subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.2076"
section_subject: "Romifidine."
cfr_reference: "21 CFR 522.2076"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.