By Christopher Moore, Controlled Substances Specialist
EHS is closely monitoring the proposed rescheduling of marijuana from a Schedule I to a Schedule III controlled substance. If enacted, this rescheduling would substantially ease restrictions imposed by the Drug Enforcement Administration (DEA) on marijuana usage in research.
How are drugs scheduled?
The Controlled Substances Act (CSA) organizes all controlled substances into five distinct schedules (I to V) based on safety, acceptable medical use, and the potential for abuse or dependency. Drugs listed under Schedule I face the most stringent requirements. The scheduling of individual substances can be amended by Congress through legislation or by the DEA through a formal rulemaking process.
Potential changes to research:
The additional licensing and compliance demands surrounding Schedule I drugs often act as a deterrent for researchers interested in including marijuana in their studies. If marijuana is rescheduled, researchers would encounter significantly fewer obstacles. This would affect:
- Licensing: Researchers must apply for two separate New York State licenses and two separate DEA registrations when working with both Schedule I and Schedule II-V controlled substances. The proposed rescheduling would allow researchers already licensed to work with Schedule III-V drugs, such as ketamine and buprenorphine, to also work with marijuana by making minor changes to their existing licensing.
- Storage: Schedule I controlled substances are required to be stored in specialized safes. The proposed rescheduling would allow researchers to instead use wall-mounted cabinets for storage, which are cost-effective and space-efficient.
- Purchase/Supply: All orders of Schedule I materials are placed using DEA-222, forms which are mailed to the vendor. The proposed rescheduling would allow licensed researchers to place orders online. Additionally, this change would most likely increase availability as production quotas are not imposed on the manufacture of Schedule III controlled substances.
Other considerations:
This rescheduling would only apply to botanically derived marijuana and would not apply to synthetically derived THC, which is outside the CSA’s definition of marijuana. Synthetic THC would remain classified as Schedule I by both the NYS Department of Health and the DEA.
Detailed timeline of rescheduling efforts:
- October 2022: President Biden directs the Secretary of Health and Human Services (HHS) to review how marijuana is scheduled under Federal Law.
- August 2023: HHS sends a recommendation to the DEA that marijuana be listed as a Schedule III controlled substance, following a detailed review by the Food and Drug Administration (FDA). The FDA findings stated that marijuana met the following criteria to be rescheduled: (1) Marijuana has a potential for abuse less than the drugs or other substances in Schedules I and II. (2) Marijuana has a currently accepted medical use in treatment in the United States. (3) Abuse of marijuana may lead to moderate or low physical dependence or high psychological dependence.
- May 2024: The DEA gives notice of proposed rulemaking to have marijuana moved from Schedule I to Schedule III of the CSA.
- July 2024: Public comment period closes with nearly 43,000 public comments.
- August 2024: DEA gives notice of public hearing to review evidence and expert opinion regarding whether marijuana should be transferred to Schedule III.
- October 2024 - January 2025: Public hearings are scheduled and then postponed.
- December 2025: President Trump issues an executive order directing the US Attorney General to expeditiously complete the process of rescheduling marijuana to a Schedule III controlled substance
When will the rescheduling of marijuana be finalized?
The Department of Justice (DOJ) has not yet announced a timetable for the potential rescheduling at this time. DOJ retains the options to schedule further public hearings, reopen the public comment period, or simply issue an interim final rule. Once a final rule is issued, it generally goes into effect within 30-60 days, but it could face legal challenges that would further delay the rescheduling effort.
How can I keep up to date?
EHS will notify all registered labs once a final rule is issued and will guide license holders interested in working with marijuana in their research through the necessary protocol changes and licensing amendments.