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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2017]
[CITE: 21CFR73.1095]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 73 -- LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

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 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 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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