(a)Identity and specifications. (1) The color additive canthaxanthin shall conform in identity and specifications to the requirements of § 73.75(a)(1) and (b).
(2) Color additive mixtures for ingested drug use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring ingested drugs.
(b)Uses and restrictions. Canthaxanthin may be safely used for coloring ingested drugs generally in amounts consistent with good manufacturing practice.
(c)Labeling requirements. The label of the color additive and of any mixtures prepared therefrom intended solely or in part for coloring purposes 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.
Title 21 published on 2014-04-01
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