The most important comparison on this site: the FDA-approved branded products versus compounded copies, on review status, consistency, cost, and 2026 legal standing.
| Factor | FDA-approved (Zepbound, Wegovy, Ozempic) | Compounded semaglutide/tirzepatide |
|---|---|---|
| FDA premarket review | Yes — safety, effectiveness, quality | No |
| Consistency | Standardized, fixed-dose | Varies by pharmacy; multi-dose vials |
| Self-pay cost (2026) | ~$349–$499/mo (fell sharply) | ~$133–$278/mo advertised |
| Insured copay | As low as ~$25/mo (eligible) | Usually not insurance-billable |
| 2026 legal status | Standard prescription | Narrow after shortages resolved |
Compounded can be cheaper cash, but the gap narrowed in 2026 and FDA-approved products are reviewed and standardized. If you have commercial coverage, the branded copay is often the lowest and the reviewed option. Price both at your dose. See FDA-approved cash price.
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.