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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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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1638]



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. 520.1638 Oxibendazole.

(a) Specifications. (1) Each gram of paste contains 227 milligrams (mg) (22.7 percent) oxibendazole.

(2) Each milliliter of suspension contains 100 mg (10 percent) oxibendazole.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Special considerations. (1) See § 500.25 of this chapter.

(2) Suspension product described in paragraph (a)(2) of this section shall be labeled: "Federal law restricts this drug to use by or on the order of a licensed veterinarian."

(d) Conditions of use in horses - (1) Amount. For uses other than for threadworms (Strongyloides westeri ), 10 mg oxibendazole per kilogram (/kg) body weight; for threadworms (Strongyloides westeri ), 15 mg/kg. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Administer suspension product by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration.

(2) Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ); small strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus ); large roundworms (Parascaris equorum ); pinworms (Oxyuris equi ) including various larval stages; and threadworms (Strongyloides westeri ).

(3) Limitations. Do not use in horses intended for human consumption.

[78 FR 28825, May 20, 2014]

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