HHS has proposed an enforcement-discretion policy covering six peptides to expand patient access while the 503A bulks list is developed through rulemaking; HHS says future FDA rulemakings may propose adding some or all of the substances.
The draft concerns Section 503A of the Federal Food, Drug, and Cosmetic Act and names BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500. HHS says it would refrain from enforcement against state-licensed pharmacies, federal facilities and licensed physicians that compound eligible chemical forms and routes while meeting the policy’s requirements. The notice says the proposal creates no rights and would not bind HHS or the public.
Requirements include sourcing ingredients from an original manufacturer registered with the Food and Drug Administration (FDA), obtaining a certificate of analysis and completing specified tests. Providers would also need a prescription for an individual patient, report serious adverse events and product-quality problems, and label products as compounded and not for resale.
HHS’s policy appendix says the FDA’s Center for Drug Evaluation and Research advised against adding any of the six peptides to the 503A list. The Pharmacy Compounding Advisory Committee, by contrast, voted to recommend listing each one; its vote did not itself add the substances to the list.
The Associated Press, citing six people who spoke anonymously about confidential deliberations, reported that most FDA scientific staff opposed the proposal and had little influence over the decision. AP also reported that staff provided technical assistance while the plan was drafted, including work on safety safeguards.
HHS says it is responding to interest in the peptides and a lack of approved products, and that it aims to expand patient access. Compounding allows a licensed pharmacist or physician to change a medication’s formulation for an individual patient. HHS cautions that compounded drugs are not FDA-approved and do not receive FDA review for safety, effectiveness or quality before marketing. The department says it may revisit the policy if safety or product-quality concerns arise.
AP also recalled the 2012 fungal meningitis outbreak linked to contaminated injections from a Massachusetts compounding pharmacy, after which compounding safety drew greater FDA attention. AP reported that the Alliance for Pharmacy Compounding said the proposal’s timing and its interaction with state pharmacy boards need clarification.
The Federal Register notice was scheduled for publication on Oct. 30 and allows comments for two weeks after publication. It does not set a separate start date for the proposed enforcement policy.
