Companies that Have Not Submitted Drug Amount Reports
Registrants, including repackers and relabelers, are required under federal law to report annually to the agency the amount of each listed drug that was manufactured, prepared, propagated, compounded or processed for commercial distribution.
Registrants that failed to provide annual amount reporting for calendar year 2024 are included on one of two lists below.
This list includes registrants with an active drug listing. This means the registrant has either certified that no changes need to be made to its drug listing or submitted an update to its drug listing.
This list includes registrants with inactivated drug listings. This means the registrant did not fulfill the requirement to review its drug listing data and either certify its data are current or update the drug listing.
The agency reminds registrants they are required to review and ensure their drug listings are accurate twice each year (June and December) and either update their listings at those times or certify annually that no changes have occurred. Visit electronic drug registration and listing instructions for information on how to delist drugs.
Contact DrugAmountReporting@fda.hhs.gov with the subject “Amount Reporting List” with any questions or if you believe your company is not subject to amount reporting.