The FDA resolved the tirzepatide shortage in December 2024, which changed what pharmacies may compound.
The FDA removed tirzepatide from its shortage list in December 2024. 503A pharmacies had until Feb 19, 2025 and 503B facilities until Mar 19, 2025 to wind down. With the shortage resolved, compounding an “essentially a copy” is restricted.
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.