The US Department of Health and Human Services has said it will not take enforcement action against licensed pharmacies and physicians that compound six unapproved peptides, a move that opens a legal route to substances popular with wellness influencers but never cleared as medicines.

The interim policy, due to appear in the Federal Register on October 30, covers BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax, according to Becker’s Hospital Review. It applies while the Food and Drug Administration develops a list of eligible bulk drug substances through rulemaking, and lasts until each peptide is addressed in a final rule. Comments are due two weeks after publication on Docket HHS-OASH-2026-0496. HHS describes the policy as a draft that is not binding on the agency or the public, and says it may revisit it if a safety signal or product-quality problem emerges.

Enforcement discretion comes with conditions. Compounders must use a peptide from an FDA-registered manufacturer that follows good manufacturing practice and obtain a certificate of analysis covering identity, purity, potency and contaminants such as endotoxins and heavy metals. They must report compounded products, serious adverse events and quality problems to FDA’s MedWatch and to states. Each product may contain only one active ingredient, must carry the label “This is a compounded drug product. Not for resale,” and may be delivered only with an FDA 510(k)-cleared syringe. Standard Section 503A requirements still apply, including a patient-specific prescription.

The permitted routes differ by peptide. BPC-157 can be given by injection, orally or topically. TB-500 and MOTS-c are limited to injection, Epitalon to injection in intermittent courses, Semax to intranasal use, and KPV to topical and oral forms. Fox Local, citing Reuters, notes that BPC-157 and TB-500 are often taken together in what users call the “Wolverine stack.”

HHS says the aim is to discourage use of research-use-only peptides from foreign manufacturers, which it says “pose a safety risk to patients in the United States.” It says “there is significant interest in the use of these peptides in compounding given the lack of approved products,” and presents the policy as a “more controlled alternative” that advances “patient choice and freedom.” Health Secretary Robert F. Kennedy Jr. has campaigned for broader access to peptides, Reuters reports.

Opposition is organised. The Alliance for Safe Biologic Medicines, a coalition that includes the American Academy of Dermatology and the National Psoriasis Foundation, wrote to HHS on October 26 asking it to hold the policy. The letter says eight panellists added by Kennedy before a July review formed the entire affirmative bloc in each 8-6 vote backing BPC-157, KPV and TB-500, and that an FDA advisory panel backed the six peptides against the conclusion of agency scientists. It cites deaths reported to the FDA after people took illicit products sold as retatrutide, and a recent nationwide recall of compounded tirzepatide over sterility assurance.

No approved products exist for the uses the peptides are promoted for, and regulators have not finished assessing their safety or effectiveness.