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FDA reminds pharmaceutical industry of annual drug listing certification requirement

Update [11/5/2018] FDA is reminding the pharmaceutical industry of the annual certification requirement deadline. By December 31, 2018, companies are required to update or certify their drug listings with the agency. This includes drug listings that were not initially listed or updated during the current calendar year.

See also FDA’s reminder for manufacturers and repackagers to update their drug listings with product identifiers.

[12/14/2017] The U.S. Food and Drug Administration is reminding the pharmaceutical industry of the December 31, 2017, deadline to update or certify their drug listings with FDA. This applies to drug listings that were not initially listed or updated during the current calendar year. This is the first deadline of the annual certification requirement under Part 207 of Title 21 of the Code of Federal Regulations.

Companies must submit this information to FDA in electronic format. They may make a blanket “no changes” certification to indicate that their listing information is up to date in FDA’s database. Information about how to certify or submit updates is available at Electronic Drug Registration and Listing System.

It is important for companies to update or certify their listings to ensure that FDA has an accurate list of marketed drugs in the National Drug Code directory.

Failure to submit an update or certification by the December 31, 2017, deadline may result in FDA action, including removing the product from the NDC directory. Companies that need further assistance to submit the required information by the December 31, 2017, deadline should contact edrls@fda.hhs.gov.