Comment from PCCA
AnonymousSupportTrade association
Summary: The Professional Compounding Centers of America (PCCA) is submitting stability data to support the inclusion of creatine monohydrate in the list of bulk drug substances for compounding. They provide laboratory results demonstrating that a 20% oral suspension of creatine monohydrate remains stable and potent for 180 days at room temperature.
During the September 2018 PCAC meeting, FDA expressed some concerns about the aqueous stability of creatine monohydrate. Because of this concern, the voting question posed to the PCAC was specific to solid oral dosage forms despite the nomination stating that patients most commonly require oral liquid doses.
While there was information in PCCA's presentation addressing aqueous stability, we committed to following up with FDA with more data. Please find the attached summary report for our stability-indicating, method validated study showing stability of compounded creatine monohydrate 20% oral suspension at 180 days, stored at controlled room temperature. This formula uses an aqueous vehicle. We hope this alleviates concerns about the aqueous stability of this formulation, particularly because the patients we serve often rely on aqueous liquid formulations.