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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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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).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2130]



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. 520.2130 Spinosad.

(a) Specifications. Each chewable tablet contains 140, 270, 560, 810, or 1620 milligrams (mg) spinosad.

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

(c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(d) Conditions of use - (1) Dogs - (i) Amount. Administer tablets once a month at a recommended minimum dosage of 13.5 mg per pound (30 mg per kilogram) of body weight.

(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (Ctenocephalides felis ) for 1 month on dogs and puppies 14 weeks of age and older and 3.3 pounds of body weight or greater.

(2) Cats - (i) Amount. Administer tablets once a month at a minimum dosage of 22.5 mg per pound (50 mg per kilogram) of body weight.

(ii) Indications for use. To kill fleas and for the prevention and treatment of flea infestations (C. felis ) for 1 month on cats and kittens 14 weeks of age and older and 2 pounds of body weight or greater.

[77 FR 60623, Oct. 4, 2012, as amended at 81 FR 48702, July 26, 2016; 87 FR 10968, Feb. 28, 2022]

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