Any material, compound, mixture, or preparation that contains medetomidine is a Schedule III controlled drug or substance, except in the following cases: (1) Dispensing, prescribing, or administering, to an animal, a drug that contains medetomidine and has been approved by the United States secretary of health and human services under 21 U.S.C. § 360b (January 1, 2026); (2) Dispensing, prescribing, or administering medetomidine to an animal, as permissible under 21 U.S.C. § 360b(a)(4) (January 1, 2026); (3) Manufacturing, distributing, or using medetomidine as an active pharmaceutical ingredient for manufacturing an animal drug: (a) Approved under 21 U.S.C. § 360b (January 1, 2026); or (b) Issued an investigational use exemption under 21 U.S.C. § 360b(j) (January 1, 2026); (4) Manufacturing, distributing, or using a medetomidine bulk chemical for pharmaceutical compounding by a licensed pharmacist or veterinarian; or (5) Any other use approved or permissible under 21 U.S.C. §§ 301 to 399i, inclusive (January 1, 2026).
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