---
kind: "section"
citation: "21 C.F.R. § 74.3602"
title: "21"
number: "74.3602"
heading: "D&C Violet No. 2."
url: "https://uscodex.org/cfr/21/74.3602"
---

# §74.3602. D&C Violet No. 2.

- (a) **Identity and specifications.** The color additive D&C Violet No. 2 shall conform in identity and specifications to the requirements of § [74.1602(a)(1)](/cfr/21/74.1602.md?p=a-1) and [(b)](/cfr/21/74.1602.md?p=a-b).
- (b) **Uses and restrictions.**
  - (1) **The color additive, D&C Violet No.** 2, may be safely used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect.
  - (2) **D&C Violet No.** 2 may be safely used for coloring sutures for use in surgery subject to the following conditions:
    - (i) At a level not to exceed 0.2 percent by weight of the suture material for coloring copolymers of 90 percent glycolide and 10 percent L-lactide synthetic absorbable sutures for use in general and ophthalmic surgery; and
    - (ii) At a level not to exceed 0.3 percent by weight of the suture material for coloring polydioxanone synthetic absorbable sutures for use in general and ophthalmic surgery.
    - (iii) At a level not to exceed 0.25 percent by weight of the suture material for coloring poliglecaprone 25 (ε-caprolactone/glycolide copolymer) synthetic absorbable sutures for use in general surgery.
    - (iv) At a level not to exceed 0.1 percent by weight of the suture material for coloring poly(ε-caprolactone) absorbable sutures for use in general surgery.
    - (v) At a level not to exceed 0.2 percent by weight of the suture material for coloring glycolide/dioxanone/trimethylene carbonate tripolymer absorbable sutures for use in general surgery.
    - (vi) At a level not to exceed 0.2 percent by weight of the suture material for coloring absorbable sutures prepared from homopolymers of glycolide for use in general surgery.
  - (3) **The color additive, D&C Violet No.** 2, may be safely used for coloring polymethylmethacrylate intraocular lens haptics at a level not to exceed 0.2 percent by weight of the haptic material.
  - (4) **The color additive, D&C Violet No.** 2, may be safely used for coloring absorbable meniscal tacks made from poly (L-lactic acid) at a level not to exceed 0.15 percent by weight of the tack material.
  - (5) 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 devices in which the color additive is used.
- (c) **Labeling.** The label of the color additive shall conform to the requirements of [§ 70.25](/cfr/21/70.25.md) of this chapter.
- (d) **Certification.** All batches of D&C Violet No. 2 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000]

### 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

[52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000]