21 CFR § 524.230 - Buprenorphine.

---
identifier: "/us/cfr/t21/s524.230"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.230 - Buprenorphine."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.230"
section_name: "Buprenorphine."
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: "524"
part_name: "OPHTHALMIC AND TOPICAL 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 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 524.230 Buprenorphine.

(a) *Specifications.* Each milliliter (mL) of solution contains 20 milligrams (mg) buprenorphine. The drug is supplied in tubes containing 0.4 mL (8 mg) or 1.0 mL (20 mg).

(b) *Sponsor.* See No. 058198 in § 510.600(c) of this chapter.

(c) *Conditions of use in cats*—(1) *Amount.* Administer topically to the dorsal cervical area at the base of the skull a single dose of 1.2 to 3.1 mg/lb (2.7 to 6.7 mg/kg) approximately 1 to 2 hours before surgery.

(2) *Indications for use.* For the control of postoperative pain associated with surgical procedures in cats.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian. Buprenorphine is a Schedule III controlled substance.

[87 FR 58962, Sept. 29, 2022]