The U.S. Department of Health and Human Services will let state-licensed compounding pharmacies make six unapproved peptides, including BPC-157, under a temporary policy made public on October 28. The other five are TB-500, epitalon, MOTS-c, KPV and semax, none of which the Food and Drug Administration has approved to treat any condition.

Compounding is the practice of a licensed pharmacy preparing a drug for an individual patient against a prescription. The policy creates a legal prescription route to substances currently sold online with claims about injury recovery, sleep and longevity, and HHS was blunt that it is not an endorsement: "The policy does not grant FDA approval or establish clinical safety and effectiveness," the department said in a statement reported by ABC News.

The conditions attached

HHS says it does not intend to take enforcement action against licensed pharmacies, federal facilities or physicians that meet specific quality conditions. Ingredients must come from an FDA-registered manufacturer following current good manufacturing practices, with a certificate of analysis covering identity, purity, potency and contaminants including endotoxins and heavy metals.

Compounders must report serious adverse events to MedWatch and to state regulators. A patient-specific prescription is still required, each product may contain only one active ingredient, and each must be labeled as a compounded drug not for resale.

Routes are capped per peptide. BPC-157 may be injected, oral or topical, semax is nasal only, KPV is topical and oral only, and TB-500, MOTS-c and epitalon are limited to injections.

Why the agency's own reviewers disagreed

The decision follows a July vote by the FDA's Pharmacy Compounding Advisory Committee recommending the same six peptides, against the conclusions of the agency's career scientists. Per an AJMC review of that meeting, FDA reviewers found five clinical studies of BPC-157 were short, small and insufficient to establish safety or effectiveness, and found no human safety studies at all for KPV, TB-500, MOTS-c or epitalon.

The votes were 8-6. The Alliance for Safe Biologic Medicines said in an October 26 letter that the eight panelists added by HHS Secretary Robert F. Kennedy Jr. made up the entire affirmative bloc on BPC-157, KPV and TB-500, and urged HHS to hold the policy.

The gray-market argument

Supporters frame this as harm reduction. "We've said all along that the question isn't whether patients are using these peptides. They are. The question is where they're getting them," said Scott Brunner of the Alliance for Pharmacy Compounding, in a statement reported by The Hill.

That argument is strong on sourcing and silent on everything else. Cleaner manufacturing lowers contamination risk; it does not generate the human data the FDA reviewers said was missing.

Bottom line

The notice publishes in the Federal Register on October 30 under docket HHS-OASH-2026-0496, with comments due two weeks later, according to Becker's Hospital Review. HHS says it may revisit the policy if a safety signal emerges, and the policy stands until the FDA issues a final rule on each peptide: what changes here is where these peptides can legally be made, not what is known about them.