Are you prepared for the upcoming FDA deadline for the Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act?
What You Need to Know
The FDA CARES Act requires drug manufacturers, re-packers and re-labelers to submit annual reports on drug production volumes. Here are the key points:
- Deadline: July 31, 2024, for the 2023 calendar year
- Who Must Report: All FDA-registered facilities under section 510(j)(3) of the Federal Food, Drug & Cosmetic Act
- What to Report: Annual production volumes for each listed drug
Why It Matters
Failure to comply with these requirements can lead to:
- Regulatory actions from the FDA
- Potential fines and penalties
- Disruptions to your business operations
- Damage to company reputation
How Reed Tech Can Help
Our experienced consulting team is ready to assist you with:
- Navigating the complexities of the CARES Act Report
- Preparing and submitting your drug accounting reports
- Developing risk management plans to ensure ongoing compliance
- Training your team on FDA reporting procedures
Act Now!
With the deadline fast approaching, it’s crucial to start preparing your submission immediately. Our team can help you streamline the process and ensure you meet all regulatory requirements. Don’t risk non-compliance. Contact us today for a free consultation on how we can support your FDA CARES Act compliance efforts.
For more information about this new annual requirement or how Reed Tech can help with your data management and submission, contact us at [email protected] or +1 (215) 557-3010.