---
kind: "section"
citation: "21 C.F.R. § 529.56"
title: "21"
number: "529.56"
heading: "Amikacin."
url: "https://uscodex.org/cfr/21/529.56"
---

# §529.56. Amikacin.

- (a) **Specifications.** Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate.
- (b) **Sponsors.** See Nos. 054771 and 058198 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in horses—**
  - (1) **Amount.** Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological saline by intrauterine infusion daily for 3 consecutive days.
  - (2) **Indications for use.** For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms including Escherichia coli, Pseudomonas spp., and Klebsiella spp.
  - (3) **Limitations.** Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.

### Amendments

[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]