The US Department of Health and Human Services has issued a draft policy saying it does not intend to take enforcement action against compounders of six peptides, provided 10 conditions are met. The policy was announced on 28 October and published in the Federal Register on 30 October.
The six peptides are BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. None of them is approved by the US Food and Drug Administration.
What the policy says
The discretion covers state-licensed pharmacies, federal facilities and licensed physicians compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. It does not extend to outsourcing facilities under section 503B. It stays in effect until each peptide is addressed in a final rule on whether it belongs on the 503A bulk substances list.
Routes are limited peptide by peptide. BPC-157 acetate is covered for subcutaneous, intramuscular, oral and topical forms, KPV acetate for topical and oral forms, and Semax free base for intranasal use. A compounded product may contain only one of the listed substances, so a BPC-157 and TB-500 combination falls outside the policy.
The notice calls itself a draft that does not bind HHS or the public, and HHS describes the policy as interim. Comments were requested within two weeks of publication, by 13 November.
Where the decision came from
The policy was issued by the Office of the Secretary, signed by Robert F. Kennedy Jr., and not by the FDA. The Associated Press reported that the agency's scientific staff had little input and opposed the change.
In July, the FDA's Pharmacy Compounding Advisory Committee voted in favour of six of the seven peptides it reviewed. The Partnership for Safe Medicines has since asked the FDA to disregard that vote.
What the evidence looks like
The policy does not approve any peptide or add one to the bulk substances list, and it does not establish that any of the six is safe or effective. For BPC-157 and TB-500 in particular, the published evidence comes mainly from animal studies.
What is still unknown
It is not yet known whether the policy will change after the comment period, how state pharmacy boards will respond, whether it will be challenged in court, or when the FDA will publish a final rule for each peptide. HHS has said it may revisit the policy if a safety signal or a product-quality problem emerges.
OrientSciences read excerpts of the Federal Register notice and the HHS policy, together with law firm and trade press analyses, but not every page of either document. Sources differ on the label: the Federal Register says draft, HHS says interim.