Are you ready for Serialization and Track & Trace requirements?
Due to counterfeiting, adulteration, theft and diversion, governments and regulatory agencies have developed regulations to enhance patient safety and supply chain security. On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) made effective several additional requirements that impact labeling and data management for commercially distributed prescription human drug product in the US.
What is Serialization?
Serialization refers to the new requirements for application of unique identification code, a serial number or EPC (electronic product code). The serial number should be applied to each unit in GS1 standard 2D DataMatrix and human-readable formats.
- January 2015: Lot-level traceability requirement became effective.
- November 2018: Unit level (serial #) requirement becomes effective; manufactures must apply to bottle or carton and case/shipper. Although not required per DSCSA, most wholesale distributors are also requiring aggregation by this deadline.
- November 2019: Wholesale distributers may not purchase or sell drug product without serialized product identifier.
- November 2023: Full until level traceability is required, including dispensers.
The Alcami Advantage
At Alcami, we are committed to directing you to achieve consistent regulatory compliance. Connect with one of our experts to achieve the best outcome for your product at every level. Read more about what this means for you.