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21 CFR § 522.1225 - Ketoprofen.

---
identifier: "/us/cfr/t21/s522.1225"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1225 - Ketoprofen."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1225"
section_name: "Ketoprofen."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---

# 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]