BPC-157 and the FDA bulks list

BPC-157 is not on the FDA's 503A bulks list. Two nominations to put it there were withdrawn by the parties that filed them. FDA continued the evaluation on its own initiative, published a review concluding that the criteria weigh against listing, and put the question to its Pharmacy Compounding Advisory Committee on 23 and 24 July 2026.

Everything below is a description of documents. It is not a statement about what the compound does in a body, and the documents themselves are careful to say that they are not that either.

Section 503A of the US Federal Food, Drug, and Cosmetic Act sets the conditions under which a pharmacy may compound a drug from a bulk substance. The substance has to satisfy one of three tests: there is a United States Pharmacopeia or National Formulary monograph for it, or it is a component of an FDA-approved drug, or it appears on FDA's list of bulk drug substances that can be used in compounding under 503A. That third list is what people mean by "the bulks list".

FDA solicited nominations for it in 2015 and has been working through them since. A final regulation in February 2019 placed six substances on the list and declined to place four others. A proposed regulation in September 2019 proposed to add five and proposed not to add twenty-six. The agency says it will continue to address nominated substances on a rolling basis through notice-and-comment rulemaking.

One condition on the same page is worth noticing on a site about certificates. FDA states that bulk drug substances must be accompanied by a valid certificate of analysis and must have been manufactured by an establishment registered with the agency. The certificate is not decoration in that framework; it is one of the conditions.

While it works through the nominations, FDA runs an interim policy that sorts nominated substances into three categories. The categories are about the state of the paperwork and the agency's enforcement posture, not about a verdict on the substance:

• Category 1 - nominated with sufficient supporting information for FDA to evaluate, not appearing on any other list. FDA does not intend to act against a compounder using these, provided the conditions in the guidance are met.
• Category 2 - nominated with sufficient supporting information, but FDA has identified significant safety risks pending further evaluation. The agency would consider taking action against a compounder using them.
• Category 3 - nominated with insufficient supporting information for FDA to evaluate at all. Not eligible for the category 1 policy, and the agency would consider taking action.

Category 3 is the one people misread. It does not mean a substance failed; it means nobody submitted enough for the question to be asked. FDA has since said it does not intend to place substances nominated on or after 7 January 2025 into these categories at all, so the scheme is a snapshot of an older process rather than a live register.

FDA publishes the category 2 material on a page titled "Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks". That page carries two tables. The first lists substances under category 2 of the interim policies, each with the date it was added and the safety risks the agency identified. The second is headed "Bulk drug substances nominated but withdrawn", and the sentence under that heading says these were previously in category 2 and were withdrawn by the nominators.

BPC-157 is in the second table. So are a number of other compounds that circulate under the research heading, among them TB-500, CJC-1295, ipamorelin, Melanotan II, Epitalon, Semax, KPV, MOTS-c, AOD-9604 and GHK-Cu. The withdrawn table carries no dates, and the page carried a content date of 22 April 2026 when it was read for this article.

This is where a widely repeated account goes wrong. A claim circulated that FDA delisted a set of peptides in April 2026, which is read as a loosening. The documents describe something narrower and close to the opposite: the nominations were withdrawn by the people who made them, FDA left its safety text for every withdrawn substance on the same page, and in the case of BPC-157 the agency carried on evaluating the substance anyway. If you cannot source a date to an FDA page, do not repeat it, and this article does not.

For the July 2026 advisory committee meeting, FDA published a briefing document dated 11 May 2026 containing its evaluation of BPC-157 free base and BPC-157 acetate as separate bulk drug substances. Its conclusion is that a balancing of the criteria weighs against either being placed on the 503A bulks list.

The reasoning is where this becomes interesting for anyone reading certificates. FDA found both substances not well characterised, on two grounds. The first is naming: the conventions in use do not follow established chemical nomenclature standards, so the same words do not reliably denote the same material. The second is missing data - the information needed to establish identity, purity and quality was either absent from the nomination packages or not found in the published literature, including testing for peptide-related impurities and aggregates, microbial quality and residual solvents.

On impurities the document is specific. Solid-phase synthesis can leave impurities from incomplete coupling reactions, truncations and side reactions; these are typically similar in structure to the target peptide, and FDA says they may be difficult to identify and quantify without sophisticated analytical methods. Further impurities can carry over from protected amino acid starting materials, and residual solvents, coupling reagents, activators, catalysts and scavengers may remain from the process.

Then the sentence this site would have written if a regulator had not written it first. FDA searched for certificates of analysis and reported that most certificates it found for BPC-157 free base contain only purity results, with no information about impurity limits or testing results to demonstrate control of the impurity profile. A purity figure is not an impurity profile, and the agency says so in a document anyone can download.

There is one more finding worth carrying to any supplier. FDA reports that in both nomination packages the substance named did not match the certificate supplied: a certificate for the acetate was filed against a nomination whose identifier, CAS number and molecular mass were those of the free base. That is a documentation error found by reviewers inside a submission to a regulator. It is exactly the error a reader can find on a commercial certificate, and it is found the same way, by checking whether the identity fields agree with each other.

• It is not a finding that the compound is dangerous. The recurring formula on the withdrawn table is that FDA has identified no, or only limited, safety-related information, and therefore lacks sufficient information to know whether the drug would cause harm when administered to humans. That is an absence, stated as an absence.
• It is not a ruling about any use. The nominations proposed ulcerative colitis; FDA did not accept that use, this site claims no use for anything, and nothing here should be read as saying the compound does anything at all.
• It is not law outside the United States. Section 503A governs US pharmacy compounding. It says nothing about how any substance is classified in the European Union or the United Kingdom, which is a separate question with a separate test.
• It is not final. An advisory committee makes non-binding recommendations, and FDA states it will not issue a final determination until the committee's input and all reviews have been considered. The committee was asked to vote on whether each of the two substances should be placed on the list.
• It is not about a vial. Every finding above concerns bulk drug substances in a regulatory submission. No document discussed here describes any material anyone can buy.

Use it as a checklist written by someone with no commercial interest in the answer. The review names what it could not find, and what it could not find is the same list a careful reader should ask a supplier for: impurity limits and results rather than a single purity figure, the identity of the salt form as distinct from the free base, water content, and a statement of the analytical methods used.

Then check the identity fields against each other, which costs nothing. For BPC-157 the publicly verifiable chemistry is a pentadecapeptide of sequence GEPPPGKPADDAGLV, formula C62H98N16O22, molecular mass about 1,419.5 g/mol, CAS number 137525-51-0 and UNII code 8ED8NXK95P for the free base. The acetate is a different substance, with its own UNII code PAR2FC72XP and CAS number 216441-37-1, and FDA's own table records no molecular mass for it at all, because the number of acetate units per molecule is left unspecified. A certificate whose heading, CAS number and mass do not describe the same thing has already told you something, and reading the rest of it is the next step rather than the first.

Peptorium publishes no certificates and states no measured figure for anything. What it publishes is what the numbers on a certificate mean, so that an incomplete one can be recognised on anybody's page, including a regulator's example of one.

Last reviewed: September 2026. This page describes published FDA documents and is not legal or medical advice.

• FDA, bulk drug substances used in compounding under section 503A - the three conditions, the rulemaking history and the definitions of categories 1, 2 and 3.
• FDA, certain bulk drug substances that may present significant safety risks - the category 2 table and the "nominated but withdrawn" table that names BPC-157.
• FDA briefing document, PCAC meeting, July 2026 - the evaluation dated 11 May 2026, the characterisation and impurity findings, and the conclusion.
• Questions for the committee - the votes put to the Pharmacy Compounding Advisory Committee.
• FDA, meeting of the Pharmacy Compounding Advisory Committee, 23-24 July 2026 - the meeting and its materials.