Drug Reporting Requirements Final Guidance to Take Effect Feb. 26

The FDA has finalized its 2021 draft version of a guidance that describes the timing and process of annual reporting of manufactured drugs, an effort intended to enhance the FDA’s visibility into drug supply chains.

The 23-page guidance, “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act,” clarifies section 510(j)(3) of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). This section requires each registrant, including repackers and relabelers, to report the amount of each finished or unfinished drug or active pharmaceutical ingredient — except for certain biologics or other exempted categories.

The guidance advises registrants that reports for calendar years 2020, 2021 and 2022 “are still required under the statute and should be submitted to the Agency as soon as possible.”

However, reports must be submitted using the FDA’s NextGen Portal, which a notice in the Federal Register explains is undergoing an update, delaying the implementation date. “To allow for the transition of technical updates to the NextGen Portal, FDA will delay implementation of the final guidance until Feb. 26, 2024,” the notice states.

Read the final guidance here.

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