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21CFR524.230

§ 524.230 Buprenorphine.

Regulation 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.

Authority

21 U.S.C. 360b.

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21CFR524.230 — § 524.230 Buprenorphine. | CFR Explorer | BioRegHub