[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: 21CFR358.701]

[Page 316]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 358_MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--
 
    Subpart H_Drug Products for the Control of Dandruff, Seborrheic 
                        Dermatitis, and Psoriasis
 
Sec.  358.701  Scope.

    Source: 56 FR 63568, Dec. 4, 1991, unless otherwise noted.


    (a) An over-the-counter dandruff, seborrheic dermatitis, or 
psoriasis 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.