US Health Secretary Robert F Kennedy Jr has announced an interim policy under which eligible pharmacies and physicians can compound six unapproved peptides, including BPC-157 and TB-500, without federal FDA enforcement action, provided they meet specified conditions.

The announcement on Wednesday, 28 October 2026, came despite concerns raised by FDA staff about the available safety evidence. It marks a significant shift in federal oversight of compounded peptide products, which have attracted growing interest in the wellness market.

What the Policy Allows for Unapproved Peptides

The policy covers BPC-157, TB-500, epitalon, KPV, MOTS-c and Semax. The policy sets conditions covering ingredient identity and quality, sourcing from appropriately registered and compliant manufacturers, testing, labelling, adverse-event and product-quality reporting, and valid patient-specific prescriptions.

It also specifies permitted dosage forms and routes of administration, among other requirements. HHS describes the measure as interim and says it may reconsider if safety signals or product-quality problems emerge.

Enforcement discretion means the agency does not intend to pursue specified enforcement actions under defined circumstances. It does not constitute FDA approval or establish that the peptides are safe or effective. Nor does it formally add the substances to the Section 503A bulk drug substances list.

HHS said the policy is intended to discourage the use of research-use-only peptides from foreign manufacturers while improving patient access through regulated compounding.

The FDA shares oversight of compounding facilities with state pharmacy boards. Compounders prepare bespoke medicines against individual prescriptions.

Critics Say Kennedy Went Around the FDA

Robert Steinbrook, director of Public Citizen's Health Research Group, said Kennedy had acted 'recklessly and unilaterally'. He warned that patients could face contamination, impurities and unknown side effects, and argued that peptides should go through the standard FDA approval process.

The FDA had previously identified significant safety concerns with several peptide substances proposed for compounding, including BPC-157, KPV, MOTS-c, Semax and thymosin beta-4 fragment (TB-500).

The agency has cited limited human safety data, possible immunogenicity and concerns about peptide-related impurities and ingredient characterisation. Some nominations were subsequently withdrawn, so the status of individual substances on the FDA's lists has changed over time.

Infectious-diseases doctor Neil Stone wrote on X: 'RFK Jr. just let pharmacies make six unapproved peptides, including BPC-157 and TB-500. His own FDA scientists concluded there isn't enough data to show they're safe or effective.'

Pharmacies and clinics that sell peptides now have a clearer route to the market, provided they meet the conditions attached. Peptides have been widely promoted on social media, despite limited human evidence of benefit.

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How the Peptides Reached This Point

The FDA placed 19 peptide or peptide-related substances in its Category 2 list in 2023, during the Biden administration. Substances in that category do not receive the agency's interim enforcement discretion.

At its 23–24 July 2026 meeting, the FDA's Pharmacy Compounding Advisory Committee considered seven peptide-related substances. It recommended adding six to the Section 503A bulk drug substances list; emideltide was not among those recommended for inclusion. The committee's recommendations were advisory and did not themselves change the law.

The committee's recommendations differed from the assessment of FDA staff scientists, who raised concerns about the lack of adequate evidence to establish the substances' safety and effectiveness. The panel was selected by Kennedy's health department and included several doctors, pharmacists and consultants who work in the peptide field.

Formally adding the peptides to the FDA's list of drugs safe for compounding would require federal rulemaking, a process that could take years and involves multiple rounds of public comment. Until then, unapproved peptides will be made under an interim policy that, by HHS's own account, can be revisited if problems surface. Whether pharmacies rush in, or wait to see if the policy survives scrutiny, is the obvious question now.

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