---
kind: "section"
citation: "21 C.F.R. § 74.3106"
title: "21"
number: "74.3106"
heading: "D&C Blue No. 6."
url: "https://uscodex.org/cfr/21/74.3106"
---

# §74.3106. D&C Blue No. 6.

- (a) **Identity.** The color additive D&C Blue No. 6 is principally [Δ2,2′-biindoline]-3,3′ dione (CAS Reg. No. 482-89-3).
- (b) **Specifications.** D&C Blue No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practice:
- (c) **Uses and restrictions.**
  - (1) **D&C Blue No.** 6 may be safely used at a level—
    - (i) Not to exceed 0.2 percent by weight of the suture material for coloring polyethylene terephthalate surgical sutures for general surgical use;
    - (ii) Not to exceed 0.25 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for general surgical use;
    - (iii) Not to exceed 0.5 percent by weight of the suture material for coloring plain or chromic collagen absorbable sutures for ophthalmic surgical use;
    - (iv) Not to exceed 0.5 percent by weight of the suture material for coloring polypropylene surgical sutures for general surgical use; and
    - (v) Not to exceed 0.5 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use.
  - (2) Authorization for these uses shall not be construed as waiving any of the requirements of sections [510(k)](/cfr/21/510.md?p=k), [515](/cfr/21/515.md), and [520(g)](/cfr/21/520.md?p=g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical device in which the color additive is used.
- (d) **Labeling.** The label of the color additive shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
- (e) **Certification.** All batches of D&C Blue No. 6 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985]

### 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.

### Amendments

[49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended at 50 FR 30698, July 29, 1985]