FDA Issues Guidance on Reporting the Amount of Listed Drugs and Biological Products Under the FD&C Act
The U.S. Food and Drug Administration (FDA) has issued draft guidance to help registrants of drug establishments in submitting reports to FDA on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution.
In March 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted to aid response efforts and ease the economic impact of the Coronavirus Disease 2019 (COVID–19). One of the requirements of the CARES Act was to enhance the FDA’s ability to identify, prevent, and mitigate potential drug shortages by improving visibility into drug supply chains.
The CARES Act updated the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require persons who register with the FDA under section 510 of the FD&C Act, including repackers and relabelers, to submit annual reports to the FDA on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
“With earlier awareness of persistent or emerging supply chain challenges, FDA is better informed and able to take more targeted and timely actions to promote stronger supply chains and reduce drug shortage risks,” explained the FDA.
The guidance document – Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act – describes the process that should be used for submitting reports on listed drugs and clarifies who is required to submit reports, what the reports must include, and the timing of reports. While reports are a legal requirement under the FD&C Act, the guidance does not establish legally enforceable responsibilities, instead, it details the FDA’s current thinking and includes best practices that should be followed.
