# BPC-157 BPC-157 is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only, so nobody knows if it helps people or how safe it is. Status checked: 2026-10-24. Last verified: 2026-10-25. Primary source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks This page has not been individually reviewed by a clinician. Information, not medical advice. | Fact | Value | Tier | Checked | Source | |---|---|---|---|---| | Also called | BPC 157, Body Protection Compound-157, Bepecin, PL 14736 | primary | 2026-10-24 | [source](https://www.fda.gov/media/193343/download) | | Class | healing-and-repair | primary | 2026-10-24 | [source](https://www.fda.gov/media/193343/download) | | Regulatory status | limbo | primary | 2026-10-24 | [source](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) | | Status source read | 2026-10-23 | primary | 2026-10-24 | [source](https://www.fda.gov/media/94155/download) | | Evidence grade | animal-only | our assessment | 2026-10-24 | [source](https://peptideindex.ai/methodology#evidence-grade) | ## Name BPC-157 Source: https://www.fda.gov/media/193343/download ## Summary A lab-made peptide first described in 1993. No country has approved it as a drug. It is sold for injury recovery and gut health. Source: https://www.fda.gov/media/193343/download ## Short answer BPC-157 is in limbo: it is not approved, and it is on neither FDA list for compounding, so no pharmacy may lawfully make it. The evidence grade is animal-only, so nobody knows if it helps people or how safe it is. Source: https://peptideindex.ai/methodology#short-answer ## Known risks - FDA warns that injected BPC-157 may set off the immune system, and that impurities and clumped peptide can make this worse [^6]. - FDA's adverse event reports include redness where it was injected, shortness of breath, and darkened skin and gums. The reports cannot prove BPC-157 caused them [^6]. - In rats and dogs injected every day for four weeks, blood clotting times changed and some liver blood tests rose [^6]. - Products sold for research use are not made to drug standards, so nobody checks what is in the vial [^6] [^16]. Source: https://www.fda.gov/media/193343/download ## What nobody knows yet - No controlled trial has shown whether BPC-157 helps people heal from muscle, tendon or joint injuries [^13]. - Nobody knows what long-term use does to the body or whether it raises cancer risk. No long-term or cancer study has been done [^6]. - Scientists do not know what BPC-157 attaches to in the body or how it works [^6]. - Nobody knows how much of a capsule or a nasal spray reaches the blood in people [^6]. Source: https://www.fda.gov/media/193343/download ## What it is BPC-157 is a lab-made chain of 15 amino acids. Amino acids are the building blocks of proteins [^6]. The name stands for Body Protection Compound. Its makers say it copies a short piece of a protein found in human stomach juice. A team in Croatia first wrote about it in 1993 [^6]. It is also called bepecin and PL 14736. No FDA-approved drug contains it [^6]. Online sellers, clinics and some pharmacies promote it for injury recovery, joint pain and gut health [^6] [^14]. It is sold as shots, capsules and nasal sprays. FDA says the name is used loosely. Products sold as BPC-157 can hold different forms of the peptide, so a buyer cannot be sure what they are getting [^6]. Source: https://www.fda.gov/media/193343/download ## Where it stands legally BPC-157 is in limbo: FDA removed it from Category 2 in April 2026 and has not added it to Category 1 [^1] [^2] [^7] [^9]. That is not approval, and it does not make compounding lawful. FDA reviewed it for ulcerative colitis, a bowel disease, but it is sold mostly for recovery from injuries [^4] [^6]. Checked 23 October 2026. Category 2 is FDA's list of substances that may present significant safety risks. Category 1 is the list of substances pharmacies may use while FDA reviews them [^3]. FDA took BPC-157 off Category 2 because the groups that had nominated it pulled their nominations [^1] [^7]. On 23 July 2026, FDA's Pharmacy Compounding Advisory Committee voted 8 to 6, with 1 member abstaining, to recommend adding it to the list pharmacies may use [^5] [^7] [^19]. FDA's own scientists had advised against this [^6]. A committee vote is only advice [^18]. FDA decides by writing a rule, and it has not proposed one [^7] [^8]. Until then, a pharmacy that makes BPC-157 is outside federal law. FDA has warned a pharmacy for doing this [^17]. Selling it for people to use is also illegal, even when the label says it is for research only [^16]. Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ## What the evidence shows The evidence grade is animal-only: the studies that show an effect used rats or cells, and no controlled trial in people has been published in full [^13] [^6]. In rats whose Achilles tendon was cut from the bone, shots of BPC-157 helped the tendon heal back onto the bone [^11]. In rats whose colon lost its blood supply, BPC-157 put on the bowel helped blood flow return [^10]. In rat tendon cells grown in a dish, BPC-157 helped the cells spread and move [^12]. Most of these animal studies came from one research group in Croatia [^10] [^11]. In people, the evidence is thin. In one small trial, people with ulcerative colitis got BPC-157 or a dummy treatment as an enema for two weeks. Only a short meeting summary was published, and FDA found it too unclear to show any benefit [^6]. A 2026 review found three small studies in people, with 30 people in all and no comparison group. It rated the evidence as very low quality [^13]. A safety study gave it by drip to two adults and found no problems, but two people are far too few to judge its risks [^15]. The human studies so far are too small and too weak to show that the animal results carry over to people [^13]. Source: https://pubmed.ncbi.nlm.nih.gov/42885452/ ## Legitimate ways to get it The only legal way to get BPC-157 in the US today is to join a clinical trial [^22]. No approved drug contains it, here or in any other country [^6]. A pharmacy may not make it under federal law. It has no official quality standard, it is not part of an approved drug, and it is not on the list pharmacies may use [^3] [^17]. That could change if FDA adds it by writing a rule after the committee vote. FDA has not proposed that rule [^7]. On 24 October 2026 the official trial registry listed one US trial in Arkansas. It tests BPC-157 after shoulder surgery and is not yet recruiting [^22]. Open trials are listed in the trials block below, with the date the registry was last checked. FDA found one early study of BPC-157 in healthy adults, registered in Mexico, with no results posted [^6]. Source: https://www.fda.gov/media/94155/download ## How people are getting it anyway This section describes what happens and is not a recommendation. Most people who use BPC-157 get it in one of three ways [^6]. The first is online sellers that label it for research use only. FDA says that label does not make it legal to sell a drug meant for people [^16]. The second is pharmacies that make it even though it is not on the federal list. FDA has warned a pharmacy for doing this [^17]. The third is clinics and medical spas that give it as shots [^6]. In all three, nobody checks what is in the product the way FDA checks an approved drug. FDA says BPC-157 powder is poorly defined. The test sheets that come with it check purity, but not impurities or germs [^6]. Reports of harm come from FDA's adverse event files and from news stories about people who say they got sick after using it [^6] [^20]. These reports cannot prove BPC-157 caused the harm. Nobody tracks how often harm happens. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023 ## Access routes Source: https://www.fda.gov/media/193343/download ### Clinical trial Detail: BPC-157 is not approved, and pharmacies may not use it. The only legal route is a clinical trial. Open trials are listed in the trials block below, with the date the official registry was last checked. Source: https://clinicaltrials.gov/study/NCT07803250 ## Unofficial channels Source: https://www.fda.gov/media/193343/download ### Research use seller What it is: Sold online as a powder or liquid with a label saying it is for research use only and not for people. Legal position: FDA treats these products as unapproved new drugs when the seller's claims show they are meant for people, whatever the label says. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023) Documented risks: - FDA warns that unapproved injectable products can carry toxins or germs straight into the blood and cause a life-threatening infection. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023) - FDA reviewed a report of a person who used a research-use product mixing BPC-157 and TB-500. Their skin and gums darkened, and it happened again when they used it again. (source: https://www.fda.gov/media/193343/download) Enforcement: - 2023-06-12: FDA warning letter to an online seller of research-use products, including BPC-157 shots and nasal spray. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023 ### Compounding outside the rules What it is: Made by a pharmacy from bulk BPC-157 powder, often for a clinic or an online prescriber. Legal position: BPC-157 has no official quality standard, is in no approved drug and is not on the federal list. A pharmacy that compounds it loses the legal exemptions for compounded drugs. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Documented risks: - FDA found that BPC-157 powder is poorly defined, and that sellers' test sheets check purity but not impurities or germs. (source: https://www.fda.gov/media/193343/download) - FDA's adverse event files include a person who had shortness of breath and went to an emergency room after a compounded BPC-157 shot. (source: https://www.fda.gov/media/193343/download) Enforcement: - 2019-07-30: FDA warning letter to a Texas compounding pharmacy that made drugs with BPC-157 acetate. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ### Clinic or med spa What it is: Offered by some wellness, anti-aging and sports clinics and medical spas, most often as a shot. Legal position: A clinic's BPC-157 comes from compounding that FDA says falls outside the federal exemptions for compounded drugs. (source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019) Documented risks: - FDA found no study of BPC-157 given as a shot under the skin in people, so the safety of clinic shots is untested. (source: https://www.fda.gov/media/193343/download) Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ## Recruiting trials Snapshot date: 2026-10-24. A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record. - nct NCT07803250, url https://clinicaltrials.gov/study/NCT07803250, phase Phase 1, title Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery, status not-yet-recruiting, sponsor University of Arkansas, countries United States, us states Arkansas - nct NCT07437547, url https://clinicaltrials.gov/study/NCT07437547, phase Phase 2, title BPC 157 for Acute Hamstring Muscle Strain Repair, status recruiting, sponsor Hudson Biotech, countries China, us states none listed Source: https://clinicaltrials.gov/api/v2/studies?query.intr=BPC-157+OR+BPC+157+OR+Bepecin+OR+PL+14736&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState ## Sources Source: https://www.fda.gov/media/193343/download ### 1. FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks ### 2. FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/media/94155/download ### 3. FDA: bulk drug substances used in compounding under section 503A Type: regulatory Tier: primary Source: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act ### 4. Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting Type: regulatory Tier: primary Source: https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html ### 5. FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 Type: regulatory Tier: primary Source: https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 ### 6. FDA briefing document on BPC-157 for the July 2026 committee meeting Type: regulatory Tier: primary Source: https://www.fda.gov/media/193343/download ### 7. McDermott Will & Schulte: what the July 2026 committee votes on peptides mean Type: legal-analysis Tier: legal-analysis Source: https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ ### 8. FDA Law Blog: the committee recommends four peptides for the 503A list Type: legal-analysis Tier: legal-analysis Source: https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ ### 9. Goodwin: FDA signals a possible change in its stance on compounding peptides Type: legal-analysis Tier: legal-analysis Source: https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides ### 10. BPC-157 in rats with colitis and loss of blood supply to the colon Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/29358856/ ### 11. BPC-157 and healing of the Achilles tendon onto bone in rats Type: animal Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/16583442/ ### 12. BPC-157 and the growth and movement of rat tendon cells Type: in-vitro Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/21030672/ ### 13. Systematic review of human evidence for BPC-157 in orthopaedic medicine, 2026 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/42885452/ ### 14. Systematic review of BPC-157 in orthopaedic sports medicine, 2025 Type: systematic-review Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/40756949/ ### 15. Pilot study of the safety of BPC-157 given by drip to two adults Type: human-trial Tier: peer-reviewed Source: https://pubmed.ncbi.nlm.nih.gov/40131143/ ### 16. FDA warning letter to an online seller of research-use products, 12 June 2023 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023 ### 17. FDA warning letter to a compounding pharmacy that used BPC-157 acetate, 30 July 2019 Type: regulatory Tier: primary Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 ### 18. STAT: FDA advisory panel narrowly backs compounding of unapproved peptides Type: reference Tier: established-news Source: https://www.statnews.com/2026/07/23/fda-panel-okays-peptides-compound-pharmacies-bpc-157-kpv/ ### 19. NBC News: FDA panel recommends easing peptide limits despite agency scientists Type: reference Tier: established-news Source: https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 ### 20. CNN and KFF Health News: people who say peptides harmed them Type: reference Tier: established-news Source: https://www.cnn.com/2026/10/13/health/peptides-maha-access ### 21. FDA: questions put to the committee at the July 2026 meeting Type: regulatory Tier: primary Source: https://www.fda.gov/media/193711/download ### 22. ClinicalTrials.gov: BPC-157 after rotator cuff repair, a US trial not yet recruiting Type: reference Tier: primary Source: https://clinicaltrials.gov/study/NCT07803250 Last verified: 2026-10-25. Sources: - https://clinicaltrials.gov/api/v2/studies?query.intr=BPC-157+OR+BPC+157+OR+Bepecin+OR+PL+14736&filter.overallStatus=RECRUITING%2CNOT_YET_RECRUITING&pageSize=50&sort=StartDate%3Adesc&countTotal=true&fields=NCTId%2CBriefTitle%2COverallStatus%2CPhase%2CLeadSponsorName%2CStartDate%2CLocationCountry%2CLocationState - https://peptideindex.ai/methodology#evidence-grade - https://peptideindex.ai/methodology#short-answer - https://pubmed.ncbi.nlm.nih.gov/42885452/ - https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023 - https://www.fda.gov/media/193343/download - https://www.fda.gov/media/94155/download [^1]: FDA: bulk drug substances that may present significant safety risks, including those withdrawn from Category 2 https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks [^2]: FDA: bulk drug substances nominated under section 503A, list updated 14 May 2026 https://www.fda.gov/media/94155/download [^3]: FDA: bulk drug substances used in compounding under section 503A https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act [^4]: Federal Register: notice of the July 2026 Pharmacy Compounding Advisory Committee meeting https://www.federalregister.gov/documents/full_text/html/2026/04/16/2026-07361.html [^5]: FDA: Pharmacy Compounding Advisory Committee meeting, 23 and 24 July 2026 https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026 [^6]: FDA briefing document on BPC-157 for the July 2026 committee meeting https://www.fda.gov/media/193343/download [^7]: McDermott Will & Schulte: what the July 2026 committee votes on peptides mean https://www.mcdermottlaw.com/insights/bulk-list-bound-pcac-backs-majority-of-peptides-in-two-day-public-meeting/ [^8]: FDA Law Blog: the committee recommends four peptides for the 503A list https://www.thefdalawblog.com/2026/07/peptide-l-wave-pcac-approves-four-bulk-drug-substances-for-the-503a-list/ [^9]: Goodwin: FDA signals a possible change in its stance on compounding peptides https://www.goodwinlaw.com/en/insights/blogs/2026/05/fda-signals-potentially-evolving-stance-toward-compounding-of-certain-peptides [^10]: BPC-157 in rats with colitis and loss of blood supply to the colon https://pubmed.ncbi.nlm.nih.gov/29358856/ [^11]: BPC-157 and healing of the Achilles tendon onto bone in rats https://pubmed.ncbi.nlm.nih.gov/16583442/ [^12]: BPC-157 and the growth and movement of rat tendon cells https://pubmed.ncbi.nlm.nih.gov/21030672/ [^13]: Systematic review of human evidence for BPC-157 in orthopaedic medicine, 2026 https://pubmed.ncbi.nlm.nih.gov/42885452/ [^14]: Systematic review of BPC-157 in orthopaedic sports medicine, 2025 https://pubmed.ncbi.nlm.nih.gov/40756949/ [^15]: Pilot study of the safety of BPC-157 given by drip to two adults https://pubmed.ncbi.nlm.nih.gov/40131143/ [^16]: FDA warning letter to an online seller of research-use products, 12 June 2023 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/warrior-labz-sarms-655280-06122023 [^17]: FDA warning letter to a compounding pharmacy that used BPC-157 acetate, 30 July 2019 https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/prescription-dispensing-laboratories-inc-dba-pd-labs-579286-07302019 [^18]: STAT: FDA advisory panel narrowly backs compounding of unapproved peptides https://www.statnews.com/2026/07/23/fda-panel-okays-peptides-compound-pharmacies-bpc-157-kpv/ [^19]: NBC News: FDA panel recommends easing peptide limits despite agency scientists https://www.nbcnews.com/health/health-news/peptides-restrictions-ease-fda-panel-recommend-bpc-157-scientists-rcna588879 [^20]: CNN and KFF Health News: people who say peptides harmed them https://www.cnn.com/2026/10/13/health/peptides-maha-access [^22]: ClinicalTrials.gov: BPC-157 after rotator cuff repair, a US trial not yet recruiting https://clinicaltrials.gov/study/NCT07803250