FDA announces removal of 12 peptides from Category 2 restricted compounding list, including BPC-157, TB-500, MOTS-c, Semax, and Epithalon
The FDA updated its Bulk Drug Substances Nominated for Use in Compounding list, providing notice that it would remove twelve peptide bulk drug substances — including BPC-157, TB-500, MOTS-c, Semax, Epitalon, and GHK-Cu (injectable) — from Category 2 after their nominators withdrew the underlying safety-risk nominations. The agency simultaneously published a Federal Register notice scheduling Pharmacy Compounding Advisory Committee meetings for July 23–24, 2026 and before the end of February 2027 to formally evaluate whether these substances should be added to the 503A bulks list. FDA emphasized that removal from Category 2 does not by itself authorize compounding.
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