The Department of Health and Human Services has filed a draft policy that would limit enforcement against certain licensed pharmacies, federal facilities and physicians that compound drugs containing six unapproved peptides. The substances are BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon.
The policy, issued by Health Secretary Robert F. Kennedy Jr.’s office, was filed with the Federal Register on Oct. 28 and is scheduled for official publication Friday. A two-week public comment period is set to begin after publication.
Conditions for compounding
Under the interim enforcement policy, HHS does not intend to take action against covered compounders when they meet requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act. That provision allows certain pharmacies and physicians to prepare medications for individual patients without meeting all of the requirements that apply to approved drugs and conventional manufacturers.
The policy would require a patient-specific prescription and ingredients obtained from manufacturers registered with the Food and Drug Administration. Compounders also would need certificates of analysis confirming each substance’s identity, purity and potency, along with testing for contaminants such as heavy metals and bacteria.
- Serious adverse events and product-quality problems would have to be reported to the FDA and relevant state authorities.
- Each product could contain only one active pharmaceutical ingredient.
- Permitted forms of administration would vary by peptide and the available safety evidence.
The document specifically covers Semax for intranasal use and limits KPV to oral and topical formulations. Other peptides would face different restrictions based on their characteristics and the safety information available for them.
Interim policy during FDA review
The measure comes from HHS rather than the FDA, which ordinarily oversees federal drug regulation. HHS describes it as an interim approach while the FDA uses a rulemaking process to determine which peptide substances should be eligible for compounding.
The Federal Register notice says the policy does not create legal rights and is not binding on HHS or the public. Its practical effect would instead be to describe circumstances in which the department currently does not plan to pursue enforcement against specified compounders.
Compounding involves combining or modifying drug ingredients to prepare medication for an individual patient. The policy’s requirements for sourcing, laboratory certification, contamination testing and adverse-event reporting are intended to establish conditions for the limited enforcement protection while the FDA evaluates the substances through its regulatory process.
