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21 CFR 520.1445

§ 520.1445 Milbemycin oxime and praziquantel.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 520.1445, § 520.1445 Milbemycin oxime and praziquantel, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87233
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(a) Specifications. Each chewable tablet contains: (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel; (2) 5.75 mg milbemycin oxime and 57 mg praziquantel; (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or (4) 23 mg milbemycin oxime and 228 mg praziquantel. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel. (ii) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved]

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.