[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: 21CFR73.1162]

[Page 366]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
Sec. 73.1162  Bismuth oxychloride.

    (a) Identity. (1) The color additive bismuth oxychloride is a 
synthetically prepared white or nearly white amorphous or finely 
crystalline, odorless powder consisting principally of BiOCl.
    (2) Color additive mixtures for drug use made with bismuth 
oxychloride may contain only those diluents that are suitable and that 
are listed in this subpart as safe in color additive mixtures for 
coloring externally applied drugs.
    (b) Specifications. The color additive bismuth oxychloride 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:

Volatile matter, not more than 0.5 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.
Bismuth oxychloride, not less than 98 percent.

    (c) Uses and restrictions. The color additive bismuth oxychloride 
may be safely used in coloring externally applied drugs, including those 
intended for use in the area of the eye, in amounts consistent with good 
manufacturing practice.
    (d) Labeling. The color additive and any mixture prepared therefrom 
intended solely or in part for coloring purposes shall bear, in addition 
to any information required by law, labeling in accordance with the 
provisions of Sec. 70.25 of this chapter.
    (e) Exemption from certification. Certification of this color 
additive is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from certification pursuant to 
section 721(c) of the act.

[42 FR 52394, Sept. 30, 1977]