Policy Watch: 16 Regulatory Updates — March 11, 2026

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

This regulatory action schedules synthetic amphetamines (DOI and DOC) as controlled substances, with minimal direct relevance to cannabis medicine practice or patient treatment protocols.

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 classified six synthetic cannabinoids into Schedule I, restricting their legal availability and potentially affecting cannabis clinicians’ understanding of illicit cannabinoid analogs and patient safety concerns.

Schedules of Controlled Substances: Placement of Ethylphenidate in Schedule I

# Regulatory Summary This DEA action schedules ethylphenidate (a synthetic stimulant) as a controlled substance, establishing regulatory precedent for novel psychoactive compounds but having limited direct clinical relevance to cannabis prescribing or patient care.

Schedules of Controlled Substances: Placement of Metonitazene in Schedule I

# Regulatory Summary The DEA placed metonitazene, a synthetic opioid, into Schedule I, establishing it as a controlled substance with no medical use—relevant to cannabis clinicians managing pain patients who may seek cannabis as an alternative to scheduled opioids.

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

# Regulatory Summary This DEA action scheduled synthetic benzodiazepines as controlled substances, relevant to cannabis clinicians managing patients using these drugs concurrently or as alternative anxiolytics.

Importer of Controlled Substances Application Biopharmaceutical Research Company – DEA1224

# Regulatory Summary A biopharmaceutical company applied to become a DEA-licensed controlled substance importer, potentially enabling legal cannabis research and therapeutic development for clinical use.

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

# Regulatory Summary DEA approval for controlled substance importation under registration 2024-20083 establishes legal framework for acquiring regulated cannabis materials for clinical research, treatment protocols, or pharmaceutical development purposes.

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

# Regulatory Summary DEA permit 2024-20082 authorizes Cambridge Isotope as a controlled substance importer, enabling production of labeled cannabis research materials for clinical studies and therapeutic development.

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.

CMS updates 2025 Medicare Part B payment policies and coverage determinations, potentially affecting reimbursement rates and covered services that cannabis clinicians bill to Medicare or Medicaid for patient care.

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)

This CMS proposed rule updates Medicare/Medicaid payment policies and coverage requirements, potentially affecting reimbursement for healthcare services cannabis clinicians provide to Medicare beneficiaries in 2025.

Bulk Manufacturer-Royal Emerald (2024-11786) DEA1368

# Regulatory Summary DEA approval of Royal Emerald as a bulk cannabis manufacturer enables increased therapeutic supply availability for clinical research and patient access through licensed medical cannabis programs.

Importer Controlled-VA Cooperative (2024-11795) DEA1374

# Regulatory Summary The DEA importer controlled substance cooperative (2024-11795) establishes controlled substance importation procedures relevant to cannabis clinicians and patients seeking regulated access to cannabis-derived medicines.

Importer Controlled- Quagen Pharma (2024-11892) DEA1381

# Regulatory Summary DEA Form 1381 filed for Quagen Pharma’s importer controlled status in 2024, potentially affecting cannabis-derived pharmaceutical product importation and availability for clinical use.

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

# Regulatory Summary The DEA’s May 2024 exemption guidance clarifies which chemical preparations containing controlled substances may be exempt from certain regulatory requirements, potentially affecting cannabis product formulations and clinical applications.

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 and coverage requirements, potentially affecting reimbursement eligibility and clinical documentation standards for cannabis-based treatments within federally-funded healthcare programs.

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-P)

CMS 2024 payment policies may affect cannabis medicine reimbursement and coverage determinations under Medicare and Medicaid, impacting clinician billing practices and patient access to cannabis-based treatments.

# Clinical Perspective These regulatory items reflect two concurrent policy priorities: ongoing efforts to control emerging synthetic drugs and analogs through DEA scheduling, and broader healthcare administration reforms focused on medication access and payment structures under Medicare and Medicaid. The scheduling actions address the persistent challenge of novel psychoactive substances that evade existing regulations, while the payment policy updates indicate continued emphasis on cost management and accountability in pharmaceutical distribution. Together, these represent the routine but essential regulatory work required to balance drug safety oversight with practical implementation of healthcare coverage policies.