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FDA to Drug Manufacturers: Outdated Listings Will be Inactivated

Posted 13 August 2019 | By Zachary Brennan 

FDA to Drug Manufacturers: Outdated Listings Will be Inactivated

While noting that tens of thousands of drug listing records have not been updated in the past year, the US Food and Drug Administration (FDA) on Tuesday announced that it will begin inactivating drug and manufacturing establishment listings that are not current in one month.

The announcement is part of FDA’s push to encourage drugmakers to ensure that their listed human drugs and any information in their drug listings, including drug establishments, are accurate.

“If drug listings are not appropriately updated, certified, or associated with a registered establishment, they will be marked by FDA as ‘inactive,’ and the date of inactivation will be added to the listing record,” the agency said. “This process will result in the closure of drug records in all public drug listing databases maintained by FDA, including the National Drug Code (NDC) Directory and the NDC SPL Data Elements (NSDE) file, until corrections to the relevant listings are made.”

Acting FDA Commissioner Ned Sharpless noted in a statement that although there have not been any public health consequences as a result of the outdated listings, “inaccurate information has the potential to compromise the integrity of the FDA’s database and the FDA’s ability to make accurate and timely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.”

Drug manufacturers are required to provide registration and listing information or updates regarding any drug listing data changes twice each year, in June and December, or they must certify that there have been no changes to previously submitted listing data by 31 December annually.

Moving forward, FDA says that 30 days after publication of Tuesday’s Federal Register notice, and every January thereafter, FDA “will begin to inactivate human drug listings that remain uncertified from the previous renewal period of October 1 to December 31. In addition, every July thereafter, FDA will begin to inactivate human drug listings that remain active and certified after the June listing update, but still contain at least one establishment that is not currently registered in accordance with FDA’s requirements.”

But NDCs that are inactivated by FDA may be reactivated with an updated and compliant drug listing submission as soon as the next business day, the notice adds.


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