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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 Nov 29, 2022.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.1225]



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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.1225 Ketoprofen.

(a) Specifications. Each milliliter of solution contains 100 milligrams (mg) ketoprofen.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter.

(1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this section.

(2) No. 061133 for use as in paragraph (d)(1) of this section.

(c) Related tolerances. See § 556.345 of this chapter.

(d) Conditions of use - (1) Horses - (i) Amount. Administer by intravenous injection 1.0 mg per pound (/lb) of body weight once daily for up to 5 days.

(ii) Indications for use. For alleviation of inflammation and pain associated with musculoskeletal disorders in horses.

(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.

(2) Cattle - (i) Amount. Administer by subcutaneous injection 3 mg per kilogram (1.36 mg/lb) of body weight once daily for up to 3 days.

(ii) Indications for use. For the control of pyrexia associated with bovine respiratory disease (BRD) in beef heifers, beef steers, beef calves 2 months of age and older, beef bulls, replacement dairy heifers, and dairy bulls.

(iii) Limitations. Not for use in reproducing animals over 1 year of age. Cattle must not be slaughtered for human consumption within 48 hours following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[86 FR 61685, Nov. 8, 2021]

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