The Food and Drug Administration’s Pharmacy Compounding Advisory Committee is scheduled to meet July 23-24 to discuss whether seven unapproved peptide injections should be moved to a list of substances that compounding pharmacies can legally produce and dispense by prescription — a change that would effectively legalize a gray market that has flourished online.
If the committee recommends easing restrictions and the FDA follows that advice, compounding pharmacies could manufacture and fill prescriptions for the peptides, which are currently banned from pharmacy production under a 2023 Biden administration rule. The FDA is not bound to follow the committee’s advice but typically does so.
Peptides are short-chain amino acids that include both FDA-approved blockbusters such as GLP-1 weight loss medications and older drugs like insulin. The seven peptides under review — BPC-157, KPV, TB-500, MOTs-C, Emideltide, Semax, and Epitalon — have not been approved by the FDA for human use. They are marketed online as wellness aids for injury recovery, anti-aging and weight loss, promoted by social media influencers and figures including Joe Rogan.
“There are a lot of patients who are foaming at the mouth waiting for these peptides to get moved to Category 1 legal status,” Mohammed Chammout, a retail pharmacist in Michigan, told The Guardian.
The committee has three voting members, six vacancies and one non-voting member from the pharmaceutical industry.
Even if restrictions are lifted, the drugs would not receive FDA approval. Drug approval requires years of phased clinical trials that grow from hundreds to thousands of participants, and most candidates fail. The change would allow pharmacies to produce the peptides without the safety and efficacy data required for full approval.
“The ban is appropriate for these peptides that have no data and all sorts of concerns regarding safety,” said Dr. Eric Topol, director and founder of the Scripps Research Translational Institute. Topol said he has been a “loud voice of caution” against the unapproved drugs.
When the Biden administration banned 19 research peptides from compounding pharmacy use in 2023, the FDA cited risks including priapism — long-lasting, painful erections — and the potential to aid tumor growth.
BPC-157, sometimes called the “wolverine peptide,” is marketed for injury recovery. Dr. Flynn McGuire, who studied the research, told Stat and Undark in 2025 that “the amount of hype to evidence is just so skewed, it’s crazy.” He said BPC-157 “should not be used by humans.” Consumer advocacy group Public Citizen has called on the FDA to require full approval rather than “a more lenient workaround.”
A poll suggests 90% of physicians are worried about patients’ self-directed peptide use, while compounding pharmacies argue the change would provide a safer supply than the unregulated gray market.
The push for change comes from the Trump administration and Health Secretary Robert F. Kennedy Jr., who recently called the Biden administration’s ban “illegal” on “The Joe Rogan Experience.” Kennedy said he is a “big fan” of peptides and has used them himself.
Dr. Anant Vinjamoori, chief medical officer of Hims — part of Hims & Hers, which cheered the FDA’s decision to re-evaluate the drugs’ status — said the evidence base is “still developing.” Through a spokesperson, Vinjamoori declined to identify a specific standard of care for the peptides. “What exists is largely preclinical, but preclinical evidence isn’t no evidence,” he said in an interview via email.
Wall Street analysts estimate that telehealth peptide prescribing could reach $2.2 billion per year, with Hims & Hers alone capturing as much as $440 million if restrictions are eased. The company acquired a U.S.-based peptide facility in 2025.
Critics — including Topol — worry the regulatory change may be a foregone conclusion. As precedent, they point to Kennedy’s overhaul of a federal vaccine advisory committee, which he fired all 17 members of in June 2025 and replaced with ideological allies. That panel then attempted to reduce the number of vaccines recommended for children, a move that a federal court blocked and that remains under litigation.
“Whatever RFK is pushing for will somehow get done,” Topol said.