HHS will permit compounding of six peptides ahead of formal rulemaking
The Department of Health and Human Services (HHS) has announced that it will not take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound six unapproved peptide bulk drug substances, provided they adhere to specific conditions outlined in an interim policy.
This policy will remain in effect until the US Food and Drug Administration (FDA) develops a list of bulk drug substances permitted for compounding on the 503A Bulks List through rulemaking.
The peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500. These compounds are proposed for various uses, including wound healing, osteoporosis, obesity, insomnia, and treating inflammatory conditions. FDA’s Pharmacy Compounding Advisory Committee voted to back the addition of these six peptides to the 503A Bulks list during a two-day meeting in July. (RELATED: FDA advisory committee backs two more peptides, rejects one for compounding list, Regulatory Focus 24 July 2026; FDA advisory committee backs two controversial peptides, Regulatory Focus 23 July 2026)
Before the meeting, the agency appointed eight new members to the committee, many of whom have been alleged to have connections to the prescribing or promotion of peptides. These apparent conflicts were reported by multiple news outlets, and some FDA officials expressed concerns about the appointments. HHS Secretary Robert Kennedy Jr. has been a vocal proponent of peptides and has vowed to make them more available.
“This limited enforcement-discretion policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative,” the policy states. “Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.”
To qualify for these exemptions, the peptide bulk drug substance must be sourced from an FDA-registered facility and possess a valid certificate of analysis (COA) that includes test results aligning with the criteria outlined in FDA guidance. Additionally, compounders are required to report any serious adverse events and product quality issues to FDA.
Two advocacy groups criticized this policy, stating that it threatens public health.
Researchers from the Center for Science in the Public Interest (CSPI) argued in a recent JAMA Viewpoint article that allowing compounders to sell unapproved peptides would undermine the FDA's drug approval process and pose safety risks by exposing the public to these unapproved substances.
“The implications of these recommendations, if adopted by the FDA, are profound. First, in effect, proponents of listing argued that the genie was out of the bottle (driven in part by the practices and pronouncements of the HHS secretary, certain public witnesses, and some advisory committee members) and that the size of the resultant market mandated listing. This principle could be applied to any compound (e.g., kratom, cannabidiol) whose illegal sales reached a certain, undefined level that required the FDA to simply capitulate to the demand,” CSPI Director Peter Lurie and colleagues wrote.
“Second, listing would fundamentally undermine the FDA drug approval process itself. Companies that might otherwise aspire to conduct clinical studies to establish the safety and effectiveness of these products and secure approval as drugs will have little incentive to do so knowing that compounders will simply be able to sell them without ever generating such evidence,” they added.
Robert Steinbrook, director of Public Citizen’s Health Research Group, urged HHS to rescind the policy.
“Apparently frustrated because the agency stood firm against his nonsensical pledge to end the FDA’s ‘war on peptides,’ Secretary Kennedy has acted recklessly and unilaterally to put Americans in danger. Kennedy has no scientific or medical qualifications,” Steinbrook said. “By allowing unproven and potentially unsafe peptides to be manufactured, marketed and prescribed without concern about potential federal enforcement actions, Kennedy has undermined the FDA and threatened public health. All peptide substances should go through the standard FDA approval process for new drugs. The HHS Secretary should support, not sabotage, needed FDA enforcement actions to protect consumers.”
Federal Register notice, HHS policy
