21 CFR § 522.2076 - Romifidine.

---
identifier: "/us/cfr/t21/s522.2076"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.2076 - Romifidine."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.2076"
section_name: "Romifidine."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "522"
part_name: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.2076 Romifidine.

(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.

[69 FR 47363, Aug. 5, 2004, as amended at 79 FR 16195, Mar. 25, 2014]