---
kind: "section"
citation: "21 C.F.R. § 520.304"
title: "21"
number: "520.304"
heading: "Carprofen."
url: "https://uscodex.org/cfr/21/520.304"
---

# §520.304. Carprofen.

- (a) **Specifications.**
  - (1) **Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.**
  - (2) **Each chewable tablet contains 25, 75, or 100 mg carprofen.**
  - (3) Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
  - (4) **Each flavored tablet contains 25, 75, or 100 mg carprofen.**
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section.
  - (1) **Nos.** 054771, 055529, and 082983 for use of products described in paragraphs [(a)(1)](#a-1) and [(a)(2)](#a-2) of this section as in [paragraph (c)](#c) of this section.
  - (2) **Nos.** 058198, 086101 and 086117 for use of product described in [paragraph (a)(2)](#a-2) as in [paragraph (c)](#c) of this section.
  - (3) **No.** 069043 for use of product described in [paragraph (a)(3)](#a-3) of this section as in [paragraph (c)](#c) of this section.
  - (4) **No.** 086101 for use of product described in paragraphs [(a)(1)](#a-1), [(a)(2)](#a-2), and [(a)(4)](#a-4) of this section as in [paragraph (c)](#c) of this section.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** 2 mg per pound (/lb) of body weight once daily or 1 mg/lb twice daily. For the control of postoperative pain, administer approximately 2 hours before the procedure.
  - (2) **Indications for use.** For the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
  - (3) **Limitations.** Federal Law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redesignated and amended at 80 FR 13229, Mar. 13, 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 88 FR 27698, May 3, 2023; 89 FR 42357, May 15, 2024; 89 FR 95103, Dec. 2, 2024; 90 FR 19625, May 9, 2025; 90 FR 40969, Aug. 22, 2025]

### Authority

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

### Source

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

### Amendments

[61 FR 66581, Dec. 18, 1996, as amended at 64 FR 32181, June 16, 1999; 66 FR 63165, Dec. 5, 2001; 67 FR 6866, Feb. 14, 2002; 67 FR 65038, Oct. 23, 2002; 67 FR 65697, Oct. 28, 2002; 70 FR 30626, May 27, 2005; 71 FR 51995, Sept. 1, 2006; 72 FR 68478, Dec. 5, 2007; 74 FR 21768, May 11, 2009; 78 FR 52853, Aug. 27, 2013; 78 FR 66264, Nov. 5, 2013; 79 FR 28819, May 20, 2014. Redesignated and amended at 80 FR 13229, Mar. 13, 2015; 80 FR 34278, June 16, 2015; 80 FR 61296, Oct. 13, 2015; 82 FR 43484, Sept. 18, 2017; 84 FR 12493, Apr. 2, 2019; 85 FR 4207, Jan. 24, 2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14817, Mar. 19, 2021; 86 FR 61684, Nov. 8, 2021; 88 FR 27698, May 3, 2023; 89 FR 42357, May 15, 2024; 89 FR 95103, Dec. 2, 2024; 90 FR 19625, May 9, 2025; 90 FR 40969, Aug. 22, 2025]