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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 April 1 2020.

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]
[Revised as of April 1, 2020]
[CITE: 21CFR522.1193]



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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1193 Ivermectin and clorsulon.

(a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) (1 percent) ivermectin and 100 mg (10 percent) clorsulon.

(b) Sponsors. See Nos. 000010, 055529, 058005, and 061133 in § 510.600(c) of this chapter.

(c) Related tolerances. See §§ 556.163 and 556.344 of this chapter.

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

(e) Conditions of use in cattle - (1) Amount. Administer 1 mL (10 mg ivermectin and 100 mg clorsulon) per 50 kilograms (110 pounds) by subcutaneous injection.

(2) Indications for use. For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (Haemonchus placei, Ostertagia ostertagi (including inhibited larvae), O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus (adults only), N. spathiger (adults only), Bunostomum phlebotomum ; lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus ); liver flukes (adults only) (Fasciola hepatica ); grubs (parasitic stages) (Hypoderma bovis, H. lineatum ); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus ); mites (Psoroptes ovis (syn. P. communis var. bovis ), Sarcoptes scabiei var. bovis ); and for control of infections of D. viviparus and O. radiatum for 28 days afer treatment; O. ostertagi, T. axei , and C. punctata for 21 days after treatment; and H. placei and C. oncophora for 14 days after treatment.

(3) Limitations. (i) Nos. 000010 and 061133: Do not treat cattle within 21 days of slaughter. Nos. 055529 and 058005: Do not treat cattle within 49 days of slaughter.

(ii) Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.

[55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR 64717, Oct. 23, 2012; 79 FR 64116, Oct. 28, 2014; 84 FR 39184, Aug. 9, 2019]

Editorial Note:

At 81 FR 22524, Apr. 18, 2016, § 522.1193 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction.

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