In 2013 the DSCSA was signed into law to track and trace prescription drugs to ensure integrity in the pharmaceutical supply chain. The DSCSA outlined a phased implementation plan which began in 2015 and will extend until November 2023. The latest deadline in particular focuses on pharmaceutical distributors having the systems and processes in place to ensure the interoperable, electronic tracing of products at the package level.
In August of 2023, the FDA announced a “Stabilization Period’ meaning the enforcement of the DSCSA would be pushed until November 2024. This gives industry players who are not yet ready, time to perfect their systems and processes. More on the stabilization period below.
Meeting the Latest DSCSA Requirements
The latest DSCSA regulations requiring Electronic Interoperability Tracing make it mandatory for you to be able to manage EPCIS files within inbound and outbound shipments effectively. This process aims to help protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs.
Opt for an all-in-one DSCSA Compliance Solution
In a snapshot, for inbound shipments, you need to be able to receive and verify EPCIS files against individual serial numbers on shipments sent by suppliers. For outbound shipments, you need to be able to create EPCIS files and send them electronically to your customers so that they can verify they have the correct product. Although several standalone solutions on the market can help you manage EPCIS Files, few all-in-one solutions currently allow you to manage and display that information afterward.
If you would like to learn more, we outline the mandatory requirements for pharma distributors regarding the DSCSA requirements in a previous article.
Learn exactly how EPCIS files are properly sent and received with Blue Link ERP during inbound and outbound shipments from the video below.
November 2024 Stabilization Period
Throughout the final stretch of the DSCSA preparedness (2022-2023) the industry noticed a lack of readiness in the pharmaceutical supply chain, FDA has decided to initiate a year-long stabilization period intended for finalizing systems and processes required to become DSCSA compliant. The requirements will not be pushed or delayed as some may think, as they are still coming into law on November 27th 2023.
Supply chain partners must use this time to work with their software vendor to ensure the system they use successfully follows requirements such as EPCIS file trading come November 2024. The FDA recognizes that there needs to be more time for pharmaceutical supply chain partners to finalize the details of interoperability. This does not mean you should halt your efforts, but instead continue implementing systems and validating processes to ensure everything is working as intended.
“This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.” – FDA
2023 Blue Link System Update
Since the DSCSA was signed into law in 2013, the Blue Link team has been working hard to ensure Blue Link Pharmaceutical Inventory Management Software also includes a DSCSA Compliance solution for our customers. As per the requirements, we are happy to share that all our pharmaceutical customers not only have access to pharmaceutical functionality (lot tracking, CSOS) but are also prepared to send EPCIS files to their partners.
This progress allows our customers to focus on scaling their business – without worrying about complying with the DSCSA. Blue Link users can receive, store, parse, and manage EPCIS files plus manage all their accounting, inventory, and operations, all through a single system.
Before an EPCIS file is received into Blue Link, it requires parsing so it can be displayed. Parsing of the file is performed behind the scenes through 3rd party integrators such as our partners Gateway Checker and LSPedia. These solutions are developed by supply chain traceability experts. The integrations are available to all our pharmaceutical customers and allow complete two-way integration between Blue Link and the integrator. The integration with Blue Link and systems such as Gateway Checker and LSPedia will help customers receive, translate, store, and send EPCIS file information as needed. This will allow pharmaceutical distributors to achieve regulatory compliance and streamline their operations. Blue Link has partnered with these two well-known integrators so pharmaceutical customers have a choice.
Are You Ready Today?
With the official deadline coming in November 2023, the question remains, are you ready to meet the DSCSA deadline now? Does your current ERP solution allow you to meet the DSCSA interoperability requirements today? If your vendor could not be ready for the original November 2023 deadline, can you trust them to be ready for November 2024?
It’s too late to wait around for electronic interoperability functionality to be developed by your current vendor or vendors you are evaluating. Again, the period from now until November 2024 should be viewed as a “stabilization period” where you are finalize implementation and conduct thorough testing to ensure a flawless execution of your plans.