Guidance

LSPedia's Response to the FDA’s DSCSA Compliance Extension

October 11, 2024
By

LSPedia wants to update you on significant developments from the FDA that may impact your operations. On October 9, 2024, the FDA issued new guidance granting temporary exemptions from DSCSA Section 582(g) requirements for certain trading partners. This advisory provides an overview of these exemptions and how they might affect your operations.

Overview of the Exemption

The FDA's guidance extends temporary exemptions beyond the initial stabilization period ending November 27, 2024. This Exemption is aimed at trading partners who have initiated systems for the electronic, interoperable exchange of transaction information but are facing challenges with data quality and reliability.  

Key Points of the Exemption

  • Eligibility: Trading partners with established electronic DSCSA data connections by November 27, 2024, are eligible. This includes those who have made documented efforts to meet the requirements but continue to experience data discrepancies.  
  • Data Connection: Efforts should focus on sending and receiving serialized data, emphasizing actual data exchanges rather than just network setups.
  • Extension Period: Provides additional time for eligible trading partners to enhance their systems.
    • Manufacturers and Repackagers: Until May 27, 2025
    • Wholesale Distributors: Until August 27, 2025
    • Dispensers with 26 or more full-time employees: Until November 27, 2025
  • Scope of Exemption: Applies to specific requirements under Section 582(g) of the FD&C Act, particularly those involving the exchange of serialized data and verification at the serial number level.
  • FDA Expectations: While these exemptions offer temporary relief, the FDA strongly encourages all trading partners to continue their compliance efforts to fully meet enhanced DSCSA drug distribution security requirements.

Impact on Your Business

This exemption allows your organization to continue operations without the immediate pressure of the original regulatory deadlines. It provides additional time to refine and improve your DSCSA operations, facilitating your trading partners' efforts to catch up with data connections.

Action Items

LSPedia advises all our customers to assess their current exemption status and ensure their processes are compliant:

  1. Know which of your suppliers and customers are eligible or ineligible.
  2. Understand your process for converting ineligible trading partners to eligible status.
  3. Track the eligibility of trading partners through your WEE process.

Exemption Tracking with OneScan

OneScan can significantly help in assessing your own and your trading partners' eligibility status.  

Question Answer
1. How many supplier trading partners do I have? From OneScan, see your supplier trading partners report at Entities/Inbound Supplier Report.
2. How many customer trading partners do I have? From OneScan, see your customer trading partners report at Entities/Outbound Customer Report.
3. Who are ineligible suppliers? Suppliers that have not sent any test or product data to you. See ineligible suppliers in Report/Supplier Non-Compliance (OneData Analytics Module required).
4. How do I demonstrate "documented efforts" of eligible trading partners? Go to EPCIS/History in OneScanTest, filter "From" using the supplier name. Similarly, same applies to the OneScan production environment at EPCIS Transaction History.
5. My ERP/WMS is not ready to process outbound shipment, are my customer trading partners ineligible? We recommend that you send 1 or more outbound test EPCIS to your customers to establish eligibility.
6. How do I send outbound EPCIS data file? From OneScan, go to Edge/Scan-out at Scan Out (Edge Module license required) to complete the shipment. EPCIS data file will be automatically generated and sent.
7. How do I buy Edge module? Contact your account manager at am@lspedia.com or our sales team.
8. How do I buy OneData Analytics Module? Contact your account manager at am@lspedia.com or our sales team.
9. How do I manage trading partner exemptions? Use OneScan WEE Module.

Thank you for your attention to this important matter. LSPedia looks forward to assisting you in making this transition as smooth as possible.