On this page
The short version is the status box. The October 28 filing is the next section. The human studies, which are small and uncontrolled, are BPC-157 human trials. The sport rules, including the Kamryn Lute sanction, are is BPC-157 banned for athletes. The research profile is BPC-157. The seller's "research use only" line is its own page.
Update, October 28, 2026
I read the public-inspection PDF, then the policy file it links, then NBC's story from the same morning. The three do not use the same number of words. The policy file is the one with the conditions.
On October 28, 2026, at 11:15 a.m., HHS filed Federal Register document 2026-22192. You can read it on public inspection and as the unpublished PDF. It is scheduled to publish on October 30, 2026. Written comments stay open until two weeks after that publication date, on regulations.gov, docket HHS-OASH-2026-0496.
The notice is a notice of availability. It announces a draft called "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances." That draft is a separate PDF: HHS enforcement discretion policy. Appendix A names six peptides: BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
HHS says it does not intend to take enforcement action against a state-licensed pharmacy, a federal facility, or a licensed physician who compounds a drug product using one of those peptides, while FDA develops the 503A Bulks List through rulemaking. A valid prescription for a specific patient is one of the conditions. The other parts of section 503A that still apply include the rule against compounding under insanitary conditions. The discretion sentence does not name a 503B outsourcing facility.
The Federal Register notice calls the policy a draft. It says the draft does not establish rights for any person and is not binding on HHS or the public. HHS may revisit the policy, in whole or in part, if a safety signal or a product-quality problem shows up.
FDA has not approved any of these six peptides. The notice says compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. The 503A Bulks List at 21 CFR 216.23 is unchanged. The policy says a later rulemaking may propose adding some or all of these peptides. This filing is not that rule.
The Secretary's reason is in the policy PDF. He wrote that this limited policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers, and that limited compounding under safeguards gives patients a more controlled alternative. NBC News, in a story by Berkeley Lovelace Jr. published October 28, 2026, reported that HHS is pausing legal action against compounding pharmacies that make the six peptides, and that those pharmacies must certify identity and purity and report side effects. An HHS spokesperson, Emily Hilliard, told NBC the department is confronting the risks of black-market peptides. NBC's account matches the peptide list and the decision not to enforce. It does not walk through the prescription requirement, the federal-facility and physician language, the single-ingredient rule, or the salt and route limits in Appendix B. Those limits are in the policy, so they are the ones this page uses.
Appendix B ties the discretion it describes to a form and a route:
- BPC-157 acetate, for subcutaneous, intramuscular, oral, or topical use. Intravenous use is not a route Appendix B names.
- TB-500 acetate, for subcutaneous or intramuscular use.
- MOTS-c acetate, for subcutaneous or intramuscular use.
- Epitalon acetate, for subcutaneous or intramuscular dosage forms dispensed in intermittent courses.
- KPV acetate, for topical and oral use.
- Semax free base, for intranasal use.
The bulk substance has to come from a facility registered with FDA under section 510, with a valid certificate of analysis for identity, purity, potency, and contaminants such as endotoxin, heavy metals, microbes, and impurities. The original manufacturer has to be registered, in compliance with current good manufacturing practice, and named with a physical location on that certificate. If a repacker, relabeler, or reseller is in the chain, that firm has to have validated the manufacturer and the certificate.
The compounder reports what was compounded, plus serious adverse events and product-quality problems, to FDA's MedWatch program and to the states where the products are compounded and where they are sent. The label given to the patient has to include the sentence "This is a compounded drug product. Not for resale." It also has to explain how to report a bad reaction or a problem with identity, strength, purity, or quality.
The compounded product contains one active ingredient from Appendix A. A blend of two of these peptides sits outside the policy. If the dosage form is a pill or another oral form, the compounder is expected to keep documentation that the specific formulation reaches an adequate level of oral bioavailability in people. The only drug-delivery device that can be packaged with the product is an FDA 510(k)-cleared syringe.
A research-use-only website is outside the list of compounders the policy names. Canada did not change today. Health Canada's April 9, 2026 advisory still says a research-use-only label does not make an unauthorized injectable legal there. WADA still lists BPC-157 in class S0, prohibited at all times. A US pharmacy sitting inside this policy would not change that sport rule.
Appendix B also says BPC-157 was in Category 2 until April 22, 2026. This site's reading of the May 14, 2026 categories document still uses that date for GHK-Cu, not for BPC-157, so the BPC-157 profile does not treat the date as settled. The profile has the same October 28 update, written for that page. MOTS-c has its own. KPV, Epitalon, and Semax do not have compound profiles on this site. TB-500's pairing with BPC-157 is BPC-157 vs TB-500.
Most of the research so far comes from laboratory and animal studies. That does not tell us whether it works in people.
United States: approval and the 503A list
FDA has not approved a drug containing BPC-157. The July 2026 briefing for the Pharmacy Compounding Advisory Committee says there is no USP or NF monograph for BPC-157 free base or BPC-157 acetate, and that the two are different bulk drug substances. Under section 503A, a bulk substance can be used in compounding if it has an applicable monograph, or is a component of an FDA-approved drug, or is on the 503A Bulks List. BPC-157 meets none of those three.
Read this next Is BPC-157 banned for athletes?
The categories document updated May 14, 2026 does not place BPC-157 in Category 1 (under evaluation), Category 2 (significant safety risks), or Category 3 (nominated without adequate support). Category 1 is the group for which FDA's interim policy generally does not intend to take action while an evaluation runs. BPC-157 is not in that group.
FDA's safety-risks page lists BPC-157 under "bulk drug substances nominated but withdrawn," substances previously in Category 2 whose nominators withdrew. The page says compounded drugs containing BPC-157 may pose a risk of immunogenicity for certain routes, and that FDA has no, or only limited, safety information for the proposed routes. The May 14 categories document uses April 22, 2026 as the withdrawal date for GHK-Cu, not for BPC-157, so this page does not assign BPC-157 that date.
A withdrawn nomination does not add a substance to the 503A Bulks List. The Bulks List is made by notice-and-comment rulemaking.
The July 2026 meeting, and what it did not change
On July 23, 2026, FDA asked the committee to vote on two questions: should BPC-157 free base be placed on the list, and should BPC-157 acetate be placed on the list. The staff slides propose that neither be included. The questions document says the same thing in the proposal line: FDA is proposing that BPC-157 free base not be included. Staff proposed keeping BPC-157 off the list, but the panel narrowly voted to add all six. No proposed rule yet.
FDA has not posted the minutes. Secondary write-ups give a tally. This page does not repeat a number that is not in the minutes or the slides we reviewed. An advisory recommendation would not be an approval even if the minutes were up. The Washington Post reported on October 7, 2026 that the committee recommended six of the seven peptides it reviewed and voted against emideltide, and that FDA does not have to follow the panel. The Post is a news report of the meeting. It is not the rule.
The Unified Agenda entry for further amendments to the 503A Bulks List (RIN 0910-AI70) was still at the proposed-rule stage when this site checked it for the athlete page, with no Federal Register citation. A search on October 23, 2026 did not find a published proposed rule adding BPC-157, and did not find posted minutes.
The same Post story said officials were crafting a plan for temporary sale of some previously restricted peptides while rules were written. Two unnamed sources described the plan. The Post said the plan had not been announced and could still change, and that it was not clear which peptides it would cover. A search on October 23, 2026 did not find an FDA order matching that description. The October 28, 2026 filing is an HHS notice of a draft enforcement-discretion policy, with a date, a docket, and an Appendix A. The update above is that document. FDA has not approved BPC-157, and this page still does not give a dose.
Canada
Health Canada's April 9, 2026 advisory names BPC-157 among unauthorized injectable peptide drugs it has seized. The advisory says these products are illegal in Canada, have not been assessed for safety, efficacy, and quality, and that a "For Research Use Only" label does not make them legal. Authorized prescription drugs carry an eight-digit Drug Identification Number. We did not find a DIN for BPC-157.
On May 7, 2026, Health Canada posted a Type I recall, RA-82047, of BPC-157 powder sold as an unauthorized active ingredient. The recall date is May 5, 2026. The depth of recall is compounding and community pharmacies. A search on October 23, 2026 did not find a later advisory that withdraws the April notice.
We have not reviewed regulators outside the United States and Canada for this page. "Legal somewhere else" is not a finding this page makes.
Athletes, briefly
Sport rules are not drug-approval rules, and they are not optional for people who compete under the World Anti-Doping Code. The 2026 WADA Prohibited List names BPC-157 in class S0, prohibited at all times, in and out of competition. USADA's 2026 Premier Sports list does the same. The sanction case, the therapeutic-use exemption language, and the supplement-label problem are on the athlete page. A pharmacy in the United States can be fully inside FDA's compounding rules and an athlete can still be sanctioned. The reverse is also true: a WADA line does not place a substance on the 503A Bulks List.
What the human studies can and cannot settle
Two small uncontrolled case series and one two-person tolerability pilot are the published human record this site counts. Lee and Burgess (2025) gave two healthy adults intravenous BPC-157 and reported no adverse effects over those two days. Two people cannot establish safety. A 2026 translational review described the published clinical evidence as fewer than 30 subjects across three uncontrolled pilot studies. The list, with the registry records that are not results papers, is BPC-157 human trials.
The tendon, wound, and ligament papers are rat and cell studies. Animal results do not tell us what happens in a person. Absence of a strong human record is not proof the compound does nothing. It means the reviewed evidence cannot establish what it does in people.
We did not find reliable interaction data in the sources reviewed. That does not mean there are no interactions.
What would change this page
A final rule placing the free base or the acetate on the 503A Bulks List, an FDA approval, or a monograph would change the statutory compounding test. A committee recommendation does not do that. The October 28, 2026 HHS notice is a draft decision not to enforce, inside the conditions in the update. It leaves the Bulks List where it was. If HHS revises the draft, or if FDA publishes a proposed or final rule, this page changes again.
In Canada, authorization would show up as a Drug Identification Number. The April and May 2026 notices are still the public record we found.
The buying questions around research-only labels, telehealth, and compounded GLP-1s are gathered on safety and buying. BPC-157 is the research-compound case. The GLP-1 case is a different statute and a different set of letters.
Common questions
Is BPC-157 legal in the United States?
There is no FDA-approved drug containing it. It is not on the 503A Bulks List, not in Category 1, and the nominations were withdrawn. On October 28, 2026 HHS filed a draft policy that says HHS does not intend to take action when a state-licensed pharmacy, a federal facility, or a licensed physician compounds it under the conditions in the October 28 update, including a prescription for a specific patient. That draft is not an approval, and it does not add BPC-157 to the Bulks List.
Is BPC-157 legal in Canada?
Health Canada has not authorized it. The April 9, 2026 advisory names it among seized unauthorized injectable peptides and says a research-use-only label does not make those products legal. What that phrase means across the August 24, 2026 FDA letters is research use only peptides. A May 2026 Type I recall covers BPC-157 powder sold as an active ingredient.
Did the July 2026 committee vote make BPC-157 legal?
No. Staff proposed keeping BPC-157 off the list, but the panel narrowly voted to add all six. FDA has not posted minutes. A committee recommendation is not a rule, and there is no proposed rule yet. The October 28, 2026 HHS filing is a separate document, and it also leaves the Bulks List unchanged.
Did removal from Category 2 make it legal to compound?
No. FDA lists it with substances previously in Category 2 whose nominations were withdrawn. That listing does not add it to the 503A Bulks List.
Is "research use only" a legal way to sell it?
Health Canada's April 9, 2026 advisory says that label does not make an unauthorized injectable peptide legal in Canada. The October 28 HHS policy says its aim is to discourage research-use-only peptides supplied by foreign manufacturers. The compounders it names are a state-licensed pharmacy, a federal facility, or a licensed physician. This site does not list sellers.
Is BPC-157 banned for athletes even if a pharmacy compounded it?
Yes. The 2026 WADA List names it in class S0, prohibited at all times. The athlete page has the USADA documents and the sanction.
Sources
Methodology. The FDA, WADA, USADA, and Health Canada documents below are the same record reviewed for the athlete page on October 15, 2026. On October 23, 2026 we searched again for posted PCAC minutes, a Federal Register proposed rule adding BPC-157, an FDA enforcement-discretion order, and a newer Health Canada advisory. None of those four was found that day. On October 28, 2026 we read Federal Register public-inspection document 2026-22192, the HHS policy PDF linked from that notice, and the NBC News story published the same day. A numeric committee tally appears in secondary reports. It is not in the FDA minutes or slides we reviewed, so it is not repeated here. Doses, sellers, and prices are left out.
Primary sources.
- HHS, Federal Register public inspection, document 2026-22192, filed October 28, 2026, publication date October 30, 2026: https://public-inspection.federalregister.gov/2026-22192.pdf
- HHS, Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (the policy PDF linked from the notice): https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
- Docket HHS-OASH-2026-0496, RIN 0910-ZD94
- NBC News, Berkeley Lovelace Jr., October 28, 2026: https://www.nbcnews.com/health/health-news/rfk-jr-takes-shortcut-make-peptides-widely-available-rcna606133
- FDA, 503A categories, updated May 14, 2026: https://www.fda.gov/media/94155/download
- FDA, bulk substances that may present significant safety risks: https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- FDA PCAC slides, July 23-24, 2026: https://www.fda.gov/media/193773/download
- FDA PCAC questions: https://www.fda.gov/media/193711/download
- FDA PCAC briefing on BPC-157: https://www.fda.gov/media/193343/download
- Unified Agenda, RIN 0910-AI70: https://www.reginfo.gov/public/do/eAgendaViewRule?RIN=0910-AI70&pubId=202510
- Washington Post, October 7, 2026: https://www.washingtonpost.com/health/2026/10/07/trump-administration-paving-way-temporary-sale-some-unapproved-peptides/
- Health Canada advisory, April 9, 2026: https://recalls-rappels.canada.ca/en/alert-recall/think-twice-injecting-peptides-bought-online-unauthorized-products-can-seriously-harm
- Health Canada recall RA-82047, May 7, 2026: https://recalls-rappels.canada.ca/en/alert-recall/ghk-cu-bpc-157-powder-unauthorized-active-pharmaceutical-ingredients
- WADA, 2026 Prohibited List: https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
Left out. Vote counts from secondary reports. An April 22, 2026 removal date, which the categories document uses for GHK-Cu, not for BPC-157. Sellers, prices, and doses.
Changes. October 23, 2026: first published, as the legal-status page. The athlete page remains the WADA file. October 28, 2026: added the HHS draft enforcement-discretion policy, document 2026-22192, after reading the public-inspection PDF, the linked policy PDF, and the NBC story. Re-check planned if HHS revises the draft, if FDA posts minutes or a proposed or final rule, and if Health Canada updates the April 2026 advisory.
