The shortage that made mass-market compounded GLP-1 possible is over. This page tracks what the FDA has done, what remains legal, and what that means before you pay for a compounded program.
Compounding semaglutide and tirzepatide became widespread in 2022–2024 only because both drugs were on the FDA shortage list. That window has closed.
| Question | Answer |
|---|---|
| Are compounded semaglutide and tirzepatide FDA-approved in 2026? | No. They are not FDA-approved, and the FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. They are not the same as Wegovy, Ozempic, Zepbound, or Mounjaro. |
| Is it still legal to get compounded tirzepatide in 2026? | Only narrowly. After shortages resolved and wind-down deadlines passed in 2025, compounding an 'essentially a copy' is restricted. Patient-specific 503A compounding can continue only with a valid individual prescription, where the product isn't essentially a copy and there is a documented clinical reason the branded drug can't be used. Cost alone doesn't qualify. |
| What did the FDA propose on April 30, 2026? | It proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them. Public comments are due by June 29, 2026; a final determination follows after the comment period. |
• A valid prescription written for you specifically after an individual clinical evaluation.
• A product that is not “essentially a copy” of the commercially available branded drug.
• A documented clinical reason the FDA-approved product can’t be used.
• Compounding not done “regularly or in inordinate amounts.”
The FDA has been explicit that affordability and access do not, by themselves, count as a clinical need.