Frequently asked questions
What is BPC-157?
A synthetic pentadecapeptide whose amino acid sequence is a fragment of BPC, a protein isolated from human gastric juice and described by a group in Zagreb in the early nineteen-nineties. The material sold under the name is made by solid-phase synthesis. It is not the gastric juice protein itself, and the two are easy to confuse because much of the literature writes about them interchangeably.
Is BPC-157 an approved medicine?
No. FDA states that neither BPC-157 free base nor BPC-157 acetate is a component of an FDA-approved drug, and that a search identified no approved product containing either substance in any country. There is also no monograph for it in the United States, European, Japanese or International Pharmacopoeia.
Can BPC-157 be sold as a dietary supplement?
This site does not assert an answer, because a first-hand regulatory document establishing one was not located during data entry. What is on the record is that FDA's own evaluation observes the substance is marketed in the United States as an ingredient in dietary supplement products, that no notification for it appears in FDA's published list of submitted new dietary ingredient notifications, and that FDA has told at least one seller its BPC-157 product was an unapproved new drug. Readers should not read any of that as a determination either way.
Can a pharmacy compound it?
It is not on FDA's list of bulk drug substances that may be used in compounding under section 503A of the FD&C Act. FDA evaluated it for that list and proposed not adding it, then put the question to its Pharmacy Compounding Advisory Committee. An advisory committee recommendation does not bind FDA, and no minutes or vote record for that meeting had been published when this entry was written. The regulatory status entries on this page give the dates and the documents. source
What does the published human research actually show?
Very little. FDA's review of the entire published medical literature found only five clinical studies, two of which are conference abstracts rather than full papers. An independent systematic review of the musculoskeletal literature classified the whole body of work as level IV and level V evidence and found no clinical safety data at all. Read the limitations section before drawing any conclusion from anything else on this page.
Why are the pharmacokinetic figures here from rats and dogs?
Because those are the only figures that exist. FDA states there is no information with which to assess the human pharmacokinetics of BPC-157, and that it found no human pharmacokinetic data for the oral, subcutaneous, nasal or transdermal route. In the human studies that used a rectal enema, the authors report the substance was not detected in plasma.
How should it be stored?
The published literature does not establish handling conditions. The figures circulating for this compound come from supplier product pages; they reached FDA's evaluation by that route and are recorded in the storage entry on this page with that provenance stated, not as a determination. FDA separately warns that peptides of this kind are extremely sensitive to formulation and environmental conditions and that significant amounts of aggregates can form during storage.
Why does the same compound have two different CAS numbers?
Because they are two different substances. BPC-157 free base and BPC-157 acetate have distinct CAS numbers and distinct UNII codes, and FDA regards them as different active pharmaceutical ingredients sharing the same active moiety. FDA notes that both nomination packages it reviewed named one form while attaching a certificate of analysis for the other, and that naming conventions in this market do not follow established chemical nomenclature standards.
What safety risks has FDA identified?
FDA's published entry states that compounded drugs containing BPC-157 may pose risk for immunogenicity for certain routes of administration and may have complexities regarding peptide-related impurities and active pharmaceutical ingredient characterisation, that it has identified no or only limited safety-related information for the proposed routes, and that it therefore lacks sufficient information to know whether the drug would cause harm when administered to humans. The full wording is reproduced in the identified safety risks entry.
Is it allowed in sport?
No. The United States Anti-Doping Agency states that BPC-157 is prohibited under the S0 Non-Approved Substances category of the World Anti-Doping Agency Prohibited List, and FDA's evaluation records the same listing.
Do certificates of analysis settle the purity question?
Not on their own. FDA reviewed the certificates supplied with both nominations and searched for others, and found that most report purity and little else, with no identified impurities, no impurity limits, and no bioburden or bacterial endotoxin testing. A purity percentage without an impurity profile does not address the peptide-related impurities and aggregates that FDA names as the specific concern.