Category 1 vs. Category 2. The FDA's peptide update, explained. Category 2 peptides are on the FDA's difficult to compound list, which effectively blocks licensed pharmacies from producing them. Category 1 means Development of 503B Bulks List FDA Moves to Reevaluate Several Peptides American Med Spa Association Regulatory Alert: FDA's April 2026 Update on BPC 157 and GHK Cu Holt Law RFK Jr. & claimed regenerative peptides like BPC 157 The Niche
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fda category 2 bulk drug substances bpc-157 list FDA considers adding a dozen peptides to its bulk drug compounding list