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FDA’s Drug Amount Reporting: Step-by-Step Guide
The U.S. Food and Drug Administration (FDA) has released updated guidance on reporting the amount of listed drugs, whether OTC, generic, prescription, or biological products under the Federal Food, Drug, and Cosmetic Act (section 510(j)(3)FD&C Act). To comply with the FDA’s framework, drug manufacturers, repackers, and relabelers must report the quantity of each listed drug product they manufacture or process on an annual basis.
Important: This process enables the FDA to monitor the U.S. drug supply and ensure transparency throughout the pharmaceutical industry. Registrants that fail to meet the annual reporting requirement will be added to a publicly available list of noncompliant entities at the beginning of the following year (next publication round will be early 2026).
Who Must Report?
Any entity engaged in the manufacture, repackaging, or relabeling of drugs listed with the FDA is required to report its annual production amounts. This includes domestic and foreign firms whose products are marketed in the United States. 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?
Firms must report the amount of each National Drug Code (NDC) that was manufactured, repackaged, or relabeled in the previous calendar year. Additionally, if a product was not manufactured in the reporting year, a zero quantity must still be reported to maintain compliance. 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)
When and How to Report?
Reports are due between January 1 and March 31 of each year, covering the data from the previous calendar year. For example, quantities manufactured in 2024 must be reported by March 31, 2025.
Companies must submit reports electronically through the FDA’s Electronic Drug Registration and Listing System (eDRLS). Before reporting, ensure your SPL (Structured Product Labeling) files are correctly formatted. Furthermore, it’s crucial to verify that your NDCs are actively listed before submitting quantity information.
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 are required to submit annual reports on their 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.
- Non-Compliance: Registrants that do not meet this annual reporting requirement and fail to submit their calendar year 2024 reports by December 31, 2025, will be listed as noncompliant in a public notice released in early 2026.
For businesses involved in drug manufacturing, staying compliant with these reporting requirements is critical to avoiding regulatory issues and ensuring supply chain stability.
Need Help?
FDA Listing Inc. can help you stay compliant with all FDA reporting requirements. Our team provides comprehensive support, from SPL creation to electronic submission, ensuring your reporting is both timely and accurate. Please contact us by phone or email for assistance.
