After an 829 day wait from the initial draft guidance, the FDA has issued the long-awaited Final Guidance on Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act – or as Reed Tech has taken to referring to it – Drug Amount Reporting (DAR). This final guidance contains a multitude of changes from the draft guidance that industry reviewed.
Key Changes
Who Must Report section added
- “Drug product that is in finished package form, a drug product that is not in finished package form, an active pharmaceutical ingredient (API) and other.”
- For Human Drugs, Contract Manufacturing Organizations (CMO) registrant reports CMO NDC amounts and Private Label Distributors (PLD) NDC amounts separately
- For Animal Drugs, CMO registrant reports PLD NDC amounts only
What To Report section added
- Added detailed reporting discussion and decision tree in Content of Report Based on Type of Drug and its Packaging section
Compliance dates updated in Timing of Reports section
- DAR must be submitted annually
- DAR to include manufactured amounts for the previous calendar year
- Drug manufacturers that did not follow the FDA recommendation to submit DARs for calendar years 2020, 2021 and 2022 are still required to report those years by law under the CARES Act and now based on the issued Final Guidance should submit those reports to the FDA “as soon as possible.”
- Compliance due dates:
| Calendar Year | Report Due Date |
| 2020, 2021, 2022 | If report is not submitted as of 2024-Feb-05, it is still required and should be submitted to the Agency ASAP |
| 2023 | 2024-Jul-31 |
| 2024 and later | March 31 of the following calendar year |
Background
This new reporting requirement was brought about by the enactment of the CARES act in March 2020. The CARES act provided authority to have more visibility into drug company supply chains to identify and mitigate potential drug shortages. According to FDA, “section 3112(e) of the CARES Act added new section 510(j)(3) of the FD&C Act, which requires that each person (including repackers and relabelers) who registers with FDA under section 510 of the FD&C Act with regard to a drug must report to FDA annually on the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.”
For more information about this new annual requirement or how Reed Tech can help with your data management and submission, contact us at [email protected] or +1 (215) 557-3010.