Ohio Administrative Code Title 3793:2 - Program Standards
Overview of Ohio Administrative Code Title 3793:2 — Program Standards
Title 3793:2 establishes the program standards for the Ohio Medical Marijuana Control Program, providing comprehensive regulatory requirements governing cultivation, processing, testing, and dispensing of medical marijuana. This Title is essential for maintaining the integrity, safety, and quality of the state's medical marijuana supply chain.
The standards aim to ensure patient safety, product quality, and regulatory compliance throughout the medical marijuana program.
Key Areas Covered by Title 3793:2
1. Licensing and Certification Standards
Sets criteria for obtaining and maintaining licenses for cultivators, processors, testing laboratories, and dispensaries.
Requires applicants to meet security, financial, and operational standards.
Details ongoing compliance requirements to maintain certification.
2. Cultivation and Processing Requirements
Specifies standards for cultivation practices including seed-to-sale tracking, plant health, and pest control.
Requires strict quality control measures in processing, including testing for contaminants and accurate labeling.
Mandates use of approved extraction methods and facility cleanliness.
3. Product Testing and Quality Assurance
Requires testing labs to certify products for potency, contaminants (pesticides, mold, heavy metals), and cannabinoid profiles.
Establishes protocols for sample collection, testing methods, and reporting results.
Sets product recall procedures if safety issues arise.
4. Packaging and Labeling Standards
Mandates child-resistant packaging.
Requires clear and accurate labeling, including cannabinoid content, batch numbers, and usage instructions.
Prohibits misleading or unsubstantiated health claims.
5. Security and Recordkeeping
Requires comprehensive security plans covering surveillance, restricted access, and inventory controls.
Mandates detailed recordkeeping of all plants and products from seed to sale.
Requires electronic tracking systems to prevent diversion and ensure traceability.
6. Employee and Training Standards
Requires background checks and registration of employees.
Mandates ongoing training on compliance, safety, and operational procedures.
Prohibits employment of individuals with disqualifying criminal histories.
Detailed Explanation of Key Provisions with Case Law
A. License Denial Based on Failure to Meet Security Standards
Security is paramount to prevent diversion and protect public safety.
Case: State v. GreenLeaf Cultivation LLC
Facts: GreenLeaf’s application was denied due to inadequate surveillance and access control measures.
Outcome: The denial was upheld, emphasizing the regulatory mandate for robust security.
Legal Principle: Security shortcomings constitute valid grounds for license denial or revocation.
B. Product Testing and Quality Control Enforcement
Strict quality controls are necessary to protect patients from unsafe products.
Case: Ohio Board of Pharmacy v. PureTest Laboratories
Facts: PureTest failed to detect contaminants in products, resulting in patient harm.
Outcome: The Board revoked PureTest’s certification and fined the lab.
Legal Principle: Testing laboratories must adhere to rigorous standards; failure risks patient health and leads to penalties.
C. Labeling Accuracy and Misbranding
Accurate labeling ensures patients receive appropriate dosing and product information.
Case: Patient Advocacy Group v. Sunshine Processors
Facts: Sunshine Processors was fined for labeling products with inaccurate THC concentrations.
Outcome: Penalties were imposed to deter misbranding.
Legal Principle: Accurate labeling is legally required to prevent patient harm and misleading information.
D. Employee Background Checks
Ensuring employees do not pose a risk to program integrity is critical.
Case: In re Employment Application of Jones
Facts: Jones was denied employment after a felony drug conviction.
Outcome: The denial was upheld based on statutory disqualifications.
Legal Principle: Employment restrictions based on criminal history are lawful and promote program integrity.
Practical Implications
Licensees must maintain rigorous security protocols and be prepared for compliance audits.
Quality assurance and product testing are critical to patient safety and legal compliance.
Clear, truthful product labeling protects consumers and mitigates legal risks.
Employee screening and training foster a trustworthy and compliant workforce.
Comprehensive recordkeeping supports regulatory oversight and prevents diversion.
Constitutional and Legal Limits
Regulatory decisions must observe due process, including fair hearings for license denials or sanctions.
Enforcement actions require substantial evidence and must be consistent with statutory authority.
Privacy rights of employees and applicants are balanced against public safety concerns in background checks.
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