Is Compounded Semaglutide Still Legal? What Changed in 2025
Every weight-loss telehealth company in our own comparison dispenses compounded semaglutide or tirzepatide. Here's what that word actually means, what changed in the law this past year, and what to ask before you enroll.
"Compounded" is one of those words that shows up in the fine print of nearly every weight-loss telehealth page and rarely gets explained. It matters, and the rules around it changed materially in 2025 — a change none of the three companies in our own investigation address directly on the pages we reviewed.
What "compounded semaglutide" actually is
Compounded semaglutide is prepared by a licensed compounding pharmacy rather than manufactured by Novo Nordisk (which makes Ozempic and Wegovy) or Eli Lilly (which makes the tirzepatide products Mounjaro and Zepbound). Per Novo Nordisk's own patient-safety page, it can share the same active molecule, but it is not the same product: compounded versions are not FDA-approved, meaning that specific compounded batch was never reviewed by the FDA for safety, effectiveness, or manufacturing quality the way the brand-name drug was.
A real quality finding, not a hypothetical. Novo Nordisk's patient-safety page states that some compounding pharmacies have used salt forms of semaglutide — a different active ingredient than the base form used in the FDA-approved products — and that testing of some compounded samples found impurities and other quality issues. This doesn't mean every compounded product is unsafe; it means "compounded" isn't a single, standardized thing the way "Ozempic" is.
What changed in 2025
Compounding semaglutide at this scale was only broadly legal because the drug sat on the FDA's official drug shortage list starting in 2022 — federal law allows expanded compounding during a genuine shortage. That changed last year:
- February 21, 2025
- The FDA announced the semaglutide shortage was resolved, based on the manufacturer's confirmed supply and manufacturing capacity meeting national demand.
- Through April 22, 2025
- 503A compounding pharmacies (smaller-scale, state-licensed) were given a transition window to continue compounding semaglutide.
- Through May 22, 2025
- 503B outsourcing facilities (larger-scale compounders) had a slightly longer transition window.
- After those dates
- Routine, shortage-based compounding of semaglutide is no longer permitted. A pharmacy can still compound it for a specific patient, but only when a prescriber documents a real clinical reason the FDA-approved version won't work for that patient — for example, an allergy to an inactive ingredient, or a need for a different dosage form.
Tirzepatide compounding followed a similar shortage-resolution timeline. The practical effect: "compounded and available to basically anyone who wants it" is no longer the accurate legal picture it was through most of 2023 and 2024. If a telehealth company's current marketing still reads that way without mentioning a documented individual reason, that's worth asking about directly.
How this maps onto our own comparison
All three companies in our Weight-Loss Telehealth investigation — Sesame Care, NewSelf, and TrimRx — disclose that their primary product is compounded and not FDA-approved. That disclosure was accurate and appropriate at the time we reviewed each page. None of the three pages we looked at addressed the narrower legal basis for compounding that took effect in 2025, which is a genuinely useful thing to ask about directly rather than assume either way.
Three questions worth asking any compounded-GLP-1 provider right now:
- What is the specific, documented medical reason I qualify for a compounded version instead of the FDA-approved brand?
- Is the compounding pharmacy 503A or 503B licensed, and can you name it?
- What exact form and salt of the medication does it use — is it the same active ingredient as the FDA-approved product, or a different salt form?
Compounded semaglutide can still be legally prescribed today, but only under narrower circumstances than during the 2022–2025 shortage, and quality varies by pharmacy in ways the FDA has flagged directly. It isn't automatically unsafe, and it isn't automatically fine either — the honest answer depends on the specific pharmacy and the specific reason it's being prescribed to you.
See how Sesame Care, NewSelf, and TrimRx actually compare on pricing, guarantees, and how much they disclose before you pay.
Read the full comparison →Sources
- Novo Nordisk (NovoMedLink) — Compounded "semaglutide" is not FDA-approved
- Forbes Health — Compounded Semaglutide vs. Ozempic: What's the Difference?
- FDA — FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- NCPA — Semaglutide shortage is over, FDA says
Not medical advice. Talk to a real clinician about whether a compounded or brand-name medication is right for you. Questions about this piece? Email contact@healthyhealthsecrets.com. See also our About page and affiliate disclosure.