As most drug companies are aware of at this point, the CARES Act requires drug manufacturers to report annual production amounts to the FDA. This requirement has been rolling out over the course of 2024 and, here at LexisNexis Reed Tech, we are receiving many questions from our customers have had questions about how to meet these requirements. As such, we presented a webinar CARES Act Reporting: Strategies for Efficient Submissions covering the requirements, timelines and strategies for efficient reporting.
The webinar was presented by LexisNexis Reed Tech subject-matter experts Gary Saner, Senior Regulatory Principal, Life Sciences. We suggest you watch the webinar recording for a full grasp of the CARES Act Reporting requirements for pharma companies, but would like to highlight a few key takeaways below.

Key Takeaways:
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- Reporting Requirements: Manufacturers must report the amount of each listed drug product manufactured, prepared, propagated, compounded, processed, repacked or relabeled for commercial distribution annually. This includes finished dosage forms, unfinished drugs and active pharmaceutical ingredients (APIs).
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- Reporting Timeline: Reports for 2020, 2021 and 2022 were due by February 5, 2024, with no firm deadline provided. The 2023 report was due by July 31, 2024. Going forward, reports for each preceding year are due annually by March 31st.
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- Submission Process: Reports can be submitted manually through the FDA’s NextGen portal or via a CSV file upload. Proper data validation and confirmation of successful submission are crucial.
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- Data Challenges: Potential issues include leading zero truncation in Excel, mapping business operations, identifying source NDCs for repackaging and handling non-U.S. distribution quantities.
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- LexisNexis ReedTech Solution: ReedTech offers a CARES Act reporting solution that streamlines data collection, validation and submission, leveraging our SingleSource™ for Drug Products platform to auto-populate report templates.
Summary
Overall, Efficient CARES Act reporting requires cross-functional collaboration, meticulous data collection and a robust submission process. Partnering with a solution provider like ReedTech can simplify compliance with this annual FDA requirement. To learn more about CARES Act reporting requirements or Reed Tech solutions, please contact us at [email protected] or +1 (215) 557-3010.