21 CFR 522.1335

§ 522.1335 Medetomidine.

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

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Citation: 21 CFR 522.1335, § 522.1335 Medetomidine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87479
Permanent ID: ys:prov:87479@1
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Full text

(a) Specifications. Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride. (b) Sponsor. See Nos. 015914 and 052483 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care. (2) Indications for use. As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care. (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.