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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 524 - Ophthalmic and Topical Dosage Form New Animal Drugs |
§ 524.916 - Fentanyl.
Latest version.
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§ 524.916 Fentanyl.
(a) Specifications. Each milliliter of solution contains 50 milligrams (mg) fentanyl.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Conditions of use -
(1) Dogs -
(i) Amount. 1.2 mg/lb (2.7 mg/kg) applied topically to the dorsal scapular area 2 to 4 hours prior to surgery.
(ii) Indications for use. For the control of postoperative pain associated with surgical procedures in dogs.
(iii) Limitations. Fentanyl is a Class II controlled substance. Observe all “black-box warnings” on product labeling. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]
[77 FR 47512, Aug. 9, 2012, as amended at 79 FR 44433, July 24, 2013; 81 FR 48703, July 26, 2016]