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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1185


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1185   Isoflupredone.

(a) Specifications. Each milliliter of suspension contains 2 milligrams (mg) of isoflupredone acetate.

(b) Sponsor. See No. 054771 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Cattle—(i) Amount. Administer 10 to 20 mg by intramuscular injection.

(ii) Indications for use. For use in the treatment of bovine ketosis. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.

(iii) Limitations. Animals intended for human consumption should not be slaughtered within 7 days of last treatment. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Horses and swine—(i) Amount—(A) Horses. Administer 5 to 20 mg by intramuscular injection for systemic effect or by intrasynovial injection into a joint cavity, tendon sheath, or bursa for local effect.

(B) Swine. The usual dose for a 300-pound animal is 5 mg by intramuscular injection.

(ii) Indications for use. For alleviation of pain associated with generalized and acute localized arthritic conditions; for treating acute hypersensitivity reactions; and as an aid in correcting circulatory defects associated with severe toxicity and shock.

(iii) Limitations. Animals intended for human consumption should not be slaughtered within 7 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16190, Mar. 25, 2014]

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