This law makes it a federal crime, “[e]xcept as authorized[,] . . . for any person knowingly or intentionally . . . [to] dispense . . . a controlled substance.” 21 C.F.R. Section 1306.04(a) grants authorization for registered doctors to dispense prescribed controlled substances—provided that the prescription is, “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of [the practitioner’s] professional practice.”At the trial level, the DOJ secured a conviction in each of the underlying cases by relying, in part, on 21 U.S.C. Section 885. Subsection (a)(1) of this law states: “It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceedings under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.”

The doctor requested a hearing before the DEA Administrative Law Judges. The DEA Chief Administrative Law Judge (CALJ) issued a recommended ruling finding that, while the doctor had issued prescriptions outside of the “usual course of professional practice” in violation of 21 C.F.R. § 1306.04(a), his misconduct was a byproduct of “inattention to detail [and] not intentional diversion.” Final Order at 14,944.

By John A. Gilbert & Karla L. Palmer –The Drug Enforcement Administration (“DEA”) recently published a decision that considers the scope of a pharmacist’s “corresponding responsibility” under 21 C.F.R. § 1306.04(a). East Main Street Pharmacy (Affirmance of Suspension Order) (Docket No. 09-48) (75 Fed. Reg. 66149 (Oct. 27, 2010)) (“EMS”).

Per Drug Enforcement Administration (DEA) regulation, a prescription is only “authorized” when a prescriber issues it “for a legitimate medical purpose” while acting in the usual course of their professional practice. See 21 C.F.R. § 1306.04(a).Petitioners, Ruan and Kahn, in this consolidated case were both medical doctors licensed to prescribe controlled substances.

of last year, a variety of state governors wrote to President Biden, praising him for kicking off the potential rescheduling process and touting that state markets would really benefit from the move (essentially). However, I think Larry Houk of Hyman, Phelps, & McNamara put it best in one of his December blog posts about that letter, writing that “. . . the governors wrote as if rescheduling cannabis to schedule III will authorize unfettered adult access for medical and recreational use. It will not. While rescheduling cannabis to Schedule III would more closely align federal law with that of the 38 states that allow for some form of cannabis for medical use (depending upon the state), it would still conflict with the laws of the 23 states that legalize cannabis for recreational use. Obtaining cannabis as a Schedule III substance would require a prescription ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’ 21 C.F.R. § 1306.04. In other words, a prescription written by a DEA-registered, state-licensed practitioner. In addition, cultivators, manufacturers, distributors, and dispensers would have to obtain DEA registrations, create and maintain transaction records, file certain reports, and maintain adequate security. Federally rescheduling cannabis to schedule III would not create the unlimited public access the governors alluded to in their letter.” Larry’s analysis and conclusions should happen if marijuana is moved to Schedule III. Still, certain industry lawyers, experts, etc. claim that the DEA will not follow existing legal precedent and regulations for marijuana as a Schedule III because state-licensed markets are just “too big” to fail or be shut down in that way. Last time I checked though, you also could not freely buy a Schedule III controlled substance at a stand-alone store.Pharma Will Care (a Lot) or It Won’t (at All). This is one around which I’ve seen lots of debate. The pro-Schedule III crow

dications, like buprenorphine, for the treatment of OUD, as currently required under 21 C.F.R. § 1301.28. Presently, all practitioners who have a current DEA registration that includes Schedule III authority may prescribe buprenorphine for Opioid Use Disorder in their practice if permitted by applicable state law and the federal Substance Abuse and Mental Health Services Administration (“SAMHSA”) encourages them to do so. SAMHSA and DEA are actively working on implementation of a separate provision of the Omnibus related to training requirements for DEA registration that becomes effective in June 2023. Under the CSA, “narcotic” drugs are defined as drugs containing opiates, cocaine, or ecgonine, as well as certain related plant materials. 21 U.S.C. § 802(17). While DEA has provided examples of Schedule II and III narcotic medications, to our knowledge, DEA has not published a complete list, and some providers may have difficulty understanding and readily applying the CSA’s definition. 21 C.F.R. § 1306.04(a). U.S. Department of Justice, Press Release, U.S. Attorneys Andrew Birge and Matthew Schneider Announce Record-Setting Drug Diversion Civil Penalty Settlement with McClaren Health Care Corporation (Jan. 19, 2021), https://www.justice.gov/usao-edmi/pr/us-attorneys-andrew-birge-and-matthew-schneider-announce-record-setting-drug-diversion. U.S. Department of Justice, Press Release, Pharmacist to Pay $275,000 to Settle Claims Related to the AllegedUnlawful Dispensation of Controlled Substances (Nov. 15, 2021), https://www.justice.gov/usao-sdga/pr/pharmacist-pay-275000-settle-claims-related-alleged-unlawful-dispensation-controlled. U.S. Drug Enforcement Administration, Press Release, DEA Serves Order to Show Cause on Truepill Pharmacy for its Involvement in the Unlawful Dispensing of Prescription Stimulants (Dec. 15, 2022), https://www.dea.gov/press-releases/2022/12/15/dea-serves-order-show-cause-truepill-pharmacy-its-involvement-unlawful.[View source.]

Federal regulation authorizes controlled substance prescriptions that are “issued for a legitimate medical purposed by an individual practitioner acting in the usual course of his professional practice.” 21 CFR s 1306.04(a).At the trials of Drs. Ruan and Kahn, jury instructions on the meaning of Section 841’s “except as authorized” clause were contested. Both juries were told that they should not convict if the doctor acted in “good faith.”

The prevailing instructions were influenced by a Federal Drug Administration regulation that said a doctor’s prescription is authorized when it is issued “for a legitimate medical purpose...acting in the usual course of his professional practice.”21 C.F.R. § 1306.04(a) (2021).The Court held the required mental state in the charging statute, knowingly or intentionally, like many criminal statutes, also applies to the except as authorized language.

Additionally, a physician's prescription of controlled substances (including opioids and other pain management drugs) is only authorized if it is "for a legitimate medical purpose . . . acting in the usual course of his professional practice." 21 CFR § 1306.04(a).The Court confronted the question of whether a prescriber could be found guilty under the CSA if the prescriber subjectively believed that a prescription was for a legitimate medical purpose (i.e., "authorized by the [CSA]") but by objective standards was not doing so.

A concomitant federal regulation authorizes registered doctors to prescribe controlled substances, but only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a). The doctors contested the trial court’s general instruction concerning intent that the government argued required no more than a showing of an “objectively reasonable good-faith effort” or “objective honest-effort.”