The FDA has said semaglutide shortages are resolved and has proposed excluding it from the 503B bulks list.
In 2026 the FDA has stated that semaglutide shortages are resolved and has proposed excluding semaglutide (and tirzepatide and liraglutide) from the 503B bulks list. This affects how and where compounded semaglutide can be produced. Compounded semaglutide remains not FDA-approved as a finished product, and patients should use licensed providers and verifiable pharmacies.
With shortages declared resolved, the regulatory basis for some large-scale compounding narrows. The proposed 503B bulks exclusion would further limit outsourcing-facility production.
Access may shift toward 503A patient-specific compounding where clinically appropriate. Verify your provider's pharmacy and licensure, and confirm pricing before enrolling.
Access continues through licensed providers, though the regulatory landscape is evolving with the shortage resolution and 503B bulks proposal.
Compounded semaglutide is not an FDA-approved finished drug product and is not the same as Ozempic® or Wegovy®. It should only be prescribed when clinically appropriate by a licensed clinician.
An FDA proposal to exclude semaglutide, tirzepatide, and liraglutide from the list of bulk substances 503B outsourcing facilities may compound.
Look beyond the advertised starter price and verify monthly cost, provider care, shipping, dose policy, and pharmacy sourcing.