503B facilities compound in larger batches under FDA registration and cGMP standards.
A 503B outsourcing facility registers with the FDA, follows cGMP standards, and can compound in batches without a patient-specific prescription — but only using substances on the 503B bulks list or for drugs on the shortage list. The FDA proposed excluding semaglutide, tirzepatide, and liraglutide from that bulks list in April 2026.
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.