Blue Link Pharmaceutical ERP software offers all the essential features you need to ensure compliance with the DSCSA. While Blue Link is primarily an inventory and accounting management ERP solution, we have secured partnerships that guarantee all our pharmaceutical customers meet the November 2024 DSCSA deadline.
Trust Blue Link for seamless compliance and efficient management.
The Drug Supply Chain Security Act (DSCSA), signed into legislation by US President Barack Obama on November 27, 2013, ushered in a new age of transparency and accountability in the pharmaceutical industry. The DSCSA outlines several phases aimed at establishing an interconnected platform that will successfully identify and trace specific prescription drugs as they move through the supply chain. As of the end of 2023 and the completion of the ten-year implementation process, the resulting system in place will enable the communication of information at the individual package level identifying where a specific drug has been at different stages of the supply chain. The goal of this transition is to permit the verification of the legitimacy of the drug products, facilitate more efficient and timely recall procedures , and enhance the detection and notification of illegal products.
For wholesale distributors dealing with pharmaceutical drugs, Blue Link closely monitors FDA, DEA and the progression of DSCSA requirements and frequently consults with existing customers and industry experts to ensure the pharmaceutical specific functionality offered continues to meet the needs of the industry and new standards/regulations as they come into effect.
Blue Link ERP seamlessly integrates with third-party applications to read, decipher, store, and transmit EPCIS file information, enhancing your receiving and shipping processes.
When inventory arrives at your warehouse, simply scan the largest unit size, and Blue Link will automatically query the third-party application for Drug Transaction Records (DTR) included in the EPCIS file. This ensures the product’s authenticity and compliance before storing the information within Blue Link for use in the outbound shipping process. With Blue Link, achieve efficient and reliable pharmaceutical compliance and traceability.
In August 2023, it was released by the FDA that they will be enforcing a ‘Stabilization Period‘ and will not be enforcing the DSCSA requirements until November 27th, 2024. The stabilization period is encouraged to be used to build and validate the systems and processes that require Pharmaceutical trading partners to be fully compliant with DSCSA requirements. Although the FDA will not be enforcing the law until 2024, it’s important that businesses do not stop or delay implementing these processes. Read the FDA Guidance documents:
Early October 2024, FDA announced an exemption from the enhanced drug distribution security requirements of section 582 of the FD&C Act for eligible trading partners, designed to prevent drug shortages on specific products for which serialized data has not been exchanged.
“This exemption applies to any product transacted by eligible trading partners, which are trading partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners, but still face challenges exchanging data.”
It is our understanding that before this exemption, as of November 27, 2024, if you were to receive a product for which there was no electronic data, you would have to quarantine that product until you receive the data. With this exemption in place, you will no longer be required to quarantine products missing inbound data.
At Blue Link, we believe that trading partners will still need to match received items to inbound data when data is available, and they will still need to send outbound data to customers by scanning the serial numbers that is sent.
In the Blue Link ERP software, you can remove the EPCIS Enabled flag for any inventory item for which you know there is no inbound data available, leaving the flag on for the other items for which there is data.
As per the FDA, the duration of the exemption is as follows:
Waivers and Exemptions Beyond the Stabilization Period | FDA
*This update is for informational purposes only and should not be construed as legal advice.
We don't really need to go into Gateway Checker because we're able to see it over here [in Elite].
Before an EPCIS file is received into Blue Link, it must be parsed to ensure proper display. This parsing is seamlessly handled by third-party integrators such as our partners, Gateway Checker and LSPedia, both developed by supply chain traceability experts. These integrations are fully embedded within the Blue Link User Interface, enabling our pharmaceutical customers to manage EPCIS file information entirely within Blue Link. Customers can receive, translate, store, and send EPCIS file information as needed without ever leaving the Blue Link environment. This complete two-way communication ensures regulatory compliance and streamlines operations for pharmaceutical distributors. Our partnerships with Gateway Checker and LSPedia provide reliable integration options, allowing users to operate exclusively within Blue Link ERP.