DSCSA Requirement for Manufacturers

DSCSA Requirement for Manufacturers

DSCSA Requirement For Manufacturers

DSCSA Requirement for Manufacturers

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: Electronic product tracing with Transaction Information, Transaction History and Transaction Statements. Knowing the DSCSA requirement for manufacturers is now more important than ever.

Product identifiers: Printing or attaching a scanned product identifier on the smallest saleable packages and homogenous cases of drugs. The identifier must meet the FDA Standard Numerical Identifier (SNI) requirement and contained the GTIN with embedded NDC, Lot Number, Serial Number, and the Expiration Date.

Interoperable electronic tracing: By Nov. 27, 2023, the FDA requires interoperable electronic tracing of product at the unit packaging level. Manufacturers need to aggregate unit packages to case packages, case packages to pallet, and provide the aggregated shipment data to downstream trading partners.  Wholesale Distributors will not accept DSCSA products that are not serialization or aggregated starting Nov. 27, 2023.

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