[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: 21CFR338.1]

[Page 234-235]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 338_NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER
HUMAN USE--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 338.1  Scope.


    (a) An over-the-counter nighttime sleep-aid 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 part 
and each general condition established in Sec. 330.1 of this chapter.

[[Page 235]]

    (b) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21 unless otherwise noted.