Customer Advisory: FDA Grants Exemption to Connected Trading Partners

Dear Valued Customer,

We are reaching out 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

We advise 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.  
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Thank you for your attention to this important matter. We look forward to assisting you in making this transition as smooth as possible.

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Best Regards,

Riya Cao

CEO

LSPedia Inc.