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Drug Supply Chain Security Act (DSCSA)
See what DSCSA requires of manufacturers, wholesale distributors and third-party logistics providers, and how MedPro Systems automates ongoing license validation.
U.S. Federal, FDA
Manufacturers, wholesale distributors and third-party logistics providers
Transaction information, history and statements at the lot level
Authorized trading partner licensing and location data
Overview
To better enhance the Food and Drug Administration’s (FDA’s) ability to protect consumers from exposure to counterfeit, stolen, contaminated or otherwise harmful drugs, the Drug Quality and Security Act (DQSA) was enacted by Congress in November 2013.
Title II of the legislation, the Drug Supply Chain Security Act (DSCSA), established one national standard for track and trace requirements for U.S. drug distribution, allowing Life Sciences companies to standardize their approach to providing transaction information.
Pharmaceutical manufacturers, prescription drug wholesale distributors and third-party logistics providers are required to provide transaction information (TI), transaction history (TH) and transaction statement (TS) of all shipments at the lot level. In most instances, to verify authorized trading partners for these shipments, these organizations must be able to obtain, verify and consolidate state licensing information and location data into a uniform and accessible database for their shipping needs.
To manage the complexity of this process and keep MDM and CRM data clean and accurate, Life Sciences organizations trust MedPro Systems for their DSCSA validation needs. With the MedProID® suite of Healthcare Professional (HCP) and Healthcare Organization (HCO) validation and enrichment solutions, organizations can automate ongoing license validation and proactively verify SLN data for every shipment to Authorized Trading Partners (ATPs) they release throughout their supply chain.
To learn more about DSCSA regulations, visit the FDA’s DSCSA page.
How MedPro Systems Can Help
We help Life Sciences and Healthcare companies drive better health outcomes by reducing complexity across their compliance and commercial operations.
Through MedProID, we offer accurate, comprehensive and trusted HCP and HCO identifying data, accessible in real time through a centralized platform that integrates directly with your internal systems. We provide automated, ongoing and proactive SLN license validation for every shipment to Authorized Trading Partners (ATPs) released throughout your supply chain.
To meet the added requirement of using Global Location Numbers (GLNs) to report location data, we’ve developed a first-of-its-kind SLN-GLN crosswalk with more than 250,000 matched associations (and growing) for seamless DSCSA compliance.
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