21 CFR § 529.536
Detomidine
June 25, 2020
(a) Specifications. Each milliliter of gel contains 7.6 milligrams (mg) of detomidine hydrochloride.
(b) Sponsor. See No. 052483 in §510.600(c) of this chapter.
(c) Conditions of use in horses—(1) Amount. Administer 0.018 mg per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually.
(2) Indications for use. For sedation and restraint.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption.
[75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011]
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