[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: 21CFR73.1095]
[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. 73.1095 [beta]-Carotene.
(a) Identity and specifications. (1) The color additive [beta]-
carotene shall conform in identity and specifications to the
requirements of Sec. 73.95(a)(1) and (b).
(2) The diluents in color additive mixtures for drug use containing
[beta]-carotene are limited to those listed in this subpart as safe and
suitable in color additive mixtures for coloring ingested drugs.
(b) Uses and restrictions. The color additive [beta]-carotene may be
safely used in coloring drugs generally, including those intended for
use in the area of the eye, in amounts consistent with good
manufacturing practice.
(c) Labeling requirements. The labeling 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.
(d) Exemption from certification. Certification of this color
additive 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.
[42 FR 15643, Mar. 22, 1977, as amended at 42 FR 33722, July 1, 1977]
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