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Reporting Amount of Listed Drugs and Biologics Cares act reporting requirements FDA

Reporting the amount of listed products is a process of submitting annual drug and biological manufacturing data to the FDA.

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 comply with the Cares Act Reporting requirements.

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 the FDA annually the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

What type of product is required 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 of the listed drug.

When should you submit the report for the amount of the listed drug?

Reports must be submitted annually. These reports should include information regarding the amount of drugs released in the calendar year from 1 January to 31 December.

FDA has set deadlines for Calander years 2020 and 2021, reporting as below.

Reports for the calendar year 2020  should be submitted no later than 15 February 2022

Reports for the calendar year 2021 should be submitted no later than 16 May 2022.

The timeline for reporting the amount of listed drugs from 2022 onwards is no later than 15 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

Please contact us if you have any questions about Reporting the Amount of Listed Drugs and Biological Products. We offer services for Reporting the Amount of Listed Drugs and Biological Products for all your products at one flat fee.