A new policy from the Department of Health and Human Services authorizes pharmacies in the United States to manufacture and market therapies that use six peptide substances not explicitly approved by the FDA. The aim, according to HHS, is to provide a regulated option that reduces reliance on peptides acquired from questionable overseas suppliers.
Under the policy, enforcement actions will not be pursued against a state-licensed pharmacy, a federal facility, or a licensed physician who compounds a drug product using one of the six designated peptide bulk drug substances.
Observers see this as a substantial victory for peptide advocates, compounding pharmacies, and proponents of medical autonomy, while also signaling that HHS Secretary Robert F. Kennedy Jr. may be growing tired of the FDA’s slow pace.
The six substances under consideration—BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500—were the focus of a summer meeting of the FDA’s Pharmacy Compounding Advisory Committee (PCAC).
The question up for debate was whether these six “bulk drug substances,” along with Emideltide, should be added to the FDA’s Section 503A Bulks List. That list governs which ingredients physicians and specialty pharmacies may combine into drug products without them being part of an already FDA-approved medication or lacking a relevant United States Pharmacopeia (USP) or National Formulary (NF) monograph.
In July, the panel voted to place six of the seven peptide-related substances under consideration on the bulks list, with Emideltide excluded. However, the panel’s vote is non-binding.
Ultimately, it remains the FDA’s decision whether to accept the advisory committee’s recommendations. To date, no formal decision has been issued.
Nonetheless, HHS later disclosed an “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.” In effect, this policy implements the committee’s recommendations by acting as a proxy for them.
Secretary Kennedy cannot guarantee FDA approval, of course. But he can—and will—prevent HHS from pursuing action against physicians or pharmacies that compound and distribute these substances under his framework.
In an explanatory note about the new policy, HHS points out that “compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.” Yet, it adds, “compounded drugs can fulfill an important medical need for certain patients,” and “there is substantial interest in the use of these peptides in compounding.”
Opponents of expanding peptide-based treatments in compounding often emphasize that these products lack FDA approval and may not benefit from the extensive trial data required for FDA-approved therapies.
Nevertheless, people are already using BPC-157, MOTS-c, and other peptides by purchasing products labeled “for research use only” or sourced from foreign distributors. Peptides even appear on discount marketplaces run by foreign sellers, including AliExpress based in China.
Giving licensed U.S. physicians and pharmacies permission to compound these substances without facing penalties would provide patients with safer, more regulated options than they currently have access to.
Pharmacies that compound peptide-based products under federal law must still be properly licensed in the states where they operate and adhere to certain stipulations, including that active ingredients used for compounding come with valid certificates of analysis and that compounding occurs only upon receipt of a valid patient-specific prescription. Under the new HHS policy, they must also comply with additional rules regarding the packaging and labeling of these peptides.
“The Secretary of HHS has determined that this limited enforcement-discretion policy will discourage the ongoing, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to U.S. patients,” the HHS explainer notes. “By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy offers patients a more controlled alternative.”
In practice, this is a policy grounded in pragmatic public-health reasoning, rather than a simplistic dichotomy in which health and safety are viewed as mutually exclusive or a single danger overwhelms all considerations.
Rather than pushing peptides into grey or black markets until (if ever) the FDA clears them, Kennedy’s HHS has chosen to strike a balance between safety and “patient choice and freedom,” as the department frames it.
