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FDA Anticipates Need for Expanding National Drug Code, Calls for Industry Input

Posted 06 August 2018 | By Ana Mulero 

FDA Anticipates Need for Expanding National Drug Code, Calls for Industry Input

The US Food and Drug Administration (FDA) announced Monday it plans to hold a public discussion on expanding the National Drug Code (NDC) format and the impact on industry.
 
FDA currently assigns 10-digit NDCs for the purposes of identifying drugs in the country and the format is comprised of three codes regarding the labeler, the product and the package.
 
“FDA anticipates that it will run out of 5-digit labeler codes in approximately 15 years,” the agency wrote in the notice on the 5 November public hearing. “FDA will begin assigning 6-digit labeler codes at some point in the future due to exhaustion of 5-digit labeler codes.”
 
Prior to implementing the new formats for longer configurations, FDA officials will seek feedback from meeting participants on the potential impact on companies’ bottom line and drug safety, as well as “issues associated with the current lack of NDC uniformity in the marketplace.”
 
The agency said the purpose of the hearing is also centered on discussing requests it has previously received from stakeholders to adopt a standardized NDC format.
 
In 2013, FDA rejected a petition to “stop using NDCs for unapproved drug products,” thwarting the concerns by arguing the codes make it easier to identify drugs regardless of their approval status.
 
FDA

Categories: Regulatory News

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