21 CFR 522.2076

§ 522.2076 Romifidine.

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

Cite this

Citation: 21 CFR 522.2076, § 522.2076 Romifidine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87530
Permanent ID: ys:prov:87530@1
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Full text

(a) Specifications. Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in horses—(1) Amount. 40 to 120 micrograms per kilogram of body weight (mcg/kg BW) intravenously for sedation and analgesia; 100 mcg/kg BW intravenously as a preanesthetic. (2) Indications for use. For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses; and for use as a preanesthetic prior to the induction of general anesthesia in adult horses. (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.