CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS > 529.536—Detomidine.

529.536—Detomidine.

(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.

Code of Federal Regulations

[75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011]