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dscsa requirements

DSCSA and The Pharmaceutical Supply Chain: Technology Considerations

DSCSA FAQs

The Drug Supply Chain Security Act (DSCSA), according to FDA.gov, establishes national licensure standards for wholesale distributors and third-party logistics providers (3PLs), and requires these organizations report licensure and additional information to the FDA annually. The DSCSA also requires distributors to notify the FDA of any pharmaceutical product issue within 24 hours.

What does this mean? It means the pharmaceutical distributors must “build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.”

Why was DSCSA enacted? To protect US consumers against counterfeit drugs, stolen drugs, contamination or harmful actions that could occur during the pharmaceutical supply chain.

What’s happening in 2019 and 2023? The DSCSA requirements state that by 11/27/2019, wholesale distributors can only “buy and sell products encoded with identifiers” including National Drug Code (NDC) and serial number. By 2023, enhanced product tracking capabilities must be in place.

What does this mean for the pharmaceutical supply chain? Change can be slow-going for pharmaceutical distributors; many distributors are running on legacy systems in which customizations are costly and time-consuming. However, with no action, costly fines and legal issues for noncompliance with these new regulations could arise. Pharmaceutical distributors need a solid plan for compliance.

DSCSA requirements 2019

DSCSA and your Enterprise Resource Planning System (ERP) & Warehouse Management System (WMS)

DSCSA serialization efforts must be scalable to support the new tracking requirements, as a tremendous amount of tracking data will be generated at multiple points in the drug supply chain. Serial numbers for the unit-level must meet the FDA’s SNI Guidelines—2D barcodes are expected to be the standard, but Global Trade Item Number (GTIN) barcodes are accepted as well.

Your ERP/WMS system must also have the capability to track at the pallet and case level to allow traceability in case of an investigation or damage. Your ERP must be able to identify individual numbers in an aggregate, if required. Supply chain partners will need to share product location and tracking information throughout the distribution process, which could be difficult if they are using software systems that do not integrate easily.

Iptor Supply Chain Systems — a DSCSA Solution

Iptor Supply Chain Systems (formerly IBS) is an on-premise supply chain management, planning and logistics software. Iptor Supply Chain Systems has more than 1,250 customers with 4,000 installations in over 40 countries worldwide. The United States’ leading pharmaceutical companies such as Metro Medical and TOPRX run their pharmaceutical distribution operations on Iptor Supply Chain Systems.

Protelo, an Iptor partner and reseller, has led the effort in designing the Iptor DSCSA compliance solution and can implement an end-to-end strategy and solution running on the Iptor (formerly International Business Systems – IBS) platform.

Iptor and Protelo Leading the Way for DSCSA Compliance

DSCSA touches several key points within the processes and transactions in the pharmaceutical manufacturing and distribution chain. Iptor and Protelo are completing the development phase for DSCSA-compliant additions to:

  • RF processes
  • Purchase order reception
  • Return to supplier
  • Package reporting
  • Customer returns
  • Internal replenishment order
  • Warehouse movement
  • Inventory transaction
  • Stock take / Physical count

Implementing a new supply chain system that is DSCSA compliant or implementing the DSCSA solution for your current Iptor Supply Chain instance is a process that should be started now to ensure compliance by the 2019-2023 DSCSA deadlines for pharmaceutical distributors.

Protelo can provide expert guidance on how to achieve DSCSA compliance.
Searching for a solution to get compliant? Let’s talk.

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