---
kind: "section"
citation: "21 C.F.R. § 520.1044c"
title: "21"
number: "520.1044c"
heading: "Gentamicin sulfate powder."
url: "https://uscodex.org/cfr/21/520.1044c"
---

# §520.1044c. Gentamicin sulfate powder.

- (a) **Specifications.** Each gram of powder contains gentamicin sulfate equivalent to:
  - (1) 16.7, 66.7, or 333.3 milligrams (mg) gentamicin.
  - (2) 333.3 mg gentamicin.
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (d)](#d) of this section as follows:
  - (1) **No.** 000061 for products described in [paragraph (a)(1)](#a-1) of this section.
  - (2) **Nos.** 016592 and 061133 for product described in [paragraph (a)(2)](#a-2) of this section.
- (c) **Related tolerances.** See [§ 556.300](/cfr/21/556.300.md) of this chapter.
- (d) **Conditions of use in swine—**
  - (1) **Amount.** Administer in drinking water for 3 consecutive days as follows:
    - (i) **For colibacillosis—** Gentamicin sulfate equivalent to 25 mg of gentamicin per gallon of drinking water to provide 0.5 mg per pound of body weight per day;
    - (ii) **For swine dysentery—** Gentamicin sulfate equivalent to 50 mg of gentamicin per gallon of drinking water to provide 1 mg per pound of body weight per day. Treatment may be repeated if dysentery recurs.
  - (2) **Indications for use.** For control and treatment of colibacillosis in weanling swine caused by strains of Escherichia coli sensitive to gentamicin, and for control and treatment of swine dysentery associated with Brachyspira hyodysenteriae.
  - (3) **Limitations.** Withdrawal period: 10 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[77 FR 4226, Jan. 27, 2012, as amended at 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019; 87 FR 10968, Feb. 28, 2022]

### Authority

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

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[77 FR 4226, Jan. 27, 2012, as amended at 81 FR 94989, Dec. 27, 2016; 83 FR 48945, Sept. 28, 2018; 84 FR 8972, Mar. 13, 2019; 87 FR 10968, Feb. 28, 2022]