Whether 21 C.F.R. § 13806.04(a) may replace the 'except as authorized' requirement in a Controlled Substances Act jury instruction, thereby permitting conviction of a physician based solely on the jury's finding that the physician's prescription fell outside the 'usual' course of medical practice or would be regarded as 'illegitimate' by most other doctors

QUESTION PRESENTED In Ruan v. United States, 142 S. Ct. 2370 (2022) (App., infra, 19a-54a), this Court held that a physician may be convicted under 21 U.S.C. § 841(a)(1) of the Controlled Substances Act (“CSA”) only if the government proves that the defendant “knew or intended that his or her conduct was unauthorized.” Id. at 2382 (App., infra, 37a) (emphasis added). The Court remanded Petitioners’ case to the Eleventh Circuit, and Dr. Shakeel Kahn’s companion case to the Tenth Circuit, so that those courts could consider whether the jury instructions comported with the “except as authorized” requirement of the statute. The question presented, on which the circuits are divided, is whether, in a CSA jury instruction, 21 C.F.R. § 13806.04(a) may replace the statute’s “except as authorized” requirement, thereby permitting the jury to convict a physician simply because she knew that her prescription would fall outside the “usual” course of medical practice or would be regarded as “qNegitimate” by most other doctors, and thus empowering a federal agency to create a felony offense that Congress itself did not enact. (i)