[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR333.201]

[Page 220]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 333--TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
               Subpart C--Topical Antifungal Drug Products
 
Sec. 333.201  Scope.

    Source: 58 FR 49898, Sept. 23, 1993, unless otherwise noted.


    (a) An over-the-counter antifungal drug product in a form suitable 
for topical administration is generally recognized as safe and effective 
and is not misbranded if it meets each of the conditions in this subpart 
and each general condition established in Sec. 330.1 of this chapter.
    (b) Reference in this subpart to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.