---
kind: "section"
citation: "21 C.F.R. § 73.1375"
title: "21"
number: "73.1375"
heading: "Pyrogallol."
url: "https://uscodex.org/cfr/21/73.1375"
---

# §73.1375. Pyrogallol.

- (a) **Identity.** The color additive pyrogallol is 1,2,3-trihydroxybenzene.
- (b) **Specifications.** Pyrogallol 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.** Pyrogallol may be safely used in combination with ferric ammonium citrate (as listed in [§ 73.1025](/cfr/21/73.1025.md)), for coloring plain and chromic catgut sutures for use in general and ophthalmic surgery, 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 level of the ferric ammonium citrate-pyrogallol complex shall not exceed 3 percent of the total weight of the suture material.
  - (3) When the sutures are used for the purposes specified in their labeling, there is no migration of the color additive to the surrounding tissues.
  - (4) If the suture is a new drug, an approved new drug application, 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) **Exemption from certification.** Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of [section 721(c)](/cfr/21/721.md?p=c) of the act.

## Notes

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]

### Authority

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

### Source

Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.

### Amendments

[42 FR 15643, Mar. 22, 1977, as amended at 49 FR 10089, Mar. 19, 1984]