Supply Chain Security Act 2023 : Interoperable Data Exchange for Drug Traceability

Abstract

The purpose of this paper is to focus on the requirements of the 2023 DSCSA Act. recommended by HDA. Drug Supply Chain Security Act (DSCSA) has outlined the guidelines to develop and enhance drug supply chain security act by 2023. This includes product tracing requirements that went into effect in 2015 for manufacturers, re-packagers, wholesale distributors and dispensers (primarily pharmacies) [1]. As we are approaching to 2023, It will be final phase of 10 yearlong implementation of Drug Supply Chain Security Act (DSCSA) since compliance enacted in 2013. Verification router services (Saleable Return) is another compliance which was scheduled to enforce on 2020 but it is now push back to 2023 due to Covid-19 impact. Under 2023 DSCSA Act, manufacturers need to provide product tracing information in secure and interoperable manner electronically to distributors and wholesaler in supply chain. Wholesaler must transfer product tracing information to dispensers and pharmacy and verify saleable returns receive from supply chain stakeholders. Dispenser/Pharmacy should be able to receive Electronic Product Code Information Services (EPCIS) and product tracing information electronically and to be able to reconcile physical product unique identifier with electronic records. Finally, everyone in supply chain must be connected electronically through interoperable network which will allow regulatory bodies to track and trace the information’s. DSCSA 2023 Act is very impactful regulation which also requires supply chain partners to exchange traceability information’s such as Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) electronically. Electronic product Code Information Services (EPCIS) version 1.2 will have all provisions of TH, TI, TS, and adaptation of EPCIS version 1.2 will fulfill the requirement for all stakeholders in supply chain.