After a shortage, lawful 503A compounding generally requires a documented clinical reason the branded drug can’t be used.
Examples a clinician might document include a need for a formulation or dose not commercially available, or a documented allergy to an inactive ingredient in the approved product. A general preference, convenience, or price is not, by itself, a clinical need.
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.