0910-AI52 202304 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Revising the National Drug Code Format and Drug Labeling Barcode Requirements

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend its regulations governing the format of the National Drug Code (NDC). This action, if finalized, will standardize the format of all NDCs. Specifically, all NDCs will be required to be 12 digits in length with three distinct segments. The first segment is the labeler code and will be 6 digits, the second segment is the product code and will be 4 digits, and the third segment is the package code and will be 2 digits. Additionally, we are proposing to revise the drug product bar code label requirements to permit the use of linear or non-linear barcodes that meet certain standards.

]]> Substantive, Nonsignificant Previously Published in The Unified Agenda Final Rule Stage Undetermined State, local, or tribal governments Private Sector 21 CFR 201.25(c) (Revision) 21 CFR 207.33(b) (Revision) 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 358 21 U.S.C. 360 21 U.S.C. 360b 21 U.S.C. 360gg to 360ss 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 379e 21 U.S.C. 381 21 U.S.C. 393 42 U.S.C. 216 42 U.S.C. 241 42 U.S.C. 262 42 U.S.C. 264 42 U.S.C. 271 No NPRM 07/25/2022 87 FR 44038 NPRM Comment Period End 11/22/2022 Final Rule 01/00/2024 No Businesses State Yes No No No Leyla Rahjou-Esfandiary 0910 Food and Drug Administration FDA 301 796-3185 leyla.rahjou-esfandiary@fda.hhs.gov 10903 New Hampshire Avenue, Building 51, Room 2262, Silver Spring MD 20993