21 CFR 74.1303 - FD&C Red No. 3.
(a) Identity and specifications.
(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.
(b) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring ingested drugs in amounts consistent with good manufacturing practice.
(d) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in part 80 of this chapter.