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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: 21CFR520.1628]



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. 520.1628 Oxfendazole powder and pellets.

(a) Specifications - (1) Powder for suspension. Each gram of powder contains 7.57 percent oxfendazole.

(2) Pellets. Each gram of pellets contains 6.49 percent oxfendazole.

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

(c) Conditions of use - (1) Amount. 10 milligrams per kilogram of body weight.

(2) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: Large roundworms (Parascaris equorum ), mature and immature pinworms (Oxyuris equi ), large strongyles (Strongylus edentatus, Strongylus vulgaris, and Strongylus equinus ), and small strongyles.

(3) Limitations - (i) Powder for suspension. For gravity administration via stomach tube or for positive administration via stomach tube and dose syringe. Discard unused portions of suspension after 24 hours. Mix drug according to directions prior to use. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Pellets. The drug is given by sprinkling on the grain portion of the ration. Withholding feed or water prior to administration is not necessary. Administer drug with caution to sick or debilitated horses. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[44 FR 35211, June 19, 1979, as amended at 46 FR 26301, May 12, 1981; 46 FR 60570, Dec. 11, 1981; 49 FR 28549, July 13, 1984; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014]

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