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 of 2013.
Title II of the legislation, the Drug Supply Chain Security Act (DSCSA), established one national standard for track and trace requirements for US 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 into a uniform and accessible database for their shipping needs.
To manage the complexity of this process and ensure clean and accurate MDM/CRM data throughout their processes, Life Sciences organizations trust MedPro System for their DSCSA validation needs. With the industry leading MedProID suite of Healthcare Professional (HCP) and Healthcare Organization (HCO) validation and enrichment solutions, organizations are able to automate on-going 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 please visit the FDA website: www.fda.gov.
Please contact us to learn more about MedPro’s DSCSA compliance solutions.