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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 Mar 22, 2024.

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: 21CFR520.1454]



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. 520.1454 Moxidectin solution.

(a) Specifications. Each milliliter (mL) of solution contains 1 milligram (mg) moxidectin.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Related tolerances. See § 556.426 of this chapter.

(d) Special considerations. See § 500.25 of this chapter.

(e) Conditions of use in sheep - (1) Amount. Administer 1 mL per 11 pounds body weight (1 mL per 5 kilograms) by mouth.

(2) Indications for use. For the treatment and control of the adult and L4 larval stages of Haemonchus contortus , Teladorsagia circumcincta , T. trifurcata , Trichostrongylus axei , T. colubriformis , T. vitrinus , Cooperia curticei , C. oncophora , Oesophagostomum columbianum , O. venulosum , Nematodirus battus , N. filicollis , and N. spathiger.

(3) Limitations. Sheep must not be slaughtered for human consumption within 7 days of treatment. Because a withholding time in milk has not been established for this product, do not use in female sheep providing milk for human consumption.

[70 FR 76163, Dec. 23, 2005, as amended at 76 FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, 2017; 86 FR 14818, Mar. 19, 2021]

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