View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AA79 Publication ID: Spring 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: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
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  09/00/1996    
NPRM Comment Period End  12/00/1996    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: No 
Agency Contact:
Melvin Lessing
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