[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: 21CFR355.1]

[Page 284]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 355.1  Scope.


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