[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR369.10]

[Page 325]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 369_INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-
 
                Subpart A_Definitions and Interpretations
 
Sec.  369.10  Conspicuousness of warning statements.

    Necessary warning statements should appear in the labeling 
prominently and conspicuously as compared to other words, statements, 
designs, and devices, and in bold type on clearly contrasting 
background, in order to comply with the provisions of section 502(c) and 
(f)(2) of the act. The warning statements should be placed in the 
labeling in juxtaposition with the directions for use and, in any case, 
should appear on the label when there is sufficient label space in 
addition to mandatory label information.