On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must be reported to FDA on an annual basis.
FDA is beginning to enforce this drug reporting requirement on July 31, 2024.
Our team at FDAImports is experienced with FDA’s drug registration, listing, and reporting requirements and assists clients with filing FDA reports, as well as with troubleshooting problems that may arise in the process. Contact our team today if you have questions about this new reporting requirement or want filing assistance.
The Details of the FDA Action
As part of the CARES Act, FDA was given enhanced authority to assess, prevent, and mitigate possible drug shortages, including improving FDA’s visibility into drug supply chains. Section 3112(e) of the CARES Act added section 510(j)(3) of the FD&C Act, which requires that each person (including repackers and relabelers) who registers with FDA must report to FDA annually on the amount of each listed drug that was manufactured by such person for commercial distribution.
The listed drugs that must be reported “include human drug products (including non-exempt biological products) marketed under an approved application, animal drug products marketed under an approved application, medical gases, homeopathic products, products marketed in accordance with requirements under section 505G of the FD&C Act (21 U.S.C. 355h),” which are also known as “over-the-counter monograph drugs, and animal drug products that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.”
FDA requires annual reporting for listed drugs. For the 2023 calendar year, reports are due no later than July 31, 2024. Subsequent calendar years have a report deadline of March 31.
Note that if you have not submitted a report for calendar years 2020, 2021, or 2022, they are also required as soon as possible.
FDA has Begun to Send Notices to Drug Companies
Drug establishments registered with FDA have started to receive notices about this new reporting requirement.
“Registrants of drug establishments (or their authorized agents) submitting annual reports of the amount of listed drugs and biological products can now report through the updated CARES Act Amount Information Reporting application. If you have already submitted your report for calendar year 2023 using the previous version of the application, you do not need to resubmit your calendar year 2023 report using the updated application.”
Contact our team today if you have questions about this new reporting requirement or have other questions about FDA’s regulatory requirements for drugs.
This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.
