---
kind: "section"
citation: "21 C.F.R. § 74.1303"
title: "21"
number: "74.1303"
heading: "FD&C Red No. 3."
url: "https://uscodex.org/cfr/21/74.1303"
---

# §74.1303. FD&C Red No. 3.

- (a) **Identity and specifications.**
  - (1) **The color additive FD&C Red No.** 3 shall conform in identity and specifications to the requirements of § [74.303(a)(1)](/cfr/21/74.303.md?p=a-1) and [(b)](/cfr/21/74.303.md?p=a-b).
  - (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](/cfr/21/part73.md) 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.
- (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](/cfr/21/70.25.md) of this chapter.
- (d) **Certification.** All batches of FD&C Red No. 3 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Authority

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

### Source

Source: 42 FR 15654, Mar. 22, 1977, unless otherwise noted.