BPC-157 / Guide

Is BPC-157 legal? Status by country

No country has approved a medicine that contains BPC-157. What that means for you depends on where you live, and in the US the rules are still under review.

By PeptideTracker editorial team · Updated November 9, 2026 · 15 sources

[00] Short answer

  1. BPC-157 is not an approved medicine in any country. FDA's July 2026 review found no approved product containing it anywhere1.
  2. US: FDA's compounding advisers reviewed BPC-157 on July 23, 2026. News reports said they voted 8 to 6 in favor of allowing it in compounding5. The vote isn't binding, and FDA had posted no decision by November 8, 20262–3.
  3. Australia: BPC-157 is Schedule 4 (prescription only), and possessing it without a prescription or other authority is illegal8.
  4. UK and Canada: there is no licensed or authorized BPC-157 product9,13. Health Canada says “research use only” labels don't make peptides legal11.
  5. Sport: WADA bans BPC-157 at all times under class S0, non-approved substances14.

Is BPC-157 legal in the US?

BPC-157 is not FDA-approved, and it isn't part of any approved drug1. That shuts it out of the normal routes into a pharmacy. Federal law lets a 503A compounding pharmacy use a bulk ingredient only if it has a USP monograph, is part of an FDA-approved drug, or is on FDA's 503A Bulks List2. FDA says BPC-157 has no USP monograph and isn't part of an approved drug1, and it isn't on the list.

FDA's briefing also notes that BPC-157 is sold in the US as a dietary supplement ingredient, in capsules and tablets, and that some websites sell it labeled “for research purposes only”1. Neither of those is an FDA approval. FDA has said in warning letters to peptide sellers that a “research use only” label doesn't stop a product being treated as an unapproved drug when the seller's own website shows it's meant for people12.

The research use only guide covers what that label means in more detail.

What did the FDA advisory committee decide on BPC-157 in July 2026?

On July 23, 2026, FDA's Pharmacy Compounding Advisory Committee discussed whether BPC-157 should go on the 503A Bulks List, looking at its use for ulcerative colitis3. FDA's question paper asked for two votes, one on BPC-157 free base and one on BPC-157 acetate4.

FDA's own reviewers recommended against both. They said BPC-157 isn't well characterized, raised concerns about immune reactions from impurities and clumping in injected forms, and found that the data don't support using it for ulcerative colitis. They also found too little safety information in people to describe its risks1. ABC News reported that the committee voted 8 to 6, with 1 abstention, in favor of adding BPC-1575. When we checked on November 8, 2026, FDA had not posted minutes or an official vote count on the meeting page3.

  • The vote is advice, not a decision. FDA's meeting page says advisory committees make non-binding recommendations3. FDA says it won't make a final determination until it has weighed the committee's input and finished its reviews2.
  • Adding it would take a regulation. The law says the 503A Bulks List is developed through regulations2. Until FDA does that, BPC-157 isn't on the list.

Was BPC-157 on FDA's Category 2 list?

Yes, in the past. FDA placed BPC-157 in Category 2, its list of bulk substances that may raise significant safety risks. The nominations that brought it to FDA were later withdrawn, so FDA now lists it under “nominated but withdrawn” (page dated April 22, 2026)6. FDA's current Category 2 list, updated May 14, 2026, doesn't include it7.

Leaving Category 2 didn't mean FDA cleared it. FDA's note on that page still says BPC-157 may carry a risk of immune reactions, may have impurity problems, and that the agency has little or no safety information on it6. FDA then reviewed BPC-157 on its own initiative for the July 2026 meeting1.

BPC-157 legal status by country

BPC-157 has no approval as a medicine in any of these countries. The table shows what the rules say beyond that.

BPC-157 status, checked November 8, 2026
WhereApproved medicine?What the rules say
United StatesNo1Not on the 503A Bulks List, so it doesn't qualify as a compounding ingredient. FDA's advisers reviewed it on July 23, 2026; FDA had posted no decision by November 8, 20262–3
United KingdomNo1,9No licensed product. A substance sold to treat or prevent disease, or that works by a drug-like action, counts as a medicine under UK law10
AustraliaNo9Schedule 4 (prescription only) and Appendix D, clause 5: possession without a prescription or other authority is illegal8
CanadaNo9,13Health Canada generally regulates injectable peptides as prescription drugs and has seized BPC-157 products. “Research use only” labels don't make them legal11
Sport (WADA)Not applicableBanned at all times, in and out of competition, under S0 (non-approved substances) on the 2026 List14

This is a summary of regulator documents, not legal advice. Rules on importing and possessing medicines differ by state, province and territory.

Is BPC-157 legal in the UK?

There is no licensed BPC-157 medicine in the UK. The TGA found it wasn't listed in the MHRA's product database in 20239, and FDA found no approved product in any country in 20261.

Under UK law, a product is a medicine if it's presented as treating or preventing disease, or if it's used to change how the body works through a pharmacological, immunological or metabolic action10. The MHRA decides this case by case, looking at claims, ingredients, websites, social media and customer reviews10. We couldn't find an MHRA statement that names BPC-157 specifically.

Is BPC-157 legal in Australia?

In Australia, BPC-157 is a Schedule 4 prescription-only medicine. It's also listed in Appendix D, clause 5 of the Poisons Standard, which covers poisons that “must not be possessed by a person without authority (for example, possession other than in accordance with a legal prescription)”8.

The TGA proposed this in 2023. Its reasons included that BPC-157 is an experimental therapy with no clinical data in humans, and that similar peptides such as thymosin beta-4, CJC-1295 and ipamorelin were already in Schedule 49. At that time no medicine containing BPC-157 was on the Australian Register of Therapeutic Goods9.

Is BPC-157 legal in Canada?

No BPC-157 product is authorized for sale in Canada. Health Canada's Drug Product Database returns no product with BPC-157 as an ingredient13. Health Canada says injectable peptides are generally regulated as prescription drugs, and that unauthorized drug products are illegal11.

In an April 2026 advisory, Health Canada listed BPC-157 among injectable peptides it had seized. It said products labeled “For Research Use Only – Not for Human Consumption” are not legal or exempt from the rules because of that label11. In May 2026, a supplier recalled BPC-157 powder sold to compounding and community pharmacies, because it was an unauthorized active ingredient15.

Is BPC-157 banned in sport?

Yes. The WADA 2026 Prohibited List names BPC-157 in class S0, non-approved substances, which are prohibited at all times, in and out of competition14. S0 covers any drug with no current approval from a government health regulator for human use14. BPC-157 has been named on the WADA list since January 20229.

For what the studies found, see the BPC-157 overview and BPC-157 vs TB-500.

Questions

Is BPC-157 FDA approved?

No. BPC-157 is not FDA-approved and isn't part of any approved drug. FDA's July 2026 review found no approved BPC-157 product in any country.

Did the FDA approve BPC-157 for compounding in 2026?

Not as of November 8, 2026. FDA's advisory committee discussed it on July 23, 2026, and news reports said it voted 8 to 6 in favor. That vote is non-binding advice. FDA says it won't make a final decision until it finishes its reviews, and adding a substance to the 503A Bulks List takes a regulation.

Is BPC-157 still on FDA's Category 2 list?

No. It was previously in Category 2, but the nominations were withdrawn and FDA now lists it as 'nominated but withdrawn'. FDA's note there still says BPC-157 may carry a risk of immune reactions and impurities, with little safety information.

Can I get BPC-157 on prescription in Australia?

BPC-157 is Schedule 4 in the Poisons Standard, which makes it prescription-only, and Appendix D, clause 5 makes possession without authority illegal. In August 2023, the TGA found no BPC-157 medicine on the Australian Register of Therapeutic Goods. Ask your doctor or pharmacist what that means for you.

Does a 'research use only' label make BPC-157 legal to buy?

No. Health Canada says that label doesn't make peptides legal or exempt from the rules. In the US, FDA has told sellers that the label doesn't stop a product being an unapproved drug when their website shows it's meant for people.

Can athletes use BPC-157?

No. WADA lists BPC-157 under S0, non-approved substances, banned at all times in and out of competition on the 2026 List.

Sources

Checked against FDA's July 2026 Pharmacy Compounding Advisory Committee documents and 503A lists, the Australian Poisons Standard (October 2026), MHRA guidance, Health Canada advisories and the WADA 2026 Prohibited List. How we check

  1. 1FDA Briefing Document: BPC-157-related bulk drug substances, Pharmacy Compounding Advisory Committee, July 23-24, 2026. sections I, II.A, II.B.3-4 and III
  2. 2FDA Briefing Document: introduction, Pharmacy Compounding Advisory Committee, July 23-24, 2026. statement on final determination; section I.A on section 503A(b)(1)(A)(i)
  3. 3FDA: July 23-24, 2026 meeting of the Pharmacy Compounding Advisory Committee. agenda and materials; no minutes or vote record posted when checked on November 8, 2026
  4. 4FDA: Pharmacy Compounding Advisory Committee, July 23-24, 2026, questions
  5. 5ABC News: FDA advisory committee votes to add popular peptide BPC-157 to drug compounding list, July 23, 2026. news report; source of the 8-6 vote count
  6. 6FDA: Certain bulk drug substances for use in compounding that may present significant safety risks. 'Bulk drug substances nominated but withdrawn'; content current as of April 22, 2026
  7. 7FDA: Bulk drug substances nominated for use in compounding under section 503A (Categories 1, 2 and 3). updated May 14, 2026; Category 2 list
  8. 8Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Federal Register of Legislation (Australia). in force from September 30, 2026 (replaces the June 2026 instrument); Schedule 4 entry and Appendix D, clause 5
  9. 9TGA: Consultation on proposed amendments to the Poisons Standard, ACMS and ACCS meetings, November 2023 (section 1.3, BPC-157). dated September 1, 2023; reasons, Australian and international regulations
  10. 10MHRA: Borderline products: how to tell if your product is a medicine. updated July 2, 2026
  11. 11Health Canada: Think twice before injecting peptides bought online (public advisory RA-81874). published April 9, 2026
  12. 12FDA warning letter to Peptide Partners LLC, August 24, 2026. footnote 1 on 'for research use only' labeling
  13. 13Health Canada Drug Product Database, active ingredient search for BPC. no products found, searched November 8, 2026
  14. 14World Anti-Doping Agency: 2026 Prohibited List. class S0, non-approved substances; in force from January 1, 2026
  15. 15Health Canada: GHK-Cu & BPC-157 powder, unauthorized active pharmaceutical ingredients (recall RA-82047). Type I recall, May 5, 2026

This guide explains what labels and published studies say. It isn't medical advice and doesn't replace your prescriber or pharmacist.

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