Compound Changes - The Era of Customized Compounded Medication
Date Published
- Twitter
- Facebook
- LinkedIn
- Instagram
- Copy Link
As of today, May 22, 2025, 503B compounding pharmacies are no longer allowed to make essential copy versions of semaglutdie. This marks a major shift in how compounded versions of semaglutide are handled—and it's closer to how tirzepatide has been operating.
We're working closely with providers to understand how they plan to respond, but please give us a little grace as many may be changing or winding down their compounded offerings altogether. Some may continue offering it, but only in customized formulations.
What does this mean for you?
If the brand-name versions of these medications (like Mounjaro, Zepbound, Ozempic, or Wegovy) are appropriate for your needs, you may no longer qualify for a compounded version. Compounded medications now require a clear medical justification—and not everyone will meet that standard.
Is compounded semaglutide or tirzepatide going away?
Not entirely, but it’s definitely becoming more limited. To continue with compounded versions, you’ll need to work with your prescriber to determine if you qualify under the new rules. If you're already on a custom dose or formulation, you may be able to continue.
What qualifies someone for a compounded version?
Your provider will need to document a medical reason that a commercially available, FDA-approved version is not appropriate. Examples may include:
- You have allergies to an ingredient in Mounjaro, Zepbound, Ozempic, or Wegovy.
- You can’t tolerate the standard available doses (e.g., 2.5, 5, 7.5, 10, 12.5, or 15 mg).
- You need a custom formulation (e.g., combining tirzepatide or semaglutide with another ingredient in a medically necessary way).
It’s also worth noting: we expect litigation to increase. Eli Lilly and Novo Nordisk have both taken aggressive steps to limit unauthorized use of their active pharmaceutical ingredients. That may lead many providers to voluntarily stop offering compounded versions—even when technically legal—to avoid legal risk.
If you're losing access to compounded tirzepatide or semaglutide...
We’re here to help. We’ll continue to support patients with:
- Providers supporting brand-name medications, when appropriate
- Providers supporting customized compounded semaglutide and tirzepatide (when medically justified)
What if you're already on customized compounds?
You may already be on a customized dose if your compounded prescription includes additives or unique dosing. If that's the case this news may not change anything for you.
If your provider stops offering compounded medication and you feel you have a medical need because name brand medication is not an option for you, we will have plenty of options.
We know this is a frustrating moment, especially if you've had success with compounded versions.
Keep Reading
Curated by
