LSPedia is committed to keeping its partners and customers informed about the latest developments in the Drug Supply Chain Security Act (DSCSA) and related regulatory updates. Following attendance at the recent HDA Traceability Seminar, LSPedia is sharing several critical updates that may impact operations across the industry.
The FDA has received nearly 400 Waiver, Exemption, and Exception (WEE) requests from companies working to align with DSCSA requirements. These requests are currently under review, with responses expected soon. In the coming weeks, approximately 150 WEERs are anticipated to receive feedback, marking significant progress toward compliance.
Ilisa Bernstein, founder of Bernstein Rx Solutions LLC and a former FDA lead on DSCSA, led the Legal Perspectives Panel at the seminar. Bernstein emphasized the importance of proactively filing WEE requests if there are concerns about DSCSA compliance. These requests can address both product-related and transaction-related non-compliance issues, making them a critical tool for companies navigating the complexities of the DSCSA.
The FDA has re-affirmed that the DSCSA compliance deadline is firm, with no additional stabilization period to be granted. This highlights the need for companies to be thoroughly prepared to meet compliance requirements by the set deadline. Immediate action is crucial, and tools like LSPedia’s OneScan Suite provide the robust support needed to ensure your operations are fully compliant and ready.
Enforcement of DSCSA provisions can occur at both the federal and local levels. While the FDA may not have immediate resources to enforce compliance, local boards of pharmacy may take independent action. Importantly, WEE approvals from the FDA preempt state-level requirements, offering protection against state non-compliance.
Managing WEE approvals presents unique challenges, particularly since these approvals are not shared publicly. To address this, LSPedia is introducing a WEE Management Module as part of the Beta launch of OneScan 7.3 on October 6, 2024. This new module is designed to help trading partners efficiently manage WEE approvals, ensuring smooth operations and compliance. LSPedia is currently accepting 10 early adopters for the Beta Program, with waived license fees for 2024. To apply, click here.
LSPedia remains dedicated to supporting the industry in navigating these regulatory challenges and ensuring compliance with DSCSA requirements. Stay informed and prepared as the compliance deadline approaches.
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