[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: 21CFR355.70]

[Page 289]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 355--ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE--Table of Contents
 
                      Subpart D--Testing Procedures
 
Sec. 355.70  Testing procedures for fluoride dentifrice drug products.


    (a) A fluoride dentifrice drug product shall meet the biological 
test requirements for animal caries reduction and one of the following 
tests: Enamel solubility reduction or fluoride enamel uptake. The 
testing procedures for these biological tests are labeled Biological 
Testing Procedures for Fluoride Dentifrices; these testing procedures 
are on file under Docket No. 80N-0042 in the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857, and are available on request to that office.
    (b) The United States Pharmacopeia fluoride dentifrice reference 
standards along with reference standard stability profiles (total 
fluoride, available fluoride ion, pH, and specific gravity) required to 
be used in the biological tests are available to any purchaser upon 
written request to the United States Pharmacopeial Convention, Inc., 
1260 Twinbrook Parkway, Rockville, MD 20852.
    (c) Alternative testing procedures may be used. Any proposed 
modification or alternative testing procedures 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 testing procedure provides results of equivalent accuracy. 
All information submitted will be subjected to the disclosure rules in 
part 20 of this chapter.