*This blog was written by Digamma Consulting and provided to Sapphire Risk Advisory Group to publish on their behalf.
As the cannabis industry evolves, so does the regulatory landscape governing its operations. With the potential reclassification of cannabis to Schedule III under the Controlled Substances Act , cannabis testing labs and product manufacturers must brace for significant changes. At Digamma Consulting , we understand the intricacies involved in this transition and the importance of adhering to Current Good Manufacturing Practices (cGMP) and International Organization for Standardization (ISO) standards. In this blog, the first of a two-part series, Digamma’s Marco Troiani , Your Cannabis Science Insider, simplifies these complex issues.
“It is important to understand how the GMP system is used in drugs, food, supplements, and cosmetics in the US,” says Troiani.”The liability for harming the end consumer is entirely the manufacturer’s responsibility, resulting in criminal prosecution when end-consumers are harmed.” Producers are responsible for their source material and all testing of source material. This contrasts with cannabis’ current 3rd-party testing system that complies with state government regulations and mandates rather than projecting all liability on the end-consumer on the producer.
The Implications of a Schedule III Reclassification
The reclassification of cannabis to Schedule III would acknowledge its accepted medical use and lower potential for abuse compared to Schedule I substances. This shift would bring cannabis more in line with other prescription medications, necessitating rigorous standards for quality control and safety. For cannabis testing labs and product manufacturers, this means heightened scrutiny and the need for stringent compliance with federal regulations.
Because medical cannabis under a Schedule III change would be under federal jurisdiction, it would be regulated by the FDA and enforced by the DEA just like any other controlled substance. However, recreational cannabis industries would not comply with federal schedule III status and would, therefore, remain under sole state jurisdiction. Digamma anticipates state governments will update their regulations to align with federal Schedule III requirements. This harmonization means testing labs and product manufacturers must be prepared for consistent standards across federal and state levels. “We anticipate a two-pronged access approach for cannabis products,” says Troiani. “Schedule III-regulated sales via pharmacies and state-regulated over-the-counter access via dispensaries.” This dual system will require labs and manufacturers to navigate differing compliance landscapes, ensuring that products meet the necessary standards for both distribution channels.
According to Troiani, with the reclassification of cannabis to Schedule III, there is significant potential for the federal government to assume regulatory oversight of state cannabis testing labs. This transition would bring cannabis testing under the same stringent regulatory framework that governs pharmaceutical products, ensuring uniformity and consistency in testing standards nationwide. Such a move may require labs to meet rigorous standards, including detailed documentation, quality control measures, and regular audits. At Digamma Consulting, we are prepared to help labs navigate this potential shift, ensuring seamless compliance with FDA regulations and maintaining the highest quality and safety standards.
Understanding GMP and ISO Standards
Understanding the requirements is the first step toward compliance. The core principle of GMP standards flows from the simple concept that the product should do no harm to the consumer. All other principles of GMP standards flow from this concept and attempt to assure its validity in different manufacturing settings. The quote often used is “the product should be fit for intended use” , and it follows from this concept that the standards for a product’s quality are often dictated by the intended use by the consumer in the GMP model. From this concept, the idea of GMP as a set of rules to follow to ensure the quality of products intended for human consumption emerges.
Adhering to standards such as current Good Laboratory Practices (cGLP) , cGMP, and those set by the ISO will be essential for cannabis testing labs and product manufacturers in the future. These standards ensure that products are produced consistently and safely, fostering trust and reliability within the cannabis and hemp industry. The following points highlight the importance of achieving and maintaining compliance and limiting liability and prosecution for manufacturers.
- Records – Keeping detailed records of all processes ensures compliance and provides a clear trail for audits, reducing legal risks.
- Training – Proper training on cGLP, cGMP, and ISO standards minimizes errors and ensures everyone understands the importance of compliance.
- Quality Checks – Regular quality checks help prevent defects and ensure products meet regulatory standards, protecting against recalls and reputation damage.
- Tracking and Tracing – Robust tracking and tracing systems allow precise monitoring from production to distribution, aiding in quick issue resolution.
- Audits and Recalls – Regular audits ensure ongoing compliance, and a solid recall procedure limits harm and legal consequences in case of product issues.
- Claims and Marketing Complaints – Managing claims and addressing complaints promptly helps maintain consumer trust and avoid regulatory challenges, protecting the manufacturer’s credibility.
Current Good Manufacturing Practices (cGMP)
cGMP encompasses a set of guidelines ensuring that products are consistently produced and controlled according to quality standards. For cannabis testing labs and product manufacturers, adhering to cGMP means implementing robust quality management systems, including comprehensive documentation, proper training, and stringent cleanliness protocols. cGMP compliance ensures that every aspect of operations, from sample handling to product manufacturing, meets the highest quality and safety standards.
International Organization for Standardization (ISO)
Compliance with ISO standards, specifically ISO/IEC 17025 for labs and ISO 9001 for manufacturers, will likely be crucial for the cannabis industry. ISO/IEC 17025 outlines the general requirements for the competence of testing and calibration laboratories, while ISO 9001 sets out the criteria for a quality management system applicable to manufacturers. Accreditation to these standards demonstrates a lab’s or manufacturer’s capability to produce precise and accurate test results or products, reinforcing trust and reliability within the industry.
Other Regulations to Watch
The Code of Federal Regulation (CFR) Title 21 , which interprets the Federal Food, Drug, and Cosmetic Act and related statutes, including the Public Health Service Act , will pose significant challenges for cannabis businesses due to the stringent requirements of Title 21 CFR. Companies will face increased regulatory oversight, requiring comprehensive documentation, strict quality control and testing, frequent inspections, and audits. They must also revise product labeling and marketing to prevent misleading claims and ensure consumer safety. Pharmaceutical, food, cosmetic, and supplement industries are governed by Title 21 CFR but have different selective applications of the GMP model based on the needs of each sector, as evidenced by relevant regulatory agency guidance and regulatory documentation. It will be interesting to see what the FDA will do with Title 21 CFR with cannabis moving forward and whether it will be included in an existing regulated GMP industry or added as an additional subsection specific to cannabis. Aligning state and federal regulations will add complexity, necessitating significant operational adjustments and investments in compliance infrastructure.
In conclusion, achieving regulatory success in the cannabis industry requires a deep understanding of cGMP and ISO standards, especially as the landscape evolves under Schedule III. At Digamma Consulting , we’re committed to guiding cannabis labs and manufacturers through this complex process, ensuring they confidently meet these rigorous requirements. Stay tuned for Part Two of this blog series, Digamma’s Seven Steps to Prepare for cGMP and ISO Compliance . It details Digamma’s pathway to regulatory success, with specific steps and strategies to help your cannabis business achieve compliance and thrive in this rapidly changing industry.