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: 21CFR74.1102]
[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]