---
kind: "section"
citation: "21 C.F.R. § 74.1109"
title: "21"
number: "74.1109"
heading: "D&C Blue No. 9."
url: "https://uscodex.org/cfr/21/74.1109"
---

# §74.1109. D&C Blue No. 9.

- (a) **Identity.** The color additive D&C Blue No. 9 is principally 7,16-dichloro-6,15 - dihydro - 5,9,14,18 - anthrazine-tetrone.
- (b) **Specifications.** D&C Blue No. 9 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.** D&C Blue No. 9 may be safely used for coloring cotton and silk surgical sutures, including sutures for ophthalmic use, subject to the following restrictions:
  - (1) The dyed suture shall conform in all respects to the requirements of the United States Pharmacopeia XX (1980).
  - (2) The quantity of the color additive does not exceed 2.5 percent by weight of the suture.
  - (3) When the sutures are used for the purposes specified in their labeling, the color additive does not migrate to the surrounding tissue.
  - (4) If the suture is a new drug, a new-drug application approved pursuant to [section 505](/cfr/21/505.md) of the act is in effect for it.
- (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. 9 shall be certified in accordance with regulations in [part 80](/cfr/21/part80.md) of this chapter.

## Notes

### Amendments

[42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993]

### 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

[42 FR 15654, Mar. 22, 1977, as amended at 49 FR 10090, Mar. 19, 1984; 58 FR 17098, Apr. 1, 1993]