21 CFR § 522.23 - Acepromazine.

---
identifier: "/us/cfr/t21/s522.23"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.23 - Acepromazine."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.23"
section_name: "Acepromazine."
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: "522"
part_name: "IMPLANTATION OR INJECTABLE 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 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.23 Acepromazine.

(a) *Specifications.* Each milliliter of solution contains 10 milligrams (mg) acepromazine maleate.

(b) *Sponsors.* See Nos. 000010 and 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs, cats, and horses*—(1) *Amount.* Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight.

(2) *Indications for use.* For use as a tranquilizer and as a preanesthetic agent.

(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.

[75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16182, Mar. 25, 2014; 86 FR 14819, Mar. 19, 2021]