On October 28, 2026, the Department of Health and Human Services said it would exercise “enforcement discretion” over six unapproved peptides, meaning it will not take legal action against compounding pharmacies that make them, NBC News reported. The six are BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax, which are promoted online for uses from faster healing to longer life. None is approved by the Food and Drug Administration.
NBC called it a shortcut. Pharmacies may normally compound only ingredients on the FDA's bulk drug substances list, and adding one requires the agency to propose a rule, take public comment and issue a final rule. Kennedy's draft policy instead says HHS “did not intend to take action” against licensed pharmacies or physicians that compound “a drug product using a peptide bulk drug substance that is not a component of an FDA-approved drug product,” CBS News reported. It stays in place until the FDA finalizes a rule on compounded peptides, which the FDA has not yet proposed, and is open for comment through November 13.
The policy does not change the peptides' legal status and covers only smaller 503A compounding pharmacies, not larger 503B outsourcing facilities, NPR reported. It requires a prescription, an FDA-registered ingredient maker, certification of identity and purity, and reporting of serious side effects. Kennedy said it “advances patient choice and freedom while appropriately protecting patient safety,” and HHS presents it as a safer alternative to gray-market peptides sold “for research use only.” An HHS spokesperson said, “The policy does not grant FDA approval or establish clinical safety and effectiveness.”
In July an FDA advisory panel narrowly voted to recommend allowing the six peptides in compounding, but the FDA's own scientists said there isn't enough evidence of safety and effectiveness for each of them, CBS and NBC reported. NBC reported that the panel included six new appointees with ties to the peptide industry. Kennedy has said he has used some peptides himself, NPR reported.
American Medical Association president Willie Underwood III said the peptides have “not undergone the rigorous testing required of FDA-approved drugs.” Peter Lurie, a former FDA official who leads the Center for Science in the Public Interest, said the FDA was essentially “turning a blind eye.” Public Citizen's Robert Steinbrook said, “Kennedy has undermined the FDA and threatened public health.” The Alliance for Pharmacy Compounding welcomed the policy as a “more accountable alternative” for patients now buying peptides on the gray market.