Embracing the Future: The Impact of Cannabis as a Schedule III Substance and the Crucial Role of cGMP 211 Certification

Published on: February 1, 2024

The landscape of the cannabis industry is dynamic and continually evolving, so who is to say exactly how they will be enforcing or regulating cannabis if it does get rescheduled, but we can learn from what we have seen in the past and what we are hearing in the back rooms of regulatory agencies. This could be a significant shift that could reshape the industry. This change would signify a recognition of its medicinal value, open doors for new opportunities, and also have some consequences for companies not prepared for the shift. In this blog, we explore the potential implications of cannabis becoming a Schedule III substance and why obtaining current Good Manufacturing Practices (cGMP) 211 Certification from an accredited certifying body is crucial for ensuring the longevity and success of cannabis businesses. What we don’t know at this time is what kind of runway we have in implementing these new standards to be compliant with them. They could give 30 days or one year, but we just won’t know until it happens. The best thing you can do for your business now is become compliant with these standards before you are required to be so.

As I spoke about in last month’s blog (1), rescheduling for the cannabis industry is a real possibility in the near future. Based on murmurings from the Drug Enforcement Administration (DEA) and Food and Drug Administration (FDA), rescheduling seems to be the path that is most favored, at this time. If they decide to move forward with the rescheduling, they will most likely be requiring a similar set of regulations as other Schedule III substances, just tweaked to fit the cannabis industry. The most likely set of regulations that will be adopted in this transition is the FDA’s Code of Federal Regulations (CFR) 211.

Understanding Schedule III Reclassification

The current classification of cannabis as a Schedule I substance at the federal level in various countries has posed significant challenges for businesses operating in the cannabis industry. Schedule I substances are considered to have a high potential for abuse and no accepted medical use, making it difficult for businesses to operate within a legal framework. This has put undue pressure on legal cannabis companies due to continued bias, lack of banking, and strict taxation laws such as 280E.

If cannabis were to be reclassified as a Schedule III substance, it would signify a shift in perception and acknowledgment of its medicinal benefits. Schedule III substances are recognized to have a lower potential for abuse and accepted medical uses, making them able to be regulated on a federal level. This change could lead to increased acceptance, accessibility, and research opportunities in the cannabis industry. On top of that, companies would be able to bank, be treated as a regular business when it comes to 280E, and potentially expand their sales market to other states.

The Importance of cGMP 211 Certification

Current Good Manufacturing Practices (cGMP) are a set of guidelines and regulations that ensure the quality, safety, and consistency of products. In the context of cannabis, cGMP compliance is vital for maintaining high production standards, especially if cannabis transitions to Schedule III. Obtaining cGMP 211 Certification from an accredited certifying body becomes paramount for several reasons.

1. Quality Assurance: cGMP 211 Certification ensures that your cannabis products meet the highest quality standards. This includes rigorous testing for potency, contaminants, pesticides, and microbial content. Quality assurance is not only crucial for compliance but also for building trust among consumers and stakeholders.

2. Compliance with Regulatory Standards: As cannabis moves to Schedule III, regulatory requirements are likely to evolve. cGMP 211 Certification positions your business to adapt seamlessly to changing regulations. By proactively adhering to these standards, your business can avoid compliance issues and legal challenges that may arise with increased scrutiny. Be ahead of the game instead of scrambling to comply at the last minute, or even worse, not being in compliance when federal regulators start to knock on doors.

3. Consumer Safety: Prioritizing consumer safety is a cornerstone of cGMP 211 Certification. This includes implementing robust quality control measures and conducting thorough testing at every stage of the production process. Ensuring the safety of consumers not only aligns with ethical business practices but also safeguards your business against potential liabilities. cGMP 211 will help your company know what to do in a recall situation, set up good employee training, and let your team know what to do in an emergency. This is the basis of how to run an efficient and safe workplace whilst making the safest product possible.

4. Market Competitiveness: In a rapidly growing and competitive industry, having cGMP 211 Certification sets your business apart and sets you up to be first in line for federal licensing that they will be requiring. It is most likely that this kind of certification will be required to even receive a license, which is starting to be the case in many state jurisdictions as well. Be competitive in the licensing process by being prepared beforehand.

Getting this certification also signals to consumers, investors, and partners that your products are manufactured with the highest standards of quality and consistency. This competitive edge can be instrumental in securing funding, market share, and fostering brand loyalty.

5. Research and Development Opportunities: With cannabis potentially moving to Schedule III, research and development opportunities are likely to expand. Obtaining cGMP 211 Certification positions your business to actively engage in research initiatives and collaborate with academic institutions or pharmaceutical companies. This not only contributes to industry knowledge but also opens doors to innovative product development, that could shoot your company’s success to the top.

6. Supply Chain Integrity: cGMP 211 Certification extends beyond the manufacturing process to encompass the entire supply chain. This includes supplier qualification and management, ensuring the integrity of raw materials. Knowing how the supply chain works and what to do when something goes wrong is a hallmark of cGMP 211. A secure and compliant supply chain is crucial for consistency in product quality and regulatory compliance.

As the cannabis industry stands on the brink of potential reclassification to Schedule III, businesses need to be proactive in preparing for this transformative shift. Obtaining cGMP 211 Certification from an accredited certifying body is not just a regulatory requirement; it is a strategic investment in the longevity and success of your business.

By adhering to cGMP standards, businesses can ensure the highest quality of their products, maintain compliance with evolving regulations, and position themselves as leaders in an increasingly competitive market. The shift to Schedule III presents unprecedented opportunities, and those businesses that embrace cGMP 211 Certification early on will be well-positioned to thrive in the evolving landscape of the cannabis industry.

Reference

Stuck, K. Rescheduling THC to Schedule III: The Potential Impact on the Cannabis Industry https://www.cannabissciencetech.com/view/rescheduling-thc-to-schedule-iii-the-potential-impact-on-the-cannabis-industry.

About the Author

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: kim.stuck@allayconsulting.com.