medical cannabis is moving from retail-style dispensaries to facilities run more like pharmacies, says Chanda Macias, CEO of National Holistic Healing Center in Washington, D.C.
The U.S. Justice Department recently reclassified state-licensed medical marijuana from Schedule 1 to Schedule 3 of the Controlled Substances Act. That change allows DEA registration for some operators and reduces the federal tax burden created by Section 280E. Macias expects a second effect: sharper federal expectations around manufacturing, distribution, patient records and clinical staffing.
Macias has been aligning her business with pharmaceutical practices for years. She holds a Ph.D. in cellular biology and a background in cancer research, and her company secured Good Distribution Practice (GDP) authorization in Germany in 2024 to supply medicinal products across parts of Europe. In the U.S., she says operators should adopt the U.S. Food and Drug Administration’s GMP (good manufacturing practice) and GDP principles well before any statutory requirement.
What will change in facilities and products – Manufacturing and cultivation: Macias expects license holders to implement written, cannabis-specific standard operating procedures that mirror pharmaceutical GMP—controlled batch records, validated cleaning, environmental monitoring and traceable supply chains. Facilities should assess capital needs now: converting a plant to GMP-like standards typically requires investments in cleanrooms, validated HVAC, documentation systems and staff for quality assurance. – Distribution: Distributors should evaluate their licenses and transport controls against GDP expectations, including chain-of-custody records, temperature controls and secure transport logs. – Retail: Retail operations will likely add clinical intake processes, privacy protections, and outcome tracking. Macias already runs HIPAA-compliant software at National Holistic Healing Center and urges other operators to treat patient records with HIPAA-level care because rescheduling will make those records more central to compliance.
Clinical staffing and training Macias predicts more pharmacies and dispensaries will require formally trained clinicians. Currently, Arkansas, Connecticut, Minnesota, New York and Pennsylvania mandate pharmacist presence in at least some medical cannabis settings. Macias is building a pharmacist training program with Howard University and the Society of Cannabis Clinicians that includes 13 modules covering the endocannabinoid system, pain, multiple sclerosis, women’s health and interactions between cannabinoids and disease.
The curriculum aims to help licensed pharmacists apply existing clinical frameworks to cannabis products instead of learning cannabis as a separate specialty. Macias highlights low-dose regimens—examples include a 2.5 mg THC plus 5 mg CBD product—as clinically discussable options that can provide symptom relief without strong intoxicating effects for many patients.
How prescriptions and products may look Macias expects prescriptions to specify ingredient composition, dose strength, dosage form or an approved branded formulation. That makes product consistency and validated potency critical: physicians and pharmacists will rely on shelf-stable formulations with documented cannabinoid and terpene profiles. She predicts botanical flower and pre-rolls will have a harder time qualifying for insurance reimbursement; reimbursable products will more likely be standardized, dose-defined formulations.
Regulatory alignment and software implications Under Schedule 3, federal oversight increases even though states retain licensing authority. Macias expects states to align their rules with federal expectations to reduce enforcement risk for multistate operators. That alignment will force software vendors and ancillary service providers to support patient recordkeeping, outcome tracking and audit trails that meet both HIPAA and pharmaceutical audit standards. Many technology companies are already redesigning their platforms to capture diagnoses, treatment records and outcome metrics.
Market impact and timing Macias does not expect an overnight shift. She anticipates a phased transition that will accelerate consolidation: some small and midsize operators may lack capital to upgrade cultivation, manufacturing and compliance systems and will sell or merge. She predicts consolidation driven by companies with pharmaceutical-level capital and compliance infrastructure rather than by traditional multi-state operators alone.
Big Pharma interest and insurance reimbursement Macias sees Germany as a preview. With national medical cannabis reimbursement models in place there, she found pathways for some cannabis medicines to be covered by healthcare systems. In the U.S., clearer federal rules and recognized pharmaceutical standards could open reimbursement and draw pharmaceutical companies that already have GMP factories, clinical trial experience and payer relationships. That could widen market access for standardized medicinal products but also increase competition for independent licensees.
Practical checklist for operators Macias advises operators to map gaps now and prepare for phased enforcement: – Review state pharmacy rules and identify staffing or licensing changes needed to run operations like a pharmacy. – Audit manufacturing facilities against FDA-style GMP elements: batch records, validated processes, quality unit oversight, environmental controls. – Ensure distribution uses GDP principles: chain-of-custody, temperature controls, documented transport. – Upgrade patient record systems toward HIPAA and outcome-tracking capabilities. – Develop pharmacist or clinician training plans; consider partnerships with universities or clinical societies.
Macias registered with the DEA and is already adapting processes. She expects regulators to publish guidance over time, but she recommends operators start investments and planning now to avoid rushed, costly upgrades later. MJBizCon will include sessions on these changes Dec. 1–4 at the Las Vegas Convention Center where operators can compare compliance strategies and vendor solutions.
Bottom line: DOJ rescheduling reduces some federal tax pressure and permits DEA registration, but it also raises the bar for manufacturing, records, and clinical care. Operators that quantify facility upgrade costs, document processes and build clinician capacity now will face fewer compliance surprises as the industry shifts toward pharmacy-style regulation.
