---
kind: "section"
citation: "21 C.F.R. § 522.1338"
title: "21"
number: "522.1338"
heading: "Medetomidine and vatinoxan."
url: "https://uscodex.org/cfr/21/522.1338"
---

# §522.1338. Medetomidine and vatinoxan.

- (a) **Specifications.** Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride.
- (b) **Sponsor.** See No. 043264 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m 2) BSA or use the dosing table provided in labeling.
  - (2) **Indications for use.** For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]

### Authority

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

### Source

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

### Amendments

[87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022]