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Electronic Code of Federal Regulations

e-CFR data is current as of December 11, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1720


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


§522.1720   Phenylbutazone.

(a) Specifications—(1) Each milliliter of solution contains 100 milligrams (mg) of phenylbutazone.

(2) Each milliliter of solution contains 200 mg of phenylbutazone.

(b) Sponsors. See sponsor numbers in §510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section.

(2) Nos. 000061, 000859, 054771, and 061133 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.

(3) Nos. 058005 and 069043 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section.

(c) Conditions of use—(1) Dogs—(i) Amount. Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.

(ii) Indications for use. It is used for the relief of inflammatory conditions associated with the musculoskeletal system.

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

(2) Horses—(i) Amount. Administer by intravenous injection 1 to 2 grams (g) per 1,000 pounds of body weight daily in three divided doses, not to exceed 4 g daily. Limit intravenous administration to not more than 5 successive days.

(ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system.

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16193, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019]

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