Scottsdale, Ariz. – September 12, 2026 -- An FDA advisory panel voted 8-6-1 in July 2026 to recommend adding BPC-157 free base and BPC-157 acetate to the Section 503A Bulks List, a move that would let pharmacies compound the peptide more broadly if finalized. The vote does not make BPC-157 FDA-approved, and the recommendation is non-binding.
FDA staff had opposed adding BPC-157 to the list
According to FDA materials reviewed by telehealth company Promise, agency review staff proposed against including either form of BPC-157 before the July 23, 2026 committee meeting. The favorable vote reflects a split between committee members and FDA staff, not an agency endorsement. FDA's briefing document notes that neither form of BPC-157 has an applicable USP/NF drug-substance monograph, and neither is a component of an already-approved drug.
Rulemaking on the bulks list addition remains pending. Even if completed, inclusion on the list would not convert compounded BPC-157 into an FDA-approved drug, since compounded preparations generally do not go through the agency's standard approval process.
A 2025 review found no clinical safety data
Human research on BPC-157 remains limited. A 2025 systematic review published in HSS Journal identified 36 studies meeting its inclusion criteria: 35 were preclinical and only one was clinical. The review reported finding no clinical safety data among the studies examined.
That gap means laboratory and animal findings cannot be read as evidence of safety or effectiveness in humans. The regulatory vote addresses how the compound can be sourced and prepared by pharmacies, not whether it works as a treatment.
Access still runs through a licensed physician review
Promise, a doctor-guided telehealth platform based in Scottsdale, Arizona, offers BPC-157 as one of its compounded peptide programs. Patients start with an online medical evaluation, and a licensed physician decides whether a prescription is appropriate. If approved, a licensed U.S. pharmacy compounds and dispenses the preparation. The company states nothing is sold without provider review, though approval is not guaranteed for every request.