---
kind: "section"
citation: "21 C.F.R. § 522.2076"
title: "21"
number: "522.2076"
heading: "Romifidine."
url: "https://uscodex.org/cfr/21/522.2076"
---

# §522.2076. Romifidine.

- (a) **Specifications.** Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride.
- (b) **Sponsor.** See No. 000010 in [§ 510.600(c)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

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