Peptides are short chains of amino acids that people inject into their bodies. HHS Secretary Robert F. Kennedy Jr. has said in the past that he is a “big fan” of the unapproved drugs, whose benefits are largely scientifically unproven.
The new policy—which was signed by Kennedy—says that after the July meetings, HHS believed there was “significant interest” in the use of obtaining these peptides from compounding pharmacies. “Therefore, to expand and improve patient access, HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A,” the notice said. The policy said that it was going to be published in the Federal Register on Oct. 30. The peptides listed in Appendix A were BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—the same ones the committee recommended allowing this summer.
The decision to allow the compounding of peptides is a boon for companies like Hims & Hers, which had reportedly been preparing to offer peptides in 2026. Analysts have said the market for peptides could be as high as $3.3 billion. Hims stock shot up 5% after the Oct. 28 announcement.
Other public-health professionals raised alarm about the decision, which they say allows compounding pharmacies to dispense these medications absent scientific evidence. “American consumers should not be treated like guinea pigs,” said Fred Mills, chief policy officer for Americans for Safe and Effective Medicines, in a statement. “It is possible to advance both patient safety and access to legitimate medicines, but this is not it.”
Many physicians have spoken up against allowing peptides to be compounded. “The peptides under consideration here are untested and poorly characterized experimental drugs that should not be allowed in compounded products,” said Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, at the public comment portion of the July meeting, reminding the committee that two women had required emergency treatment after receiving peptides at a Las Vegas festival.
"Compounding can and should play a legitimate clinical role, from hospitals to home infusion to filling gaps during drug shortages. But it is not a substitute for FDA-approved manufacturing, and that distinction is where a lot of today's risk sits,” she said in a statement. “My concern is that pharmacies rushing into this space will move to make a dollar faster rather than make sure they meet every requirement, from ingredient sourcing and facilities to staff training and sterility testing.”
Shortly after the new notice was published, a number of telehealth websites were already marketing the six peptides, each for a price of anywhere from $199 to $249 a month.
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