Drug Supply Chain Security Act (DSCSA): What Data Exchange Formats Will be Acceptable to Trading Partners?

Electronic Data Interchange (EDI) is the most commonly accepted electronic data exchange format by trading partners. Electronic Product Code Information Service (EPCIS) is another electronic format.  However, it appears that only a small number of companies will use EPCIS.  You should consider whether large wholesalers are willing to accept EPCIS before deciding on a data exchange format.  Not all large wholesalers have indicated they will accept EPCIS.  Another option to consider is an electronic invoice, which is an electronic method of transferring data from an invoice.  But, wholesalers may try to dissuade you from using electronic invoices to carry data such as lot numbers, transaction statements and other data required by the DSCSA due to complexities of pulling that data out of this format for further use.

The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.