21 CFR 522.224

§ 522.224 Bupivacaine.

United States · 21 CFR — Food and Drugs · Status: effective

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Citation: 21 CFR 522.224, § 522.224 Bupivacaine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87396
Permanent ID: ys:prov:87396@1
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.