21 CFR § 522.56 - Amikacin.

---
identifier: "/us/cfr/t21/s522.56"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.56 - Amikacin."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.56"
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: "522"
part_name: "IMPLANTATION OR INJECTABLE 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 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.56 Amikacin.

(a) *Specifications.* Each milliliter of solution contains 50 milligrams (mg) of amikacin as amikacin sulfate.

(b) *Sponsor.* See No. 069043 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* 5 mg/pound (lb) of body weight twice daily by intramuscular or subcutaneous injection.

(2) *Indications for use.* For treatment of genitourinary tract infections (cystitis) caused by susceptible strains of *Escherichia coli* and *Proteus* spp. and skin and soft tissue infections caused by susceptible strains of *Pseudomonas* spp. and *E. coli.*

(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 17338, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016]