[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR74.1203]

[Page 422]
 
                        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. 74.1203  FD&C Green No. 3.

    (a) Identity and specifications. (1) The color additive FD&C Green 
No. 3 shall conform in identity and specifications to the requirements 
of Sec. 74.203(a)(1) and (b).
    (2) Color additive mixtures for drug use made with FD&C Green 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 drugs.
    (b) Uses and restrictions. The color additive FD&C Green No. 3 may 
be safely used for coloring drugs generally in amounts consistent with 
current 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 Green No. 3 shall be 
certified in accordance with regulations in part 80 of this chapter.

[47 FR 52144, Nov. 19, 1982]