21 CFR 522.1193 - Ivermectin and clorsulon.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 522 [§ 522.23 - § 522.2694]

§ 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, 061133, and 061651 in § 510.600(c) 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); cattle grubs (parasitic stages) (Hypoderma bovis, H. lineatum); sucking lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus); mange mites (cattle scab) (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 after 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. Do not treat cattle within 21 days of slaughter. 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; 86 FR 14820, Mar. 19, 2021; 86 FR 57997, Oct. 20, 2021] 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.

authority: 21 U.S.C. 360b.

source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

cite as: 21 CFR 522.1193