FDA Drug Reporting under the CARES Act

Feb 06, 2024

Did you know that transfillers must register their drug establishments and listings every year? Additionally, the CARES Act now requires them to report drug volumes annually.

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was enacted on March 27, 2020, in response to the COVID-19 pandemic. The CARES Act mandates that all drug manufacturers report specific details about their drug volumes to the FDA.

The FDA recently issued the final guidance for industry: Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act

The recommended timeline for submitting reports for the calendar year 2023 has been updated to no later than July 31, 2024, with reports for subsequent years recommended to be submitted no later than March 31st of the following calendar year. 

Any organization that runs a facility involved in manufacturing, preparing, distributing, compounding, or processing for commercial distribution annually and not exempt from establishment registration requirements under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or 21 CFR part 207, are required to submit a report to the FDA.

This reporting requirement gives the FDA crucial insights into drug manufacturing activities. This supports the prevention of potential drug shortages and enhances the FDA's oversight of drug and medical product supply chains.

Drug manufacters, including tranfillers of medical oxygen need to follow the FDA CARES Act reporting rules to ensure they comply with regulations.

Not sure where to start? We can help you perform your Drug Reporting! Just fill out the Drug Reporting form here to get started.

Contact registration@applied-inc.com for any questions.

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