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Understanding the FDA’s Drug Amount Reporting Requirements
The U.S. FDA has released updated guidance on reporting the amount of listed drugs and biological products under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This requirement, introduced under the CARES Act, aims to enhance the FDA’s ability to assess, prevent, and mitigate potential drug shortages by improving transparency in the drug supply chain.
Who Must Report?
Any establishment that manufactures, repacks, relabels, or processes drugs for commercial distribution must report annually to the FDA. This includes:
- Manufacturers of human and animal drugs, including active pharmaceutical ingredients (APIs)
- Contract manufacturers
- Medical gas producers
- Homeopathic and over-the-counter OTC monograph drug manufacturers
- Repackers and relabelers
What Needs to Be Reported?
Establishments must provide detailed information about the amount of each listed drug manufactured, prepared, or processed for commercial distribution. The data should be organized:
- By National Drug Code (NDC)
- By Year/Month
- By type of drug (finished product, API, or drug not in finished package form)
The report must also include information on business operations related to the manufacturing process, such as repackaging or labeling activities.
When and How to Report?
- The 2023 calendar year reports must be submitted by July 31, 2024.
- Reports for subsequent years are due annually by March 31 of the following year.
- Reports for past years (2020-2022) that have not yet been submitted should be sent to the FDA as soon as possible.
- Reports should be submitted electronically through the FDA Portal.
Why Is This Important?
The FDA uses this data to monitor trends in drug production, identify potential shortages, and make informed decisions about supply chain vulnerabilities. The information also helps the agency determine the need for regulatory action and prioritize facility inspections based on risk assessment.
Key Takeaways
- Mandatory Reporting: Drug manufacturers and related entities must submit annual reports on production volumes.
- Supply Chain Monitoring: The FDA uses these reports to prevent and manage drug shortages.
- Strict Deadlines: The first major deadline is July 31, 2024, with annual reporting due by March 31 thereafter.
- Electronic Submission: Reports must be submitted through the FDA’s designated portal.
For businesses involved in drug manufacturing, staying compliant with these reporting requirements is critical to avoiding regulatory issues and ensuring supply chain stability. Please call or email us if you need assistance reporting the drug amount.
