---
kind: "section"
citation: "21 C.F.R. § 522.1225"
title: "21"
number: "522.1225"
heading: "Ketoprofen."
url: "https://uscodex.org/cfr/21/522.1225"
---

# §522.1225. Ketoprofen.

- (a) **Specifications.** Each milliliter of solution contains 100 milligrams (mg) ketoprofen.
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 054771 for use as in paragraphs [(d)(1)](#d-1) and [(d)(2)](#d-2) of this section.
  - (2) **No.** 061133 for use as in [paragraph (d)(1)](#d-1) of this section.
- (c) **Related tolerances.** See [§ 556.345](/cfr/21/556.345.md) 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.

## Notes

### Amendments

[86 FR 61685, Nov. 8, 2021]

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[86 FR 61685, Nov. 8, 2021]