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HHS/FDA RIN: 0910-AA79 Publication ID: Spring 1999 
Title: Over-the-Counter Human Drugs; Labeling Requirements 
Abstract: The final rule will provide standardized format and content requirements for over-the-counter (OTC) drug product labeling, including legibility and design features for the presentation of such information as the uses for the drug, directions for use, warnings, drug interactions, 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: Final Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: 21 CFR 201    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  02/27/1997  62 FR 9024   
NPRM Comment Period End  10/06/1997  62 FR 33379   
Reopening of Comment Period (Study B)  12/30/1997  62 FR 67770   
Reopening of Comment Period (Study A)  02/13/1998  63 FR 7331   
Final Action  04/00/1999    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: Yes 
Agency Contact:
Dr. Debra Bowen
Division of OTC Drug Evaluation
Department of Health and Human Services
Food and Drug Administration
HFD-560, Center for Drug Evaluation and Research, 9200 Corporate Boulevard,
Rockville, MD 20850
Phone:301 827-2222