FDA announces the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements

Intended to minimize the impact of FDA running out of ten-digit national drug codes (NDCs)

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA announces the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements   FDA is announcing the availability of a proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351), that is intended to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs. The NDC is the FDA standard for uniquely identifying drugs marketed in the United States. FDA is proposing to change the NDC to 12 digits in length with three distinct and consistent segments and one uniform format. Additionally, FDA is proposing to revise the drug product barcode label requirements. NDCs are currently used across the healthcare system. Changes to the NDC would impact human and animal drug manufacturers, insurers/payors, wholesale distributors, drug databanks, pharmacies, hospitals, small clinics and healthcare practitioners, dentist offices, prisons, nursing care facilities, importers, federal agencies using the NDC, state and local governments, and other supply chain stakeholders that use FDA-assigned NDCs. More information: Revising the National Drug Code Format and Drug Label Barcode Requirements National Drug Code Directory The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2022 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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