21 CFR 529.539

§ 529.539 Dexmedetomidine.

United States · 21 CFR — Food and Drugs · Status: effective

Cite this

Citation: 21 CFR 529.539, § 529.539 Dexmedetomidine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87686
Permanent ID: ys:prov:87686@1
SHA-256: 137b9a861d6ae1ac2426bb7dd26fcd9511b1aaa95cf03a37049b5e296ac38852

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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.