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NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS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Have you received the email from FDA with  NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS?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

NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS

FDA has started sending emails to labelers (manufacturer /brand owner of the product ), notifying the “NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS.”  There are many drug listings that have not been updated in the calendar year, or no change certification is not submitted to certify that current information is updated or drug listings include manufactured who are currently not registered with FDA. The FDA will inactivate all such outdated drug listings.

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.

 

ndc renewal

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

As per FDA registration and listing requirements, it remains the registrant’s responsibility to keep the drug listing up-to-date. If any of these drugs are currently not marketed or discontinued, the registrant must notify the  FDA by submitting the drug listing with marketing end dates.

All the outdated drug listings which are not updated in the current year or without no change certification will be inactivated and removed from the database starting September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 the status of your drug listings and assist in updating to the current year.  Also, we offer services for drug establishment registration.

It will take less than two working days to update the drug listing to the current year.

If you have any questions, please contact us. 

 

 

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