose class stated on every record. Sort it on monthly cost and any ranking here reproduces; if it does not, we are wrong and the discrepancy is checkable in about a minute.
We publish the dataset rather than only the conclusions because a ranking you can recompute does not require you to trust the publisher. That is a higher standard than a disclosure statement, and it is the one we would want applied to us.
Reading the price against the market
Where this sits in the market
The figures in this page sit inside a market with a measurable shape, and that shape is what makes any single price readable.
12 programmes publish a price for both molecules. Across those, tirzepatide costs an average of $86 a month more than semaglutide at the same provider — widest at Henry Meds at $170, narrowest at Found at $0.
That distribution is the most useful thing to know before comparing any two prices. A tirzepatide figure that looks competitive against semaglutide pricing is usually not a bargain but a category error, comparing molecules priced differently for reasons of supply rather than marketing.
Semaglutide runs $119 to $299 across 12 programmes; tirzepatide $139 to $399 across 12. Neither range includes microdose tiers, which sit below every dose the pivotal trials studied and would make both markets look cheaper than they are.
Where this sits in the market
The figures in this page sit inside a market with a measurable shape, and that shape is what makes any single price readable.
12 programmes publish a price for both molecules. Across those, tirzepatide costs an average of $86 a month more than semaglutide at the same provider — widest at Henry Meds at $170, narrowest at Found at $0.
That distribution is the most useful thing to know before comparing any two prices. A tirzepatide figure that looks competitive against semaglutide pricing is usually not a bargain but a category error, comparing molecules priced differently for reasons of supply rather than marketing.
Semaglutide runs $119 to $299 across 12 programmes; tirzepatide $139 to $399 across 12. Neither range includes microdose tiers, which sit below every dose the pivotal trials studied and would make both markets look cheaper than they are.
Questions this page answers
Where do these prices come from?
Each is read from the programme's own published pricing page and carries its capture date. The full set of 24 standard-dose records is at /api/prices.json with molecule and dose class on every record.
What is the cheapest verified GLP-1 programme?
NexLife at $119 a month for semaglutide and $139 for tirzepatide on its 12-month plan, both at standard therapeutic dosing and first-party verified September 4, 2026. Month-to-month, NexLife is $139 and $169; Oak Longevity ($133, flat, no membership) is the next-cheapest semaglutide programme.
Are compounded GLP-1 medicines FDA-approved?
No. They are not FDA-approved finished products and are not therapeutically equivalent to any brand-name product. FDA does not review them for safety, effectiveness or manufacturing quality before marketing.
Why do the same programmes quote two different prices?
Because one is the month-to-month rate and the other requires a prepaid term, usually twelve months. We rank on the month-to-month figure and state the prepaid rate separately, since a rate requiring a year's commitment is not the same offer.