---
kind: "section"
citation: "21 C.F.R. § 520.1615"
title: "21"
number: "520.1615"
heading: "Omeprazole."
url: "https://uscodex.org/cfr/21/520.1615"
---

# §520.1615. Omeprazole.

- (a) **Specifications.** Each gram of paste contains 0.37 gram omeprazole.
- (b) **Sponsor.** See No. 000010 in [§ 510.600(c)](/cfr/21/510.600.md?p=c) of this chapter.
- (c) **Special considerations.** When labeled for use as in [paragraph (d)(2)(i)](#d-2-i) of this section, product labeling shall bear: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
- (d) **Conditions of use in horses—**
  - (1) **Amount.**
    - (i) For treatment of gastric ulcers, 1.8 milligrams per pound (mg/lb) of body weight (4 milligrams per kilogram (mg/kg)) once daily for 4 weeks. For prevention of recurrence of gastric ulcers, 0.9 mg/lb of body weight (2 mg/kg) once daily for at least an additional 4 weeks.
    - (ii) **For prevention of gastric ulcers using the premarked syringe, one dose per day for 8 or 28 days.** Each dose delivers at least 1 mg/kg of body weight. Horses over 1,200 lb body weight should receive two doses per day.
  - (2) **Indications for use.**
    - (i) For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.
    - (ii) **For prevention of gastric ulcers in horses.**
  - (3) **Limitations.** Do not use in horses intended for human consumption.

## Notes

### Amendments

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]

### Authority

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

### Source

Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.

### Amendments

[69 FR 13220, Mar. 22, 2004, as amended at 71 FR 59374, Oct. 10, 2006; 84 FR 39183, Aug. 9, 2019]