21 C.F.R. § 522.1450
Moxidectin solution.
Cite as 21 C.F.R. § 522.1450 (2026)
(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]
- Cross-references to the CFR
- 500.25510.600556.426