U.S. regulatory status

BPC-157

Also known as Body Protection Compound 157 · Bepecin · PL 14736

Under reviewNot on the 503A Bulks List; before the FDA advisory committee Jul 23, 2026

Is BPC-157 legal right now?

BPC-157 is not an FDA-approved drug and is not on the FDA's Section 503A Bulk Drug Substances List, so compounding pharmacies have no affirmative federal authorization to compound it. It is scheduled for evaluation by the FDA's Pharmacy Compounding Advisory Committee (PCAC) on July 23, 2026 (Docket FDA-2025-N-6895), where the FDA's own pre-meeting briefing proposes NOT adding it to the list, citing characterization, immunogenicity, and efficacy concerns. No final determination has been made; the committee's recommendation is advisory, and any addition would still require formal rulemaking.

Under review: Actively before the FDA advisory committee; a decision is pending and the status can move.

Verified Jul 7, 2026 (ET) · status held since Apr 16, 2026

Primary source: Federal Register All 3 sources

Where it sits in the process

Nominated(completed)
Under review(current stage)
Rulemaking(upcoming)
Compounding-legal(upcoming)

Next milestoneFDA advisory committee (PCAC) evaluates BPC-157 for the 503A list - Jul 23, 2026 (in 15 days)

What changed last

Apr 16, 2026
Placed on the July 23, 2026 FDA advisory committee agenda (Docket FDA-2025-N-6895); FDA's briefing proposes not adding it to the 503A list.
Review scheduledView on federalregister.gov

Status elsewhere

BPC-157: regulatory status by jurisdiction
Jurisdiction	Status	Note
United States (FDA)	Under review	Not on the 503A Bulks List; under active PCAC review, meeting July 23-24, 2026.
Australia (TGA)	Restricted	Reported as Schedule 4 (prescription-only) under the Poisons Standard.
Sport / anti-doping (WADA)	Restricted	Prohibited at all times under category S0 (non-approved substances).

Sources & transparency

Sources for this entry

Federal Register - PCAC notice of meeting (Docket FDA-2025-N-6895) Federal Register · primaryAnnounces the July 23-24, 2026 PCAC meeting and BPC-157 on the July 23 agenda.
FDA - PCAC briefing document, BPC-157 (July 2026 meeting) FDA · primaryFDA proposes not adding BPC-157 to the 503A list.
USADA - BPC-157 prohibited for athletes analysisProhibited under WADA category S0.

Last verified by a human: Jul 7, 2026 (ET) · how we verify
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