---
kind: "section"
citation: "21 C.F.R. § 522.246"
title: "21"
number: "522.246"
heading: "Butorphanol."
url: "https://uscodex.org/cfr/21/522.246"
---

# §522.246. Butorphanol.

- (a) **Specifications.** Each milliliter of solution contains butorphanol (as butorphanol tartrate) in the following amounts:
  - (1) 0.5 milligrams (mg);
  - (2) 2 mg; or
  - (3) 10 mg
- (b) **Sponsors.** See sponsors in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter as follows:
  - (1) **No.** 054771 for use of the product described in [paragraph (a)(1)](#a-1) as in [paragraph (d)(1)](#d-1) of this section; for use of the product described in [paragraph (a)(2)](#a-2) as in [paragraph (d)(2)](#d-2) of this section; and for use of the product described in [paragraph (a)(3)](#a-3) as in [paragraph (d)(3)](#d-3) of this section.
  - (2) **Nos.** 000061, 017033, and 059399 for use of the product described in [paragraph (a)(3)](#a-3) of this section as in [paragraph (d)(3)](#d-3) of this section.
- (c) **Special considerations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.
- (d) **Conditions of use—**
  - (1) **Dogs—**
    - (i) **Amount.** Administer 0.025 mg per pound of body weight by subcutaneous injection at intervals of 6 to 12 hours, as required. If necessary, increase dose to a maximum of 0.05 mg per pound of body weight. Treatment should not normally be required for longer than 7 days.
    - (ii) **Indications for use.** For the relief of chronic nonproductive cough associated with tracheo-bronchitis, tracheitis, tonsillitis, laryngitis, and pharyngitis associated with inflammatory conditions of the upper respiratory tract.
  - (2) **Cats—**
    - (i) **Amount.** Administer 0.2 mg per pound of body weight by subcutaneous injection. Dose may be repeated up to 4 times per day. Do not treat for more than 2 days.
    - (ii) **Indications for use.** For the relief of pain in cats caused by major or minor trauma, or pain associated with surgical procedures.
  - (3) **Horses—**
    - (i) **Amount.** Administer 0.05 mg per pound of body weight by intravenous injection. Dose may be repeated within 3 to 4 hours. Treatment should not exceed 48 hours.
    - (ii) **Indications for use.** For the relief of pain associated with colic and postpartum pain in adult horses and yearlings.
    - (iii) **Limitations.** Do not use in horses intended for human consumption.

## Notes

### Amendments

[72 FR 27957, May 18, 2007, as amended at 73 FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13229, Mar. 13, 2015; 87 FR 17945, Mar. 29, 2022; 88 FR 16547, Mar. 20, 2023; 91 FR 41560, July 7, 2026]

### Authority

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

### Source

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

### Amendments

[72 FR 27957, May 18, 2007, as amended at 73 FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13229, Mar. 13, 2015; 87 FR 17945, Mar. 29, 2022; 88 FR 16547, Mar. 20, 2023; 91 FR 41560, July 7, 2026]