We want to update you on the latest FDA guidance regarding waivers and exemptions under the Drug Supply Chain Security Act (DSCSA), and how it may impact your operations as manufacturers, wholesalers, or dispensers.
In addition, with changing regulatory requirements, LSPedia be maintaining an FAQ page to provide answers to common questions on the topic as well as hosting a Customer Advisory webinar on June 25, 2024 at 2:00 EDT.
Maintaining compliance with DSCSA regulations remains crucial for the integrity and safety of the pharmaceutical supply chain. As such, LSPedia advises all customers to stay the course and continue efforts towards full compliance.
The FDA has granted waivers to small dispensers, exempting them from Enhanced DSCSA requirements until November 27, 2026. In addition, any other trading partners receiving the FDA approval will introduce complexity, particularly in managing dual processes for ASN (Advanced Shipping Notices) and EPCIS (Electronic Product Code Information Services) to accommodate both lot-level and serial-level product tracing. For customers who don't have ASN capability, please reach out to AM@lspedia.com for an quote. Once you approve the quote, you will be added to the implementation waitlist.
It is important to note that FDA approval of waivers relies heavily on the self-evidence provided in waiver applications. This self-evidence may be utilized in future compliance audits post-waiver period, especially after November 2026. Therefore, meticulous preparation and documentation in waiver applications is essential to mitigate compliance risks.
LSPedia recommends that our customers stay the course. For customers that are applying for the waiver, please reach out to AM@lsepdia.com to plan and navigate this regulatory change carefully:
• Compliance Roadmap: Work closely with LSPedia to design a comprehensive compliance roadmap tailored to your organization’s needs.
• Execution Timeline: Aim to achieve full compliance by 2025 to allow for stabilization and readiness by the end of the waiver period in 2026.
• Collaborative Approach: Our team is here to support you in implementing robust compliance strategies and adapting to evolving FDA requirements.
• Evaluate Eligibility: Assess whether your organization qualifies for small dispenser exemptions or needs to consider submitting a waiver request.
• Engage Early: Begin discussions with LSPedia to initiate your compliance roadmap and ensure timely execution. Waiver applications are accessible on the FDA website.
• Documentation: Prepare thorough documentation to support waiver applications, anticipating future compliance audits.
We are committed to providing expert guidance and support throughout your compliance journey. Our team is ready to assist you in navigating regulatory complexities, optimizing operational efficiency, and safeguarding your business continuity.
Staying ahead of regulatory changes is key to maintaining your competitive edge and ensuring patient safety. Should you have any questions or require further clarification, please contact our customer support team.
Thank you for your continued trust in LSPedia as your partner in compliance excellence.
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