21 CFR § 520.1892 - Pregabalin.

---
identifier: "/us/cfr/t21/s520.1892"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1892 - Pregabalin."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1892"
section_name: "Pregabalin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1892 Pregabalin.

(a) *Specifications.* Each milliliter (mL) of solution contains 50 milligrams (mg) pregabalin.

(b) *Sponsor.* See No. 052483 in § 510.600(c) of this chapter.

(c) *Conditions of use*—(1) *Amount.* Administer orally as a single dose of 5 mg/kg (0.1 mL/kg) approximately 1.5 hours before the start of the transportation or veterinary visit.

(2) *Indications for use.* For alleviation of acute anxiety and fear associated with transportation and veterinary visits.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[89 FR 14410, Feb. 27, 2024]