21 CFR § 520.1441Chapter I

§ 520.1441 Milbemycin.

Primary source

Verbatim text below is from the Electronic Code of Federal Regulations (eCFR), a public-domain U.S. government work. Always verify the current version with the eCFR before relying on it for any legal matter.

Full Text

Specifications.(a) Each flavored tablet contains 2.3, 5.75, 11.5, or 23.0 milligrams (mg) of milbemycin oxime.

Sponsors.(b) See Nos. 013744 and 058198 in § 510.600(c) of this chapter.

Conditions of useDogsAmount.(c) —(1) —(i) For hookworm, roundworm, and whipworm, administer 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)). For heartworm, administer 0.05 mg/lb of body weight (0.1 mg/kg). Administer once a month.

Indications for use.Dirofilaria immitis,Ancylostoma caninum,Toxocara canisToxascaris leoninaTrichuris vulpis(ii) For prevention of heartworm disease caused by control of hookworm infections caused by and removal and control of adult roundworm infections caused by and and whipworm infections caused by in dogs and puppies 4 weeks of age or greater and 2 pounds body weight or greater.

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

CatsAmount.(2) —(i) Administer 0.91 mg/lb of body weight (2.0 mg/kg) once a month.

Indications for use.Dirofilaria immitisToxocara catiAncylostoma tubaeforme(ii) For prevention of heartworm disease caused by and the removal of adult (roundworm) and (hookworm) infections in cats 6 weeks of age or greater and 1.5 pounds body weight or greater.

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

[84 FR 12494, Apr. 2, 2019]

eCFR data current as of: June 10, 2026

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.