[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: 21CFR333.301]

[Page 228]
 
                        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--
 
                  Subpart D_Topical Acne Drug Products
 
Sec.  333.301  Scope.

    Source: 56 FR 41019, Aug. 16, 1991, unless otherwise noted.


    (a) An over-the-counter acne drug product in a form suitable for 
topical application 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) References in this subpart to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.