As of April 2026, the FDA formally proposed - in a Federal Register notice - removing semaglutide, tirzepatide, and liraglutide from the 503B outsourcing bulks list
The review process generally takes 12-18 months, after which decisions on approval and any licensing conditions are made
McDonnell, T., Cussen, L., McIlroy, M
2026 PS Peptides Shop Retatrutide Reconstitution Guide Semaglutide Guide
Diabetes Care 41 , e133e135 (2018)
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