[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: 21CFR74.1340]

[Page 434]
 
                        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. 74.1340  FD&C Red No. 40.

    (a) Identity and specifications. (1) The color additive FD&C Red No. 
40 shall conform in identity and specifications to the requirements of 
Sec. 74.340(a)(1) and (b).
    (2) Color additive mixtures for drug use made with FD&C Red No. 40 
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.
    (3) The listing of this color additive includes lakes prepared as 
described in Sec. Sec. 82.51 and 82.1051 of this chapter, except that 
the color additive used is FD&C Red No. 40 and the resultant lakes meet 
the specification and labeling requirements prescribed by Sec. Sec. 
82.51 or 82.1051 of this chapter.)
    (b) Uses and restrictions. (1) FD&C Red No. 40 and FD&C Red No. 40 
Aluminum Lake may be safely used in coloring drugs, including those 
intended for use in the area of the eye, subject to the restrictions on 
the use of color additives in Sec. 70.5(b) and (c) of this chapter, in 
amounts consistent with current good manufacturing practice.
    (2) Other lakes of FD&C Red No. 40 may be safely used in coloring 
drugs, subject to the restrictions on the use of color additives in 
Sec. 70.5 of this chapter, in amounts consistent with current good 
manufacturing practice.
    (c) Labeling. The label of the color additive and any lakes or 
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. 40 and lakes thereof 
shall be certified in accordance with regulations, in part 80 of this 
chapter.

[42 FR 15654, Mar. 22, 1977, as amended at 59 FR 7636, Feb. 16, 1994]