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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 Dec 22, 2023.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR529.1044a]



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 529 -- CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

Sec. 529.1044a Gentamicin solution for infusion.

(a) Specifications. Each milliliter of solution contains 50 or 100 milligrams gentamicin sulfate.

(b) Sponsors. See Nos. 000061, 016592, 054771, 058005, 058198, 061133, and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. Infuse 2 to 2.5 grams per day for 3 to 5 days during estrus.

(2) Indications for use. For control of bacterial infections of the uterus (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin.

(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.

[71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14821, Mar. 19, 2021; 88 FR 55567, Aug. 16, 2023]

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