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Industry Builds on FDA Plans for Expansion of National Drug Code

Posted 09 January 2019 | By Ana Mulero 

Industry Builds on FDA Plans for Expansion of National Drug Code

Industry expressed mixed reactions to a recent US Food and Drug Administration (FDA) notice that informed of an anticipated need to expand the National Drug Code (NDC) format within 15 years.

Hindered by efforts to meet deadlines from the Drug Supply Chain Security Act (DSCA), the link between NDC and the Globe Trade Item Number (GTIN), the amount of time and resources that would be required to make the transition and unintended supply disruptions were among some of the concerns cited in comments submitted to FDA’s August 2018 notice. Commenters also praised the agency for its efforts to engage stakeholders early as it considers various options for implementing a new NDC format. “Any changes to the NDC will require a substantial amount of time and resources to revise production and packaging systems,” PhRMA senior directors Ryan Kaat and Olivia Shopshear said, urging FDA to wait on announcing implementation of a new format until after a 27 November 2023 DSCSA deadline.

The issue with transitioning to a new NDC format while seeking to comply with DSCA requirements relates to these already being implemented using the current format, which relies on 5-digit labeler codes. With FDA’s proposal to start issuing 6-digit labeler codes as it runs out of 5-digit labeler codes sometime between the next 10 to 15 years, NDC would be expanded from the current 10 to 11 digits.

Out of the four options that FDA proposed for the transition prior to a hearing held in November 2018 for industry feedback, several commenters showed support for the fourth. This approach would allow for harmonizing a standard configuration for all NDCs and converting existing NDCs with new leading zeros. “Companies are making significant investments to implement DSCSA requirements and requiring that these systems be upgraded again to accommodate a new NDC format for all products is an unnecessary resource drain on the entire biopharmaceutical supply chain,” Kaat and Shopshear said.

Commenters also proposed recommendations for the agency to consider as it moves forward with its plans for the new NDC format. These include giving industry a minimum of five to ten years from FDA’s implementation notice to avoid adversely impacting supply to patients.

Eli Lily also encouraged FDA to engage its sister agencies “to ensure that any proposed NDC changes function in the systems, methodologies and legal guidances followed by these agencies for implementing various statutory obligations related to coverage, payment and reimbursement for prescription drugs and biologicals.”

Apotex, meanwhile, said it “proposes to increase the length of the labeler code to seven digits but remain within the GS1 system so that the current barcoding and communications systems can remain relatively unchanged.” Under this proposal, Apotex added that “the country code digits would increase the labeler code to 7 digits and in thus maintain the uniqueness of one NDC(GTIN) for each product.” The Association for Accessible Medicine backed the current “logic link” between the NDC and GTIN, as well.

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