BPC-157 Goes Before the FDA: What to Watch at the July Compounding Hearing
On July 23 and 24, an FDA advisory committee reviews seven peptides, including BPC-157, TB-500, and Semax, for the list that decides which substances pharmacists may legally compound.
On July 23 and 24, the FDA’s Pharmacy Compounding Advisory Committee will convene at the agency’s White Oak campus in Silver Spring, Maryland, to take up a question the peptide field has circled for years: which of these molecules, if any, should pharmacists be permitted to compound for individual patients?
Per the Federal Register notice (docket FDA-2025-N-6895, published April 16), the committee will evaluate seven peptides nominated for the section 503A Bulk Drug Substances List, the roster of raw ingredients that state-licensed pharmacists and physicians may lawfully use in traditional compounding. Section 503A exempts compounded drugs from certain approval, labeling, and manufacturing requirements, but only if the bulk substance meets one of three conditions: it complies with a US Pharmacopeia monograph, it is a component of an FDA-approved drug, or it appears on the 503A list. As the Regulatory Affairs Professionals Society notes, none of these seven satisfies the first two, so the list is their only lawful route.
The first day covers BPC-157, KPV, TB-500, and MOTS-C; the second turns to emideltide (delta sleep-inducing peptide, or DSIP), Semax, and Epitalon. Each is listed in both free-base and acetate forms. The notice also publishes the use or uses FDA evaluated for each: ulcerative colitis for BPC-157, wound healing for TB-500, and insomnia for Epitalon, while listing several uses apiece for the others, including wound healing and inflammatory conditions for KPV, obesity and osteoporosis for MOTS-C, opioid withdrawal, chronic insomnia, and narcolepsy for emideltide, and cerebral ischemia, migraine, and trigeminal neuralgia for Semax. Each listed use is a claim under review, not an established indication.
The stakes are heightened by history. Several of these peptides had been placed in a 2023 “Category 2” designation, a status that effectively barred them from compounding on safety grounds. Their reappearance as candidates reflects a shift that has drawn political attention: HHS Secretary Robert F. Kennedy Jr. has argued for bringing peptides into a regulated market rather than ceding them to a gray-market supply chain.
The committee’s role is strictly advisory. Adding any substance to the 503A list still requires formal notice-and-comment rulemaking, a process that can run more than a year, and FDA is not bound by the panel’s recommendation. The meeting is a step, not a verdict.
For readers following the science rather than the noise, the process leaves a paper trail. Requests to present orally were due June 30, and public comments received by July 9 are forwarded to committee members ahead of deliberations, with the docket accepting written comments through July 22. FDA’s own briefing materials are posted no later than two business days before the meeting. A second session, covering five more peptides, is expected before the end of February 2027.