Final reminder that CARES volume reports for 2024 are due no later than 31 March 2025 for all registered drug establishments. Do remember how vital it is to ensure all NDC listings reflect their correct status. The FDA will expect volume information for an NDC no longer manufactured that has not entered a marketing end date. If you have stopped marketing a specific product, the marketing end date should be entered into the NDC SPL file which will give the FDA accurate information on when the drug product ceased manufacture. Your NDC listing will continue to display on the public database until the marketing end date is reached.
If you have already submitted your report for calendar year 2024, no further action is required.
If you are still struggling with your 2023 report, EAS can assist in resolving outstanding issues. Please reach out to Victoria Pankovich for support with CARES volume reporting.
Posted in Drugs, FDA and USDA Regulatory Update.