The FDA’s Pharmacy Compounding Advisory Committee recommended six peptides for inclusion on the FDA’s compounding list.
Dr. Joshua Starbuck, MD, IFMCP - Makena Health
The question at hand was never whether these compounds should be FDA approved. It was whether a licensed 503A compounding pharmacy should be legally permitted to prepare them for an individual patient holding a valid prescription from a licensed clinician.
That distinction collapses fast in translation. The 503A Bulks List is the mechanism that allows this kind of compounding, and a substance only lands on it after a full sequence: nomination, a PCAC recommendation like this one, a comment period, then formal rulemaking through the Federal Register. Even in the fastest scenario, that takes roughly 90 days from here. The last time the list actually gained anything new was 2019, six substances, five of them topical, and those six remain the only ones ever added across fourteen meetings of this committee. Fourteen meetings, six substances. That’s a fair question to sit with on its own: whether the list was ever built to move at the pace patients actually need.
Separate from the Bulks List, and important not to confuse with it, sits FDA’s category system, an interim enforcement policy built because the rulemaking path is so slow. Category 1 means FDA doesn’t currently intend to act against compounding while it works through evaluation. Category 2 means the agency identified safety concerns. Category 3 means the nomination lacked sufficient data. A substance in Category 1 is not on the Bulks List, and can sit there for years without the rulemaking that would make it official ever finishing.
Patients have been asking about these compounds for years, evidence gaps and all, because the alternative was never no access, it was unregulated access.
The votes were close, not unanimous, and each went against FDA’s own scientific staff, who had recommended against inclusion. The evaluation framework runs on four factors regardless: characterization, safety, efficacy if known but not required, and history of use.
None of this is FDA approval. The 505 pathway demands an IND, full clinical trials, and often hundreds of millions to billions of dollars before a single indication is granted. This vote doesn’t touch that pathway, and these peptides remain unapproved drugs regardless of what the rulemaking eventually does. That gap between a recommendation and an actual legal listing is where the real work now sits.
That work took shape during the public hearing, the most human part of two otherwise procedural days. Dr. Elizabeth Yurth’s testimony on BPC-157 nearly brought me to tears, she named patients describing lives improved dramatically after years searching for a provider willing to try it. Reading the public docket alongside testimony like hers made the process feel less abstract, a decision with real suffering and real relief on the other side of it.
The hearing is also where the practical path forward took shape, as speakers spent less time arguing the science and more time proposing a safer bridge while rulemaking grinds forward. Dr. Jeffrey Egler and others laid out pieces of it: a verified-sourcing registry for API suppliers, something like a greens list; expanded state-level regulatory pathways; and a structured adverse-event reporting system, the same instinct behind VAERS. None of that needs a final rule, and none builds itself either. The next challenge isn’t waiting for these six to clear rulemaking, it’s building those guardrails now, so access arrives the right way instead of just faster.
Underneath all of it, the foundation this community already knows doesn’t change. Sleep, nutrition, hydration, movement, community, stress management, and recovery carry the weight. Peptides, if they arrive on the list at all, are the icing, not the cake. Physicians carry a real responsibility to model that hierarchy rather than let it invert, appropriate use, not overuse. A reason for use rooted in the patient in front of you, informed consent that’s honest, and monitoring that catches problems early.
Get that part right, and the rest follows. When patients win, we all win.
Dr. Joshua Starbuck, MD
Originally published in The Longevity Medicine Intelligence newsletter (#100).
