DSCSA Requirement for Dispensers
DSCSA Requirement for Dispensers
The Drug Supply Chain Security Act (DSCSA) sets out multiple phases of compliance that started Nov. 27, 2013 and finish rolling out Nov. 27, 2023. This includes Serialization and Product Tracing. Understanding the DSCSA Requirement for Dispensers is vital in today’s market.
Serialization: Dispensers may not accept DSCSA Products that are not serialized with a product identifier on each smallest saleable package and homogenous case that meets the FDA Standard Numerical Identifier (SNI) requirement. Dispensers may accept non-serialized products manufactured before Nov. 27, 2018 provided there is documentation of such “grandfathered” status. Dispensers must still verify the lot number of suspect product and validate any applicable transaction history and transaction information in their possession.
Electronic product tracing: Dispensers must provide the Transaction Information, Transaction History and Transaction Statement in an electronic format. Paper packing lists or paper invoices can’t be accepted by trading partners as of Nov. 27, 2017. Shipments received by trading partners without electronic product tracing or proper TI, TH, TS information in the electronic product tracing will be returned to the manufacturers.
Interoperable electronic tracing: Dispensers may not accept DSCSA Products that aren’t serialized or properly aggregated starting Nov. 27, 2023. To meet this requirement, manufacturers need to aggregate unit packages to case packages, case packages to pallet, and provide the aggregated shipment data to downstream trading partners.
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