21 CFR § 520.23 - Acepromazine.

---
identifier: "/us/cfr/t21/s520.23"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.23 - Acepromazine."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.23"
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: "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"
---


# 520.23 Acepromazine.

(a) *Specifications.* Each tablet contains 10 or 25 milligrams (mg) acepromazine maleate.

(b) *Sponsors.* See Nos. 000010 and 086117 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* 0.25 to 1.0 mg per pound (/lb) body weight orally.

(ii) *Indications for use.* As an aid in tranquilization and as a preanesthetic agent.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) *Cats*—(i) *Amount.* 0.5 to 1.0 mg/lb body weight orally.

(ii) *Indications for use.* As a tranquilizer.

(iii) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[75 FR 10165, Mar. 5, 2010, as amended at 88 FR 84699, Dec. 6, 2023]