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Wholesale Distributor Requires EDI ASN As Data Exchange For DQSA Transaction Report

By April 8, 2014April 30th, 2018Company News

“Beginning not later than January 1, 2015…a wholesale distributor shall not accept ownership of a product unless the previous owner…provides the transaction history, transaction information, and a transaction statement…” –DQSA, Title II, Sec. 582

The urgency of implementing DQSA was apparent at the Cardinal Health’s April serialization conference call. Every year, 75,000 SkUs of pharmaceutical products move through Cardnial’s supply chain. The only way to manage that effectively while meeting the compliance requirement of Drug Quality and Security Act is to receive DQSA Transaction Report (Transaction Information, Transaction History, Transaction Statement) electronically.  Carnidal is not the only one who requires electronic transmission. Many US wholesale distributors  published requirements for manufacturers mandating EDI shortly after DQSA was signed into law late last year. The EDI ASN testing with manufacturers starts as early as June at Cardinal. Shipments without DQSA transaction report will be put into quarantine until proper documentation receives. Shipments with paper will be cleared through a manual process. There is an imminent concern that processing the shipment with missing DQSA document and processing shipment with paper DQSA document will impact company’s operational efficiency, driving up Days of Inventory and operational cost. Cardinal does “intend to impose financial penalties for not complying with … electronic receipt of transactional data.” said on the Cardinal’s letter to manufacturers. 

Important Dates

  • June 2014 – Cardinal EDI testing
  • Nov 2014 – FDA to issue guidance for interoperable data exchange 
  • Jan 2015 – DQSA 2015 compliance deadline

LSPediA offers the DQSA 2015 Readiness Audit to help manufacturers and distributors to on-board DQSA and EDI quickly. This service will:  

  1. Assess the data, process, and system gaps
  2. Make recommendations to changes and systems needed for DQSA 2015 compliance

Please contact Riya Cao to discuss: [email protected], 248.973.2008