21 CFR § 524.1450 - Moxidectin.

---
identifier: "/us/cfr/t21/s524.1450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1450 - Moxidectin."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1450"
section_name: "Moxidectin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.1450 Moxidectin.

(a) *Specifications.* Each milliliter of solution contains:

(1) 5 milligrams (mg) moxidectin (0.5 percent solution).

(2) 25 mg moxidectin (2.5 percent solution).

(b) *Sponsors.* See sponsor numbers in § 510.600 of this chapter:

(1) No. 058198 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; and

(2) No. 058198 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.

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

(d) *Conditions of use*—(1) *Cattle*—(i) *Amount.* Administer topically 0.5 mg per kilogram (kg) of body weight.

(ii) *Indications for use.* Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (*Ostertagia ostertagi* (adult and L4, including inhibited larvae), *Haemonchus placei* (adult and L4), *Trichostrongylus axei* (adult and L4), *T. colubriformis* (adult and L4), *Cooperia oncophora* (adult and L4), *C. pectinata* (adult), *C. punctata* (adult and L4), *C. spatulata* (adult), *C. surnabada* (adult and L4), *Bunostomum phlebotomum* (adult), *Oesophagostomum radiatum* (adult and L4), *Nematodirus helvetianus* (adult and L4)); lungworms (*Dictyocaulus viviparus* (adult and L4)); cattle grubs (*Hypoderma bovis, H. lineatum*); mites (*Chorioptes bovis, Psoroptes ovis* (*P. communis* var. *bovis*)); lice (*Linognathus vituli, Haematopinus eurysternus,* *Solenopotes capillatus, Bovicola* (*Damalinia*) *bovis*); and horn flies (*Haematobia irritans*). To control infections and to protect from reinfection with *H. placei* for 14 days after treatment, *O. radiatum* and *O. ostertagi* for 28 days after treatment, and *D. viviparus* for 42 days after treatment.

(iii) *Limitations.* A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal. See § 500.25 of this chapter.

(2) *Dogs*—(i) *Amount.* Administer topically a minimum of 1.1 mg per pound (lb) (2.5 mg/kg) of body weight, once monthly using the appropriate preloaded applicator tube.

(ii) *Indications for use.* For the prevention of heartworm disease caused by *Dirofilaria immitis,* as well as the treatment and control of intestinal hookworm (*Ancylostoma caninum* (adult, immature adult, and L4 larvae) and *Uncinaria stenocephala* (adult, immature adult, and L4 larvae)), roundworm (*Toxocara canis* (adult and L4 larvae) and *Toxascaris leonina* (adult)), and whipworm (*Trichuris vulpis* (adult)) infections in dogs and puppies that are at least 7 weeks of age and that weigh at least 3 lbs.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, 2001. Redesignated at 76 FR 48715, Aug. 9, 2011, as amended at 80 FR 53460, Sept. 4, 2015; 82 FR 21691, May 10, 2017; 86 FR 14821, Mar. 19, 2021]