[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1075]

[Page 359]
 
                        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. 73.1075  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 
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.