The U.S. Food and Drug Administration (FDA) requires all drug manufacturers marketing drug products in the United States to both register their establishments and list the individual drug products made at those establishments. On September 12, 2019, FDA will remove any drug listing that contains outdated or incomplete information from this database, effectively prohibiting the sale and distribution of that drug product in the United States.
Registration and Listing Renewal
FDA requires the reporting of any updates made to listed drug products twice annually, in June and December. As of 2017, if no changes or updates are required, drug manufacturers must submit a ‘blanket no change certification’ for these listings. Failure to update or certify a drug listing during the renewal period may cause FDA to consider the listing outdated or incomplete, thus resulting in the inactivation of that listing. Marketing or importing drugs with inactivate listings in the U.S. is a prohibited act.
According to FDA, there are tens of thousands of drug listings in their database that are outdated or incomplete. FDA considers the drug listing inactivated until either the listings have been updated or certification is properly submitted.
Additionally, FDA requires the renewal of drug establishment registrations annually between October 1 and December 31. Failure to renew an establishment registration during this renewal period can result in FDA considering the registration expired, preventing that establishment from marketing in the United States. Drug listings that are associated with establishments that failed to renew their registrations will also be removed from FDA’s database.
Registrar Corp assists businesses with compliance of FDA regulations. Registrar Corp can properly update your listing submission so it will not be removed from FDA’s database. We can also verify your establishment’s registration and listings are properly filed by FDA. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.