This checklist provides a structured approach to DSCSA compliance for all trading partner types.
For Manufacturers
- ☐ Implement serialisation at saleable unit level (SGTIN in DataMatrix barcode)
- ☐ Implement aggregation (case and pallet-level serialisation)
- ☐ Generate Transaction Information (TI) for each product transfer
- ☐ Implement EPCIS-based electronic data exchange with trading partners
- ☐ Implement saleable returns verification process
- ☐ Establish suspect product investigation procedures
- ☐ Register with FDA as authorised trading partner
For Wholesale Distributors
- ☐ Verify product identifier on receipt of each product
- ☐ Receive and store Transaction Information electronically
- ☐ Transmit Transaction Information to downstream trading partners
- ☐ Implement EPCIS-based electronic data exchange
- ☐ Implement saleable returns verification before redistribution
- ☐ Establish suspect product quarantine and investigation procedures
- ☐ Maintain records for 6 years
For Dispensers (Pharmacies, Hospitals)
- ☐ Verify product identifier on receipt of each product
- ☐ Receive and store Transaction Information electronically
- ☐ Implement suspect product investigation procedures
- ☐ Respond to FDA requests for transaction information within 2 business days
- ☐ Maintain records for 6 years