FDA advisory committee backs two controversial peptides
An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for wound treatment and inflammatory conditions – be added to the list of drugs eligible for bulk compounding, known as the 503A Bulks List.
Over the course of a two-day meeting at FDA’s headquarters in Silver Spring, MD that will continue Friday, the agency’s Pharmacy Compounding Advisory Committee (PCAC) will consider a total of seven popular peptides to be eligible for pharmacy compounding. While the committee was originally slated to consider four peptides on Thursday, the meeting was running significantly behind and a third peptide, TB-500 was still being discussed at the time of publication. The remaining peptides up for consideration include MOTS-C, emideltide, epitalon, and semax.
The recommendations by the committee could nudge the agency to allow these peptides to be eligible for a state-licensed compounding pharmacy to compound the substances for individual patients. These ingredients are not part of a USP/NGF monograph or an approved drug product.
Last year, FDA called on PCAC to evaluate whether a dozen peptide drugs should be eligible for compounding by licensed facilities. These peptides are used to treat opioid use disorder, wound healing, insomnia, and other conditions. (RELATED: FDA considers adding a dozen peptides to its bulk drug compounding list, Regulatory Focus 16 April 2026)
The move to approve these peptides has the support of Robert F. Kennedy Jr, the secretary of the Department of Health and Human Services (HHS) who said he is a “big fan” of peptides and asserted he would work to overturn the restrictions imposed by former president Joe Biden.
Prior to the meeting, in June, the agency added eight new members to PCAC, many of whom have alleged ties to prescribing or promoting peptides. The apparent conflicts were covered by multiple news outlets and were reportedly the subject of concern by some FDA staff members.
Earlier this week, FDA added several additional temporary voting members to the committee with academic, clinical research, and pain and substance use backgrounds.
In a scientific review posted ahead of the meeting, FDA staff recommended against adding these peptides to the 503A Bulks List due to safety and efficacy concerns.
BPC-157
In its briefing package, FDA staff said that there is a “lack of evidence to support the effectiveness of BPC-157 (free base) and BPC-157 acetate as a treatment for ulcerative colitis.”
During the meeting, FDA’s Russell Wesdyk raised a question: "What is BPC-157?" He said that some people believe it is an amino acid sequence, while others have different opinions. “We cannot establish quality standards” until more is known about the substance. FDA’s Mai Tu concurred that this peptide is “not well-characterized.”
The briefing materials also note that FDA staff has received three adverse event (AE) reports following BPC-157 injection: a 55-year-old woman reported use of BPC-157 injection and reported nine days of redness and swelling around the injection site. However, she was also using injectable compounded thymosin. In addition, a 28-year-old male reported use of BPC-157 acetate SC injection for an injury. The patient developed shortness of breath, which resulted in an emergency room visit.
The briefing materials also noted that it is unclear whether these AEs were attributable to BPC-157. The FDA’s ability to interpret FAERS reports is limited by a lack of information and confounding factors, such as concomitant medications.
During an open public hearing before the vote, the panel heard from multiple speakers, including public health advocates, physicians, and peptide companies, who expressed widely differing views on whether BPC-157 should be included on the 503A bulk drug list.
The PCAC was nearly evenly divided on whether to recommend including this compound on the bulk drug list.
PCAC member Elizabeth Rebello, a professor in the Department of Anesthesiology and Perioperative Medicine at the University of Texas MD Anderson Cancer Center, noted the "lack of efficacy data and randomized controlled trials" for these compounds. Similarly, committee member Bill Zamboni expressed his concerns, stating, "There are too many unknowns about this product." On the other hand, PCAC member David Pope from XiFin Pharmacy Solutions stated, "I voted yes because it's time to put this decision back in the hands of the physician and pharmacist."
