Peptide Regulation Watch · Substance File

BPC-157

Not Permitted STATUS VERIFIED AUGUST 22, 2026 · HAS A SHELF LIFE

A synthetic peptide fragment derived from a human gastric protein, widely discussed in healing and repair contexts — and, as of the date above, not lawful to compound for human use via any pathway.

Also encountered as: Body Protection Compound-157 · class: healing / repair

Where it actually stands

On July 23–24, 2026, FDA's Pharmacy Compounding Advisory Committee voted to recommend BPC-157 for the 503A compounding bulks list. (Trade reports differ on the exact tally; FDA has posted no official vote record.) That vote is the most misread event in this space: PCAC is advisory, FDA staff entered the process recommending against, and no rulemaking has followed. BPC-157 sits on no permitted category and is not on the 503B bulks list. Removal from Category 2 in April placed it in no category — limbo, not clearance.

The one-sentence version: a committee recommended it; the agency has not acted; it cannot lawfully be compounded for human use today.

The record

APR 1, 2026

Utah physician indicted for supplying misbranded, China-sourced peptides — including BPC-157 — to 200+ patients.

APR 15, 2026

FDA removes BPC-157 (among 12 peptides) from Category 2 — placing it in no category. Docket FDA-2025-N-6895.

JUL 23–24, 2026

PCAC votes to recommend for the 503A bulks list. Advisory, non-binding, over FDA staff objections.

AUG 2026

No FDA rulemaking. Expert timelines put actual rule changes 12–24+ months out; "research use only" marketing remains an enforcement target.

Primary sources

FDA PCAC meeting record, Jul 23–24 2026 · Federal Register doc. 2026-07361 / docket FDA-2025-N-6895 · FDA bulk substances / safety-risk pages (updated 4/22/26) · DOJ records, D. Utah indictment, Apr 2026 · Holland & Knight client alert, Aug 4 2026. Full citation list available on request.