[Code of Federal Regulations]
[Title 21 Volume 5]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR352.77]

[Page 284]
 
                        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 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.