U.S. Drug Supply Chain Security Act (DSCSA) requirements and implementation plans
Ms. Connie T. Jung, Senior Advisor for Policy, U.S. Food and Drug, introduced the scope of the law and outlined the major milestones of the DSCSA. The scope of the law and milestones being:
- 2014-2015: 3PL and wholesale distributors report to the FDA
- 2015: Product tracing and verification by authorized trading partners
- 2017-2018: Product identification and serialisation
- 2019 and beyond: Product verification, down to the package level
- 2023: Electronic, interoperable system with product tracing down to the package level
Ms. Jung also explained the requirements of product identification and serialisation in 2017 and 2018.
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