[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.77]

[Page 301-302]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 352_SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 
[STAYED INDEFINITELY]--Table of Contents
 
                      Subpart D_Testing Procedures
 
Sec. 352.77  Test modifications.

    The formulation or mode of administration of certain products may 
require modification of the testing procedures in this subpart. In 
addition, alternative methods (including automated or in vitro 
procedures) employing the same basic procedures as those described in 
this subpart may be used. Any proposed

[[Page 302]]

modification or alternative procedure shall be submitted as a petition 
in accord with Sec. 10.30 of this chapter. The petition should contain 
data to support the modification or data demonstrating that an 
alternative procedure provides results of equivalent accuracy. All 
information submitted will be subject to the disclosure rules in part 20 
of this chapter.