The practical differences: review, quality oversight, consistency, cost, and legal status in 2026.
• Review: FDA-approved products undergo premarket review; compounded do not.
• Consistency: branded products are standardized; compounded vials vary by pharmacy.
• Cost: compounded was cheaper during the shortage; FDA-approved self-pay prices have since fallen.
• Legal status: with shortages resolved, compounding copies is now restricted.
| What to know |
|---|
| Review: FDA-approved products undergo premarket review; compounded do not. |
| Consistency: branded products are standardized; compounded vials vary by pharmacy. |
| Cost: compounded was cheaper during the shortage; FDA-approved self-pay prices have since fallen. |
| Legal status: with shortages resolved, compounding copies is now restricted. |
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.