---
kind: "section"
citation: "21 C.F.R. § 522.224"
title: "21"
number: "522.224"
heading: "Bupivacaine."
url: "https://uscodex.org/cfr/21/522.224"
---

# §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)](/cfr/21/510.600.md?p=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.

## Notes

### Amendments

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

### Authority

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

### Source

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

### Amendments

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