[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1303]

[Page 403]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
Sec. 74.1303  FD&C Red No. 3.

    (a) Identity and specifications. (1) The color additive FD&C Red No. 
3 shall conform in identity and specifications to the requirements of 
Sec. 74.303(a)(1) and (b).
    (2) Color additive mixtures for ingested drug used made with FD&C 
Red No. 3 may contain only those diluents that are suitable and that are 
listed in part 73 of this chapter as safe for use in color additive 
mixtures for coloring ingested drugs.
    (b) Uses and restrictions. FD&C Red No. 3 may be safely used for 
coloring ingested drugs in amounts consistent with good manufacturing 
practice.
    (c) Labeling. The label of the color additive and 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) Certification. All batches of FD&C Red No. 3 shall be certified 
in accordance with regulations in part 80 of this chapter.