21 CFR § 520.1044a - Gentamicin sulfate oral solution.

---
identifier: "/us/cfr/t21/s520.1044a"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1044a - Gentamicin sulfate oral solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1044a"
section_name: "Gentamicin sulfate oral solution."
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1044a Gentamicin sulfate oral solution.

(a) *Specifications.* Each milliliter of aqueous solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin.

(b) *Sponsor.* See No. 000061 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.300 of this chapter.

(d) *Conditions of use*—(1) *Amount.* Colibacillosis: 1 milliliter per 2 gallons of drinking water for 3 consecutive days, to provide 0.5 milligram/pound/day; swine dysentery: 1 milliliter per 1 gallon of drinking water for 3 consecutive days, to provide 1.0 milligram/pound/day.

(2) *Indications for use.* In weanling swine for control and treatment of colibacillosis caused by strains of *E. coli* sensitive to gentamicin, and in swine for control and treatment of swine dysentery associated with *Treponema hyodysenteriae.*

(3) *Limitations.* Do not slaughter treated swine for food for at least 3 days following treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 10302, Mar. 11, 1983. Redesignated at 49 FR 572, Jan. 5, 1984, and amended at 49 FR 14332, Apr. 11, 1984; 52 FR 7832, Mar. 13, 1987; 62 FR 34169, June 25, 1997; 71 FR 13542, Mar. 16, 2006; 81 FR 94989, Dec. 27, 2016; 88 FR 84700, Dec. 6, 2023]