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Federal regulations · Through 2026-08-25 · Newer source version available

21 CFR 529.536: Detomidine.

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Where this section sits in the code
  1. Title 21—Food and Drugs
  2. CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  3. SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
  4. PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

(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.

Collected 2026-08-27T02:24:47Z. Source file · JSON

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