[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: 21CFR349.1]

[Page 283]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF 
 
PART 349_OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN
USE--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 349.1  Scope.


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