What changed at the FDA, how a prescriber decides where you restart, what the approved versions cost in 2026, and the exact list to bring to your appointment.
The legal basis for large-scale compounding of these drugs rested on the FDA shortage list. The FDA declared the tirzepatide shortage resolved in December 2024 and the semaglutide shortage resolved in February 2025. Once a drug is off the shortage list, the exemption that allowed pharmacies to mass-produce copies goes away with it.
What followed was the heaviest enforcement this category has seen. In September 2025 the FDA published more than 55 warning letters to online sellers of compounded GLP-1 products. On 3 March 2026 it issued 30 warning letters to telehealth companies whose websites suggested compounded versions were equivalent to the approved drugs, giving them 15 business days to correct. A further round of 25 letters followed in June 2026, covering website content, social posts and patient messaging.
On 30 April 2026 the FDA proposed removing semaglutide, tirzepatide and liraglutide from the 503B bulks list, the catalogue of ingredients outsourcing facilities are allowed to compound from in bulk. The stated finding was that there is no clinical need. If that proposal is finalised, the last high-volume pathway closes.
What remains is narrow: a 503A pharmacy filling a prescription for one specific patient with a documented individual reason — an allergy to an inactive ingredient, for example. That is not a route for routine monthly refills, and it is not a route most telehealth programs can operate at scale. The large platforms have already moved off compounded semaglutide.
The practical takeaway: treat the switch as something to plan, not something to wait out. Supply is not coming back.
| Product | Molecule | Start | Steps |
|---|---|---|---|
| Wegovy (injection) | semaglutide | 0.25 mg weekly | 0.25 → 0.5 → 1 → 1.7 → 2.4 mg, at least 4 weeks per step. A 7.2 mg high-dose option was added to the label in 2026. |
| Wegovy (tablet) | semaglutide, oral | daily tablet | Approved for weight management in 2026. A different product from Rybelsus, which is licensed for type 2 diabetes only. |
| Ozempic | semaglutide | 0.25 mg weekly | 0.25 → 0.5 → 1 → 2 mg. Indicated for type 2 diabetes, not weight management. |
| Zepbound | tirzepatide | 2.5 mg weekly | Titrated upward in steps. A different molecule from semaglutide. |
| Foundayo (orforglipron) | orforglipron, oral | daily tablet | Approved April 2026. A different molecule again — not semaglutide, not tirzepatide. |
These are the labeled schedules. Where you start is a separate question, and it is the next section.
Most compounded programs mirrored the Wegovy ladder: 0.25, 0.5, 1, 1.7, 2.4 mg. Some compressed it. Some used increments that appear on no approved label at all. So the milligram number on your vial is only one of three things that decide where you restart, and on its own it is the weakest of the three.
1. What was actually in the vial. Only semaglutide base is the approved form. A number of compounded preparations used salt forms such as semaglutide sodium or acetate, which are not approved and were never established to deliver the same amount of drug. If your label names a salt form, your effective exposure is not something anyone can assume carries across.
2. Whether your schedule maps onto a labeled one. If you finished on a compressed ladder or a non-standard increment, there is no step on the approved label that corresponds to where you are.
3. How long the gap has been. Tolerance to the gastrointestinal side effects fades. A few weeks off and a prescriber may step you back down regardless of where you left off — not to be cautious for its own sake, but because the nausea comes back with the dose.
For contrast, the clean case is Ozempic to Wegovy: identical molecule, established content, and prescribers typically continue at the matching strength rather than re-titrating. Compounded to brand is not that case, because what was in the vial was never characterised the way a labeled product is. And compounded semaglutide to Zepbound is not a conversion at all — different molecule, no mapping, the standard approach is to begin at 2.5 mg and titrate.
So: do not pick your own number, and do not let a website pick it for you. Bring the facts below and let the person writing the prescription decide. That is the entire reason this page has a checklist instead of a chart.
Five routes, roughly cheapest to most expensive. Every figure here moves — manufacturers have been repricing these programs every few months, and introductory offers expire on fixed dates. Check the official page before you build a budget on a number.
| Route | Rough monthly cost | Catch |
|---|---|---|
| Commercial insurance plus manufacturer savings card | Lowest available | Requires your plan to actually cover the drug for weight management. Many plans prefer one brand and require an exception process for the other. |
| Medicare GLP-1 Bridge | Flat copay, introduced July 2026 | Eligibility criteria apply and the program runs for a limited period. |
| Manufacturer direct self-pay — oral options | Low end of the range | Promotional pricing with expiry dates. |
| Manufacturer direct self-pay — injections (NovoCare, LillyDirect) | Middle of the range, varies by dose | Government beneficiaries (Medicare, Medicaid, TRICARE, VA) are excluded. Self-pay does not count toward your deductible or out-of-pocket maximum. The prescription has to be sent to that specific pharmacy. |
| Retail without insurance | Well into four figures | The list price. Almost nobody should end up here without checking the routes above first. |
The gap between compounded and brand-name pricing has narrowed considerably since 2025. If cost was your only reason for being on a compounded product, the arithmetic may have changed since you last ran it. Full cost breakdown.
The appointment goes faster and lands better when the prescriber has the three inputs above in front of them. Seven things:
Do I have to restart at 0.25 mg? Not necessarily. Restarting low is the conservative default, not an automatic rule — it depends on the three factors above, particularly the gap since your last dose.
Can I keep taking a compounded version? Patient-specific compounding at a 503A pharmacy remains legal in narrow circumstances tied to a documented individual clinical need. What is ending is routine high-volume supply, which is what most telehealth programs were running on.
Will I regain weight during the gap? Some, usually. How much and how fast is covered on the stopping and regain page.
Will the approved version feel different? It can. Approved products have established content and delivery, so if your compounded preparation was under- or over-delivering, the side-effect profile may shift. What to expect, week by week.
I was doing fine and now I have to change everything. Is my progress gone? No. A transition gap is a pause, not a reset — see how a stall compares against the trial curve on the plateau page.
FDA statements on compounding and the resolution of the semaglutide and tirzepatide shortages; the FDA announcement of 30 warning letters to telehealth companies, 3 March 2026; the FDA proposal to exclude semaglutide, tirzepatide and liraglutide from the 503B bulks list, 30 April 2026 (Federal Register, docket FDA-2018-N-3240); the current prescribing information for Wegovy, Ozempic and Zepbound; and the published NovoCare and LillyDirect self-pay program pages.
Last reviewed 14 September 2026. Prices and program terms change frequently; verify on the manufacturer pages before relying on a figure.
This page is information, not medical advice. It does not recommend a dose, a product or a provider, and it is not a substitute for a consultation with a licensed clinician who can see your history. Compounded medications are not FDA-approved and have not been reviewed by the FDA for safety, effectiveness or manufacturing quality. Decisions about starting, stopping, switching or dosing a prescription medication belong with your prescriber.
Some links on this site are affiliate links, which means we may earn a commission if you start a paid program through them. This does not change what is written above, and we are not paid to recommend any particular dose or product.
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