Whether the Controlled Substances Act's authorization is defined by regulatory prescription standards or statutory text, and what mens rea applies to non-authorization under 21 U.S.C. § 841(a)

I. Is authorization under the Controlled Substances Act defined in terms of the regulatory definition of an effective prescription or by the plain meaning of the statutory text? II. Does the mens rea required under 21 U.S.C. § 841(a) and this Court’s opinion in Ruan attach to the fact of non -authorization or to the regulatory standard for an effective prescription contained in 21 C.F.R. § 1306.04?