DSCSA: Transaction Statement

This is the third in a series of essays about data exchange components required by the Drug Supply Chain Security Act (DSCSA) beginning next January.  The previous essays in this series include DSCSA Transaction Information (TI) and DSCSA Transaction History (TH).   The DSCSA, which is Title II of the Drug Quality and Security Act (DQSA), defines Transaction

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2 thoughts on “DSCSA: Transaction Statement”

  1. Hi Dirk –
    Which TS would be applicable to a manufacturer that makes most of the products that it sells but that does carry a few products it buys from other manufactuers (e.g. licensed, JV, etc.)?

    What about the scenario where all products (made and bought) are sold on the same customer order and shipped together in the same delivery? Which TS would apply? The Manufacturer’s? Wholesaler’s? Both?

    Thanks,
    Ricardo

    1. Ricardo,
      This is a an excellent question. It makes sense that the TS provided by a seller must make clear exactly which products in the shipment it covers. In the shipment you describe where there is a mix of products that a manufacturer makes themselves and some that they license or distribute from others, both the TH and the TS for each product would probably be different. This same situation applies to all trading partners in the supply chain because shipments are often made with a mixture of products (especially wholesale distributors).

      Remember that for most shipments of a given product, the TI, TH, and TS must be contained in a single document, whether that is paper or electronic. In this way it will be clear which products your TS applies to. However, this also means that for overall “shipments” that include multiple products that have different histories or required a different set of TS assertions, you will need to include more than one document containing the transaction data. Don’t expect to use a single document for an entire “shipment” unless the entire load is composed of a single product from a single lot and they all have a single supply chain history.

      I’m sure the FDA’s guidance will explain all that with more clarity.

      Thanks,
      Dirk.

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