DSCSA Whitepaper

DSCSA Whitepaper

DSCSA Requirement For Manufacturers

FDA’s DSCSA Requirement

The Drug Supply Chain Security Act (DSCSA) sets forth multiple phases of compliance starting November 27, 2013 through to November 27th, 2023. Of critical importance are the following dates: November 27, 2017, November 27, 2018, and November 27, 2023.

NOVEMBER 27, 2017

Product Tracing

Manufacturers must provide the Transaction Information, Transaction History and Transaction Statement in electronic format, AKA electronic product tracing.  The commonly accepted electronic product tracing is EDI 856 Advanced Shipping Notice (ASN). Paper packing lists or paper invoices in lieu of electronic information can no longer be accepted by trading partners as of November 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.

HDA DSCSA enabled EDI ASN 856 supports the exchange of Transaction Information (TI), Transaction History (TH) and Transaction Statement (TS).

Serialization

Manufacturers must affix or print PI on smallest saleable packages and homogenous cases. The product identifier shall conform to the FDA Standard Numerical Identifier (SNI) requirement. The PI shall contain four elements, GTIN with embedded NDC, Lot Number, Serial Number, and the Expiration Date.

The enforcement of this requirement is delayed one year to November 27, 2018 per FDA’s draft guidance, “Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.” Published on June 30, 2017.

NOVEMBER 27, 2018

Serialization

Repackagers must affix or print PI on smallest saleable packages and homogenous cases. The product identifier shall conform to the FDA Standard Numerical Identifier (SNI) requirement. The PI shall contain four elements, GTIN with embedded NDC, Lot Number, Serial Number, and the Expiration Date.

Wholesale Distributors will not accept DSCSA Products that are not serialized. For non DSCSA Products including grandfathered products and exempted products, manufacturers shall keep FDA compliant records for inquiries per FDA or trading partner request.

NOVEMBER 27, 2023

Interoperable Electronic Product Tracing

Effective November 27, 2023, the FDA requires interoperable electronic tracing of product at the unit packaging level.

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.  Wholesale Distributors will not accept DSCSA Products that are not serialization or aggregated starting November 27, 2023.

DSCSA Wholesale Distributors’ Requirement

To maintain existing operation level, the Wholesale Drug Distributors (WDD) have the following requirement for the manufacturers:

ASN

WDDs expect Lot Level DSCSA product tracing data in HDA DSCSA enabled EDI ASN 856 until Lot Level Traceability is sunset on November 27th, 2023 or sooner.

Shipper Label with SSCC

WDDs require a Shipper Label affixed to non-homogeneous cases, or totes, and pallets…

 

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