Trump Officials Weigh Letting Pharmacies Compound Peptides

The Trump administration is drafting a plan that would let state-licensed pharmacies legally compound several unapproved research peptides, including BPC-157 and KPV, without the FDA writing a single new regulation — by having the agency simply promise not to enforce against the pharmacies that make them.

The workaround, explained

According to Washington Post reporting syndicated by the Anchorage Daily News, two people familiar with the plans say HHS and the FDA are drafting a policy of "interim enforcement discretion": the agency would announce it is focusing its enforcement resources elsewhere, which in practice lets compounding pharmacies prepare certain peptides for patients with a prescription. Nothing has been announced, the timing is unclear, and it isn't settled which peptides would be covered. The reason this route is even on the table is that the alternative — formally adding peptides to the FDA's list of substances pharmacies may legally compound, known as the 503A Bulks List — requires notice-and-comment rulemaking that can take months or years. Enforcement discretion skips that process entirely; it changes nothing about a peptide's legal status, only whether the FDA chooses to act on it.

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, told the Post his group has met with the FDA twice about the idea and wants conditions attached if it moves forward: mandatory patient disclosures, serious-adverse-event reporting and data collection on who is actually using these peptides and for what. Health Secretary Robert F. Kennedy Jr., who has called himself a "big fan" of peptides, has pushed to widen access since taking office; he announced earlier this year that BPC-157 and TB-500 were being removed from the FDA's high-risk compounding list, where they had sat since 2023.

How we got here: a split vote in July

The stopgap idea follows directly from a two-day meeting of the FDA's Pharmacy Compounding Advisory Committee on July 23 and 24 at agency headquarters in Silver Spring, Maryland, where a 20-member panel — several of them added to the roster that same week — reviewed seven peptides for the 503A list: BPC-157, KPV, TB-500, MOTS-c, epitalon, semax and emideltide. The FDA had received more than 1,900 public comments beforehand, and agency staff recommended against all seven, citing a lack of safety and efficacy evidence, according to Fortune's republication of Associated Press reporting. FDA staff told the panel they had found only five short-term studies of BPC-157, all with small samples, and no human studies of TB-500 at all.

The panel voted anyway. On the first ballot, covering BPC-157 and KPV, members voted 8-6 with one abstention to recommend both for the compounding list, according to RAPS (the Regulatory Affairs Professionals Society) and confirmed independently by ABC News. By the time the two days were over, the committee had recommended six of the seven peptides and voted against only emideltide, which had been proposed for opioid withdrawal and insomnia. The committee's recommendations aren't binding — the FDA doesn't have to follow them, though it usually does.

What's actually known versus unknown

The vote split along a real disagreement about what the evidence shows, not just politics. FDA associate director Russell Wesdyk told the panel one basic problem with treating something like BPC-157 as a defined substance at all: "There's no way to know what the substance actually is, was or will be tomorrow because that name has no legal meaning," he said, according to Fortune. Dr. Elizabeth Rebello of MD Anderson Cancer Center voted no for a similar reason: "I'm concerned we're responding to a market-induced demand rather than a decision based in solid science." David Pope, chief pharmacy officer at Xifin Pharmacy Solutions, voted yes anyway: "It's time to put this decision back in the hands of the patient, the physician and the pharmacist." Rita Jew, president of the Institute for Safe Medication Practices, called the outcome "really alarming."

Two structural problems sit underneath that disagreement. First, at least seven of the panel's members have financial ties to the peptide industry — ownership stakes in wellness clinics, compounding pharmacies or consulting businesses built around these products — a conflict HHS-appointed panels have drawn criticism for before. Second, even the FDA's own review found essentially no controlled human trials for any of the seven peptides; what exists is mostly rodent data, plus a handful of small, short, uncontrolled studies in people. That gap is exactly what the proposed enforcement-discretion plan would let compounding pharmacies operate inside of — not resolve.

A polling memo commissioned by the American Academy of Peptide Medicine from Tony Fabrizio, a pollster who has worked for President Trump, and viewed by the Post, reportedly found a "political upside" to expanding peptide access. Lee Rosebush, the Academy's chairman, urged HHS to "use temporary enforcement discretion to allow access to these as soon as possible." Not everyone agrees that speed is the right call: Paul Knoepfler, a UC Davis School of Medicine professor, said loosening access "puts people at more risk," and Ilisa Bernstein, a former deputy director of the FDA's drug compliance office, told the Post "it seems inevitable that the floodgates will open," arguing that any guardrails the agency attaches now matter precisely because the underlying safety data won't exist regardless of what the policy says.

What this means for researchers

Nothing about this proposal would make BPC-157, KPV or the other five peptides FDA-approved drugs, and nothing about it would generate the controlled human trials the agency's own staff say are missing. What it would do, if finalized, is move a set of already widely-used research compounds from a legal gray zone into a different, narrower legal channel — prescription-based pharmacy compounding — while the evidence base underneath them stays exactly where the FDA found it in July. The Journal has covered the FDA's enforcement side of this same gap before: warning letters sent to online sellers labeling peptides "research use only" while marketing them for personal use. Enforcement discretion for compounding pharmacies and warning letters to RUO sellers are two different tools aimed at two different parts of the same supply chain, and neither one changes what is or isn't known about how these molecules behave in a human body outside a lab.

For now, the honest summary is the one FDA staff gave the committee in July: a handful of small, short, uncontrolled studies, extensive animal data that doesn't reliably predict human effects, and a name — "BPC-157" or any of the others — that carries no legal or manufacturing standard behind it, whichever agency rule ends up governing who gets to compound it. Readers tracking the underlying biology can find background on these compounds on Torrey Labs' compound guide; the regulatory question of who may legally prepare them for a patient is a separate matter from what is actually known about them, and as of this week, that second question is still the harder one.