In the EU and other countries, cannabis is regulated as an active pharmaceutical ingredient (API). Australia and Germany are just two examples. With the US Department of Health's recent recommendation to reschedule cannabis from Schedule I to Schedule III, this plant will likely exist in a pharmaceutical context in the United States soon.
If cannabis evolves into an API in the US, cultivators, manufacturers, and suppliers will be subject to strict quality controls and greater regulatory oversight. After all, this is the status quo in the global pharmaceutical market, and with the US's current trajectory, this likelihood isn't far off.
What will these new standards look like? For starters, the Current Good Manufacturing Practices (CGMP) will become critical, and with that, the need for consistency and precision control in the grow room — and elsewhere along with the seed-to-sale supply chain.
The Future of Cannabis as an Active Pharmaceutical Ingredient
In two to five years, following the predicted transition to Schedule III, cannabis could be classified alongside "drugs, substances, or chemicals […] with a moderate to low potential for physical and psychological dependence." It could very well exist within the same grouping as other pharmaceuticals like Tylenol with codeine, ketamine, anabolic steroids, and testosterone.
In Australia, regulators already treat the plant as an API. It's considered an "active ingredient that is the starting material for the manufacturing process of the finished product." This classification covers extracted cannabinoids, triturations of the plant, or simply dried flower.
Across the EU, other countries are following a similar path forward to regulating cannabis (although there are still discrepancies between countries and, at times, even within). Germany is one example where certain states require that cannabis imports come in under API restrictions.
With the cannabis industry trending toward global regulation under an API framework, several major international cannabis companies are already marketing their products as such. Bedrocan International, based in the Netherlands, is just one example.
Bedrocan now offers five different cannabis APIs, either as flower or trichome powder. They state these forms "can be used as a raw material for pharmaceutical product development or as an API."
If this is the future of cannabis in the US, how can cannabis cultivators and manufacturers get ahead of the curve to implement the required elevated quality standards?
Quality Controls for Active Pharmaceutical Ingredients
Active pharmaceutical ingredient means any substance that is intended for incorporation into a finished drug product and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. (Food and Drug Administration)
Global regulation of cannabis as an API means high-quality controls mirroring those used across the conventional pharmaceutical sector. In the US today, there may not be any nationwide quality controls on cannabis because it's still under Schedule I classification. Still, we can look at how the FDA regulates pharmaceuticals for insight. As per the FDA, "The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMP) regulations for human pharmaceuticals."
In this sector, CGMP provides systems "that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations."
We've written about the importance of GMPs previously, but to review CGMPs cover:
- Facility Upkeep: Clean, contamination-free, and inspection-ready
- Methods & Processes: Documented and consistent processes
- Operation: Staff training
- Documentation: Record keeping, change orders
- Accounting: batch history, distribution, etc.
- Recall Plans: Process for recalls
- Complaint Management: Process for complaints, investigations, and corrective actions
Pharmaceutical GMP: The Impact on US Cultivators and Manufacturers
Of course, many Americans would prefer total deregulation of cannabis rather than slight down regulation. However, there are still possible advantages to moving it to Schedule III. For starters, the move will mean much higher quality controls over cannabis cultivation and production of cannabis consumables.
If the sector evolves to treat cannabis as an API, all cannabis-touching businesses will have to implement CGMP. With standardization and rigorous quality controls, consumers can be more assured, whether it's for safety, potency, and efficacy.
But, cultivators and manufacturers will also have a significant onus to meet these quality controls. Within CGMP, there is an emphasis on facility infrastructure, documentation, and recall plans — and, therefore, investment in infrastructure improvements and comprehensive employee training programs. This could entail revamping facilities to make them always inspection-ready, implementing sophisticated tracking systems and continual documentation.
In today's hyper-competitive landscape, few companies invest in these infrastructure and process implementations. But with a significant regulatory transition coming, the handful of companies that do will be the only ones ready to hit the ground running. They could very well be the ones who make it in the cannabis industry of the future.
If you aren't already considering building or retrofitting with CGMP in mind, now is the time. At the same time, this infrastructure will help you achieve better environmental controls and enhanced consistency across cultivation cycles. The payoff isn't just the CGMP seal of approval but In-Process Quality Control (IPQC), predictable and controllable grow room conditions, and consistently replicable harvests.
Future Proofing for Cannabis as an Active Pharmaceutical Ingredient
Soon, CGMP won't just apply to cannabis exports to Australia and the EU. It will apply to all aspects of the US industry. Businesses need to adapt to this coming regulation or risk falling behind.
A critical component of pharmaceutical CGMP is the building or retrofitting of your facility to improve environmental consistency and climate controls. TSRgrow's innovative technology combines advanced LED lighting, powered by remote power servers, environmental control and monitoring, and grow management software into one fluid turn-key solution.
We provide the lighting, power, data, and monitoring you need to help achieve CGMP in cannabis cultivation. Discover the diverse and innovative suite of solutions from TSRgrow today and unlock the potential of your cannabis cultivation journey.
