Virtual | Virtual
Event Title
Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
November 17, 2022
- Date:
- November 17, 2022
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ABOUT THIS WEBINAR
FDA will discuss a proposed rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, 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.
TOPICS COVERED
- Overview of National Drug code (NDC) and its current status
- Discussion of key provisions of the proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
- Discussion of timeline as noted in the proposed rule
INTENDED AUDIENCE
- Regulatory science and regulatory affairs professionals working on drug listing submissions to FDA, NDC assignment, labeling
- Registration and listing submission vendors
- Consultants
- Drug data banks and IT professionals
- Healthcare professionals working with electronic health records, e-prescribing, dispensing
- Foreign manufacturers, importers, regulators
FDA SPEAKERS
Leyla Rahjou-Esfandiary, Pharm. D.
Lead Consumer Safety Officer
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration and Unapproved Drugs (DLRUD) Office of Unapproved Drugs and Labeling Compliance (OUDLC) | Office of Compliance (OC) | CDER
FDA RESOURCES
- Federal Register Notice Revising the National Drug Code Format and Drug Label Barcode Requirements (Docket No. FDA-2021-N-1351)
- Revising the National Drug Code Format and Drug Label Barcode Requirements (Proposed Rule) Regulatory Impact Analysis, Federal Register 87 FR 44038, Docket FDA-2021-N-1351
- National Drug Code Directory
- National Drug Code Directory Searchable Database
- Electronic Animal Drug Product Listing Directory