What are the DSCSA requirements for Manufacturers and Distributors?
The DSCSA creates a complex web of compliance issues around tracing and verification of drug product transactions between suppliers and their trading partners. To minimize risks and costs associated with DSCSA compliance, businesses may need to put new IT resources in place, perform due diligence on logistics partners and other third parties, and document and address any gaps in their overall compliance strategy.
A recent poll by TraceLink, indicated that Warehouses are not yet ready for serialization. Respondents overwhelmingly indicated they are not yet equipped to handle serialized product in their warehouses, or have they begun to implement serialization with their manufacturing partners. Only 38% of respondents said they were confident their ERP or WMS systems will be able to handle all their serialized distribution needs.
Timeline of DSCSA Requirements
Manufacturers serialize product
Repackagers serialize product
Distributors transact only serialized product
Dispensers transact only serialized product