A policy notice signed by Health Secretary Robert F. Kennedy Jr. and released October 28 says the Department of Health and Human Services does not intend to act against pharmacies, federal facilities, or doctors that make six unapproved peptides. HHS told reporter Celine Gounder that the policy "does not grant FDA approval or establish clinical safety and effectiveness."

The six are BPC-157, TB-500, KPV, MOTS-c, Semax, and Epitalon, all compounds widely sold online as "research use only" chemicals. Under the policy, makers must meet its conditions and every label must carry the sentence "This is a compounded drug product. Not for resale."

What the reviewers found

The FDA's own drug reviewers recommended against listing all six on the bulk-ingredient list that lets compounding pharmacies legally use them. For BPC-157 they cited "insufficient clinical safety information" and found no evidence it treats ulcerative colitis, the specific use they reviewed. A 2026 systematic review of BPC-157 for injuries and tissue repair turned up three human studies covering 30 people in total and rated the evidence very low.

The agency's Pharmacy Compounding Advisory Committee went the other way in July, voting 8 to 6 on BPC-157. That vote came weeks after the FDA named eight new members, six with ties to the wellness industry.

The gray-market baseline

The case for the policy is that the alternative is worse, and it is not a weak case. A CBS News reporter bought a $90 vial labeled retatrutide at a Brooklyn bodega; University of Iowa scientists found filler and 13 bacterial colonies in it and no peptides at all.

A preprint analysis of roughly 6,400 samples sent to a testing lab found more than a third contained a dose more than 10% above or below the label. A licensed pharmacy at least has to document where its ingredient came from.

Where the safety net stops

The policy's main added quality check is a certificate of analysis on the raw powder, with no test of the finished vial. That is precisely the step the New England Compounding Center failed in 2012, in an outbreak that sickened 753 people and killed 64.

Much of the rest depends on after-the-fact reporting. Pharmacies must send serious adverse events to MedWatch, but the policy sets no deadline and asks only for serious ones, and the FDA's reviewers counted about 80 people who had received BPC-157 across all human studies combined.

What happens next

The policy is still a draft, and public comment runs at regulations.gov, docket HHS-OASH-2026-0496, from October 30 through November 13. It stays in effect until the FDA finalizes a rule listing or rejecting each peptide, and no such rule has been proposed.

Meanwhile Hims & Hers says it plans to sell BPC-157 by prescription once regulators clear the way, with its CEO telling shareholders he is "extremely excited about this category." A phase 2 placebo-controlled trial in about 120 participants with hamstring strains is estimated to finish collecting its main data in February 2027.