Compounded semaglutide and tirzepatide: what to know before you start

By the Next You Health team · Updated November 7, 2026 · 6 min read

Medical review pending. This guide has not yet been reviewed by our medical director.

The short answer

Compounded semaglutide and tirzepatide are prepared by licensed pharmacies for individual patients based on a prescription. They are not FDA-approved, which means FDA has not reviewed them for safety, effectiveness or quality, and they are not the same product as Wegovy, Ozempic, Zepbound or Mounjaro. FDA declared the national shortages of both medications resolved, so the rules for compounding them are now stricter than they were in 2022 to 2024.

What “compounded” means

Compounding is when a licensed pharmacist or physician combines, mixes or alters ingredients to make a medication for a specific patient. It exists for real clinical reasons, for example when a patient needs a different strength, form or ingredient than a commercially available product offers.

Compounded drugs do not go through FDA's pre-market approval process. FDA says telehealth companies should not suggest that a compounded drug is FDA-approved, or that it is the same as, or has been proven as safe and effective as, an approved drug.

How they relate to Wegovy and Zepbound

Semaglutide is the active ingredient in Wegovy, which FDA approved on June 4, 2021, for chronic weight management alongside a reduced-calorie diet and increased physical activity. Tirzepatide is the active ingredient in Zepbound, approved for chronic weight management on November 8, 2023.

A compounded medication can contain the same active ingredient as a branded product and still be a different product. The formulation, added ingredients, strength, quality controls and supporting evidence are not the same, and the clinical trial results for the brands do not automatically apply to compounded versions.

What changed when the shortages ended

While semaglutide and tirzepatide were on FDA's drug shortage list, pharmacies had more room to compound them. FDA later determined that both shortages were resolved: tirzepatide in late 2024 and semaglutide on February 21, 2025. FDA's temporary enforcement discretion for compounders then ended in 2025.

In practice, a pharmacy now generally can't regularly compound what amounts to a copy of an approved product. A compounded prescription usually has to differ in a way the prescriber documents as clinically significant for that patient. Rules in this area have changed several times and may change again.

Questions to ask any telehealth provider

Which pharmacy will prepare my medication, and is it licensed in Florida?
Is the medication compounded or FDA-approved? If compounded, why is it appropriate for me?
Who is my prescribing clinician, and are they licensed in Florida or registered as an out-of-state telehealth provider?
What labs or follow-up visits are required, and what do they cost?
How often am I billed, and how do I cancel?

How Next You Health approaches this

Every prescription treatment requires an evaluation by a licensed clinician who decides whether a medication is appropriate. Not everyone qualifies. Our semaglutide and tirzepatide programs are listed with their exact prices, and the medications are described as compounded. Programs are not yet available while we complete pharmacy, clinical and legal review.

FDA has received reports of adverse events with compounded GLP-1 products, including dosing errors. Only use a GLP-1 medication under the care of a licensed clinician, from a licensed pharmacy.

Sources

This guide is general education and is not medical advice. Talk with a licensed clinician about your own situation. If you have a medical emergency, call 911.