FDA Drug Reporting - Amount of Listed Drugs

FDA had announced a new requirement of reporting the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed for commercial distribution, in order to identify, prevent, and mitigate possible drug shortages, and improves FDA’s visibility into drug supply chains.

Who is Required to Report:

Each person who registers with the FDA (including repackers and relabelers) with regard to a listed drug is required to report. This includes:

  • Finished dosage form products
  • Active pharmaceutical ingredients (APIs)
  • Other listed drugs, such as medical gases, homeopathic products, OTC monograph drugs, and animal drug products.

**Exemption:** Biological products or categories thereof exempted by an FDA order under section 510(j)(3)(B) are not required to report.

Reporting for Private Label Distributors (PLD):

In the case of products manufactured under the trade name or label of a private label distributor, the data must be submitted separately by the NDC associated with the registrant's labeler code and the NDC associated with the private label distributor's labeler code.

Submission Details and Deadline:

These reports can be submitted by the registrant or by an authorized agent that has knowledge regarding the amount of drug released.

Reports on the amount of each registrant’s listed drugs must be submitted annually. Such reports should include information regarding the amount of drugs released for the respective calendar year (January 1 – December 31). Reports for each calendar year must be submitted before March 31st of the following calendar year. The drug reporting for calendar year 2024 must be submitted before March 31, 2025.

Need Assistance?

Navigating the complexities of the FDA's annual drug amount reporting (CARES Act Section 510(j)(3)) can be challenging. LMG is here to help! We offer expert services to assist your firm in compiling, preparing, and submitting all required drug amount reports accurately and on time to ensure full regulatory compliance. Contact us today to learn how LMG can streamline your FDA drug reporting process.

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