The national drug code (NDC) is a unique number used by the US Food and Drug Administration (FDA) to identify and report drugs.

The FDA is mandating new standardised NDC regulations for drugs sold in the US. Traditionally, a 10-digit code — with a varying (4-5)-(3-4)-(1-2) format, with each part representing the labeller, product and package, respectively — was adopted; however, maintaining the current system is no longer an option.

Announced in July 2022, the proposed rule, “Revising the National Drug Code Format and Drug Label Barcode Requirements,” will require NDC to codes follow a strict 12-digit 6-4-2 format.

Joe Compton, Senior Director Business Development and Alliance Management, believes that one of the biggest impacts for pharma companies and their packaging partners is the change in the required number of global trade item numbers (GTINs), which means updating current practices to cater to the new FDA compliance, including updating:

• hardware to ensure the correct equipment with the ability to print valid serialisation codes is on-hand;
• software suites to become equipped with the latest tools (with the technical capability to compose and implement the unique NDC identifier);
• stock keeping units (SKUs) to efficiently track product inventory.

Read the full article to find out more information: https://www.manufacturingchemist.com/news/article_page/Changes_ahead_as_the_US_FDA_proposes_longer_national_drug_codes/207839