FDA NDC Final Rule Timing

Patricia Milazzo, RPh and Dave Schuetz, RPh, Senior Consultants at PHSL, wrote an article featured in the Viewpoint column of the September/October 2022 edition of ComputerTalk for the Pharmacist.  Their article focuses on the FDA’s plans for the National Drug Code (NDC).  At the time the article was published, the authors expected the FDA would publish the Final Rule for NDC expansion by the end of 2023 or very early 2024.  However, the expected date of the Final Rule has been deferred.

According to the latest Unified Agenda of Regulatory and Deregulatory Actions posted by the OMB Office of Information and Regulatory Affairs, the Final Rule for “Revising the National Drug Code Format and Drug Labeling Barcode Requirements” is not expected to be published by HHS/FDA until August 2024.

PHSL continues to monitor for information regarding this important change to the NDC and will post more news as it becomes available.


Posted January 2024

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