---
kind: "section"
citation: "21 C.F.R. § 522.2005"
title: "21"
number: "522.2005"
heading: "Propofol."
url: "https://uscodex.org/cfr/21/522.2005"
---

# §522.2005. Propofol.

- (a) **Specifications.** Each milliliter of emulsion contains 10 milligrams (mg) propofol.
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
  - (1) **No.** 086064 for use as in paragraphs [(c)(1)](#c-1), [(c)(2)(i)](#c-2-i), (c)(3), (d)(1), [(d)(2)(i)](#d-2-i), and (d)(3) of this section.
  - (2) **No.** 054771 for use as in paragraphs [(c)(1)](#c-1), [(c)(2)(ii)](#c-2-ii), (c)(3), (d)(1), [(d)(2)(ii)](#d-2-ii), and (d)(3) of this section.
  - (3) **Nos.** 054771 and 068504 for use as in paragraphs [(c)(1)](#c-1), [(c)(2)(iii)](#c-2-iii), and (c)(3) of this section.
- (c) **Conditions of use in dogs—**
  - (1) **Amount.** Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.
  - (2) **Indications for use.**
    - (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
    - (ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
    - (iii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- (d) **Conditions of use in cats—**
  - (1) **Amount.** Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.
  - (2) **Indications for use.**
    - (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics.
    - (ii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic.
  - (3) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.

## Notes

### Amendments

[75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016; 90 FR 6800, Jan. 21, 2025; 90 FR 19625, May 9, 2025]

### Authority

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

### Source

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

### Amendments

[75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016; 90 FR 6800, Jan. 21, 2025; 90 FR 19625, May 9, 2025]