The vote in the title did happen. On July 23, 2026, the FDA’s Pharmacy Compounding Advisory Committee (PCAC) voted 8 to 6, with one abstention, to recommend adding BPC-157 to the 503A bulks list. That list names the bulk ingredients that state-licensed pharmacies may use to compound drugs. The panel made that recommendation even though FDA staff had recommended against it.123
The vote did not approve BPC-157 as a drug. It did not make compounded BPC-157 legal, and it said nothing new about whether the peptide works. Advisory committee votes are not binding. Pharmacies cannot compound a substance on the strength of a vote alone. The FDA would first have to finish notice-and-comment rulemaking, and as of mid-September 2026 we found no proposed rule adding BPC-157 to the list.46
What did change is the tone of the debate. For about two and a half years, the FDA listed BPC-157 as a substance that may pose significant safety risks in compounding. It now sits in a regulatory gray zone. A federal advisory panel has endorsed it, the agency’s own reviewers have argued against it, and the human evidence is still very thin. This article covers each of those threads and how they fit together.
What the advisory committee actually voted on
The PCAC met on July 23 and 24, 2026, at the FDA’s White Oak campus in Silver Spring, Maryland, under docket FDA-2025-N-6895. The panel was asked whether seven peptides should be added to the 503A bulks list. BPC-157, KPV, TB-500 and MOTS-c were on the first day’s agenda. Emideltide (also called DSIP), Semax and Epitalon were on the second day’s.1
Compounding nominations are reviewed for specific uses. The FDA’s meeting materials listed the use under review for BPC-157 as ulcerative colitis. The committee was not asked about tendon repair, sports injuries or general recovery, which are the uses most often mentioned in online discussion of the peptide.1
Several outlets reported the BPC-157 result as 8 in favor, 6 against and 1 abstention. KPV passed by the same margin that day.23 By the end of the second day, the committee had voted in favor of six of the seven peptides: BPC-157, KPV, TB-500, MOTS-c, Epitalon and Semax. It did not recommend emideltide.4
| Peptide | Meeting day | Committee recommendation |
|---|---|---|
| BPC-157 | July 23 | Add to 503A bulks list (8 yes, 6 no, 1 abstain) |
| KPV | July 23 | Add to 503A bulks list (8 yes, 6 no, 1 abstain) |
| TB-500 | July 23 | Add to 503A bulks list |
| MOTS-c | July 23 | Add to 503A bulks list |
| Semax | July 24 | Add to 503A bulks list |
| Epitalon | July 24 | Add to 503A bulks list |
| Emideltide (DSIP) | July 24 | Not recommended |
Why FDA reviewers opposed it
FDA staff recommended against adding BPC-157 to the list. According to reporting on the briefing, the reviewers pointed to limited evidence of effectiveness and noted that approved treatments for ulcerative colitis already exist. They found only one relevant clinical report: a meeting abstract describing about 46 people who received BPC-157 as an enema. That is a different route from the injections most people associate with the peptide.3
Reviewers also questioned the substance itself. RAPS reported that FDA official Russell Wesdyk raised basic questions about how BPC-157 is defined and characterized. The briefing also described three adverse event reports with unclear causality. One involved a 28-year-old man who developed shortness of breath after an injection of BPC-157 acetate and needed emergency care.2
The panel itself was divided. Members who voted no cited the lack of efficacy data and randomized controlled trials. Some also worried that listing the peptide would suggest it had passed a level of review it has not.2 Members who voted yes argued that the decision should rest with physicians and pharmacists. Time reported that several members had ties to telehealth companies, which is not typical for a committee usually made up of academics and researchers.3
How BPC-157 got onto, and off, the Category 2 list
The vote makes more sense with the history in view. When a bulk substance is nominated for 503A compounding, the FDA places it in one of several interim categories while the evaluation is pending. Category 1 substances may be compounded under the agency’s interim enforcement policy. Category 2 substances are those the FDA believes may pose significant safety risks. In practice, pharmacies treated Category 2 as a do-not-compound list.56
The FDA placed BPC-157 in Category 2 in 2023.6 Its explanation is still posted on the agency’s safety risks page. The FDA said compounded BPC-157 may pose a risk of immunogenicity (an unwanted immune response) for certain routes of administration. It also said the peptide may be difficult to characterize and may carry peptide-related impurities. Finally, the agency said it had found no, or only limited, safety information for the proposed routes, so it could not tell whether the drug would harm people.5
In April 2026, the people who had nominated BPC-157 and 11 other peptides withdrew their nominations, and the FDA removed those substances from Category 2. The agency’s page, last updated April 22, 2026, now lists BPC-157 under “nominated but withdrawn.” The safety language is still there.56 Removal did not move BPC-157 into Category 1. Legal analysts noted at the time that the interim enforcement policy covers only Category 1 substances. That left the peptide outside both the restricted list and the permitted one, and it was then renominated for PCAC review.6
Where regulation stands as of September 2026
As of September 17, 2026, BPC-157’s status in the United States looks like this:
- Not an approved drug. The FDA has not approved BPC-157 for any use, and no company has an approved application for it.
- Not on the 503A bulks list. The PCAC recommendation is advisory only. The National Community Pharmacists Association told its members that pharmacies may not compound the recommended peptides until final rulemaking is complete.4
- Not in Category 2. BPC-157 has been off the safety risks list since April 2026, but the FDA’s stated concerns are still published.5
- Not in Category 1. A favorable committee vote does not by itself make a substance eligible under the interim policy.6
- Banned in sport. The World Anti-Doping Agency lists BPC-157 under S0, non-approved substances, which are prohibited at all times.7
The next formal step would be a proposed rule from the FDA, followed by a public comment period and then a final rule. NCPA noted that additions also require approval from the Secretary of Health and Human Services.4 The FDA can still decline to follow the committee’s advice, and it can narrow any listing by route or use. Outside the compounding system, BPC-157 is widely sold as a research chemical. Our explainer on what “research use only” actually means covers why that label does not make a product legal for people to take.
| Date | Event |
|---|---|
| 2015 to 2016 | Phase 1 safety and pharmacokinetics trial (PCO-02) registered by PharmaCotherapia; no results posted |
| 2023 | FDA places BPC-157 in 503A Category 2 (significant safety risks) |
| April 2026 | Nominations withdrawn; BPC-157 removed from Category 2 but not moved to Category 1 |
| July 23, 2026 | PCAC votes 8 to 6, with 1 abstention, to recommend adding BPC-157 to the 503A bulks list |
| September 2026 | No proposed rule identified; compounding not yet authorized |
The WADA status has not changed
The compounding debate has no effect on sport. USADA and other national anti-doping agencies list BPC-157 under the WADA Prohibited List’s S0 class. S0 covers pharmacological substances that no government health authority has approved for human therapeutic use.7 Adding BPC-157 to a compounding list would not count as that kind of approval. An athlete subject to the WADA Code who tests positive could still face a violation, even with a prescription.
USADA has also noted the lack of published human trial data, pointing out that some studies appear to have been canceled or stopped without published conclusions.7 One registered trial fits that pattern. PCO-02, a safety and pharmacokinetics study sponsored by the Croatian company PharmaCotherapia, lists a start date of October 2015, an estimated enrollment of 42, a status of “unknown,” and no posted results.12
What human research exists
The published human record for BPC-157 is very small. A 2025 systematic review in the HSS Journal screened 544 articles published from 1993 to 2024. Of the 36 studies it included, 35 were preclinical and 1 was clinical. The authors found no clinical safety data and graded the evidence as level IV and V, the lowest tiers.8
Most of the human reports since then come from one clinician group in Florida and appear in Alternative Therapies in Health and Medicine:
| Study | Design | Participants | Reported finding | Main limitations |
|---|---|---|---|---|
| Lee & Padgett, 2021 | Retrospective chart review and phone survey, knee injection | 16 (12 BPC-157 alone) | 11 of 12 in the BPC-157-only group reported significant pain improvement | No control group, no validated outcome measures, recall-based |
| Lee, Walker & Ayadi, 2024 | Single-arm pilot, injections into the bladder wall during cystoscopy | 12 women with interstitial cystitis | 10 reported complete symptom resolution; no adverse events reported | No placebo or blinding, small sample, single clinic |
| Lee & Burgess, 2025 | Pilot intravenous safety study | 2 adults who had previously received IV BPC-157 | No measured changes in heart, liver, kidney, thyroid or glucose markers over 3 days | Two people, very short follow-up, prior exposure |
The knee study asked patients to recall their pain by phone, 6 to 12 months after injection, without standardized tools for function or quality of life.9 The interstitial cystitis pilot used a compounded product and a single global response questionnaire.10 The intravenous study gave 10 mg and then 20 mg infusions to two people. Although the authors described the results as showing safety, they also said more studies were needed.11 None of these studies was randomized or placebo-controlled. None was large enough to detect uncommon harms.
The ulcerative colitis enema abstract that FDA reviewers cited is the only report that matches the use the committee actually considered, and it has not appeared as a full peer-reviewed paper.3 For a closer look at reported adverse effects, see our review of BPC-157 side effects and safety.
The animal research base
Nearly all of the reasons BPC-157 draws interest come from animal and cell studies. BPC-157 is a synthetic 15-amino-acid peptide. It is based on a partial sequence of a protein first described in human gastric juice.7 Most of this work has been done in rodents, and much of it comes from one research group in Zagreb, Croatia.
The HSS Journal review summarizes what those preclinical studies report:8
- Better functional, structural and biomechanical healing in rodent models of muscle, tendon, ligament and bone injury.
- Higher growth hormone receptor expression and activity in pathways tied to cell growth and new blood vessel formation (angiogenesis).
- Lower levels of inflammatory cytokines.
- Metabolism in the liver, a half-life of under 30 minutes, and clearance through the kidneys.
- No adverse effects across several organ systems in preclinical safety testing.
These findings explain why researchers are interested, but they have clear limits. Results in rodents often fail to hold up in larger human trials. Much of the animal work comes from a small number of laboratories and has not been widely replicated. The same pro-angiogenic activity that may help tissue repair also raises theoretical questions about tumor growth, and short animal studies are not designed to answer those questions. The review’s authors concluded that adverse effects are possible because of unregulated manufacturing, contamination and unknown clinical safety.8 For context on how BPC-157 compares with related compounds, see our overview of common research peptide types.
What the vote does and does not mean
The July vote is significant, but mainly for policy reasons. It is the first time a federal advisory body has formally backed a legal compounding pathway for BPC-157, and it was a split vote over the objections of the agency’s own scientists. That tells you about the current direction of compounding policy. It tells you very little about the peptide’s pharmacology.
Listing on the 503A bulks list, if the FDA finalizes it, would not require proof of efficacy of the kind needed for drug approval. It would allow licensed pharmacies to prepare BPC-157 for individual patients under a prescription, subject to pharmacy quality standards. It would not answer the questions FDA reviewers raised about identity, impurities, immunogenicity and clinical benefit. The evidence behind the vote is the same set of rodent studies and small uncontrolled human reports described above.
Frequently asked questions
Did the FDA approve BPC-157 in 2026?
No. An FDA advisory committee recommended adding BPC-157 to the 503A bulks list for pharmacy compounding. That recommendation is not binding and is not a drug approval. The FDA would need to complete rulemaking before compounding is permitted.
What was the exact vote?
On July 23, 2026, the Pharmacy Compounding Advisory Committee voted 8 in favor, 6 against, with 1 abstention. The use under review was ulcerative colitis.
Is BPC-157 still on the FDA’s Category 2 list?
No. It was removed in April 2026 after its nomination was withdrawn. The FDA’s page still lists its safety concerns under “nominated but withdrawn,” and removal did not place it in Category 1.
Can athletes use BPC-157?
Athletes subject to anti-doping rules should not. BPC-157 is prohibited at all times under WADA’s S0 non-approved substances class, and the compounding vote does not change that.
Is there good human evidence that BPC-157 works?
Not yet. The published human data consist of a retrospective knee survey, a 12-person uncontrolled bladder study, a 2-person intravenous safety pilot and an unpublished colitis abstract. No randomized controlled trial results have been published.
Sources
- US Food and Drug Administration. July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee. FDA, 2026. https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- Regulatory Affairs Professionals Society. FDA advisory committee backs two controversial peptides. RAPS, 2026. https://www.raps.org/resource/fda-advisory-committee-backs-two-controversial-peptides.html
- Time. An FDA Committee Just Voted in Favor of Peptides, Despite the Agency’s Opposition. Time, 2026. https://time.com/article/2026/07/23/fda-committee-peptides/
- National Community Pharmacists Association. FDA advisory committee nominates six peptides for pharmacies to compound. NCPA, 2026. https://ncpa.org/newsroom/qam/2026/07/31/fda-advisory-committee-nominates-six-peptides-pharmacies-compound
- US Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. FDA, updated April 22, 2026. https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- Frier Levitt. FDA to Remove 12 Popular Peptides from the Category 2 “Do Not Compound” List. Frier Levitt, 2026. https://www.frierlevitt.com/articles/fda-peptides-do-not-compound-list-update-2026/
- US Anti-Doping Agency. BPC-157: Experimental Peptide Creates Risk for Athletes. USADA. https://www.usada.org/spirit-of-sport/bpc-157-peptide-prohibited/
- Vasireddi N, Hahamyan H, Salata MJ, et al. Emerging Use of BPC-157 in Orthopaedic Sports Medicine: A Systematic Review. HSS Journal. 2025;21(4):485-495. https://pubmed.ncbi.nlm.nih.gov/40756949/
- Lee E, Padgett B. Intra-Articular Injection of BPC 157 for Multiple Types of Knee Pain. Alternative Therapies in Health and Medicine. 2021;27(4):8-13. https://pubmed.ncbi.nlm.nih.gov/34324435/
- Lee E, Walker C, Ayadi B. Effect of BPC-157 on Symptoms in Patients with Interstitial Cystitis: A Pilot Study. Alternative Therapies in Health and Medicine. 2024;30(10):12-17. https://pubmed.ncbi.nlm.nih.gov/39325560/
- Lee E, Burgess K. Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study. Alternative Therapies in Health and Medicine. 2025;31(5):20-24. https://pubmed.ncbi.nlm.nih.gov/40131143/
- ClinicalTrials.gov. PCO-02: Safety and Pharmacokinetics Trial (NCT02637284). US National Library of Medicine. https://clinicaltrials.gov/study/NCT02637284
Editorial note: This article is for general information only and is not medical or legal advice. BPC-157 has not been evaluated by the FDA to diagnose, treat, cure or prevent any disease. Research peptides such as BPC-157 are sold for research use only and are not intended for human consumption. Laws vary by location and change often, so verify the rules that apply where you are. Always talk to a licensed healthcare provider before use, especially if you are under 21, pregnant or nursing, taking medication, or managing a health condition.