21 CFR § 529.56 - Amikacin.

---
identifier: "/us/cfr/t21/s529.56"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 529.56 - Amikacin."
title_number: 21
title_name: "Food and Drugs"
section_number: "529.56"
section_name: "Amikacin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "529"
part_name: "CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13881, Mar. 27, 1975, unless otherwise noted."
cfr_part: "529"
---


# 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) 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.

[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]