The US Drug Supply Chain Security Act (DSCSA) is a federal regulation enacted to enhance the security and traceability of pharmaceuticals as they move through the supply chain. Enacted in 2013, the DSCSA aims to safeguard public health by addressing concerns related to counterfeit, adulterated, or otherwise compromised drugs.
Key provisions of the DSCSA include a phased implementation approach, with full compliance expected by 2023 followed by a one year stabilization period. The central component is the establishment of a traceability system that enables the tracking and tracing of prescription drugs at the individual package level. Manufacturers are required to affix a product identifier to each package, containing information such as the National Drug Code (NDC), serial number, lot number, and expiration date.
Pharmaceutical supply chain stakeholders, including manufacturers, repackagers, wholesale distributors, and dispensers, are mandated to exchange transaction information, history, and statements (T3 information) when transferring ownership of pharmaceutical products. This information must be electronically accessible and retrievable for a predefined period, ensuring transparency and accountability throughout the supply chain.
Furthermore, the DSCSA establishes requirements for handling suspect and illegitimate products, facilitating the prompt investigation and notification of potential issues. The overarching goal of the DSCSA is to create a closed, secure supply chain that enables quick response to potential threats and ensures that only genuine and safe medications reach patients, reinforcing the integrity of the U.S. pharmaceutical distribution system.
Verification & 3911 Reporting
EPCIS Interoperability
Aggregation & Unit Level Traceability
Trading Partner Locations
Customer Retention Rate
Exceptions Resolved
EPCIS Data Files Processed
Client Locations Switched to LSPedia
Solutions built for integration with workflow, automation, and data security at the core.
All data is encrypted
Encrypted data is stored in our secured cloud
Receive Pick Pack Ship Verify
VRS EPCIS errors and discrepancies
Single or multi-facility operations
Fully qualified computer system validation
OneScan suite is the industry's #1 turnkey, cloud-based DSCSA compliance and exceptions management solution suite for the entire pharmaceutical supply chain.
OneScan is the industry's leading platform for serialization and EPCIS data interoperability. EPCIS is where serialized events are created, updated, and stored. OneScan enables serial generation, encoding, commissioning, reworking, and decommissioning.
OneScan Connector offers 24+ standard RESTful APIs for easy integration to your business systems. Connector enables master data, serialized product data, and order data to flow seamlessly in real-time or in batches between connected systems. No more double data entry or human (data entry) errors!
OneScan is the industry's leading platform for serialization and EPCIS data interoperability. EPCIS is where serialized events are created, updated, and stored. OneScan enables serial generation, encoding, commissioning, reworking, and decommissioning.
OneScan offers easy FDA 3911 reporting with auto-fill. With just the click of a button, OneScan will generate a complete 3911 form auto-populated with all of the correct data, ready to send, saving time and eliminating human errors from manual data entry.
OneScan Edge enables scan-in (receive) and scan-out (pick, pack, ship) of packages utilizing the 1D UPC barcode and the 2D data matrix barcode. It also enables aggregation for serialized packages.
Access the OneScan ATP database of more than 31,000 authorized trading partners. Quickly find, add, verify, and manage your trading partners. DSCSA requires all of your trading partners to be authorized.
OneScan Investigator is the #1 cloud-based exceptions management solution for FDA's Enhanced Supply Chain Security requirement under the DSCSA. Investigator automatically identifies, alerts, and resolves EPCIS errors and discrepancies. There's no longer a need to hire additional staff to manage exceptions.
Management of expiring drugs has never been easier or more accurate. OneScan Expiry is a proactive platform with simple reporting and automatic notification of soon-to-expire products. Easy to use and fully automated to save you time and money.
OneScan suite is the leading traceability solution, designed and proven to increase productivity, profitability, and supply chain visibility. LSPedia's seamless, cloud-based compliance solution streamlines the track and trace requirements with little impact on your daily processes.
Contact UsExplore the challenges and strategies in securing pharmaceutical, food and other supply chains. Discover how innovative technologies and collaborative efforts can safeguard public health and enhance consumer trust in today’s interconnected marketplace.
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