In the U.S., the Food and Drug Administration (FDA) has defined standards to secure the drug supply chain. Standardized numerical identification for prescription drug packages is now required. This is serialization.

Serialization entails marking packages with a product identifier (GTIN), a unique serial number, a lot number and an expiration date. The serialization must be done to the smallest packaging level of a product, should it be a box, a vial or a bottle, and all data must be included in a 2D Data Matrix (GS1) data carrier.

Aggregation is the next logical step and requirement of the DSCSA. All companies that have just finished implemented the serialization process are expected to undertake this next critical step by 2023.

 

Ultimate Guide of Drug Supply Chain Security Act ( DSCSA )