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# Guidance on Reporting Listed Drug Amounts
- URL: https://www.fdaweb.com/guidance-on-reporting-listed-drug-amounts/
- Published: 2024-02-05T12:00:00.000Z
- Updated: 2026-09-14T14:22:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156289

FDA has released a [final guidance](https://www.fda.gov/media/175933/download?ref=fdaweb.com) entitled “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act.” The document is intended to assist registrants of drug establishments in submitting reports to the agency on the amount of each listed drug manufactured, prepared, propagated, compounded, or processed for commercial distribution, as required by section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act.

FDA says such data provides it with a more comprehensive picture of the drug supply chain, which can inform operational decisions to reduce drug shortage risks. “When FDA is notified of an impending interruption in manufacturing that is likely to lead to a supply disruption, these data can provide insight into how much manufacturing typically occurs at the affected establishment and whether the interruption may lead to a drug shortage,” it says. “Furthermore, these data can help the agency identify and assess supply chain vulnerabilities that could be long-term risk factors for drug shortages.”