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Latest version is 'based on our evolving understanding of the DSCSA'
Having issued a preliminary version of 856 ASN in April, the Healthcare Distribution Management Assn. is now back with an updated, “formal” version, available at the HDMA Store. The document is relevant mostly to IT and database-management personnel who need to adapt the existing ASN data fields to the requirements of the Drug Supply Chain Security Act passed last November. That HDMA has come out twice with updates is a testament to the urgency of getting data-forwarding practices in order among US drug distributors: come January, distributors will need to be able to verify shipments (at the lot level) to pharmacies and other customers. This is the legislated mandate from Congress when it passed the Drug Quality and Security Act (of which DSCSA is a part); FDA is on call to Congress to issue guidelines for drug tracking by late November. How well everybody—manufacturers (who need to put appropriate labels on their product cartons), wholesalers, retailers and FDA—will meet these mandates remains to be seen.