The Food and Drug Administration (FDA) requires reports on the amount of each listed drug annually manufactured, prepared, propagated, compounded, or processed for commercial distribution. FDAbasics can help you with comply with Cares Act Reporting requirements FDA
Who is required to comply with “Reporting Amount of Listed Drugs and Biological Products” requirements (Drug Volume Reporting)?
Domestic and foreign facilities engaged in the manufacturing, preparation, propagation, compounding, or processing of a drug for commercial distribution in the United States drug must report to FDA annually on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
What type of product requires to comply with Cares Act Reporting requirements FDA?
All finished dosage form products, including active pharmaceutical ingredients (API) and other types of listed drugs, except for biological products, must submit reports on amounts on the listed drug.
When to submit the report for the amount of the listed drug?
Reports must be submitted annually. These reports should include information regarding the amount of drug released in the calendar year from 1st January to 31st December.
FDA has set deadlines for Calander year 2020 and 2021 reporting as below.
Reports for the calendar year 2020 should be submitted no later than 15th February 2022
Reports for the calendar year 2021 should be submitted no later than 16th May 2022.
The timeline for reporting the amount of listed drugs for the calendar year 2022 onwards is no later than 15th February of the following year.
What information is required for Reporting?
- NDC number
- Name of the manufacturer
- Information about the primary and secondary package
- Sale volume per month
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