The Drug Supply Chain Security Act (DSCSA) was signed into law by President Obama in November of 2013, placing new requirements on the traceability of prescription drugs. The Healthcare Distribution and Management Association (HDMA) has been at work advocating for this standardized, electronic solution which will make prescription drugs safer and drug recalls easier. Further, the legislation will reduce harmful, illegal or contaminated drugs from entering the market and enable tracking down to the individual package level.
Drug manufacturers, wholesale drug distributors, drug repackagers, and pharmacies will be involved in the standardized exchange of information about when and where drugs are exchanged throughout the supply chain. This creates tracing and verification compliance issues and businesses may need to employ new IT resources to manage the technology that will automate and exchange tracking information.
The DSCSA will phase the implementation of the law with Lot Level Management going into effect January 1, 2015, Item Serialization between 2017-2019 and Serialized Item-Level Traceability by 2023. The cost to drug manufacturers and participants in the drug supply chain is likely to be between $30 and $40 million to implement the technology to support these requirements, according to experts.
However, there’s more in compliance than simply avoiding fines and sanctions. The “compliance ROI” that is predicted to result is due to business process improvement associated with increased inventory accuracy and velocity, improved tracking of new sales orders, improved returns processing, and lastly reduced financial liability for expired and damaged goods.
Warehouse Management Systems (WMS) are already a vital aspect of the drug supply chain, and will help provide some of the necessary transaction information for the ASN (Advanced Shipping Notice) which is the Electronic Data Interchange (EDI) document that will facilitate compliance. The information stored in a WMS includes lot number of product, date of transaction, date of shipment, and business names and addresses of where product is being transferred to and from.
Want to find out more about the DSCSA and how it could impact your business and your distribution operations? Download this complementary eGuide from AccellosOne WMS Solutions.
About Accellos, a HighJump Product
AccellosOne Warehouse Management System (WMS) optimizes warehouse processes, equipment and space to drive an efficient, accurate, and scalable warehouse environment. AccellosOne WMS is the most adaptable and personalizable warehouse software solution built for the mid-market with certified integrations to most popular ERP packages. Trusted by over 700 customers in 27 countries, the solution is available on-premise or in a cloud-based software as a service (Saas) model and is built on a modern technology platform featuring a user-friendly interface and simplified technical administration. The single platform includes automated barcode data collection, business intelligence, parcel shipping, and trading partner integration (EDI). HighJump Software supports more than 14,000 customers in 77 countries, ranging from small businesses to global enterprises. For more information, visit www.accellos.com and www.highjump.com.