This electronic document was downloaded from the GPO web site, August 2002, and is provided for information purposes only. The Code of Federal Regulations, Title 21, is updated each year in early summer. The most current version of the regulations may be found at the GPO web site or from the current printed version.

 
 [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: 21CFR73.1575]
 
 [Page 371-372]
 
                         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. 73.1575  Titanium dioxide.
 
     (a) Identity and specifications. (1) The color additive titanium
 dioxide shall conform in identity and specifications
 
 [[Page 372]]
 
 to the requirements of Sec. 73.575(a)(1) and (b).
     (2) Color additive mixtures for drug use made with titanium dioxide
 may contain only those diluents that are suitable and that are listed in
 this subpart as safe in color additive mixtures for coloring drugs, and
 the following: Silicon dioxide, SiO<INF>2,</INF> and/or aluminum oxide,
 Al<INF>2</INF>O<INF>3,</INF> as dispersing aids--not more than 2 percent
 total.
     (b) Uses and restrictions. The color additive titanium dioxide may
 be used for coloring ingested and externally applied drugs generally, in
 amounts consistent with good manufacturing practice. External
 application includes use in the area of the eye.
     (c) Labeling. The label of the color additive and any mixtures
 prepared therefrom and intended solely or in part for coloring purposes
 shall conform to the requirements of Sec. 70.25 of the chapter.
     (d) 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 the certification requirements
 of section 721(c) of the act.


Color Additive Regulations
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