503B bulks list
FDA list of drugs outsourcing facilities may compound from bulk substance. Semaglutide proposed for removal April 2026.
503B outsourcing facilities can only compound from bulk drug substances on this FDA list (or facing shortage). On April 30, 2026 the FDA proposed permanently removing semaglutide, tirzepatide, and liraglutide, finding no clinical need. If finalized, large-scale compounded GLP-1s end.