[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: 21CFR73.1075]
[Page 360-361]
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. 73.1075 Canthaxanthin.
(a) Identity and specifications. (1) The color additive
canthaxanthin shall conform in identity and specifications to the
requirements of Sec. 73.75(a)(1) and (b).
(2) Color additive mixtures for ingested drug use made with
canthaxanthin may contain only those diluents that are suitable and that
are listed in this subpart as safe in color additive mixtures for
coloring ingested drugs.
(b) Uses and restrictions. Canthaxanthin may be safely used for
[[Page 361]]
coloring ingested drugs generally in amounts consistent with good
manufacturing practice.
(c) Labeling requirements. The label of the color additive and of
any mixtures prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of Sec. 70.25 of this
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.
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