Are You Ready for Serialization 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.
The Alcami Advantage
Alcami has made significant investments to upgrade our packaging lines for full serialization and aggregation capability. Alcami has partnered with leading track and trace solution provider, TraceLink® to launch the enterprise level serial number management system, through TraceLink® Life Sciences Cloud, which will enable serial number generation and commissioning as well as data transfer with our clients and trading partners. Our serial number management system has flexibility to integrate with other solutions and supports various serial number provisioning models.
Committed to consistent regulatory compliance, Alcami has successfully transitioned several clients into our serialization program and expect to continuously onboard additional clients. Connect with one of our experts to achieve the best outcome for your product at every level.
- 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.