Legal Status of BPC-157: FDA, WADA, TGA & EU

Summary: This guide explains the legal status of BPC-157 in major regions. It covers the FDA’s stance, WADA’s prohibition, Australia’s TGA scheduling, and the EU framework. The article is for education only, not for legal or medical advice. For science details, see the comprehensive BPC-157 guide.

Introduction: Interest in peptides has grown worldwide. The legal status of BPC-157 is one of the most asked questions. BPC-157 is not approved as a medicine in most places, cannot be sold as a dietary supplement in the U.S., and remains banned in sport. Each region uses its own system, so understanding the legal status of BPC-157 requires looking at drug approval, compounding, supplement law, import rules, and anti-doping policy.

Why the legal status of BPC-157 confuses many people

Peptides often fall into grey areas. A substance may be unapproved as a drug but still marketed “for research only.” It can also appear on anti-doping lists even when no country approves it as medicine. Therefore, the legal status of BPC-157 seems contradictory: widely marketed online yet restricted by regulators and anti-doping authorities.

United States: FDA’s position and supplement laws

FDA: unapproved new drug, not a dietary ingredient

In the U.S., the legal status of BPC-157 starts with the Food, Drug, and Cosmetic Act. Any product that claims to diagnose, treat, or affect the body is a drug. Because FDA never approved BPC-157, products sold for human use are “unapproved new drugs.” FDA warning letters cite companies selling it in injectable or intranasal form (FDA warning letter). In short, U.S. law does not allow marketing BPC-157 for people.

In addition, FDA listed BPC-157 in its Category 2 compounding risk list. The agency states that Category 2 substances may carry safety risks such as immune reactions or poor quality control (FDA compounding list). This means U.S. pharmacies cannot compound BPC-157 under the interim policy. FDA also makes clear that it is not a legal dietary ingredient, so supplement sales are not permitted.

Implications for U.S. users

• BPC-157 has no FDA approval. Selling for human use counts as an unapproved drug.
• Pharmacies cannot compound it under current FDA policies.
• It cannot be lawfully sold as a dietary supplement.

World Anti-Doping Agency: strict prohibition

The legal status of BPC-157 in sport is very clear. WADA bans it under S0: “Non-approved substances.” This category covers any drug not approved by a regulator. BPC-157 appears on WADA’s 2025 Prohibited List (WADA Prohibited List, 2025 PDF). National agencies like USADA confirm this (USADA BPC-157 advisory). Therefore, athletes must treat BPC-157 as banned in and out of competition.

Australia: TGA scheduling and enforcement

Schedule 4 with Appendix D controls

Australia took a strict step in 2024. The TGA listed BPC-157 as a Schedule 4 medicine with Appendix D clause 5. This means it is prescription-only and possession without authority is illegal. The rule took effect on 1 June 2024 (TGA final decision, Poisons Standard 2024). As a result, the legal status of BPC-157 in Australia makes supply and possession tightly controlled.

Sports enforcement

Sport Integrity Australia echoes WADA’s position (SIA BPC-157 page). Thus, for Australian athletes, BPC-157 is both prescription-only and banned in sport.

European Union: EMA and novel food law

No EMA approval

The EMA has never authorized BPC-157 as a medicine (EMA authorization overview). Therefore, the legal status of BPC-157 in the EU remains “unapproved medicine.” No EU country lists it as a registered drug.

Not a legal supplement

Could it be sold as a supplement? No. EU Novel Food law bars unapproved novel ingredients. The Commission’s Novel Food catalogue shows no entry for BPC-157 (EU Novel Food tools). Therefore, EU supplement marketing is not legal.

Other countries

New Zealand

Medsafe notes that no BPC-157 medicine exists. They considered placing it under prescription controls (Medsafe minutes). Thus, the legal status of BPC-157 in New Zealand is restrictive.

Canada

Health Canada seizes unauthorized peptides and warns about safety (Health Canada recall). Therefore, the legal status of BPC-157 in Canada is “unauthorized.”

Anti-doping vs. national law

Even if one country approved it, WADA S0 would still ban it. As a result, athletes face a uniform rule worldwide: BPC-157 is prohibited regardless of legal drug status.

Misconceptions about the legal status of BPC-157

“It’s sold online, so it must be legal.”

That is false. FDA warning letters prove that online sales are not approval. “Research only” labels do not change the legal status of BPC-157.

“It’s a supplement ingredient.”

No regulator lists BPC-157 as a lawful supplement. EU and U.S. laws clearly reject that use.

“Australia allows prescriptions, so importation is fine.”

No. Schedule 4 plus Appendix D rules mean unauthorized imports are illegal. Customs seizes shipments under these rules.

Checklist: how to read the legal status of BPC-157

1. Athletes: BPC-157 is always banned under WADA S0 (WADA list).
2. United States: FDA does not approve it; sales and compounding are not legal.
3. Australia: Schedule 4 with possession controls; unauthorized supply and import banned.
4. EU: No EMA approval; not in Novel Food list; supplement marketing is illegal.
5. Canada and New Zealand: Agencies restrict or seize products; BPC-157 is unauthorized.

Timeline of legal changes

• 2010s: Online sales as “research use.” No drug approvals.
• 2022: WADA adds BPC-157 to Prohibited List.
• 2023–2025: FDA issues warning letters; Australia places BPC-157 in Schedule 4 with Appendix D.

Bottom line: the legal status of BPC-157

The legal status of BPC-157 is restrictive everywhere. FDA calls it an unapproved drug. WADA bans it for athletes. Australia lists it as prescription-only with strict controls. The EU does not approve it as a medicine or supplement. Therefore, whether you are a clinician, athlete, or consumer, treat BPC-157 as investigational only. For more science background, see our BPC-157 guide.