A key legal concept: compounders generally may not make a near-duplicate of an available FDA-approved drug.
Federal law restricts compounding a drug that is “essentially a copy” of a commercially available FDA-approved product. During a shortage, that restriction is relaxed. Once the shortage resolves and the drug is considered available again, making a near-duplicate is restricted — which is why the 2024–2025 shortage resolutions changed the market.
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.