Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 516.900: Fluralaner.

(a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) of fluralaner
(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. 2.5 mg per kilogram (1.13 mg per one pound).
(2) Indications for use. For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Environmental temperature affects the withdrawal period. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60 °F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60 °F after administration and are slaughtered at 44 days. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows: use in these cattle may cause drug residues in milk and/or calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

Where this section sits in the code

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 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart E—Conditionally Approved New Animal Drugs For Minor Use and Minor Species

(a) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) of fluralaner

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(2) Indications for use. For the prevention and treatment of infestations caused by New World screwworm (Cochliomyia hominivorax) larvae (myiasis) and treatment and control of cattle fever tick (Rhipicephalus microplus) in beef cattle 2 months of age and older and replacement dairy heifers less than 20 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Environmental temperature affects the withdrawal period. Cattle must not be slaughtered for human consumption within 98 days of treatment. If cattle are continuously exposed to temperatures at or above 60 °F after product administration, then cattle may be slaughtered for human consumption 44 days after treatment. Violative residues may result if cattle are exposed to temperatures below 60 °F after administration and are slaughtered at 44 days. Not for use in female dairy cattle 20 months of age or older, including dry dairy cows: use in these cattle may cause drug residues in milk and/or calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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