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  4. Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act - 09/08/2022
  1. News & Events for Human Drugs


Event Title
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
September 8, 2022

September 8, 2022
9:30 AM - 3:30 PM ET

Agenda Coming Soon

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In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.

In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations). FDA will also provide a discussion of registration and listing requirements, and how they pertain to the drug amount reporting program. The event will also include industry presenters, who will provide feedback regarding the drug amount reporting program. Conference participants will also have an opportunity to ask questions during question-and-answer sessions.


  • Scope and purpose of drug amount reporting
  • Connection between drug registration and listing requirements and section 510(j)(3) reports (including with respect to contract manufacturer reporting)
  • Who in the supply chain is required to submit section 510(j)(3) reports
  • Recommendations for how to report drug amount data, including for:
    • non-US manufactured drugs
    • private label distributed drugs
    • multi-level packaged drugs
    • applicant submitting report on behalf of a registrant
  • Scenarios presented by industry regarding the drug amount reporting program



Registrants (including contract manufacturer registrants) of listed drugs, including a finished dosage form product, an active pharmaceutical ingredient (API), and other types of listed drugs. The types of listed drugs also include medical gases, homeopathic products, over-the-counter drugs, and animal drugs.



Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been:

  • pre-approved by RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • pre-approved by SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • pre-approved by SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • approved by ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


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