In August 2023, the U.S. Department of Health and Human Services ("HHS"), based on the federal Controlled Substances Act's ("CSA's") Eight Factor Analysis, recommended that the Drug Enforcement Administration ("DEA") reschedule marijuana from schedule I to schedule III. The U.S. Department of Justice subsequently conducted a separate Eight Factor Analysis and concurred with HHS' rescheduling recommendation. DEA published a Notice of Proposed Rulemaking ("NPRM"), signed by Attorney General Merrick Garland, proposing to reschedule marijuana in May 2024 that elicited over 43,500 comments. In January a public hearing began to receive factual evidence and testimony on whether marijuana should be rescheduled. The hearing is currently on hold pending an appeal by several of the parties.
There exists confusion as to what rescheduling marijuana to schedule III would mean so we thought we would clear up some of the misunderstanding about schedule III requirements.
Even scheduling to less restrictive schedule III would continue to have significant implications for marijuana-related businesses. The NPRM states that if marijuana is rescheduled to schedule III, "the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations." Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. Reg. 44,597, 44,621 (May 21, 2024).
Unless marijuana is descheduled, that is decontrolled entirely, or there are marijuana-specific exemptions, even after rescheduling to schedule III, marijuana cultivators, producers, and processors, distributors, importers, exporters, dispensers, and practitioners, will be subject to specific regulatory requirements under the CSA and DEA regulations. Requirements will vary depending on the registered business activity.
If rescheduled to schedule III, marijuana businesses would be required to obtain DEA registrations, take initial and biennial inventories of marijuana on-hand, maintain transaction records, file theft and significant loss reports, and label and secure products appropriately. Dispensing marijuana to patients, as required for other schedule III substances, would require a prescription issued for legitimate medical purpose by a DEA-registered and state licensed practitioner. 21 U.S.C. 829(b). Pharmacists would be required to exercise their corresponding responsibility under the CSA to ensure that marijuana is prescribed and dispensed for legitimate medical purpose. 21 C.F.R. § 1306.04(a).
Marijuana activities would be subject to CSA criminal prohibitions under 21 U.S.C. §§ 841-844. Schedules of Controlled Substances, 44,621. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act. Id.
Marijuana down-rescheduled to schedule III would still be regulated for legitimate medical, scientific and industrial use. Rescheduling would not authorized marijuana for adult recreational use.
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