For clinicians
BPC-157 for prescribers: status, evidence and what FDA has said
A neutral reference. It reports BPC-157's regulatory status, the quality of its human evidence and what FDA has said about it. It does not suggest a dose, a protocol or a source.
Status reviewed 2026-10-01 · By the Grey Peptides Editorial Board · Regulatory fields generated from our tracker
| Also known as | Body Protection Compound 157, Bepecin, PL-14736 |
| Substances FDA reviewed | BPC-157 (free base) and BPC-157 acetate |
| FDA approval | Not FDA-approved |
| Compounding (503A) | Not compoundable; PCAC recommended it 8–6 (Jul 2026), FDA has not acted |
| Outsourcing (503B) | No 503B status recorded |
| FDA advisory committee | Reviewed July 23–24, 2026 (docket FDA-2025-N-6895): recommended, 8–6, 1 abstention |
| WADA 2026 List | Prohibited (S0) |
| WADA 2027 List | Prohibited (S0) |
| Evidence grade | Low |
| Status reviewed | 2026-10-01 |
What FDA has said
FDA staff's position, in its briefing for the July 23–24, 2026 committee meeting: FDA proposes not adding either BPC-157 substance to the 503A Bulks List. Its case rests on four points: the substances are not well characterised, there is a lack of information on safety and immunogenicity, the evidence is insufficient to conclude BPC-157 works for ulcerative colitis, and several approved drugs already treat ulcerative colitis — a serious chronic disease that can cause life-threatening complications.
The use FDA evaluated. Nominated for ulcerative colitis, Crohn's disease, coeliac disease and tendonitis. FDA evaluated only ulcerative colitis — it said the nomination did not contain enough information to assess the other three, and it found no clinical studies of BPC-157 in those populations.
FDA's objections
FDA treats BPC-157 (free base) and BPC-157 acetate as two different active ingredients, and says both are inadequately characterised. Two reasons: naming that does not follow established chemical nomenclature standards (USAN, INN, IUPAC), and missing or inadequate data on quality attributes needed to establish identity, purity and quality for the proposed dosage forms.
A theme running through the whole document: FDA repeatedly notes it is often unclear whether the BPC-157 described in a given published paper is the free base or the acetate salt. That ambiguity limits what the literature can be used to prove about either substance specifically.
FDA concluded there is insufficient evidence to reach a conclusion on whether BPC-157 is effective for ulcerative colitis.
Nonclinical toxicology was limited in scope and duration for the proposed routes of administration. FDA notes the nomination did not include, and it is not aware of, information showing BPC-157 does not present immunogenicity risk — particularly by rectal or transdermal routes.
Specific to BPC-157
FDA searched its Adverse Event Reporting System and describes case reports involving compounded BPC-157 — including a 15 mg-per-vial compounded acetate injection used for inflammation and injury, another compounded injection supplied by a compounding pharmacy, and a report involving a combined BPC-157 and TB-500 product labelled for research purposes only. This is the only one of the seven where FDA cites FAERS cases involving compounded product.
FDA notes BPC-157 is marketed in the US as an ingredient in dietary supplement capsules and tablets, and that there is no USP dietary supplement monograph for it.
The briefing document quotes clinic marketing calling BPC-157 the “wolverine compound.” FDA's inclusion of this is not incidental — the promotional framing around a substance forms part of the historical-use record it weighs.
FDA lists BPC-157 among substances it has identified as potentially presenting significant safety risks outside Category 2 (page current as of 2026-04-22). In FDA's words:
Compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization. FDA has identified no, or only limited, safety-related information for the proposed routes of administration. Therefore, the agency lacks sufficient information to know whether the drug would cause harm when administered to humans.
Monitoring: what the literature does and does not say
- No label. BPC-157 has no FDA-approved label, and therefore no labelled guidance on monitoring.
- What FDA has said about its risks is quoted above, from its list of bulk substances that may present significant safety risks.
- Immunogenicity. FDA's July 2026 review found no adequate information to assess the risk that BPC-157 provokes an immune response.
- What is in the vial. FDA judged the substance not well characterised physically and chemically — the property FDA relies on to know what a compounded product actually contains.
- Adverse event reports. FDA's search of its Adverse Event Reporting System found reports involving compounded BPC-157; they are summarised above, as FDA described them.
- Findings specific to BPC-157. FDA's review also describes points particular to this compound, some of them safety signals; they are set out above in FDA's own terms.
These are gaps, not a monitoring schedule. This page does not supply one, and for a compound in this position the human evidence would not support one.
Compounding: where it stands
Today's position for BPC-157: Not compoundable; PCAC recommended it 8–6 (Jul 2026), FDA has not acted. An FDA advisory committee's vote is a non-binding recommendation; until FDA acts, a vote does not change what may be compounded. Our explainer on the 503A and 503B categories sets out what each status means, and the regulatory tracker is updated as FDA acts.
The evidence
Grey Peptides grades BPC-157's evidence base as low. That grade predates this meeting and is unchanged by it. The overwhelming majority of BPC-157 research is animal work, much of it from a single research group. The human data FDA could find was not sufficient to support a conclusion either way on ulcerative colitis.
The encyclopedia entry lists the human and animal studies we hold, each with its PMID and FDA's full briefing is summarised on our page for the July 2026 review.
What this page leaves out
Doses, regimens, cycle lengths and sources. That is deliberate. A reference that reports status and evidence is useful only if it is not also a protocol, and for a compound in this position there is no approved one to report.
Sources
- US Food and Drug Administration. Pharmacy Compounding Advisory Committee meeting, July 23–24, 2026: briefing documents, docket FDA-2025-N-6895. FDA
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. Content current as of 2026-04-22; read 2026-10-01. FDA
- Grey Peptides regulatory tracker, row for BPC-157, reviewed 2026-10-01. Tracker · dataset
- World Anti-Doping Agency. Prohibited List 2027, dated August 26, 2026, in force January 1, 2027. WADA
This page is a reference for qualified professionals. It is not medical advice, it does not recommend any treatment, and it is not a substitute for the prescriber's own judgement and their state and federal obligations.
Others in this group: Emideltide (DSIP) · Epitalon · KPV · MOTS-c · Semax · TB-500