21 CFR § 520.43Chapter I

§ 520.43 Afoxolaner.

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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.

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Specifications.(a) Each chewable tablet contains 11.3, 28.3, 68, or 136 milligrams (mg) afoxolaner.

Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter.

Conditions of useAmount.(c) —(1) Administer orally once a month at a minimum dosage of 1.14 mg/pound (2.5 mg/kilogram).

Indications for use.Ctenocephalides felisIxodes scapularisDermacentor variabilisAmblyomma americanumRhipicephalus sanguineusHaemaphysalis longicornisBorrelia burgdorferiIxodes scapularis(2) Kills adult fleas and for the treatment and prevention of flea infestations (); and the treatment and control of (black-legged tick), (American dog tick), (lone star tick), (brown dog tick), and (longhorned tick) infestations in dogs and puppies 8 weeks of age and older, weighing 4 pounds of body weight or greater, for 1 month; and for the prevention of infections as a direct result of killing vector ticks.

Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[78 FR 66264, Nov. 5, 2013, as amended at 79 FR 37619, July 2, 2014; 84 FR 8972, Mar. 13, 2019; 84 FR 39182, Aug. 9, 2019; 88 FR 55563, Aug. 16, 2023]

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.