---
kind: "section"
citation: "21 C.F.R. § 520.980"
title: "21"
number: "520.980"
heading: "Fluoxetine."
url: "https://uscodex.org/cfr/21/520.980"
---

# §520.980. Fluoxetine.

- (a) **Specifications.** Each chewable tablet contains 8, 16, 32, or 64 milligrams (mg) fluoxetine hydrochloride.
- (b) **Sponsor.** See No. 055246 in [§ 510.600](/cfr/21/510.600.md) of this chapter.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** 1 to 2 mg per kilogram body weight once daily.
  - (2) **Indications for use.** For the treatment of canine separation anxiety in conjunction with a behavior modification plan.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017]

### Authority

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

### Source

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

### Amendments

[72 FR 6463, Feb. 12, 2007, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017]