FDA announces plans to revamp national drug code

Regulatory NewsRegulatory News
| 26 July 2022 | By Joanne S. Eglovitch 

The US Food and Drug Administration (FDA) on Monday proposed an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years.
The rule would retain the three-segment code consisting of the labeler code, the product code and the packaging code. The NDC is used to register and track pharmaceutical products through the supply chain.
Under the proposed revision, the labeler code will consist of six digits, the product code four digits, and the packaging code two digits.
To ease the transition, FDA will not require industry to “resubmit all of their drug existing drug listing files to convert the NDCs from one of the discontinued 10-digit formats to the new, uniform, 12-digit, 6-4-2 format. Instead, FDA intends to convert existing NDCs on its own, on the effective date, by adding leading zeros to the appropriate segments.”
According to FDA, NDCs are used across the healthcare system, and these changes will “impact human and animal drug manufacturers, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the NDC, state and local governments, and other supply chain stakeholders that use FDA-assigned NDCs.”
FDA presented the pharmaceutical industry with four options in addressing the looming shortage of codes in a public hearing in November 2018.
The four options were to continue using the 5-digit label codes until the inventory is exhausted and then move to a 6-digit format; move to a 6-digit format on a designated date; convert the current 10-digit NDC to an 11-digit format, then to a 12-digit format once the 5 -digit label codes are exhausted; or to adopt the 12-digit NDC on a designated date before the 5-digit labels codes are exhausted.
Most of the comments were in favor of adopting the last option, said FDA. Also, many comments advocated for a ten-year delay in complying with the final rule.
In response, FDA proposes to grant a five-year delay to comply following the publication of a final rule to allow stakeholders time to develop and implement such systems. The agency also proposed to grant industry a three-year transition period to comply with the final rule.
FDA said during the three-year transition, firms should begin updating their labeling to replace the 10-digit NDCs with the new 12-digit NDCs by adding leading zeros to the labeler code, product code, and/or package code segments, said FDA.
FDA said the costs of converting current NDC codes to the proposed format would include one-time costs of updating software systems, providing new training for employees, coordinating labeling updates, and reading and understanding the proposed rule. These costs would be $12.4 million annually to update the NDC, ranging from $6.1 million to $19.4 million.
Proposed rule


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Tags: FDA, NDCs

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