21 C.F.R. § 520.1044c

Gentamicin sulfate powder.

Last amended: 2022Year: 2026Length: 248 wordsSubsections: 5Official source

Cite as 21 C.F.R. § 520.1044c (2026)

(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) of this chapter for use as in paragraph (d) of this section as follows: (1) No. 000061 for products described in paragraph (a)(1) of this section. (2) Nos. 016592 and 061133 for product described in paragraph (a)(2) of this section. (c) Related tolerances. See § 556.300 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. [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]
Cross-references to the CFR
510.600556.300
21 C.F.R. § 520.1044c: Gentamicin sulfate powder. | Justis AI