---
kind: "section"
citation: "21 C.F.R. § 522.52"
title: "21"
number: "522.52"
heading: "Alfaxalone."
url: "https://uscodex.org/cfr/21/522.52"
---

# §522.52. Alfaxalone.

- (a) **Specifications.** Each milliliter contains 10 milligrams (mg) alfaxalone.
- (b) **Sponsor.** See No. 054771 in [§ 510.600(c)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 360b.

### Source

Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.

### Amendments

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