CFR - Code of Federal Regulations Title 21

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR529.56]

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. 529.56 Amikacin.

(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate.

(b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological saline by intrauterine infusion daily for 3 consecutive days.

(2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms including Escherichia coli, Pseudomonas spp., and Klebsiella spp.

(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.

[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]