[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: 21CFR74.1705]
 
[Page 412]
 
                        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. 74.1705  FD&C Yellow No. 5.
 
    (a) Identity and specifications. (1) The color additive FD&C Yellow
No. 5 shall conform in identity and specifications to the requirements
of Sec. 74.705 (a)(1) and (b).
    (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance
with the requirements of Sec. 82.51 of this chapter.
    (3) Color additive mixtures for drug use made with FD&C Yellow No. 5
may contain only those diluents that are suitable and are listed in part
73 of this chapter as safe for use in color additive mixtures for
coloring drugs.
    (b) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used
for coloring drugs generally, including drugs intended for use in the
area of the eye, in amounts consistent with current good manufacturing
practice.
    (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring
drugs intended for use in the area of the eye, when prepared in
accordance with Sec. 82.51 of this chapter.
    (c) Labeling requirements. (1) The label of the color additive and
any mixtures intended solely or in part for coloring purposes prepared
therefrom shall conform to the requirements of Sec. 70.25 of this
chapter.
    (2) The label of OTC and prescription drug products intended for
human use administered orally, nasally, rectally, or vaginally, or for
use in the area of the eye, containing FD&C Yellow No. 5 shall
specifically declare the presence of FD&C Yellow No. 5 by listing the
color additive using the names FD&C Yellow No. 5 and tartrazine. The
label shall bear a statement such as ``Contains FD&C Yellow No. 5
(tartrazine) as a color additive'' or ``Contains color additives
including FD&C Yellow No. 5 (tartrazine).'' The labels of certain drug
products subject to this labeling requirement that are also cosmetics,
such as: antibacterial mouthwashes and fluoride toothpastes, need not
comply with this requirement provided they comply with the requirements
of Sec. 701.3 of this chapter.
    (3) For prescription drugs for human use containing FD&C Yellow No.
5 that are administered orally, nasally, vaginally, or rectally, or for
use in the area of the eye, the labeling required by Sec. 201.100(d) of
this chapter shall, in addition to the label statement required under
paragraph (c)(2) of this section, bear the warning statement ``This
product contains FD&C Yellow No. 5 (tartrazine) which may cause
allergic-type reactions (including bronchial asthma) in certain
susceptible persons. Although the overall incidence of FD&C Yellow No. 5
(tartrazine) sensitivity in the general population is low, it is
frequently seen in patients who also have aspirin hypersensitivity.''
This warning statement shall appear in the ``Precautions'' section of
the labeling.
    (d) Certification. All batches of FD&C Yellow No. 5 shall be
certified in accordance with regulations in part 80 of this chapter.
 
[42 FR 15654, Mar. 22, 1977, as amended at 44 FR 37220, June 26, 1979;
50 FR 35782, Sept. 4, 1985; 51 FR 24519, July 7, 1986; 59 FR 60897, Nov.
29, 1994]