21 CFR 524.230

§ 524.230 Buprenorphine.

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

Cite this

Citation: 21 CFR 524.230, § 524.230 Buprenorphine, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87572
Permanent ID: ys:prov:87572@1
SHA-256: 385f81236a52cb976552560c58df67a8ef93f219071dd5d2ae105e1fa21252d9

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(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.

Legislative history

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