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HHS/FDA RIN: 0910-AG34 Publication ID: Fall 2010 
Title: Over-the-Counter Human Drugs; Labeling Requirements(Completion of a Section 610 Review) 
Abstract: Section 201.66 (21 CFR section 201.66) established a standardized format for the labeling of OTC drug products that included: (1) Specific headings and subheadings presented in a standardized order, (2) standardized graphical features such as headings in bold type and the use of “bullet points” to introduce key information, and (3) minimum standards for type size and spacing. FDA issued the final rule to improve labeling after considering comments submitted to the agency following the publication of the proposed regulation in 1997. In 1999, FDA published the final rule and stated that a standardized labeling format would significantly improve readability by familiarizing consumers with the types of information in OTC drug product labeling and the location of that information. In addition, a standardized appearance and standardized content, including various ”user-friendly” visual cues, would help consumers locate and read important health and safety information and allow quick and effective product comparisons, thereby helping consumers to select the most appropriate product. FDA undertook a review of section 201.66 under section 610 of the Regulatory Flexibility Act. The purpose of this review is to determine whether the regulation in section 201.66 should be continued without change, or whether it should be further amended or rescinded, consistent with the stated objectives of applicable statutes, to minimize adverse impacts on a substantial number of small entities. FDA will consider, and is soliciting comments on the following: (1) The continued need for the regulation in section 201.66; (2) the nature of the complaints or comments received concerning the regulation in section 201.66; (3) the complexity of the regulations in section 201.66; (4) the extent to which the regulations in section 201.66 overlap, duplicate, or conflict with other Federal, State, or governmental rules; and (5) the degree to which technology, economic conditions, or other factors have changed for the products still subject to the labeling standard regulations in section 201. No comments were received. FDA's review of these regulations concluded that they should be continued without change. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Completion of a Section 610 Review 
CFR Citation: 21 CFR 201.66   
Legal Authority: 5 USC 610   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Begin Review of Current Regulation  08/03/2009    
End Review of Current Regulation  05/27/2010    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
M. Scott Furness
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO22, 10903 New Hamphsire Avenue,
Silver Spring, MD 20993
Phone:301 796-2090
Fax:301 796-9899
Email: micheal.furness@fda.hhs.gov