eCFR Reference Browser

---

title: "21 CFR §520.538"

source: "https://www.ecfr.gov/current/title-21/section-520.538"

title_number: "21"

volume_number: "6"

chapter_number: "Unknown"

subchapter_code: "E"

subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"

part_code: "520"

part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"

subpart_code: "B"

subpart_subject: "Specific Administrative Rulings and Decisions"

section_number: "520.538"

section_subject: "Deracoxib."

cfr_reference: "21 CFR 520.538"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 500 to 599"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Specifications. Each tablet contains 12, 25, 50, 75, or 100 milligrams (mg) deracoxib.

(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c)[Reserved]

(d)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.

§520.538 - Deracoxib.