21 CFR § 529.539 - Dexmedetomidine.

---
identifier: "/us/cfr/t21/s529.539"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 529.539 - Dexmedetomidine."
title_number: 21
title_name: "Food and Drugs"
section_number: "529.539"
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: "529"
part_name: "CERTAIN OTHER 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 13881, Mar. 27, 1975, unless otherwise noted."
cfr_part: "529"
---


# 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) 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.

[81 FR 17608, Mar. 30, 2016]