Policy Watch: 16 Regulatory Updates — March 13, 2026

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Policy Watch
March 13, 2026. 16 regulatory items above the clinical relevance threshold of 40. Sources include Federal Register, regulations.gov, and regulatory RSS feeds. Listed in descending order of relevance score.

Score 70Regulations.gov

Schedules of Controlled Substances: Placement of 2,5-dimethoxy-4-iodoamphetamine and 2,5-dimethoxy-4-chloroamphetamine in Schedule I

This regulation schedules synthetic amphetamine derivatives as Schedule I controlled substances, which is not directly relevant to cannabis medicine practice or patients.

Score 70Regulations.gov

Schedules of Controlled Substances: Temporary Placement of MDMB–4en–PINACA, 4F–MDMB–BUTICA, ADB–4en–PINACA, CUMYL–PEGACLONE, 5F–EDMB–PICA, and MMB–FUBICA into Schedule I

The DEA temporarily placed six synthetic cannabinoid compounds into Schedule I, restricting their legal availability and potentially affecting clinical research and patient access to alternative cannabinoid treatments.

Score 70Regulations.gov

Schedules of Controlled Substances: Placement of Ethylphenidate in Schedule I

Regulatory Summary

This action schedules ethylphenidate as a controlled substance, which is minimally relevant to cannabis clinicians as it addresses a different drug class and does not directly impact cannabis prescribing, patient access, or medical cannabis regulations.

Score 70Regulations.gov

Schedules of Controlled Substances: Placement of Metonitazene in Schedule I

Regulatory Summary

The DEA placed metonitazene, a synthetic opioid, in Schedule I, establishing it as a controlled substance with no accepted medical use—relevant to cannabis clinicians managing pain patients seeking alternative therapeutic options.

Score 70Regulations.gov

Schedules of Controlled Substances: Temporary Placement ofEtizolam, Flualprazolam, Clonazolam, Flubromazolam, and Diclazepam in Schedule I

Regulatory Summary

The DEA temporarily placed five benzodiazepine analogs in Schedule I, restricting their availability; this affects cannabis clinicians managing anxiety or seizure patients who may have relied on these substances as adjunct treatments.

Score 70Regulations.gov

Importer of Controlled Substances Application Biopharmaceutical Research Company – DEA1224

Regulatory Summary

This DEA application enables biopharmaceutical research companies to legally import controlled substances, including cannabis, for clinical research and development of cannabis-derived medicines.

Score 55Regulations.gov

Importer of Controlled-Bright Green(2024-20083)DEA1426

Regulatory Summary

DEA registration 2024-20083 authorizes an entity to import controlled substances; clinicians and patients should verify supplier legitimacy and compliance status for cannabis product sourcing.

Score 55Regulations.gov

Importer of Controlled-Cambridge Isotope(2024-20082)DEA1429

Regulatory Summary

This DEA import authorization permits Cambridge Isotope to import controlled substances, potentially including cannabis-derived isotopic standards used in research and quality testing relevant to cannabis medicine development and clinical applications.

Score 55Regulations.gov

Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; etc.

Regulatory Summary

CMS establishes 2025 Medicare Part B payment rates and coverage policies, potentially affecting reimbursement for cannabis-related clinical services and consultations provided by healthcare practitioners.

Score 55Regulations.gov

Medicare and Medicaid Programs; CY 2025 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Prescription Drug Inflation Rebate Program (CMS-1807-P)

Regulatory Summary

This proposed rule establishes 2025 Medicare payment policies and coverage requirements that may affect cannabis clinicians’ ability to bill for services and patients’ access to cannabis-related treatments under federal insurance programs.

Score 55Regulations.gov

Bulk Manufacturer-Royal Emerald (2024-11786) DEA1368

Regulatory Summary

DEA approval for Royal Emerald as a bulk cannabis manufacturer (2024-11786) expands licensed production capacity, potentially improving clinical supply availability and research access for cannabis medicine practitioners and patients.

Score 55Regulations.gov

Importer Controlled-VA Cooperative (2024-11795) DEA1374

Regulatory Summary

The DEA importer cooperative framework (2024-11795) establishes controlled substance import procedures potentially affecting cannabis researchers’ access to standardized plant material for clinical studies.

Score 55Regulations.gov

Importer Controlled- Quagen Pharma (2024-11892) DEA1381

Regulatory Summary

DEA import control action on Quagen Pharma involves controlled substance importation oversight, potentially affecting cannabis-derived pharmaceutical product availability and supply chains for clinical and patient access.

Score 55Regulations.gov

Exempt Chemical Preparations May 2024 (2024-10465) – DEA372

The DEA’s May 2024 exemption for certain chemical preparations clarifies which cannabis-derived or cannabis-related compounds may be manufactured and distributed without Schedule I restrictions, affecting clinical availability and prescribing practices.

Score 55Regulations.gov

Medicare and Medicaid Programs; CY 2024 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Continued Implementation of Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts; Medicare Advantage (CMS-1784-F)

This CMS final rule establishes 2024 Medicare/Medicaid payment policies; cannabis clinicians should note it does not explicitly address cannabis, maintaining current coverage restrictions under federal scheduling.

Score 55Regulations.gov

Regulatory Summary

This CMS rule establishes 2024 Medicare payment policies and coverage requirements that may affect cannabis medicine access by defining allowable treatments under federal insurance programs and reimbursement standards.

Digest-Level Clinical Commentary

Dr. Caplan’s Take
Clinical Reflection on DEA Regulatory Digest

These items signal a regulatory environment where synthetic cannabinoids and novel psychoactive substances continue to face scheduling pressure while legitimate cannabis research and pharmaceutical importation proceed through established DEA pathways, suggesting that clinicians practicing cannabis medicine should expect ongoing distinction between scheduled synthetics and plant-derived cannabinoids under evolving state-federal frameworks. The concurrent Medicare policy updates (items 9-10, 15) indicate that reimbursement structures are being refined independently of cannabis scheduling status, which may create opportunities for documentation and billing of cannabis-related consultations if state law permits. Collectively, this digest reflects a bifurcated regulatory posture: aggressive control of unregulated synthetics paired with administrative normalization of clinical practice infrastructure, though federal scheduling of cannabis itself remains unchanged.

Clinical Perspective

These regulatory items reflect the DEA’s ongoing efforts to control emerging synthetic drugs of abuse while maintaining legitimate pharmaceutical supply chains for controlled substances used in clinical practice. The concurrent Medicare policy updates indicate healthcare system efforts to align medication access, pricing, and prescribing practices with evolving clinical needs and fiscal constraints. Together, these represent the complex regulatory environment clinicians navigate when prescribing controlled substances and managing patient care within reimbursement frameworks.

Controlled Substances SchedulingDEA LicensingMedicare PolicyPharmaceutical Regulation

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