---
kind: "section"
citation: "21 C.F.R. § 520.538"
title: "21"
number: "520.538"
heading: "Deracoxib."
url: "https://uscodex.org/cfr/21/520.538"
---

# §520.538. Deracoxib.

- (a) **Specifications.** Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.
- (b) **Sponsors.** See Nos. 013744, 058198, and 086101 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Administer orally as needed, as a single daily dose based on body weight:
    - (i) 1 to 2 mg/kilogram (kg) (0.45 to 0.91 mg/pound (lb)), for use as in paragraph (d)(2)(i) of this section.
    - (ii) 1 to 2 mg/kg (0.45 to 0.91 mg/lb) for 3 days, for use as in paragraph (d)(2)(ii) of this section.
    - (iii) 3 to 4 mg/kg (1.4 to 1.8 mg/lb) for up to 7 days, for use as in paragraph (d)(2)(iii) of this section.
  - (2) **Indications for use.**
    - (i) **For the control of pain and inflammation associated with osteoarthritis.**
    - (ii) **For the control of postoperative pain and inflammation associated with dental surgery.**
    - (iii) **For the control of postoperative pain and inflammation associated with orthopedic surgery.**
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019; 86 FR 61684, Nov. 8, 2021]

### Authority

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

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[67 FR 68760, Nov. 13, 2002, as amended at 68 FR 18882, Apr. 17, 2003; 72 FR 37437, July 10, 2007; 73 FR 33692, June 13, 2008; 77 FR 3928, Jan. 26, 2012; 84 FR 39183, Aug. 9, 2019; 86 FR 61684, Nov. 8, 2021]