This electronic document was downloaded from the GPO web site, August 2002,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated each year in early summer.
The most current version of the regulations may be found at the
GPO web site or from the current
printed version.
[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: 21CFR74.1303]
[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.