US drug supply chain lacked serialization and traceability, risking public health.
["Product identifier (serialization) on all prescription drugs", "Transaction documentation for each change of ownership", "Verification of suspect and illegitimate products"]
Up to $250,000 per violation
Affected HS Codes: ["3001", "3002", "3003", "3004", "3005", "3006"]
Issuing Authority: US Food and Drug Administration