HHS lets pharmacies compound six unapproved peptides, including BPC-157, ahead of FDA rulemaking

The US Department of Health and Human Services filed an interim policy with the Federal Register on 28 October under which it will not take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound six peptides not approved by the Food and Drug Administration: BPC-157, epitalon, KPV, MOTS-c, semax and TB-500. The notice, signed by Health Secretary Robert F. Kennedy Jr. and published on 30 October, applies until each peptide is addressed in a final rule on whether it belongs on the list of bulk substances that pharmacies may use under section 503A of the Federal Food, Drug, and Cosmetic Act.

The mechanism is notable. This is not a rule, and the notice states that it is not binding on HHS or the public. It was issued by the Office of the Secretary rather than by the FDA, and it follows a vote in July by the agency's Pharmacy Compounding Advisory Committee in favour of the six substances, against the recommendation of the FDA's drug centre, which had advised against listing each of them. The committee voted against a seventh peptide, emideltide, which is not included. Comments may be submitted for two weeks after publication, and HHS says it may revisit the policy if a safety signal or product quality issue arises.

The conditions are more demanding than the headline suggests. Each compounded product must be made under a valid patient-specific prescription, contain a single peptide from the list, and use bulk material from a facility registered with the FDA under section 510 that complies with current good manufacturing practice, with a certificate of analysis meeting testing standards for identity, impurities, endotoxins and microbial contamination. Routes of administration are restricted: semax may be given only intranasally, for example, and oral forms require documentation of adequate bioavailability. Compounders must report serious adverse events and quality problems to the FDA and to the states. Outsourcing facilities under section 503B are not covered.

The stated rationale is harm reduction. HHS argues that patients are already buying research-use-only peptides from foreign suppliers, and that licensed US compounders offer a more controlled alternative. That argument has some force: a grey market exists whether or not regulators acknowledge it. But the policy reverses the FDA's position of 2023, when these substances were placed in a category of compounding ingredients that may present significant safety risks, and the evidence base for most of them consists largely of animal and small human studies rather than controlled trials.

Critics have responded sharply. Robert Steinbrook of Public Citizen said Mr Kennedy had acted recklessly and unilaterally, and Fred Mills of Americans for Safe & Effective Medicines said a legal pathway does not resolve problems with untested products or misleading claims. The Partnership for Safe Medicines has petitioned the FDA to disregard the committee vote, arguing that the reconstituted panel breached federal advisory committee and ethics law. Mr Kennedy has described himself as a supporter of peptides and pledged to end what he called the FDA's war on them.

Commercially, the beneficiaries are compounding pharmacies and the telehealth companies that sell through them. Michael Cherny, an analyst at Leerink Partners, called the notice a yellow light that pulls forward the opportunity by several months, while remaining short of the green light that Hims & Hers might need, and has estimated that the peptide telehealth market could be worth $1.1 billion to $2.2 billion a year. Hims & Hers was among the parties that sought meetings with Office of Management and Budget reviewers before the policy was released. The six peptides are distinct from the GLP-1 drugs at the centre of earlier compounding disputes, where the FDA has pursued manufacturing concerns at large compounders.

For drugmakers the precedent matters more than the products. A policy that allows substances to reach patients through compounding, on the strength of an advisory vote overriding agency scientists and without approved applications, weakens the link between evidence and market access that underpins the approval system. State boards of pharmacy may also decline to follow, creating a patchwork of federal tolerance and state restriction.

The policy question is whether enforcement discretion becomes a template for contested substances more broadly. The FDA's eventual rulemaking on the 503A bulks list, and any safety signals reported under the new requirements, will determine whether this remains a narrow accommodation or becomes a lasting route around the conventional approval process.