In July 2019, Health Canada issued notices to medical cannabis producers for non-compliance in case of three drugs and health/diversion-related deficiencies for 65 out of the 257 drugs it inspected.
The reasons ranged from process insufficiencies such as quality-assurance to oversight of certain activities, unapproved procedures followed by personnel and inefficient implementation of standard operating procedures.
Some of the other factors that can attract a warning or a non-compliance rating include released batches failing testing, manufacturing and packaging issues, contamination, fraud and illegal activity.
The Compliance Quagmire
Medical cannabis is still in its nascent stages, slowly gaining acceptance, but with lots of ifs and buts even in the United States where only three drugs using this ingredient have received FDA approval since 2018. The legality is further obfuscated by the fact that its use is legal in many parts of the country as the 2018 Farm Bill (FB) legalized the industrial cultivation of hemp provided it contains less than three-tenths of one percent of THC (Tetrahydrocannabinol). Toxicity can cause psychotropic behaviors and side effects such as hyperemesis and bronchospasm. While 33 states have legalized the use of medical marijuana, it is still listed as Schedule I drug by CSA, creating a conflict. Some products containing cannabis and cannabis-derived compounds also do not conform to the Federal Food, Drug and Cosmetic Act (FD&C Act), endangering the health and safety of consumers.
With drug-injury litigation being the second most frequent reason for medical malpractice lawsuits, cannabis risk-management is not just about compliance. Medical cannabis producers and healthcare service providers working with these drugs need to have strong risk-management policies and mitigation strategies around cannabis use.
This is difficult considering the contradictions (complexity?) in the U.S. laws and regulations at this stage. There is lack of standardization for the potency of medical marijuana and Cannabidiol (CBD) across states in the US. It also lacks Current Good Manufacturing Practices (CGMPs) and industry standards approved by the FDA. Therefore, knowing the regulations in every state and ensuring the drugs conform to the permitted levels is important for the producers.
Thirdly, there are many experiments being conducted on marijuana strains and hybrid varieties to address specific disease conditions. This makes it difficult to assess the exact THC and CBD in a product, making compliance and risk management that much more difficult. The mode of administering the cannabis - vaping, smoking and eating – also impacts the way it affects the system which healthcare professionals need to be aware of.
In this uncertain state of affairs, it must also be remembered that obtaining the license is only one part of the story. Continuing to maintain it and adapt to regulatory changes as the processes become standardized will be just as important for cultivators, manufacturers and dispensaries as well as independent laboratories who undertake the testing of the cannabis products. Some of the key factors to consider would include, potency, residual solvents, processing chemicals, residual pesticides and microbials such as E.coli and mold.
Some of the key compliances will include reconciling the inventory every day between the physical counts, POS inventory, state-mandated tracking inventory and the accounting system for associated tax payments, a major infarction common to the industry.
Facility tracking logs, be it for waste, security and surveillance or application and production, need to be complete and sufficient. Financial documentation is mandatory with Currency Transaction Reports (Form 8300), 280e compliance and physical access to all financial and inventory records being readily available for inspection by the authorities concerned. Regulatory authorities are also becoming strict about sufficient public safety warnings that are clear and visible to avoid any potential health risks.
Walking With You All the Way
ComplianceQuest, an EQMS built on the Salesforce.com Platform, can be customized for use in the Cannabis industry. Medical marijuana and key players in the cannabis industry can take advantage of the robust set of features that’ll drive quality and regulatory compliance across the product lifecycle.
Over the last year or so, we’ve helped a number of startups and growth companies in this segment take advantage of our EQMS, especially our non-conformances, deviations, audit, CAPA and change management modules.
The product enables a customer to have a top-down approach to enforce SOPs, Quality System Regulations (QSR), ISO requirements and other best practices. Needless to add, Document Management for regulatory needs can also be stored in a single, easily accessible repository.
To request for a demo or know more, click here: https://www.compliancequest.com/cannabis-industry/