Research material and lot documents.
FDA's briefing document dated May 11, 2026 states that BPC-157 (free base) and its acetate form have no applicable United States Pharmacopeia or National Formulary monograph and that neither is a component of an FDA-approved drug. This page quotes FDA and WADA records with their dates. It does not say whether any use of BPC-157 is legal.
The briefing document, prepared for the Pharmacy Compounding Advisory Committee, says: "There is no applicable United States Pharmacopeia (USP) or National Formulary (NF) drug substance monograph for BPC-157 (free base) or its acetate form, and neither is a component of an FDA-approved drug." It also says that there is "no approved product containing BPC-157-related BDSs in any country at this time". Source: FDA briefing document, dated May 11, 2026.
FDA's identifier page for BPC-157 carries this note: "UNII availability does not imply any regulatory review or approval." Source: FDA UNII record 8ED8NXK95P.
FDA's page "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks", marked "Content current as of: 04/22/2026", lists BPC-157 under the heading "Bulk drug substances nominated but withdrawn". The page says: "This list of bulk drug substances previously in category 2 of the interim policies were withdrawn by the nominators." The BPC-157 entry says that compounded drugs containing BPC-157 "may pose risk for immunogenicity" for certain routes of use and "may have complexities with regard to peptide-related impurities and active pharmaceutical ingredient (API) characterization." It says that FDA "has identified no, or only limited, safety-related information" for the proposed routes of use. It ends by saying that the agency lacks sufficient information to know whether the drug would cause harm in humans. The linked page gives the entry in full.
Source: FDA safety-risks page, content current as of 04/22/2026.
FDA's document "Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act", marked "Updated May 14, 2026", describes three categories: "Category 1: Bulk Drug Substances Under Evaluation", "Category 2: Bulk Drug Substances that Raise Significant Safety Concerns" and "Category 3: Bulk Drug Substances Nominated Without Adequate Support". A text search of the document found no entry for BPC-157, Bepecin or PL-14736 in any of the three. Source: FDA 503A categories document, updated May 14, 2026.
FDA's meeting page for the Pharmacy Compounding Advisory Committee lists BPC-157-related bulk drug substances, BPC-157 (free base) and BPC-157 acetate, for discussion on July 23, 2026 and gives "Ulcerative colitis (UC)" as the use FDA evaluated. The briefing document says the nominations "were withdrawn and FDA is evaluating the substances at its discretion." It ends: "Accordingly, we propose not adding BPC-157 (free base) or BPC-157 acetate to the 503A Bulks List."
The committee's questions document asked for votes, including "Should BPC-157 (free base) be placed on the list?" FDA's meeting page says that advisory committees "make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so." On October 15, 2026, the meeting page did not list minutes or vote results.
The sources on this page do not establish a human safety profile. FDA's briefing document concludes: "There is insufficient clinical safety information to characterize the safety profile of BPC-157 (free base) and BPC-157 acetate." FDA searched its adverse event reporting system through December 4, 2025 and found three reports, and it wrote that "it is unclear whether these AEs were attributable to BPC-157." Source: FDA briefing document, section II.D.
The BPC-157 research page lists what the animal studies and the three small human reports found.
Yes. WADA's 2026 Prohibited List, published on September 24, 2025 and in force from January 1, 2026, names BPC-157 in section S0, Non-approved substances: "This class covers many different substances including but not limited to BPC-157, 2,4-dinitrophenol (DNP), ryanodine receptor-1-calstabin complex stabilizers [e.g. S-107, S48168 (ARM210)] and troponin activators (e.g. reldesemtiv and tirasemtiv)." The same section says that "All prohibited substances in this class are Specified Substances" and that substances in the class are "prohibited at all times." WADA published its 2027 List on September 21, 2026, to take effect on January 1, 2027. Section S0 of the 2027 List keeps BPC-157 in the same sentence and adds "peptides" to its examples of non-approved substances. Sources: WADA 2026 Prohibited List, section S0, WADA publication notice, September 24, 2025, WADA 2027 Prohibited List, section S0, WADA publication notice, September 21, 2026 and WADA's Prohibited List page.
This page does not answer that question. FDA's records above describe the substance, the categories and the advisory committee process. They are dated, and FDA can update its pages. The FDA page on bulk drug substances used in compounding under section 503A shows its own date, which was "Content current as of: 05/14/2026" when this page was checked.
FDA's records describe the substance, not a lot. A lot report describes one lot. Curo's lot certificate library lists reports by lot number, and the BPC-157 for sale page explains how to read a listing against the identity records. The BPC-157 identity page has the identifiers.