[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR357.101]

[Page 306]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 357_MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE--Table of Contents
 
                  Subpart B_Anthelmintic Drug Products
 
Sec. 357.101  Scope.

    Source: 51 FR 27759, Aug. 1, 1986, unless otherwise noted.


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