21 CFR § 522.224 - Bupivacaine.

---
identifier: "/us/cfr/t21/s522.224"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 522.224 - Bupivacaine."
title_number: 21
title_name: "Food and Drugs"
section_number: "522.224"
section_name: "Bupivacaine."
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: "522"
part_name: "IMPLANTATION OR INJECTABLE 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 13858, Mar. 27, 1975, unless otherwise noted."
cfr_part: "522"
---


# 522.224 Bupivacaine.

(a) *Specifications.* Each milliliter (mL) of liposomal suspension contains 13.3 milligrams (mg) bupivacaine.

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

(c) *Conditions of use*—(1) *Dogs*—(i) *Amount.* Administer 5.3 mg/kg (0.4 mL/kg) by infiltration injection into the tissue layers at the time of incisional closure.

(ii) *Indications for use.* For single-dose infiltration into the surgical site to provide local postoperative analgesia for cranial cruciate ligament surgery.

(2) *Cats*—(i) *Amount.* Administer 5.3 mg/kg per forelimb (0.4 mL/kg per forelimb), for a total dose of 10.6 mg/kg/cat, as a 4-point nerve block prior to onychectomy.

(ii) *Indications for use.* For use as a peripheral nerve block to provide regional postoperative analgesia following onychectomy.

[81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020]