21 CFR § 522.558 - Dexmedetomidine.

---
identifier: "/us/cfr/t21/s522.558"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.558 - Dexmedetomidine."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.558"
section_name: "Dexmedetomidine."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.558 Dexmedetomidine.

(a) *Specifications.* Each milliliter of solution contains:

(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or

(2) 0.5 mg dexmedetomidine hydrochloride.

(b) *Sponsors.* See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) Nos. 017033, 068504, 069043, 086101, and 086117 for use of product described in paragraph (a)(2) of this section.

(2) No. 052483 for use of products described in paragraph (a) of this section.

(c) *Conditions of use*—(1) *Dogs*—(i) *Indications for use and amount.* (A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m
<sup>2</sup>) of body surface area by intravenous injection or 500 µg/m
<sup>2</sup> of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m
<sup>2</sup> of body surface area or 375 µg/m
<sup>2</sup> of body surface area by intramuscular injection.

(ii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) *Cats*—(i) *Amount.* 40 µg/killogram by intramuscular injection.

(ii) *Indications for use.* For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, Mar. 13, 2015; 86 FR 57997, Oct. 20, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 27699, May 3, 2023; 88 FR 84701, Dec. 6, 2023; 91 FR 5301, Feb. 6, 2026]