Update
FDA advisory committee votes to recommend BPC-157 and TB-500 for pharmacy compounding, over agency staff's own objections
Reported by Maciek Zaremba
At its July 23-24, 2026 meeting, FDA's Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 to recommend adding both BPC-157 and TB-500 to the 503A Positive Bulk Drug Substances List, despite FDA staff's own briefing materials recommending against listing both substances, citing a lack of human injectable safety and efficacy data for either compound.
What changed
The PCAC, an outside advisory committee, voted in favor of recommending both substances for the list that would let compounding pharmacies legally prepare them. This is the first formal advisory vote in favor of either compound's compounding legality.
What didn't change
Neither substance is FDA-approved for any use. A PCAC vote is a recommendation only — FDA itself must still propose adding a substance to the 503A list through formal notice-and-comment rulemaking, which had not happened as of this writing. No product containing either substance is legally marketed for human use.