[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1331]

[Page 408-409]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
Sec. 74.1331  D&C Red No. 31.

    (a) Identity. (1) The color additive D&C Red No. 31 is principally 
the calcium salt of 3-hydroxy-4-(phenylazo)-2-naphthalenecarboxylic 
acid.
    (2) Color additive mixtures for drug use made with D&C Red No. 31 
may contain only those diluents that are suitable and that are listed in 
part 73 of this chapter as safe for use in color additive mixtures for 
coloring externally applied drugs.
    (b) Specifications. D&C Red No. 31 shall conform to the following 
specifications and shall be free from impurities, other than those 
named, to the extent that such other impurities may be avoided by good 
manufacturing practice:

Sum of volatile matter (at 135  deg.C) and chlorides and sulfates 
(calculated as sodium salts), not more than 10 percent.
Aniline, not more than 0.2 percent.
3-Hydroxy-2-naphthoic acid, calcium salt, not more than 0.4 percent.
Subsidiary colors, not more than 1 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.

[[Page 409]]

Total color, not less than 90 percent.

    (c) Uses and restrictions. D&C Red No. 31 may be safely used in 
externally applied drugs in amounts consistent with good manufacturing 
practice.
    (d) Labeling. The label of the color additive and any mixtures 
prepared therefrom intended solely or in part for coloring purposes 
shall conform to the requirements of Sec. 70.25 of this chapter.
    (e) Certification. All batches of D&C Red No. 31 shall be certified 
in accordance with regulations in part 80 of this chapter.