Comment from PCCA
AnonymousSupportTrade association
Summary: The Pharmaceutical Compounding Coalition of America (PCCA) is providing information to support the nomination of creatine for inclusion on the 503A Bulk Drug Substances list. They argue that compounded creatine is necessary for patients with mitochondrial disorders who cannot use commercially available products due to specific concentration or excipient requirements.
This comment is in response to FDA's request for clarification for the nomination of creatine to the 503A Bulk Drug Substances List.