CDER Now Requiring Confirmation of U.S Agency for NDC Labeler Code Requests

Sep 22, 2021 | Drugs, FDA, Imports, Law & Regulatory

Effective summer 2021, the Center for Drug Evaluation and Research (CDER) requires confirmation of U.S. Agency assignments for National Drug Code (NDC) drug labeler code requests submitted to the Food and Drug Administration (FDA). If the U.S. Agent has not been confirmed, the NDC labeler code request will not be fulfilled. There have been instances when CDER may deactivate existing labeler codes if they contain unconfirmed U.S. agency appointments.

Previously, CDER did not require a confirmation from a U.S. Agent to proceed with either labeler code requests or facility registrations; however, designated U.S. Agents are now required for both. This new verification system is currently only applicable to NDC labeler code requests; however, CDER’s actions indicate their intention to increase visibility for U.S. Agent assignments. U.S. agents in the food and medical device space are already required to confirm their appointments. 

An NDC labeler code request includes a field for the U.S. Agent to be listed; since this is not a listing that must be renewed, those records are often not updated when a company’s U.S. Agent is changed. We recommend companies with NDC labeler codes review their records and verify the U.S. Agent listed. If the listed agent is incorrect, contact CDER to update those records.  

For companies requiring a U.S. Agent, it is always important to ensure the person or entity appointed is valid, consenting and trusted to be responsive when communicating with FDA on your behalf. Please contact us today to find out about our U.S Agency services.  

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