Attention all compounders: just a friendly reminder that lawfully compounded drugs, and raw materials for compounds, are exempt from the DSCSA. See FDA’s FAQ (question #2) as well as the definition of “product” under Section 581(13) of the DSCSA, or a “prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 582, does not include […] a drug compounded in compliance with section 503A or 503B.” For more information on how to stay compliant with DSCSA, please see our DSCSA checklist and standard operating procedure guidance here.
NCPA
