[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: 21CFR73.1100]

[Page 365]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table of Contents
 
                            Subpart B--Drugs
 
Sec. 73.1100  Cochineal extract; carmine.

    (a) Identity and specifications. (1) The color additives cochineal 
extract and carmine shall conform in identity and specifications to the 
requirements of Sec. 73.100(a) (1) and (2) and (b).
    (2) Color additive mixtures for drug use made with carmine and 
cochineal extract may contain only those diluents that are suitable and 
that are listed in this subpart as safe in color additive mixtures for 
coloring drugs.
    (b) Uses and restrictions. Cochineal extract and carmine may be 
safely used for coloring ingested and externally applied drugs in 
amounts consistent with good manufacturing practice.
    (c) Labeling requirements. The label of the color additives 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.
    (d) Exemption from certification. Certification of these color 
additives is not necessary for the protection of the public health, and 
therefore batches thereof are exempt from the certification requirements 
of section 721(c) of the act.