21 CFR 522.536

§ 522.536 Detomidine.

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

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Citation: 21 CFR 522.536, § 522.536 Detomidine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87417
Permanent ID: ys:prov:87417@1
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Full text

(a) Specification. Each milliliter of solution contains 10 milligrams of detomidine hydrochloride. (b) Sponsor. See Nos. 015914, 052483, and 059399 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. For sedation, analgesia, or sedation and analgesia: 20 or 40 micrograms per kilogram (0.2 or 0.4 milliliter per 100 kilogram or 220 pounds) by body weight, depending on depth and duration required. For sedation, administer by intraveneous (IV) or intramuscular (IM) injection; for analgesia, administer by IV injection; for both sedation and analgesia, administer by IV injection. (2) Indication for use. As a sedative and analgesic to facilitate minor surgical and diagnostic procedures in mature horses and yearlings. (3) Limitations. Do not use in horses intended for human consumption. 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.