DSCSA is bringing secure, interoperable, electronic data exchange to the pharmaceutical supply chain. Are you ready?
DSCSA has been ten years in the making, starting with the Drug Quality and Security Act (DQSA). This act came into existence on November 27, 2013, for drug product tracing. Within DQSA, Title II, which is also referred to as the Drug Supply Chain Security Act (DSCSA), establishes a federal system for tracing prescription drug products through the pharmaceutical distribution supply chain. It requires trading partners to pass, receive, and maintain certain product and distribution information.
DSCSA went into effect in November 2019 for distributors and the enhanced drug distribution security requirements will come full circle on November 27, 2023.A Brief DSCSA Timeline
Now in 2023 and beyond, the DSCSA focus has been recalibrated for implementing interoperable, electronic tracing of pharmaceutical drugs down to the package level, while establishing national standards for Authorized Trading Partners (ATPs), state licensure verification for wholesale distributors, and third-party logistics (3PLs), and dispensers.Maintaining integrity from the manufacturer to the end user – the patient – is mission critical and quality, trusted data is needed to validate and answer:
What are Authorized Trading Partners? In the pharmaceutical supply chain, all trading partners are licensed either by the FDA or a State Board of Pharmacy. This includes manufacturers, re-packagers, wholesale distributors, dispensers, and third-party logistics. Members of the supply chain can buy or sell products only to those parties with active licenses. This effectively means that each partner in the supply chain is regularly evaluating the licenses of its customers and suppliers.
You need quality, up-to-date data you can trust to meet these compliance regulations and ensure all touchpoints throughout the drug supply chain are authorized parties and be prepared to meet audit requirements.
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