FDA removes 12 peptides from Category 2; review set for July

The Food and Drug Administration announced on April 15, 2026 that 12 peptide-related bulk drug substances would be removed from Category 2 of its interim 503A compounding framework after seven calendar days, because the nominations asking FDA to add them to the 503A bulks list had been withdrawn. The next day, a Federal Register notice (91 FR 20465) announced an advisory committee meeting for July 23-24 to consider seven of them for the bulks list anyway.

The 12, as listed by the SSRP Institute on the day of FDA’s update (Orrick’s analysis gives the same count): BPC-157, TB-500 (thymosin beta-4 fragment), KPV, MOTS-c, emideltide (DSIP), Semax, Epitalon, cathelicidin LL-37, dihexa, GHK-Cu for injection, PEG-MGF and Melanotan II.

Category 2 in one paragraph

FDA sorts nominated bulk substances into three interim categories while it decides whether to add them to the 503A bulks list by rulemaking. Category 1 substances get interim enforcement discretion; Category 2 substances are ones where FDA “has identified significant safety risks”; Category 3 nominations lacked enough information. In 2023, FDA placed a group of peptides in Category 2, citing immunogenicity, peptide-related impurities and limited human safety data. Our Category 2 explainer lists each substance and FDA’s stated reasons.

Not a green light

The law firm Orrick’s April 16 analysis puts it plainly: removal from Category 2 “does not, by itself, place these substances on the 503A bulks list or into Category 1 for which FDA is exercising enforcement discretion.” The substances were not moved to Category 1 and were not added to the bulks list. On FDA’s page today they sit in a table headed “Bulk drug substances nominated but withdrawn,” with the same safety language FDA wrote when it first categorized them.

The political backdrop

The change came seven weeks after HHS Secretary Robert F. Kennedy Jr. said on Joe Rogan’s podcast that he was “a big fan of peptides” and expected action on about 14 of them (report). On the day of the update, Kennedy wrote in a post on X, as reported by Scientific American, that the action “begins to restore regulated access and will immediately begin shifting demand away from the black market.”

What followed

The advisory committee voted on July 23-24 to recommend six of the seven peptides (report). In October an interim access policy went to OMB (report). FDA said the remaining five would go to a PCAC meeting before the end of February 2027.