Changes ahead as the US FDA proposes longer national drug codes

Published: 28-Mar-2023
Packaging Regulatory

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

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Section 510 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §360, requires all registered pharmaceutical manufacturers to provide the FDA with a current list of all drugs that it produces, prepares, propagates, compounds or processes for commercial distribution. 

Changes in the act, resulting from the Food and Drug Administration Amendments Act (FDAAA) of 2007 (Public Law 110-85) require that drug establishment registration and drug listing information be submitted electronically unless a waiver is granted. Joe Compton, Senior Director of Business Development and Alliance Management at Tjoapack, reports.

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