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Posted: December 19, 2017

Drug Listing Certification

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.

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About DailyMed

DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements. The drug labeling information on this Web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. These labels have been reformatted to make them easier to read.