Comment from PCCA
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Summary: The Pharmaceutical Compounding Coalition of America (PCCA) supports the inclusion of creatine monohydrate on the 503A Bulk Drug Substances list. They argue that patient-specific compounding of creatine is necessary for managing mitochondrial disorders due to varied dosing needs and the need for combination therapies.
This comment is in response to FDA's request for clarification for the nomination of creatine monohydrate to the 503A Bulk Drug Substances List.