FDA Implementation of Manufacturing Volume Data Reporting Requirements under CARES Act Section 3112(e)

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FDA Implementation of Manufacturing Volume Data Reporting Requirements under CARES Act Section 3112(e) 

This communication is to clarify the timing of FDA's implementation of new reporting requirements for manufacturing volume data under section 3112(e) of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The effective date of these requirements - September 23, 2020, which is 180 days after the CARES Act was enacted - is the earliest the FDA is authorized to begin collecting these data. The FDA does not intend to begin this collection until it is able to do so through an electronic data submission portal, which will not be ready by September 23.

The CARES Act includes authorities that enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supply chains. Specifically, section 3112(e) amends the Federal Food, Drug, and Cosmetic Act to require that each registered drug establishment annually report the “amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed” by the registrant for commercial distribution. This CARES Act amendment also provides that such “information may be required to be submitted in an electronic format."

FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues.