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The medicines

Compounded GLP-1 medicines

During the shortages of 2022 to 2025, compounding pharmacies made their own versions of semaglutide and tirzepatide, and many people still take them. They are not FDA-approved products, and the FDA has been unusually vocal about the risks. This page sets out what it has said.

By the Cafeity teamUpdated 3 min read

The short answer

Compounded GLP-1 medicines are versions of semaglutide or tirzepatide made by compounding pharmacies rather than approved manufacturers. The FDA does not review compounded drugs for safety, effectiveness or quality before they are marketed, and it has reported concerns including dosing errors — some leading to hospitalisation — and the use of unapproved salt forms.12 With the national shortages resolved, the FDA has clarified that compounders face tighter limits on making copies of approved drugs.3 If you take a compounded product, check the concentration and the dose in both milligrams and millilitres with your pharmacist, every time.

What compounding is

Compounding is when a pharmacy prepares a medicine itself rather than dispensing a manufactured product — legitimately, for example, to make a version without an ingredient someone is allergic to. During drug shortages, the rules allow wider compounding of copies of approved drugs. That is how compounded semaglutide and tirzepatide became widespread while the approved products were in short supply.

What the FDA has said

  • Not FDA-approved. Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality before they are sold.1
  • Dosing errors. The FDA has warned about dosing errors with compounded injectable semaglutide, including people measuring and injecting the wrong amount and prescriptions calculated wrongly, some needing hospital care.2
  • Unapproved forms. It has raised concerns about products using salt forms of the active ingredients that are not the ones in approved products.1
  • After the shortages. With the shortages resolved, the FDA set end dates for the temporary flexibility it had allowed. Outside a shortage, compounders are generally not permitted to make what are essentially copies of an approved drug.3

Rules have changed several times; the FDA's own pages are the current authority.

If you take a compounded product

  • Make sure the product, concentration and dose are written down — in milligrams and in the volume or "units" you draw — and confirmed by your pharmacist.
  • Use the syringe your pharmacy supplies and ask to be shown how to measure the dose.
  • Record exactly what you inject, every time, so an error is visible rather than repeated.
  • Report side effects to your prescriber, and to the FDA through MedWatch.4

Cafeity records whatever you tell it, including compounded prescriptions. It will never calculate a dose, convert units to milligrams for you, or recommend a source — those need your pharmacist.

When to contact your prescriber

Common questions

Is compounded semaglutide FDA-approved?
No. Compounded drugs are not reviewed by the FDA for safety, effectiveness or quality before they are marketed.1
Is compounded semaglutide still legal?
The rules tightened once the national shortages were resolved; the FDA has set out its current policy for compounders.3 Ask your pharmacist or prescriber about your own prescription.
Does Cafeity work with compounded medicines?
Yes, it records what you take. It never calculates or converts doses and never recommends a source.

Sources

  1. FDA's concerns with unapproved GLP-1 drugs used for weight loss US Food and Drug Administration
  2. Compounding risk alerts (including dosing errors with compounded injectable semaglutide, July 2024) US Food and Drug Administration
  3. FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize US Food and Drug Administration
  4. MedWatch — report a side effect to the FDA US Food and Drug Administration
  5. Semaglutide injection and tablets for weight management — US prescribing information DailyMed, US National Library of Medicine, version published 30 June 2026

Written by the Cafeity team from the sources listed here. Figures from prescribing information are quoted as the label states them; trial results are averages from those trials, not predictions for any one person. This page has not yet been reviewed by a clinician — see the editorial policy for how pages are researched and corrected.