RFK Jr. to ease access to unapproved peptides, draft policy states
Summary
Health and Human Services Secretary Robert F. Kennedy Jr. issued a draft policy that would allow compounding pharmacies to prepare six peptides that lack FDA approval. The policy sets requirements for prescriptions, ingredient sourcing, quality testing, and safety reporting, but does not establish that the drugs are safe or effective. Public comments are scheduled from Friday through Nov. 13.Key Facts
- The six peptides named in the draft are BPC-157, Epitalon, KPV, MOTS-c, Semax, and TB-500.
- Compounding pharmacies prepare customized medications by mixing ingredients.
- An FDA advisory panel recommended in July that the peptides be allowed for compounding, but the panel vote did not grant FDA approval.
- FDA scientists said there was not enough evidence to determine whether each peptide is safe and effective.
- The draft requires patient-specific prescriptions, ingredients from an FDA-registered maker, laboratory certificates for raw ingredients, and reports of serious side effects.
- HHS said the policy does not establish clinical safety and effectiveness or grant FDA approval.
- The policy will remain in place until the FDA finalizes a rule on compounded peptides; the FDA has not proposed such a rule.
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