FDA Product Tracing Requirements and Impact to Supply Chain

Drug and Supply Chain Security Act (DSCSA)

Food and Drug Administration (FDA) through its Drug and Supply Chain Security Act (DSCSA) has stipulated product level tracing requirements.

These requirements are applicable to Pharmaceutical Supply Chain companies including Manufacturers, Distributors, Re-packagers, 3PL providers. Dispenser, Manufacturer, Re-packager, 3PL, Wholesale distributor. The main benefit of this act is that quarantine and recall become easy with the trace-ability.

This act requires all companies within Pharmaceutical supply chain to develop an electronic system designed to increase trace-ability of products at any stage in the supply chain. Manufacturer location, in transit, in 3PL warehouse all should be able to be traced and recalled when needed.

Packaging Requirements for Pharmaceutical Products

Product tracing requirements are at manufacturing lot level by 2015 and by package level by 2023.

Some of the requirements of this act are

  1. All packages to have a unique serial number. Standardized numerical identifier with 2D or 3D barcodes to be used on all packages.
  2. Transaction and Transaction history to be maintained by all parties in the supply chain. Transaction is defined as a transfer of product where a change of ownership occurs. Transaction history is ability to identify who handled the items and when it was handled.
  3. Transaction documentation – Ownership transfer documents to be maintained.
  4. Packing Slips and Carton labels are to be used for visibility of items being shipped and their detailed history.
  5. Electronic data transmission of package and serial number details across the supply chain

Electronic Data Interchange (EDI) and DSCSA

Using an EDI system enables easy compliance of these regulations.

An EDI system creates Packing Slips and Package Labels that have unique serial number identifiers. As seen in this packing slip, each shipment is accompanied by a packing slip that has the details of the product being shipped



In addition to the Packing slip, a detailed package level labels are required. These labels will have the detail of the product and the Lot number and expiration date. Each package has a unique serial number to trace the package at any location in the supply chain



TPSynergy provides a pre-built supply chain solution for EDI, Packing Slips and Carton labels that can be used in Pharmaceutical Supply Chain

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