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 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

Drug amount reports for the calendar year 2024 should be submitted starting January 1, 2025, but no later than March 31, 2025.

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 annually.

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.