21 CFR § 522.52 - Alfaxalone.

---
identifier: "/us/cfr/t21/s522.52"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.52 - Alfaxalone."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.52"
section_name: "Alfaxalone."
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"
---


# 522.52 Alfaxalone.

(a) *Specifications.* Each milliliter contains 10 milligrams (mg) alfaxalone.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in cats and dogs*—(1) *Amount*—(i) *Cats*—(A) *Induction of general anesthesia.* Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.

(B) *Maintenance of general anesthesia following induction.* Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.

(ii) *Dogs*—(A) *Induction of general anesthesia.* Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.

(B) *Maintenance of general anesthesia following induction.* Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.

(2) *Indications for use.* For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in dogs and cats.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. Alfaxalone is a Class IV controlled substance.

[77 FR 64717, Oct. 23, 2012, as amended at 79 FR 64116, Oct. 28, 2014; 88 FR 84700, Dec. 6, 2023]