Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 73.1095: β-Carotene.

(a) Identity and specifications. (1) The color additive β-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 β-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 β-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.

Where this section sits in the code

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

(a) Identity and specifications. (1) The color additive β-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 β-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 β-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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

Browse this collection