November 2026 | Regulatory Affairs & Advocacy
The International Society of Cannabis Pharmacists (ISCPh) has submitted formal recommendations to the U.S. Food and Drug Administration (FDA) on FDA botanical drug development, emphasizing pharmaceutical quality standards, medication safety, clinical research, and the role of pharmacists in advancing cannabis-derived medicines.
Submitted October 27, 2026, in response to FDA’s request for information (Docket No. FDA-2026-N-9550), ISCPh’s comments outline opportunities to strengthen botanical product standardization, improve the interpretation of clinical evidence, and explore pharmacist-assisted access to selected FDA-approved cannabis-derived medicines.
FDA Botanical Drug Development: Establishing Appropriate Quality Standards
Whole-plant and minimally purified botanical products present unique challenges compared with highly purified, single-constituent drugs. Differences in chemical composition, manufacturing processes, formulations, and administration methods can complicate product standardization and the interpretation of clinical outcomes.
ISCPh recommends that FDA establish scientifically justified, formulation-specific expectations for product characterization and potency.
For cannabis flower, ISCPh proposes that FDA consider an acceptance range of 80–120% of labeled cannabinoid content, subject to appropriate sampling, quality controls, and clinical risk assessment. For manufactured formulations, including oils, tinctures, and capsules, ISCPh recommends a tighter 90–110% range, where scientifically appropriate.
These recommendations recognize differences in botanical variability while maintaining expectations for product quality and consistent dosing.
ISCPh also emphasizes that flexibility in potency specifications must not compromise contaminant testing or patient safety.
Expanding the Role of Pharmacists in Cannabis Medicine
Pharmacists are uniquely positioned to contribute to the safe and effective use of complex botanical medicines through medication reconciliation, individualized dosing, drug-interaction assessment, adverse-effect monitoring, and patient counseling.
ISCPh recommends that FDA recognize pharmacists as essential participants in botanical drug development, including research protocols, medication-safety assessments, clinical documentation standards, and regulatory discussions.
The submission also encourages consideration of a pharmacist-assisted, behind-the-counter access model for selected FDA-approved cannabis-derived medicines, where nonprescription use is scientifically justified and legally permissible.
Under this proposed model, patients could access qualifying medicines following pharmacist consultation, including assessment of medication interactions, contraindications, appropriate use, and the need for additional medical evaluation.
This proposal would require FDA and DEA to clarify the applicable regulatory and controlled-substance requirements. It does not represent an existing authorized access pathway.
Recognizing Real-World Evidence and Clinical Experience
ISCPh encourages FDA to consider how scientifically credible real-world evidence and established clinical experience may contribute to the development of botanical medicines.
Research involving products already used in state-regulated medical cannabis programs may provide valuable information about medication exposure, therapeutic outcomes, adverse effects, and changes in conventional medication use.
Such evidence can complement controlled clinical trials, inform future research, and potentially reduce unnecessary duplication of studies when applicable regulatory standards can be met.
ISCPh also recommends standardized approaches to documenting cannabinoid exposure and medication-related outcomes so that findings can be meaningfully interpreted across research and clinical settings.
Addressing Regulatory Barriers and Future Pharmacy-Based Care
ISCPh encourages greater coordination between FDA and the Drug Enforcement Administration (DEA) to clarify research requirements, investigational product sourcing, manufacturing expectations, and potential pathways for pharmacy-based access to cannabis-derived medicines.
In a related but separate initiative, ISCPh is exploring whether standardized, multi-constituent botanical cannabis extracts could be considered for patient-specific pharmacy compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act.
ISCPh has requested FDA clarification regarding previously evaluated cannabis extracts, bulk drug substance eligibility, and appropriate procedures for further regulatory consideration.
This exploratory inquiry is distinct from the botanical drug development comments and does not imply that botanical cannabis extracts are currently eligible for compounding under Section 503A.
Moving Toward Evidence-Based Cannabis Medicine
ISCPh supports regulatory approaches that facilitate responsible innovation while maintaining appropriate standards for product quality, safety, and effectiveness.
Meaningful pharmacist participation, clinically relevant quality specifications, and standardized medication-use data are essential to developing a stronger evidence base for botanical medicines.
ISCPh welcomes opportunities to collaborate with regulators, researchers, manufacturers, professional organizations, and other stakeholders to advance these priorities.
FDA Docket: FDA-2026-N-9550
Submitted October 27, 2026, by the International Society of Cannabis Pharmacists.