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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1044c]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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) 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 Treponema 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]

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