HHS said it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound drugs using six unapproved peptides, as long as they meet a set of conditions, according to an interim policy scheduled for the Oct. 30 Federal Register. The policy applies while the FDA develops its list of bulk drug substances eligible for compounding through rulemaking.
The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. An FDA advisory panel backed the same six peptides in July, against the conclusion of agency scientists. Patients who say they were harmed by peptides have also said their accounts are being drowned out. The policy’s dosage form limits vary by peptide:
- BPC-157 acetate: Subcutaneous, intramuscular, oral and topical forms.
- TB-500 acetate and MOTS-c acetate: Subcutaneous or intramuscular injections.
- Epitalon acetate: Subcutaneous or intramuscular injections dispensed in intermittent courses.
- Semax free base: Intranasal use.
- KPV acetate: Topical and oral forms.
To fall within the policy, compounders must use a peptide with the identity described in the policy, from a manufacturer registered with the FDA and compliant with current good manufacturing practices, with a certificate of analysis showing testing for identity, purity, potency and contaminants such as endotoxins and heavy metals. They must report the products they compound, serious adverse events regardless of whether they are considered drug-related and product quality issues to the FDA’s MedWatch program and to states. Products must contain only one active ingredient, carry the label “This is a compounded drug product. Not for resale” and use no delivery device other than an FDA 510(k)-cleared syringe. Compounders of oral products must document adequate oral bioavailability. The statutory requirements of Section 503A remain, including a patient-specific prescription and a ban on compounding under insanitary conditions.
HHS said the policy is meant to discourage widespread use of research-use-only peptides from foreign manufacturers that pose safety risks, offering patients “a more controlled alternative,” and that it advances “patient choice and freedom.” It said it may revisit the policy if a safety signal or product quality issue arises, and the policy lasts until each peptide is addressed in a final rule. The notice calls the document a draft and says it is not binding on HHS or the public. Comments are due two weeks after publication on Docket HHS-OASH-2026-0496.
The Alliance for Safe Biologic Medicines, a coalition of patient and physician groups including the American Academy of Dermatology and the National Psoriasis Foundation, asked HHS in an Oct. 26 letter to hold the policy and defer the advisory panel’s recommendations. The group asked the department to first address the FDA scientists’ objections to specific peptides, order an independent review of conflicts on the advisory panel and put adequate adverse event reporting, product traceability and enforcement safeguards in place.
The letter says the eight panelists Kennedy added to the committee before the July review voted for BPC-157, KPV and TB-500, forming the entire affirmative bloc in each 8-6 vote. It also points to the deaths reported to the FDA after people took illicit products sold as retatrutide and to a recent nationwide recall of compounded tirzepatide for lack of sterility assurance, as reasons to strengthen oversight before widening access.
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