---
kind: "section"
citation: "21 C.F.R. § 520.455"
title: "21"
number: "520.455"
heading: "Clomipramine."
url: "https://uscodex.org/cfr/21/520.455"
---

# §520.455. Clomipramine.

- (a) **Specifications.** Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.
- (b) **Sponsors.** See Nos. 051311, 086039, and 086101 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Conditions of use—**
  - (1) **Amount.** 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.
  - (2) **Indications for use.** For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021; 91 FR 20340, Apr. 16, 2026]

### Authority

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

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007; 86 FR 57996, Oct. 20, 2021; 91 FR 20340, Apr. 16, 2026]