SUMMARY

The U.S. FDA CDER NextGen Portal Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Reporting initiative streamlines and enhances the reporting process, allowing for efficient and transparent communication between stakeholders and the FDA in compliance with the CARES Act requirements.
The CARES Act amended the FD&C Act to require that each establishment (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such establishment for commercial distribution, including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs, except for biological products or categories of biological products exempted by an order under section 510(j)(3)(B)), also medical gases, drugs labeled as homeopathic, OTC drugs, followed by an animal drugs, and even animal drugs that are not approved, conditionally approved, or indexed under sections 512, 571, and 572 of the FD&C Act.