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Code · CFR · Title 21 — Food and Drugs · Part 522 — Implantation or Injectable Dosage Form New Animal Drugs · § 522.1450

§ 522.1450. Moxidectin solution.

330 words·~2 min read·/us/cfr/t21/s§ 522.1450

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Specifications. Each milliliter
(mL)of solution contains 10 milligrams
(mg)moxidectin.
(b)Sponsors. See Nos. 055529, 058198, and 061133 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 cattle—(1) Amount. Administer by subcutaneous injection 1 mL for each 110 pounds
(lb)(50 kilograms (kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight.
(2)Indications for use. Beef and nonlactating dairy cattle: For treatment and control of Gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum; Mites: Psoroptes ovis (Psoroptes communis var. bovis); Lice: Linognathus vituli and Solenopotes capillatus. For protection from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, with Haemonchus placei for 35 days after treatment, and with Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment.
(3)Limitations. Cattle must not be slaughtered for human consumption within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for preruminating calves. Do not use in calves to be processed for veal. [70 FR 36337, June 23, 2005, as amended at 71 FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, 2017; 86 FR 14820, Mar. 19, 2021; 88 FR 27699, May 3, 2023; 89 FR 95103, Dec. 2, 2024]
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