The stabilization period has ended, and in the wake of FDA guidance granting DSCSA compliance exemptions, state Boards of Pharmacy are pushing for progress, making it clear that deadline extensions don’t excuse inaction. Kowa Pharmaceuticals America, Inc. recently encountered this firsthand when the Louisiana Board of Pharmacy requested their Standard Operating Procedures (SOPs) and proof of secure trading partner connections. The inquiry aimed to ensure that Kowa Pharmaceuticals America, Inc.’s exempt partners were genuinely exempt and that the company’s processes met regulatory expectations. The manufacturer is a longtime LSPedia customer and is well ahead of the curve in terms of DSCSA compliance, was well prepared to accommodate the request.
This regulatory scrutiny reflects a growing trend: state Boards are increasingly requiring evidence of compliance, even for companies operating under FDA exemptions. Kowa Pharmaceuticals America, Inc.’s experience highlights the urgent need for businesses across the supply chain to demonstrate progress toward full DSCSA compliance, regardless of extended deadlines.
“DSCSA continues to bring industry challenges and changes in how we comply across jurisdictions and regulatory agencies, including state Boards of Pharmacy,” said Brad King, Regulatory & Healthcare Compliance Manager, Kowa Pharmaceuticals America, Inc. “For example, Boards like Louisiana are integrating DSCSA requirements into their inspection checklists—segregating license application classes such as Manufacturer, Wholesaler, and 3PL as they relate to FDA reporting—and requesting detailed information such as interoperable system status, recall policies, and proof that trading partners meet any exceptions.”
Regulatory Oversight Intensifies Despite Exemptions
While the FDA has provided exemptions for certain trading partners working toward DSCSA compliance, state Boards are ramping up their oversight. Louisiana’s request for Kowa Pharmaceuticals America, Inc.’s documentation—particularly regarding trading partners with Waivers, Exceptions, and Exemptions (WEEs)—underscores the importance of robust verification and tracking systems.
Tish Pahl, Partner at OFW Law, noted the significance of proactive engagement with state Boards:
“I am generally advising clients [in Louisiana] to reach out to George Lovecchio, Executive Director, Louisiana Board of Drug and Device Distributors, to establish communication. Should there be an issue, it’s in everyone’s interest to resolve it swiftly.” The guidance applies wherever in the United States you are operating.
Importance of Trading Partner Verification
Kowa Pharmaceuticals America, Inc.’s case emphasizes the need for companies to validate that their trading partners are fully authorized and compliant, even under exemptions. Louisiana’s Board required proof that exempt partners were genuinely exempt, signaling the increasing demand for clear, documented trading partner relationships.
Stay Ahead with LSPedia’s Solutions
For companies navigating the complexities of DSCSA compliance, LSPedia’s solutions are essential. The Authorized Trading Partner (ATP) Module provides real-time license validation, communication features, and OCI integration to ensure trading partners are fully authorized. The WEE Management Module offers a comprehensive system to manage waivers and exemptions, giving companies complete visibility over their compliance status.
These tools enable businesses to meet state and federal requirements efficiently, equipping them with the documentation necessary to satisfy regulatory inquiries. Kowa Pharmaceuticals America, Inc.’s experience is a reminder that, despite FDA exemptions, companies need to act now to establish secure, compliant systems.
Preparing for Future Regulatory Scrutiny
As more state Boards of Pharmacy mirror Louisiana’s actions, pharmaceutical companies should anticipate further inquiries. Leveraging LSPedia’s ATP and WEE Management Modules ensures you’re prepared to meet regulatory demands with transparency and security across your trading partner relationships.
For more information on how LSPedia’s solutions can help you keep pace with evolving FDA guidelines, contact us at trace@lspedia.com.
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