§520.304. Carprofen.
21 C.F.R. § 520.304
Specifications.
Each caplet contains 25, 75, or 100 milligrams (mg) carprofen.
Each chewable tablet contains 25, 75, or 100 mg carprofen.
Each chewable tablet contains 25, 37.5, 50, 75, or 100 mg carprofen.
Each flavored tablet contains 25, 75, or 100 mg carprofen.
Nos. 054771, 055529, and 082983 for use of products described in paragraphs (a)(1) and (a)(2) of this section as in paragraph (c) of this section.
Nos. 058198, 086101 and 086117 for use of product described in paragraph (a)(2) as in paragraph (c) of this section.
No. 069043 for use of product described in paragraph (a)(3) of this section as in paragraph (c) of this section.
No. 086101 for use of product described in paragraphs (a)(1), (a)(2), and (a)(4) of this section as in paragraph (c) of this section.
Conditions of use in dogs—
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.
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.
Limitations. Federal Law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
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]