[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1575]
[Page 368-369]
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
Subpart B Drugs
Sec. 73.1575 Titanium dioxide.
(a) Identity and specifications. (1) The color additive titanium
dioxide shall conform in identity and specifications 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, SiO2, and/or aluminum oxide,
Al2O3, 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
[[Page 369]]
are exempt from the certification requirements of section 721(c) of the
act.
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