21 CFR § 522.1962 - Promazine.

---
identifier: "/us/cfr/t21/s522.1962"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.1962 - Promazine."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.1962"
section_name: "Promazine."
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"
---


# 522.1962 Promazine.

(a) *Specifications.* Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride.

(b) *Sponsors.* See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section.

(2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section.

(c) *Conditions of use*—(1) *Horses*—(i) *Amount.* (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours.

(B) 0.2 to 0.5 mg/lb body weight intravenously as required.

(ii) *Indications for use.* (A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus.

(B) For use as a tranquilizer and preanesthetic.

(iii) *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.

(2) *Dogs and cats*—(i) *Amount.* 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours.

(ii) *Indications for use.* For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs.

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

[46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, Mar. 13, 2019]