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:
The FDA is granting exemptions from specific requirements of section 582 of the FD&C Act for small dispensers (pharmacies) until November 27, 2026. This provides small dispensers the opportunity to stabilize their processes necessary for DSCSA compliance. The FDA defines a small dispenser as a company with 25 or fewer full-time employees licensed as pharmacists or pharmacy technicians. Trading partners who do not qualify as small dispensers and are unable to meet the DSCSA deadline of November 27, 2024, can now request a waiver or exemption.
The FDA recommends trading partners request waivers or exemptions by August 1, 2024, although submissions can be made at any time. Compliance with the DSCSA remains mandatory until the FDA approves or denies the request.
Requests should adhere to the FDA’s guidance on waivers, exceptions, and exemptions. A complete request should include:
Review the FDA guidance: Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act | FDA
Two FDA webpages for more details on where to submit your request:
On behalf of Primed and Adelphia I would like to thank you and your staff for working with us in creating our custom project. It’s working out great so far! It has reduced lots of work time on our end and we were able to swiftly import and update all our missing data for the past year. We are finally starting to get great use out of Blue Link and enjoy using this software! Absolutely brilliant work. We really appreciate all the effort you and your staff have put into this project to make it work…thanks again for a job well done!
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.
Blue Link ERP provides integrated Accounting Software and Inventory Management Software to small and medium sized businesses, primarily wholesalers & distributors. READ MORE
