fda dscsa recommendations

[Blog] FDA issued two draft guidances to help trading partners comply with DSCSA


The document recommends using GS1’s EPCIS standard to provide and maintain electronic data.






The issuing of these two draft guidances has a crucial role in Drug Supply Chain Security Act (DSCSA) Implementation. The intention is to be facilitated the creation of a uniform methodology for product tracing. The unified standards will help to achieve the electronic tracing of drug products at the package level and identify and track the distribution of certain prescription drugs. Moreover, such a model would ensure the protection of confidential information. As a trusted company, SoftGroup supports the standards` uniformity and recommends using such methodology. The result of these collective actions would be a significant improvement in FDA`s ability to protect patients from counterfeited and harmful medicines.


The guidance applies to manufacturers, wholesale distributors, dispensers, and repackagers who engage in transactions of products.  Specifically, this guidance addresses the status of some entities as DSCSA trading partners, including private-label distributors, salvagers, returns processors and reverse logistics providers.




  • Use of Electronic Product Code Information Services (EPCIS) standard


The secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain could be achieved with a developed form and format recognized by a widely international standards development organization such as GS1. EPCIS, the global GS1 standard, would allow trading partners to exchange information about products as they are transacted through the whole supply chain. The international standard can support and enable interoperable interfaces that trading partners use. It is compatible with a range of different technological approaches and helps in ensuring compliance with DSCSA.


FDA recommends collaborative efforts between trading partners (TP). Following the same standards for data association will help ensure successful and efficient enhanced drug distribution security interoperability.


The revisions enable the interoperable exchange of DSCSA-related information uniformly. This reflects the enhanced drug distribution security requirements that will go into effect on November 27, 2023.