Comment from PCCA
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Summary: The Pharmaceutical Compounding Coalition of America (PCCA) supports the inclusion of melatonin on the 503A Bulk Drug Substances list. They argue that melatonin is necessary for patient-specific compounding to treat sleep disorders in children with autism spectrum disorders, for whom no FDA-approved medications currently exist.
This comment is in response to FDA's request for clarification for the nomination of melatonin to the 503A Bulk Drug Substances List.