Mounjaro is the FDA-approved product; compounded tirzepatide is a pharmacy preparation that is not FDA-approved. They are not interchangeable.
• Mounjaro: FDA-approved, premarket-reviewed, standardized, fixed-dose delivery.
• Compounded tirzepatide: not FDA-approved, not reviewed for safety/effectiveness/quality, quality varies by pharmacy.
• Cost: compounded was cheaper during the shortage; FDA-approved self-pay prices have since fallen, so price both.
• Legal status: with the tirzepatide shortage resolved, compounding a near-copy is now restricted.
They share an active-ingredient name but are not the same product and are not interchangeable.
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.