What the new peptide policy says.
On October 28th, the Department of Health and Human Services (HHS) released a notice, signed by Health Secretary Robert F. Kennedy Jr., saying it doesn’t intend to act against pharmacies, federal facilities, or doctors that make six unapproved peptides. They are BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon. Makers must meet the policy’s conditions, and each product’s label must include the sentence “This is a compounded drug product. Not for resale.”
HHS told me the policy “does not grant FDA approval or establish clinical safety and effectiveness.”
What testing found in peptides sold online.
Thousands of Americans take BPC-157, and almost all of them buy it from online vendors that sell it “for research use only.” CBS News’ Adam Yamaguchi bought a $90 vial labeled as a different experimental peptide, retatrutide, at a Brooklyn bodega. University of Iowa scientists found filler and 13 bacterial colonies inside and no peptides. A preprint analysis covered about 6,400 samples that buyers and sellers sent to a testing lab. More than a third held a dose more than 10% higher or lower than labeled.
If people are going to inject these drugs anyway, yes, a licensed pharmacy beats a corner store. A pharmacy has to show where its ingredient came from. HHS told me its work “includes confronting the risks of black-market peptides.”
What did the FDA’s scientists say?
Federal law limits which bulk ingredients a pharmacy can use. The ingredient must be part of an approved drug, meet an official quality standard, or be listed by the Food and Drug Administration (FDA) as serving patients whose medical needs can’t be met by an FDA-approved drug. That list lets pharmacies use ingredients that no drug company ever took through approval, often old treatments that doctors have relied on for years. Before the FDA adds a substance to that list, it weighs what it is, whether it’s safe, whether it works, and how pharmacies have used it. That bar is lower than drug approval, which requires clinical trials.
The FDA’s drug reviewers recommended against listing all six. For BPC-157, they found “insufficient clinical safety information”. They also found no evidence that it treats ulcerative colitis, the specific use they reviewed. A 2026 systematic review of BPC-157 for injuries and tissue repair found 3 human studies with 30 people in all, and it rated the evidence very low.
In July, the FDA’s Pharmacy Compounding Advisory Committee voted the other way, 8 to 6 on BPC-157. The vote came weeks after the agency named eight new members, six of them with ties to the wellness industry. According to the Associated Press, citing six people who know how the policy came together, HHS changed course after FDA staff wouldn’t back a rule deeming the peptides safe.
A listing would have required a final FDA rule finding that the four criteria favored each peptide. This policy relies instead on a finding by Secretary Kennedy that the new policy protects patient safety. In May, the FDA took a similar approach to unauthorized vapes and nicotine pouches. It wrote that its restraint “in no way has a bearing” on whether those products would ever win authorization.
How the policy answers the FDA’s safety worries.
For TB-500, the policy says the reviewers’ safety concerns “are inferential rather than observed.” For Semax, they’re “mechanistic rather than observed.” For KPV, it says their conclusion “reflects an absence of information rather than an observed signal.”
Harm is “observed” only after someone collects the data, and the FDA’s reviewers counted about 80 people who had received BPC-157 across all human studies. A side effect that hits 1 user in 100 could go unseen in a group that small.
Who’s watching after the vials ship?
Because the policy discounts harms nobody has observed, much of its safety system depends on what happens after the vials ship. HHS may revisit the policy if, among other things, “a safety signal or product quality issue” emerges. Pharmacies must report serious side effects and product-quality problems to the FDA’s MedWatch program and to states. The policy sets no deadline for those reports, and it asks only for serious ones.
The policy’s main added quality check is a certificate of analysis for the raw ingredient, which tests the powder before a pharmacy turns it into a shot. It adds no test of the finished vial. That’s the step where the New England Compounding Center in Massachusetts failed in 2012. Its tainted steroid shots caused an outbreak of fungal meningitis and other infections that sickened 753 people and killed 64.
Last year, two women had to be put on ventilators to help them breathe after shots that included unnamed peptides at a Las Vegas anti-aging festival. Nevada’s pharmacy board couldn’t figure out why they got sick. Investigators tried to get the product to test it and couldn’t.
Hims & Hers plans to sell BPC-157.
The policy remains in effect until the FDA finalizes a rule that adds each peptide to the list or keeps it off. The FDA hasn’t proposed one, and the notice sets no end date. Meanwhile, Hims & Hers has said it plans to sell BPC-157 by prescription once regulators clear the way. Its CEO told shareholders he’s “extremely excited about this category.” A phase 2 placebo-controlled trial of BPC-157 for hamstring strains in about 120 study participants is estimated to finish collecting its main data in February 2027.
Who still has a say.
Because the policy is still a draft, the public gets a say. Anyone can comment at regulations.gov, docket HHS-OASH-2026-0496, starting tomorrow, October 30th through November 13th. A final version could require tests of each finished batch for strength, sterility, and endotoxin. It could set a deadline for side-effect reports, and an end date that forces the FDA to decide.
States license these pharmacies, and the doctors who prescribe from them, and every compounded vial still needs a prescription. In May, Alabama’s medical board warned doctors against prescribing “research-grade” peptides that the FDA hasn’t approved.