---
kind: "section"
citation: "21 C.F.R. § 522.558"
title: "21"
number: "522.558"
heading: "Dexmedetomidine."
url: "https://uscodex.org/cfr/21/522.558"
---

# §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)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section:
  - (1) **Nos.** 017033, 068504, 069043, 086101, and 086117 for use of product described in [paragraph (a)(2)](#a-2) of this section.
  - (2) **No.** 052483 for use of products described in [paragraph (a)](#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 2) of body surface area by intravenous injection or 500 µg/m 2 of body surface area by intramuscular injection.
      - (B) For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 of body surface area or 375 µg/m 2 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.

## Notes

### Amendments

[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]

### Authority

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

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

[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]