In November 2023, item-level traceability under DSCSA introduces significant regulatory challenges and operational complexity for healthcare organizations and pharmacies.
- Dispensers must receive and ensure they match updated Transaction Information (TI) data that now includes serialized product identifiers to products they receive from suppliers.
- DSCSA TI and Transaction Statements (TS) must now be exchanged in an electronic, interoperable electronic format (EPCIS or other).
- A new requirement to have the ability to gather and product the transaction information for each transaction going back to the manufacturer, in the event of an investigation or recall, now come into place as the Transaction History sunsets.
- Requirements to verify the serialized product identifier at the package level under suspect or illegitimate product investigations remain in place.
These regulations, combined with the business requirements imposed by trading partners, place significant new operational and supply chain burdens on pharmacy dispensers. They also create new opportunities to leverage enhanced product and network data to improve pharmacy operations.
Traceability, Verification, and Serialization