The FDA has been explicit that affordability and access do not, by themselves, justify a compounded copy.
“It’s cheaper than Zepbound” is not a lawful clinical basis for a compounded copy. For most people who chose compounded GLP-1 primarily to save money, the remaining 503A exceptions generally do not apply.
| What to know |
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| The FDA has been explicit that affordability and access do not, by themselves, justify a compounded copy. |
| “It’s cheaper than Zepbound” is not a lawful clinical basis for a compounded copy. |
The FDA resolved the tirzepatide (Dec 2024) and semaglutide (Feb 2025) shortages, and wind-down deadlines passed in 2025. On Apr 30, 2026 the FDA proposed excluding these drugs from the 503B bulks list; public comments are due by Jun 29, 2026. Patient-specific 503A compounding continues only narrowly, and cost alone is not a clinical need. Full regulatory status →
Compounded semaglutide and tirzepatide are not FDA-approved and are not the same as Wegovy, Ozempic, Zepbound, or Mounjaro. The FDA does not review compounded drugs for safety, effectiveness, or quality before marketing. Primary source: FDA — Human Drug Compounding.