A draft policy announced this week says HHS does not intend to take enforcement action against pharmacies and physicians compounding six unapproved peptides, provided they meet 10 conditions. Appendix A names BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500.

What HHS is offering is enforcement discretion, which applies to state-licensed pharmacies, federal facilities, and licensed physicians. None of the six peptides is FDA-approved or on the bulk drug substances list under section 503A of the Federal Food, Drug, and Cosmetic Act, and the FDA has not proposed adding them. Compounded drugs are not reviewed by the FDA for safety, effectiveness, or quality before marketing.

The 10 conditions

Bulk substances must come from an FDA-registered original manufacturer complying with current good manufacturing practice, with a certificate of analysis covering identity, purity, potency, and the absence of contaminants including endotoxins and heavy metals. Serious adverse events and product quality issues must be reported to FDA's MedWatch program and to the relevant states.

Each product may contain only one active ingredient, must be labeled as a compounded product not for resale, and still requires a patient-specific prescription. Copackaged delivery devices must be 510(k)-cleared syringes, and oral products require documented bioavailability.

Overruling the agency's own scientists

The policy follows a July 23 vote by the FDA's Pharmacy Compounding Advisory Committee, which backed BPC-157, KPV, and TB-500 for the 503A list 8-6 with one abstention. The committee recommended six of the seven peptides it reviewed, against career FDA scientists who had recommended against all seven.

Appendix B concedes that the FDA's Center for Drug Evaluation and Research opposed listing each of the six. HHS characterized the center's safety concerns for TB-500, epitalon, and semax as inferential or mechanistic rather than observed, and for KPV as reflecting an absence of information.

The gray market HHS says it is targeting

HHS said it wants to discourage use of research-use-only peptides from foreign manufacturers by offering a "more controlled alternative." Catherine Varney, DO, of UVA Health told AJMC that gray-market peptides often contain 5% to 75% of the labeled amount, with some carrying arsenic at up to 10 times acceptable levels.

FDA briefing materials found available studies, including five of BPC-157, were short, small, and insufficient to establish safety or effectiveness. In a preprint analysis of one clinical-notes database, newly confirmed BPC-157 users rose from 4 in early 2020 to 134 in early 2026, with 36% of 205 users who documented a source citing a compounding pharmacy and 35% a gray-market vendor.

What happens next

The notice, signed by HHS Secretary Robert F. Kennedy Jr, is scheduled for Federal Register publication on October 30, with written comments due two weeks later under Docket No. HHS-OASH-2026-0496. The draft is not binding, and the policy stands for each peptide until the FDA addresses it in a final rule, a process that can take 12 to 24 months.