HHS Secretary Robert F. Kennedy Jr. said on October 20 that the administration wants a state regulated marketplace for certain unapproved peptides, with 503A pharmacies at the center. In an interview, Kennedy argued that Americans are buying peptides anyway, and products should be inspected and match their labels. He also said that FDA should generally step in when there is a safety signal, and otherwise leave decisions to patients and their doctors.
The next day, Sen. Roger Marshall (Kan.) wrote to Acting Commissioner of Food and Drugs, Kyle Diamantas urging the agency to use enforcement discretion for the compounding of certain peptides. Marshall wrote that FDA’s restrictions push patients toward gray-market sources. He asked FDA to allow compounding in the interim under conditions that include API from FDA-registered, cGMP-compliant facilities, compounding only in registered outsourcing facilities or state-licensed 503A pharmacies, prescriptions for identified patients, and ongoing review of safety data with PCAC.
APC is calling for guardrails to be part of any peptide policy. Read APC’s recommendations at a4pc.org/peptides.