Have you received the email from FDA with NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS ? Here is the detailed action plan for you.
FDA has started sending emails to labelers (manufacturer /brand owner of the product ) notifying about the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS” . There are many drug listings which have not been updated in calendar year, no change certification is not submitted to certify that current information is update, or drug listings include manufactured who are currently not registered with FDA. All such outdated drug listings will be inactivated by FDA.
FDA has announced its intention to begin inactivating NDC drug listing records which are improperly listed in accordance with FDA requirements. If your drug listing falls in any of the below criteria then FDA may consider as improperly listed.
As per FDA registration and listing requirements it remains registrants responsibility to keep the drug listing up-to date. If any of these drugs are currently not marketed or discontinued, registrant must notify this to FDA by submitting the drug listing with marketing end dates.
All the out dated drug listings which are not updated in the current year or without no change certification will be inactivated and removed from the database starting September 12, 2019.
We can help you to verify status of your drug listings and assist for updating to current year. Also, we offer services for drug establishment registration.
It will take less than two working days to update the drug listing to current year.
If you have any questions, please contact us.BACK