FDA Compounding Panel Backs 6 of 7 Peptides Despite Safety Risks in Oversight and Production

By Gina Shaw Rita Jew, PharmDThe FDA Pharmacy Compounding Advisory Committee’s (PCAC’s) recommendation that six of seven peptides be added to the 503A bulk drug substances list has alarmed leading medication safety experts.The move departs from the evidence-based process the agency normally follows and leaves several unresolved safety questions in place, noted Rita Jew, PharmD, the president of the Institute for Safe Medication Practices (ISMP), part of ECRI. Demand for peptide produ