[Code of Federal Regulations]
 [Title 21, Volume 1]
 [Revised as of April 1, 2002]
 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]