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HHS/FDA RIN: 0910-AA79 Publication ID: Fall 1996 
Title: Over-the-Counter Human Drugs; Labeling Requirements 
Abstract: The proposed rule would provide standardized format and content requirements for OTC drug product labeling, including legibility and design features of such information as the uses for the drug, directions for use, warnings, drug interactions, precautions, active ingredients and other information that the consumer would need to know to use the product safely and effectively. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 330   
Legal Authority: 21 USC 321    21 USC 351    21 USC 352    21 USC 353    21 USC 355    21 USC 360    21 USC 371   
Timetable:
Action Date FR Cite
NPRM  12/00/1996    
NPRM Comment Period End  03/00/1997    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: No 
Agency Contact:
Diana Hernandez
Division of OTC Drug Evaluation
Department of Health and Human Services
Food and Drug Administration
Suite 3047 (HFD-560), Center for Drug Evaluation and Research, 1451 Rockville Pike,
Rockville, MD 20852
Phone:301 827-2222