Short answer: no. Here’s what that means for safety, quality, and your decision.
No. Compounded semaglutide and tirzepatide are not FDA-approved, and the FDA does not review compounded drugs for safety, effectiveness, or quality before they are marketed. “FDA-registered pharmacy” (for 503B) is not the same as an FDA-approved drug.
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.