What compounded semaglutide and tirzepatide are, how they differ from FDA-approved products, and why the distinction matters.
Compounded GLP-1s are prepared by licensed pharmacies for an individual patient, not mass-manufactured and FDA-reviewed like Wegovy, Ozempic, Zepbound, or Mounjaro. They use the same active ingredient name but are not the same product and are not FDA-approved. Quality depends entirely on the specific pharmacy.
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 (comment closed 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.