[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR331.21]

[Page 221]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 331--ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE--Table of Contents
 
                      Subpart C--Testing Procedures
 
Sec. 331.21  Test modifications.

    The formulation or mode of administration of certain products may 
require a modification of the United States Pharmacopeia 23/National 
Formulary 18 acid neutralizing capacity test. Any proposed modification 
and the data to support it shall be submitted as a petition under the 
rules established in Sec. 10.30 of this chapter. All information 
submitted will be subject to the disclosure rules in part 20 of this 
chapter.

[61 FR 4823, Feb. 8, 1996]