0910-AF08 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls The final rule amends the packaging and labeling control provisions of the current good manufacturing practice regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. The final rule also permits the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. Substantive, Nonsignificant Previously Published in The Unified Agenda Completed Actions No No 21 CFR 211.122 21 USC 321 21 USC 351 21 USC 352 21 USC 355 21 USC 356 21 USC 360b 21 USC 371 21 USC 374 No NPRM 07/29/1997 62 FR 40489 NPRM Comment Period End 10/27/1997 Final Action 03/20/2012 77 FR 16158 No Businesses None No No Howard Muller P. 0910 Food and Drug Administration FDA 301 796-3601 301 847-8440 howard.mullerjr@fda.hhs.gov Suite 3037 (HFD-7), Center for Drug Evaluation and Research, WO 51, Room 6234, 10903 New Hampshire Avenue, Silver Spring MD 20993-0002