Services to Ease FDA Regulatory Compliance

NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS

6

Sep

2019

Have you received the email from FDA with  NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS  ?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.  

NDC number
Inactive NDC

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emails  to labelers (manufacturer /brand owner of the product )   notifying  about the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS” .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 All such outdated drug listings will be  inactivated by FDA.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.

  1. Drug listings are not certified as being active and up to date
  2. Drug listings those are associated with the manufacturing which are not registered with FDA (Drug Firm Establishment Registration)
  3. Drug listing are not updated or  no change certification is no submitted in the calendar year

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. 

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