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Regulatory Focus™ > News Articles > FDA to Pharma Firms: Update or Certify Drug Listings by End of Month

FDA to Pharma Firms: Update or Certify Drug Listings by End of Month

Posted 14 December 2017 | By

FDA to Pharma Firms: Update or Certify Drug Listings by End of Month

To ensure the National Drug Code directory is accurate, the US Food and Drug Administration (FDA) on Thursday sent a reminder to pharmaceutical companies that 31 December 2017 is the deadline by which the firms must update or certify their drug listings with FDA via electronic format.

This applies to drug listings that were not initially listed or updated during the current calendar year and is the first deadline of the annual certification requirement under Part 207 of Title 21 of the Code of Federal Regulations.

"They may make a blanket ‘no changes’ certification to indicate that their listing information is up to date in FDA’s database," FDA said. "Information about how to certify or submit updates is available at Electronic Drug Registration and Listing System."

Failure to submit an update or certification by the deadline may result in FDA action, including removing the product from the NDC directory, FDA added. Companies that need further assistance to submit the required information should contact edrls@fda.hhs.gov.


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