[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: 21CFR73.1075]
 
 [Page 364]
 
                         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.