21 CFR § 520.980 - Fluoxetine.

---
identifier: "/us/cfr/t21/s520.980"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.980 - Fluoxetine."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.980"
section_name: "Fluoxetine."
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: "520"
part_name: "ORAL 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 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 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 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.

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