[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1100]
[Page 361]
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
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.
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