CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.2134]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2134 Spinosad and milbemycin.

(a) Specifications. Each chewable tablet contains 140 milligrams (mg) spinosad and 2.3 mg milbemycin oxime, 270 mg spinosad and 4.5 mg milbemycin oxime, 560 mg spinosad and 9.3 mg milbemycin oxime, 810 mg spinosad and 13.5 mg milbemycin oxime, or 1,620 mg spinosad and 27 mg milbemycin oxime.

(b) Sponsor. See No. 058198 in § 510.600 of this chapter.

(c) Conditions of use in dogs - (1) Amount. Administer once a month at a minimum dosage of 13.5 mg/pound (lb) (30 mg/kilogram (kg)) of body weight spinosad and 0.2 mg/lb (0.5 mg/kg) of body weight milbemycin oxime.

(2) Indications for use. To kill fleas; for the prevention and treatment of flea infestations (Ctenocephalides felis ); for the prevention of heartworm disease (Dirofilaria immitis ); and for the treatment and control of adult hookworm (Ancylostoma caninum ), adult roundworm (Toxocara canis and Toxascaris leonina ), and adult whipworm (Trichuris vulpis ) infections in dogs and puppies 8 weeks of age or older and 5 lbs of body weight or greater.

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

[76 FR 12563, Mar. 8, 2011, as amended at 81 FR 48702, July 26, 2016]