BPC-157
Also sold as: Body Protection Compound 157, PL 14736, Bepecin, BPC-157 acetate
BPC-157 is not approved as a drug in any country, is not on FDA's 503A bulks list, and may not lawfully be used in 503A pharmacy compounding; FDA staff proposed not adding BPC-157 (free base) or BPC-157 acetate to that list ahead of the Pharmacy Compounding Advisory Committee meeting of 23-24 July 2026. In that evaluation FDA reported a lack of evidence of effectiveness for ulcerative colitis — the only use it agreed to evaluate — identified no study administering BPC-157 to humans by the oral, subcutaneous, nasal or transdermal routes it is sold for, and considers the substance not well-characterized.
Which molecule this is. A synthetic pentadecapeptide derived from a partial sequence of human gastric juice protein BPC. FDA evaluates two related substances: BPC-157 (free base) and BPC-157 acetate.
The FDA advisory committee vote, 23 July 2026
The Pharmacy Compounding Advisory Committee voted to recommend adding this substance to the 503A bulks list (8-6, one abstention), against FDA’s own staff, who had recommended not adding it.
It is still not on the list. An advisory committee makes recommendations; it does not change what is permitted. We checked the 503A bulks list on 29 July 2026 and it is still dated 14 May 2026, with this substance absent from it. Adding a substance requires separate FDA action, which has not happened.
Vote tally reported by ABC News and other outlets; FDA had not published minutes or a transcript as of 29 July 2026, so there is no primary document for the tally yet. We will replace it with FDA’s own record when it publishes. The bulks-list status is from the primary document.
FDA status
FDA has not approved this and it is not in active development toward approval. That says nothing about whether it is being sold — most substances in this category are.
Not an FDA-approved drug for any indication, and not in active development toward approval. That says nothing about whether it is sold — it is.
503A compounding
The nominator withdrew the nomination. This is not a legalisation event — the substance is not on the 503A bulks list and remains non-compoundable.
Absent from Categories 1, 2 and 3 in the list updated 2026-05-14 — verified by fetching and text-extracting the document directly. It left Category 2 because the nominators withdrew the nominations, not because it moved toward legality. It did not enter Category 1, it is not on the 503A bulks list, and it remains non-compoundable. Widely reported as 'removed from Category 2, access is coming' — that framing is backwards.
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
The tier label reads more generously than this record supports, so read the note, not the badge. 'Promising-but-unproven' is assigned only because human data EXISTS — the tier vocabulary reserves it for programmes with a human signal that were tested and were not established, explicitly including ones that failed. This is one that failed. FDA identified five clinical studies that administered BPC-157 to humans, and among them a single randomised controlled trial: Ruenzi et al. 2005, reported only as a meeting abstract, which did not show a benefit. The decisive gap is ROUTE, not count. FDA found no study administering BPC-157 by any route it is actually sold for — oral, subcutaneous, nasal or transdermal. The five studies FDA counted used rectal enema (24 healthy subjects, and approximately 26 subjects with UC), intra-articular injection (17 subjects with knee pain), intravesical injection (12 subjects with interstitial cystitis) and IV infusion (2 healthy subjects). None of those is how anyone buys it. On ClinicalTrials.gov FDA retrieved a single phase 1 study in healthy subjects in Mexico (NCT02637284). State only what FDA states about it: subjects 'were to receive' oral BPC-157, 'The estimated enrollment was 42 subjects. There are no results posted, and we were unable to find an associated published study.' Planned is not conducted, and an estimated enrolment is not an enrolment.
“Our search of the public medical literature in PubMed and Embase yielded five clinical studies that utilized BPC-157.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA staff propose not adding BPC-157 to the 503A Bulks List, ahead of the Pharmacy Compounding Advisory Committee meeting on 23-24 July 2026.
A staff proposal is not a final determination. The briefing document states: 'The FDA will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.'
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List.”
Checked against the source on .BPC-157 was nominated for ulcerative colitis, Crohn's disease, celiac disease and tendonitis. FDA evaluated only ulcerative colitis, declining the other three because the nomination did not include sufficient information and FDA identified no clinical studies in those populations.
This is an EVIDENTIARY VACUUM, NOT A REGULATORY LOOPHOLE — the distinction is the opposite of how the market reads it. FDA did not decline to evaluate tendonitis because tendon use is somehow outside its remit; it declined because nobody submitted evidence and no clinical studies exist. That cuts against the recovery-market claims, not for them. Separately, and regardless of which uses were evaluated: BPC-157 is not on the 503A bulks list, so it may not lawfully be used in 503A compounding for ANY use. That follows from its absence from the list itself, not from the scope of FDA's evaluation.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“BPC-157 was nominated for use in UC, Crohn's disease, Celiac disease, and tendonitis. However, FDA did not evaluate the proposed uses of Crohn's disease, Celiac disease, and tendonitis because the nomination did not include sufficient information for the Agency to evaluate whether the substance is appropriate for these uses in compounded drug products. In addition, FDA did not identify clinical studies using BPC-157 in these populations.”
Checked against the source on .FDA found a lack of evidence of effectiveness for BPC-157 in ulcerative colitis — the single use it agreed to evaluate — resting on one small trial reported only as a meeting abstract.
The trial is Ruenzi et al. 2005: 53 subjects with mild-to-moderate UC randomised 1:1 to a BPC-157 enema or placebo. Per FDA's summary of the abstract, the between-group difference in Disease Activity Index was 1.6 points with a 95% CI of -4.84 to 1.62 — an interval that crosses zero. This is the ONLY randomised controlled trial of BPC-157 in humans that FDA identified, it was never published in full, and it does not show a benefit.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“There is a lack of evidence to support the effectiveness of BPC-157 (free base) and BPC-157 acetate as a treatment for UC. There has been a single, small trial evaluating BPC-157 in the treatment of UC, however, interpretation of the results is limited by the lack of details provided in the meeting abstract and the exploratory nature of the study.”
Checked against the source on .FDA identified no studies administering BPC-157 to humans by any of the routes it is actually sold for — oral, subcutaneous, nasal or transdermal.
This is the finding that matters most against the consumer market, and it is easy to miss. Human administration of BPC-157 is not zero — FDA counted five clinical studies, and the two it discusses in detail used a RECTAL ENEMA. Injection, capsules and nasal sprays are how BPC-157 is overwhelmingly sold. FDA found no human study using any of them. So the honest statement is not 'no human data' — it is that the human data that exists was generated by a route almost nobody buys, and cannot be carried across to the routes they do.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“There is insufficient clinical safety information to characterize the safety profile of BPC-157 (free base) and BPC-157 acetate. We found no studies that administered BPC-157 to humans via the proposed oral, SC, nasal, or transdermal ROA.”
Checked against the source on .FDA considers both BPC-157 (free base) and BPC-157 acetate not well-characterized, and cannot rule out immunogenicity from impurities and peptide aggregates.
A characterization failure, not an evidence failure — a separate and independent ground for the proposal. FDA notes it has 'encountered multiple salts, and derivatives, including different active moieties, sold commercially under the same common name', and that neither nomination's certificate of analysis matched the substance nominated. Both nominators nominated by a code matching the free base and attached a CoA for the acetate. FDA's concern is explicit: patients 'may be dosed with a different bulk drug substance than the physician ordered'. Note this cuts against the common assumption that a CoA settles the question of what is in the vial.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Because there is lack of information regarding potential impurities that can be present in BPC-157 (free base) and the lack of information on the potential of peptide aggregation, we cannot rule out the potential for immunogenicity associated with these impurities and peptide-related aggregates.”
Checked against the source on .No approved drug product containing BPC-157 exists in any country, and there is no USP, European, Japanese or International Pharmacopeia monograph for it.
Not merely 'not FDA-approved'. FDA searched globalEDGE and found BPC-157 is not a component of an approved product ANYWHERE. There is no jurisdiction to point at, which forecloses the usual 'approved in Europe / available abroad' framing. FDA also records that New Zealand's Medicines Classification Committee proposed in May 2023 that BPC-157 be classified as a prescription medicine — a restriction, not an approval.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“There is no approved product containing BPC-157-related BDSs in any country at this time, nor is BPC-157 (free base) or BPC-157 acetate found in the European, Japanese, or the International Pharmacopeias.”
Checked against the source on .FDA's outsourcing facility product reporting data from January 2017 to June 2025 records no compounded drug products containing BPC-157 (free base) or BPC-157 acetate.
Read this precisely. It is a report of ZERO from registered 503B outsourcing facilities over eight and a half years — it is not evidence that nobody is compounding BPC-157. FDA's own search found compounding-pharmacy and med-spa websites marketing it, and FAERS reports naming the compounding pharmacies by name. What the zero establishes is that BPC-157 has no documented history of legitimate compounding for FDA to weigh, which is one of the criteria the evaluation turns on. FDA's conclusion: available data 'is too limited for FDA to understand the historical use'.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“According to the FDA's outsourcing facility product reporting data from January 2017 to June 2025, there were no reported compounded drug products containing BPC-157 (free base) or BPC-157 acetate.”
Checked against the source on .FDA's briefing document records that BPC-157 is on the World Anti-Doping Agency's prohibited list, in the S0 non-approved substances section.
S0 is the category for substances with no current approval by any governmental regulatory health authority for human therapeutic use. Prohibited at all times, in and out of competition. Directly relevant because the recovery and athletic market is where BPC-157 is chiefly sold.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“BPC-157 is listed on the World Anti-Doping Agency's prohibited list under the non-approved substances (S0) section.”
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Documented safety signals
Three FAERS reports, all associated with injectable BPC-157: injection-site redness and swelling, an emergency-department visit for shortness of breath, and reproducible hyperpigmentation on rechallenge.
Three, not two — count them against the document. FDA ID 194222121: a 55-year-old woman using BPC-157 injection compounded by Promise Pharmacy reported 9 days of injection-site redness and swelling. FDA ID 23130696: a 28-year-old man using BPC-157 acetate compounded by Revive Rx Pharmacy developed shortness of breath resulting in an emergency room visit. FDA ID 26053573: a 40-year-old woman using a BPC-157/TB500 product from Cellular Peptide LLC labelled 'research purposes only' developed diffuse hyperpigmentation and gingival darkening, with identical reproducible reactions on rechallenge. FDA's limitation on each report is DIFFERENT, and flattening them into one is how this gets misread: concomitant thymosin in the first; in the second, 'No further information was provided (i.e. duration of use, concomitant medications, or temporal relationship to product)' — information absent, not another drug present; and in the third FDA went the other way, writing that the AEs 'were likely due to the drug product considering that the AEs occurred upon rechallenge', limited only because the product contained two peptides. FDA did examine the recovery market under safety — the 'wolverine compound' marketing appears in the briefing document. The claim that FDA simply never looked at athletic use is wrong.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The Office of Surveillance and Epidemiology conducted a search of the FAERS database for reports of adverse events (AEs) for BPC-157 through December 4, 2025. The search retrieved three reports. All reports were associated with injectable BPC-157.”
Checked against the source on .In 28-day repeat-dose toxicity studies in rats and dogs, FDA characterised the reported findings as clinically relevant safety signals: altered clotting properties (aPTT shortening in rats, aPTT prolongation in dogs) and liver-associated signals.
Worth stating plainly because BPC-157 is marketed as having a clean animal safety record. It is FDA, not a critic, calling these signals clinically relevant, and they are in the SAME paper (Xu et al. 2020) the market cites for the finding that BPC-157 is not a mutagen. The intramuscular route used here is not one of the nominated routes, and FDA notes that because bioavailability by the nominated routes is unknown, these animal exposures cannot be used to estimate safety margins for them. FDA also identified no carcinogenicity studies at all, and no studies covering a complete reproductive cycle.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Findings from repeat-dose toxicity studies suggested that 28-day treatment of rats and dogs with BPC-157 (free base) via the IM ROA appeared to be associated with clinically relevant safety signals, including: (i) aPTT shortening and aPTT prolongation (suggestive of altered clotting properties) in rats and dogs, respectively, and (ii) liver-associated signals (increased serum ALT, glucose, and TG levels).”
Checked against the source on .FDA identified no study that formally investigated the immunogenicity of any BPC-157 product, and states BPC-157 may pose a significant immunogenicity risk when injected or given nasally.
The burden runs the other way from how the market reads it. FDA's closing line on this is 'The nomination did not include, and FDA is not aware of, information about BPC-157 to suggest that this substance does not present these risks.' Absence of reported harm is not the same as evidence of safety, and here there is no immunogenicity study to be absent from.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nominators did not provide, and we did not identify any studies that formally investigated the immunogenicity of BPC-157 products. As a peptide with 15 amino acids that is administered through a parenteral or nasal ROA, BPC-157 may pose a significant risk for immunogenicity, potentially amplified by aggregation as well as potential peptide-related impurities …”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is BPC-157 legal in 2026?
No — BPC-157 may not lawfully be used in pharmacy compounding under section 503A of the Federal Food, Drug, and Cosmetic Act, because it is absent from FDA's 503A bulk drug substances list, which was last updated on 14 May 2026. BPC-157 is also not an approved drug product in any country. Being absent from the list is not a neutral status: a bulk drug substance that is neither the subject of a USP monograph nor a component of an approved drug must appear on that list to be used in 503A compounding, and BPC-157 does not appear on it in any category.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .- Did BPC-157 become legal again when FDA removed it from Category 2?
No. BPC-157 left FDA's Category 2 because the two nominators — Wells Pharmacy Network and LDT Health Solutions — withdrew their nominations, not because FDA resolved anything in BPC-157's favour. FDA's own briefing document states: 'The nominations were withdrawn and FDA is evaluating the substances at its discretion.' The status moved sideways, not toward legality: BPC-157 did not enter Category 1, it is not on the 503A bulks list, and it remains unusable in 503A compounding. FDA continued the evaluation on its own initiative and its staff have since proposed not adding BPC-157 to the list at all.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“The nominations were withdrawn and FDA is evaluating the substances at its discretion.”
Checked against the source on .- Is there any human evidence that BPC-157 works?
No — FDA identified one randomised controlled trial of BPC-157 in humans, reported only as a 2005 meeting abstract, and it did not demonstrate a benefit. In that trial 53 subjects with mild-to-moderate ulcerative colitis were randomised 1:1 to a BPC-157 enema or placebo; per FDA's summary, the between-group difference in Disease Activity Index was 1.6 points with a 95% confidence interval of -4.84 to 1.62, an interval that crosses zero. FDA's conclusion was that 'There is a lack of evidence to support the effectiveness of BPC-157 (free base) and BPC-157 acetate as a treatment for UC.' The claims BPC-157 is chiefly sold on — tendon, ligament and gut healing — rest on rodent studies; FDA identified no clinical studies of BPC-157 in tendonitis, Crohn's disease or celiac disease at all.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“There is a lack of evidence to support the effectiveness of BPC-157 (free base) and BPC-157 acetate as a treatment for UC.”
Checked against the source on .- Can I get BPC-157 from a compounding pharmacy?
Not lawfully. BPC-157 is absent from FDA's 503A bulk drug substances list, which is what a pharmacy would need to compound it under section 503A, and FDA's outsourcing facility product reporting data from January 2017 to June 2025 records no compounded drug products containing BPC-157 (free base) or BPC-157 acetate from any registered 503B outsourcing facility. That said, FDA reports that 'A Google search for BPC-157 generally identified websites of compounding pharmacies as well as several med spas and clinics in the United States that mentioned BPC-157 for a variety of uses', and all three BPC-157 adverse event reports in FDA's FAERS database name a compounding pharmacy or a seller. Being obtainable and being lawful are not the same question.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“According to the FDA's outsourcing facility product reporting data from January 2017 to June 2025, there were no reported compounded drug products containing BPC-157 (free base) or BPC-157 acetate. […] A Google search for BPC-157 generally identified websites of compounding pharmacies as well as several med spas and clinics in the United States that mentioned BPC-157 for a variety of uses …”
Checked against the source on .- Is BPC-157 safe?
Unknown — FDA states that 'There is insufficient clinical safety information to characterize the safety profile of BPC-157 (free base) and BPC-157 acetate.' FDA found no study that administered BPC-157 to humans by the oral, subcutaneous, nasal or transdermal routes it is sold for, no study that formally investigated its immunogenicity, and no carcinogenicity studies. Three adverse event reports appear in FDA's FAERS database: an injection-site reaction, shortness of breath resulting in an emergency room visit, and diffuse hyperpigmentation with gingival darkening that recurred identically on rechallenge. FDA's interpretation of each report is limited, but for a different reason each time — by concomitant thymosin in the first, by missing information in the second, and in the third, where FDA judged the reactions 'likely due to the drug product considering that the AEs occurred upon rechallenge', by the product containing two peptides. FDA states it 'cannot make definitive conclusions regarding the safety of BPC-157 based on FAERS data alone'. An unstudied compound is not a compound shown to be safe.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“There is insufficient clinical safety information to characterize the safety profile of BPC-157 (free base) and BPC-157 acetate.”
Checked against the source on .- What did FDA propose at the July 2026 PCAC meeting about BPC-157?
FDA staff proposed not adding BPC-157 to the 503A bulks list, in the briefing document for the Pharmacy Compounding Advisory Committee meeting of 23-24 July 2026: 'Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List.' FDA gave four grounds: the substances are not well characterized physicochemically; there is a lack of information on their safety profile and immunogenicity risks; there is insufficient evidence to conclude they are effective for ulcerative colitis; and FDA-approved drug products already exist for ulcerative colitis. This is a staff proposal, not a final determination — the document states FDA 'will not issue a final determination on the issues at hand until input from the advisory committee process has been considered and all reviews have been finalized.' It does not change BPC-157's current status, which is that it is not on the list.
BPC-157-Related Bulk Drug Substances — FDA Briefing Document, Pharmacy Compounding Advisory Committee Meeting, July 23-24, 2026 — FDA, 23 July 2026“Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List.”
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