---
kind: "section"
citation: "21 C.F.R. § 529.539"
title: "21"
number: "529.539"
heading: "Dexmedetomidine."
url: "https://uscodex.org/cfr/21/529.539"
---

# §529.539. Dexmedetomidine.

- (a) **Specifications.** Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride).
- (b) **Sponsor.** See No. 052483 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer onto the oral mucosa between the dog's cheek and gum at a dose of 125 micrograms per square meter.
  - (2) **Indications for use.** For the treatment of noise aversion in dogs.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[81 FR 17608, Mar. 30, 2016]

### Authority

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

### Source

Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.

### Amendments

[81 FR 17608, Mar. 30, 2016]