---
kind: "section"
citation: "21 C.F.R. § 522.1720"
title: "21"
number: "522.1720"
heading: "Phenylbutazone."
url: "https://uscodex.org/cfr/21/522.1720"
---

# §522.1720. Phenylbutazone.

- (a) **Specifications.**
  - (1) **Each milliliter of solution contains 100 milligrams (mg) of phenylbutazone.**
  - (2) **Each milliliter of solution contains 200 mg of phenylbutazone.**
- (b) **Sponsors.** See sponsor numbers in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter for use as in [paragraph (c)](#c) of this section:
  - (1) **No.** 054771 for use of product described in [paragraph (a)(1)](#a-1) as in [paragraph (c)](#c) of this section.
  - (2) **Nos.** 000061, 054771, 058198, and 061133 for use of product described in [paragraph (a)(2)](#a-2) of this section as in [paragraph (c)](#c) of this section.
  - (3) **Nos.** 058005 and 069043 for use of product described in [paragraph (a)(2)](#a-2) as in [paragraph (c)(2)](#c-2) of this section.
- (c) **Conditions of use—**
  - (1) **Dogs—**
    - (i) **Amount.** Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow.
    - (ii) **Indications for use.** It is used for the relief of inflammatory conditions associated with the musculoskeletal system.
    - (iii) **Limitations.** Federal law restricts this drug to use by or on the order of a licensed veterinarian.
  - (2) **Horses—**
    - (i) **Amount.** Administer by intravenous injection 1 to 2 grams (g) per 1,000 pounds of body weight daily in three divided doses, not to exceed 4 g daily. Limit intravenous administration to not more than 5 successive days.
    - (ii) **Indications for use.** For the relief of inflammatory conditions associated with the musculoskeletal system.
    - (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.

## Notes

### Amendments

[79 FR 16193, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021]

### Authority

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

### Source

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

### Amendments

[79 FR 16193, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021]