Marijuana Reclassified to Schedule 3: Clinical, Research, and Coverage Implications

Under the Trump administration, the US Department of Justice (DOJ) reclassified state-licensed medical marijuana from a Schedule I drug to Schedule III under the Controlled Substances Act.

Although this policy shift does not legalize cannabis at the federal level, it represents a significant change in how marijuana is regulated, studied, and potentially integrated into clinical and research settings.¹ The order, signed by Acting Attorney General Todd Blanche, reduces regulatory barriers, expands research access, and introduces new tax implications for licensed operators.

Key Regulatory Changes

Under the new order, state-licensed medical marijuana is no longer categorized with substances such as heroin, 3,4-methylenedioxymethamphetamine (MDMA, ecstasy), or lysergic acid diethylamide (LSD) as a Schedule I substance, which are categorized as having no acceptable medical use and high substance abuse potential. The new order recognizes marijuana as a Schedule III drug, labeling it as a substance with moderate to low potential for dependence and accepted medical use.²

Along with this policy, immediate changes include the following:

• Expanded research access: Previously, research on cannabis was restricted through limited access to research-grade material; having to undergo the extensive process of obtaining state-licensed sources, which required Drug Enforcement Administration (DEA) registration; and navigating complicated procurement pathways through federally authorized suppliers.³ The new registration potentially reduces any administrative burden, increases the feasibility of federally approved clinical trials, and improves the ability to evaluate cannabis’ safety, efficacy, pharmacokinetics, and drug-drug interactions in controlled settings.³
• Tax Relief: Businesses may now deduct ordinary expenses previously disallowed under Internal Revenue Code Section 280E.⁴ This previously prevented cannabis-related businesses from receiving standard federal tax deductions due to marijuana’s classification as a Schedule I substance.⁴
• DEA registration pathway: A streamlined system enables licensed producers and distributors to register federally, creating a clearer pathway for state-licensed operators to comply with DEA requirements.

The DOJ says the purpose of the reclassification is to widen treatment options and improve the evidence base surrounding cannabis safety and efficacy.

Clinical Legitimacy and Practice Expectations

The Schedule III classification acknowledges cannabis for having legitimate medical use, which pushes for advancement in its clinical practice.² This may present several challenges, including a lack of standardized dosing across cannabis products, limited high-quality evidence on drug-drug interactions, and unclear requirements for documentation in electronic health records.²

The variability and potency in cannabis product composition make consistent dosing difficult, and limited data on metabolism and drug interactions can cause complications in safety assessments.² In addition, the lack of clear documentation standards may hinder accurate medication reconciliation and continuity of care as cannabis use becomes more common in clinical practice.²

This regulatory shift may push the expansion of standardized, cannabis-derived pharmaceutical products and the clinical research on cannabis-derived therapies beyond current approvals like cannabidiol (Epidiolex; Jazz Pharmaceuticals).⁵

Utilizing durable clinical trials and decreasing barriers for research may ultimately support additional submissions to the FDA and prompt greater engagement from Pharmacy and Therapeutics committees as institutions evaluate emerging data for formulary inclusion and clinical use.⁵

Insurance Coverage and Reimbursement Disruption

One potential consequence of Schedule III classification is the potential impact on reimbursement. Unlike Schedule I substances, Schedule III drugs can qualify for insurance coverage under certain conditions, depending on payer policies, FDA approval status, and established clinical indications.²

In the event that cannabis-derived therapies enter formal reimbursement pathways, payers could implement selective coverage criteria and require utilization management strategies such as prior authorization, step therapy, and formulary restrictions in order to ensure appropriate use.²

This may increase pharmacists’ involvement in benefit design and utilization management as institutions evaluate coverage decisions and align utilization policies with evolving clinical evidence and payer requirements.²

Patient Counseling Considerations

Provider-to-patient counseling will play an essential role as legal and regulatory status continues to evolve. It is crucial to keep patients informed on what Schedule III does and does not mean in terms of cannabis use moving forward.

Patients should understand that Schedule III status does not guarantee safety or uniform efficacy in cannabis products. Likewise, addressing variability in product potency and formulation helps the patient understand that cannabis products are not all the same strength or made the same way, which affects how they work in the body for each user.

Health care providers with access to patients’ medical history can assist in counseling to determine whether cannabis can negatively interact with medications and should be avoided. It is important to ensure patients and providers follow the cannabis laws that apply in their specific state, especially in circumstances where patients interpret rescheduling as a full endorsement of cannabis as a standardized therapeutic option.

Broader Policy Context: Federal-State Alignment

The rescheduling demonstrates the established divide between federal law and state-level cannabis programs. Most states now allow cannabis use for medicinal purposes, with many other states permitting its recreational use.⁶

Previously, federal prohibition goes back to the Marihuana Tax Act of 1937, which exemplifies the historic shift in the new classification.⁷

Emerging Parallel: Psychedelics and Psilocybin Research

An emerging parallel with these cannabis policy changes is the growing federal interest in expanding access to psychedelic-assisted therapies, particularly psilocybin. Early-stage research increasingly evaluates psilocybin for conditions such as treatment-resistant depression and end-of-life psychological distress. The National Institutes of Health supports the research in the exploration of therapeutic applications of psilocybin under controlled settings.⁸

This can imply a broader regulatory trend toward reassessing Schedule I substances with emerging clinical evidence, suggesting that cannabis rescheduling may be part of a larger shift in federal attitudes toward previously restricted psychoactive compounds.

Although the reclassification does not change the legal federal status of the drug, it does represent a pivotal change in US drug policy with immediate and long-term implications for clinical practice, research infrastructure, and reimbursement systems.

REFERENCES

1. Trump reclassifies state-licensed medical marijuana as a less-dangerous drug. MedPage Today. April 23, 2026. Accessed April 23, 2026. https://www.medpagetoday.com/publichealthpolicy/healthpolicy/120919

2. Drug Enforcement Administration. Drug scheduling. US Department of Justice. Accessed April 23, 2026. https://www.dea.gov/drug-information/drug-scheduling

3. NIDA. Cannabis (marijuana). National Institute on Drug Abuse. September 24, 2024. Accessed April 20, 2026. https://nida.nih.gov/research-topics/cannabis-marijuana

4. Cannabis industry. Internal Revenue Service. Accessed April 24, 2026. https://www.irs.gov/businesses/small-businesses-self-employed/cannabis-industry

5. FDA regulation of cannabis and cannabis-derived products: Q&A. FDA. 2019. Accessed April 24, 2026. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

6. State medical cannabis laws. National Conference of State Legislatures. July 12, 2024. Accessed April 24, 2026. https://www.ncsl.org/health/state-medical-cannabis-laws

‌7. Tikkanen A. Why is marijuana illegal in the US? Encyclopedia Britannica. June 13, 2025. Accessed April 24, 2026. https://www.britannica.com/story/why-is-marijuana-illegal-in-the-us

8. The RECAP2 study: midazolam and psilocybin. ClinicalTrials.gov. Updated April 3, 2026. Accessed April 23, 2026. https://clinicaltrials.gov/study/NCT06692192?term=psilocybin&viewType=Card&rank=1