21 CFR §74.1303

1. (a)Identity and specifications.
   1. (1)The color additive FD&C Red No. 3 shall conform in identity and specifications to the requirements of § 74.303(a)(1) and (b).
   2. (2)Color additive mixtures for ingested drug used made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring ingested drugs.
2. (b)Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice.
3. (c)Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.
4. (d)Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter.