FDA puts some peptides off limits Restoring Balance: What the FDA's Peptide Announcement Could Mean for Patient Access and Safety Empower Pharmacy Are Peptides coming off of the FDA Category 2 list? A legal breakdown Holt Law The reason peptide access is changing comes down to two regulatory categories most patients don't know exist: 503A and 503B. 503A = traditional compounding pharmacies. State licensed, patient specific prescriptions. 503B = FDA registered outsourcing RFK Jr. & claimed regenerative peptides like BPC 157 The Niche of the Federal Food, Drug, and Cosmetic Act (FDCA).*