What is the current regulatory status of BPC-157?

In late 2023 the FDA placed BPC-157 into 503A Category 2, which effectively prohibited compounding it. In April 2026 it was removed from Category 2, but it was not added to the 503A positive list — the list of substances affirmatively permitted — so it became neither prohibited nor authorised. In July 2026 the Pharmacy Compounding Advisory Committee voted 8–6 to recommend adding it to that list. That vote is a recommendation rather than a rule: the FDA has not acted on it, and doing so requires formal rulemaking that ordinarily takes a year or more. As things stand it remains without FDA approval and without an approved indication.