Pharmaceutical Groups Urge FDA To Upgrade From NDC To GTIN To Avoid Conflicts With DSCSA

17 Jan 2019

• By Joanne S. Eglovitch

Pharmaceutical manufacturers and distributors complain that FDA’s plan to add digits to the NDC would be a mistake and could potentially conflict with global standards as well as the bar code technology systems put into place under the Drug Supply Chain Security Act. They suggest embedding the NDC into the GS1 Global Trade Identification number (GTIN) to avoid these conflicts.

US FDA’s plans to add digits to the National Drug Code (NDC) would conflict with the global standards and track-and-trace requirements under the Drug Supply Chain Security Act, warn pharmaceutical manufacturers and distributors. They say that FDA needs to “think outside the box” in devising a solution to the problem.

Some suggested embedding the NDC into the GS1 Global Trade Identification Number (GTIN) to avoid coding conflicts with the systems...