“This is a high-precision, clinical-grade cannabinoid formulation designed for oncology care teams implementing CMS BEI—not a consumer wellness product.”

Blue Key Clinical CBD Tincture (EOM Edition)

BEI-Ready Clinical Product Description

Product Classification

Hemp-Derived Cannabidiol (CBD) Oral Tincture
Designed for integration into CMS BEI-supported oncology care models (EOM & ACO REACH)

Clinical Purpose

The Blue Key Clinical CBD Tincture (EOM Edition) is formulated to support:

• Oncology-related pain
• Chemotherapy-induced neuropathy
• Sleep disruption
• Anxiety and stress response
• Inflammation-related discomfort

This product is intended as a non-intoxicating adjunctive therapy within a physician-guided care plan.

Formulation & Composition

• CBD Content: 50 mg/mL (high-potency, standardized)
• THC Content:
  • Preferred: THC-Free (0.0%)
  • Alternative: ≤0.3% hemp-derived THC (≤3 mg per serving)
• Delivery Method: Oral / Sublingual
• Carrier Oil: Pharmaceutical-grade MCT (or equivalent)
• Flavor Profile: Neutral or light peppermint (low irritation, patient-friendly)

Manufacturing Standards

• Produced in GMP-aligned facility
• Batch-specific third-party testing (COA) for:
  • Cannabinoid potency
  • Heavy metals
  • Pesticides
  • Residual solvents
  • Microbial contaminants
• Full lot traceability
• Stability validated under standard storage conditions

Dosing Standardization (UPDATED)

Each 1 mL provides:

• 50 mg CBD (± validated variance)

Precision Dosing:

• 0.1 mL = 5 mg CBD
• 0.25 mL = 12.5 mg CBD
• 0.5 mL = 25 mg CBD
• 1.0 mL = 50 mg CBD

? This higher concentration allows:

• Lower liquid volume per dose
• Improved patient compliance
• More precise titration

Clinical Dosing Framework (Aligned with BEI Use)

• Initiation: 5–10 mg CBD daily
• Titration: Increase by 5–10 mg every 3–5 days
• Typical Range: 20–60 mg/day
• Higher Needs: Up to 100 mg/day (provider-monitored)

Split dosing recommended for pain management.

Safety & Tolerability Profile

• Non-intoxicating at recommended doses
• Generally well tolerated

Clinical Considerations:

• CYP450 enzyme interaction potential
• Monitor in patients on:
  • Chemotherapy agents
  • Benzodiazepines
  • Opioids
• Use caution in:
  • Hepatic impairment
  • Polypharmacy populations

Compliance Alignment (CMS BEI Requirements)

Designed to meet BEI program parameters:

✔ Hemp-derived (≤0.3% THC)
✔ Oral administration only
✔ ≤3 mg THC per serving (if THC present)
✔ Physician-guided use
✔ Compatible with outcomes tracking protocols

Clinical Integration Use Case

Appropriate for inclusion in:

• Oncology symptom management protocols
• Supportive care pathways
• Adjunctive therapy plans

Used alongside:

• Pain management regimens
• Sleep support strategies
• Anxiety reduction protocols

Documentation & Traceability

Each unit includes:

• Certificate of Analysis (COA)
• Lot number tracking
• Expiration dating
• Standardized dosing reference

What Makes This “Clinical-Grade”

• High-potency 50 mg/mL standardized formulation
• Reduced dosing volume → better adherence in oncology patients
• Protocol-ready (aligned with BEI documentation requirements)
• EMR-compatible integration
• Built for healthcare system adoption—not retail environments