FDA Wants Companies to Update Drug Listing Information

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The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

FDA announced on Aug. 13, 2019 that it will be inactivating listing records in its database that have not been updated or certified. This action is being done to ensure the agency is quickly assessing quality issues. Domestic and foreign drug manufacturing companies are required to register with FDA, and federal regulations require that these drug listing records be kept accurate. The agency has found that there are thousands of drug listing records that have not been updated or certified in a year and is therefore taking steps to clean up the database. Inactive listings will be removed from the database as of Sept. 12, 2019. FDA is advising manufacturers to update their drug listing information as soon as possible.

“While most companies are compliant, we have observed that some drug listings contain obsolete or inaccurate information. While there hasn’t been any public health consequence yet of these outdated listings, inaccurate information has the potential to compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely decisions to protect public health. To ensure we’re working with the most updated and complete information, the agency is putting companies on notice that these outdated records will be inactivated. Products with inactivated listings may not be legally marketed in the [United States] until the company brings their records up to date. We’ll continue to enforce drug establishment registration and listing requirements, and we’ll work closely with manufacturers to ensure that registration or listing deficiencies do not affect the availability and quality of medicines for patients or result in drug shortages,” said FDA Acting Commissioner Ned Sharpless, MD, in a statement.

The database helps FDA catalog drugs that are commercially distributed in the US. Manufacturers are required to register and list information, or updates to this information, twice each year. Up-to-date listing records can be found on FDA’s National Drug Code Directory. More information on updating requirements can be found on the Federal Register.


Source: FDA