[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: 21CFR74.1102]

[Page 398]
 
                        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. 74.1102  FD&C Blue No. 2.

    (a) Identity. (1) The color additive FD&C Blue No. 2 shall conform 
in identity to the requirements of Sec. 74.102(a)(1).
    (2) Color additive mixtures for use in ingested drugs made with FD&C 
Blue No. 2 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) The color additive FD&C Blue No. 2 for use in coloring ingested 
drugs shall conform to the specifications in Sec. 74.102(b).
    (c) The color additive FD&C Blue No. 2 may be safely used for 
coloring ingested drugs in amounts consistent with current good 
manufacturing practice.
    (d) 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.
    (e) Certification. All batches of FD&C Blue No. 2 shall be certified 
in accordance with regulations in part 80 of this chapter.

[48 FR 5260, Feb. 4, 1983, as amended at 49 FR 10090, Mar. 19, 1984; 64 
FR 48290, Sept. 3, 1999]