In January, the FDA published a new cannabis guidance titled, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research. As an entrepreneur in the cannabis space, you might be wondering how this guidance affects you.
Overview
The guidance is directed only towards clinical research of cannabis or cannabis-derived drugs. To date, the FDA has not approved any marketing applications for cannabis in the treatment of any disease or condition.
Cannabis and cannabis-derived compounds remain federally illegal and are regulated on a state-by-state basis.
If you are in the clinical cannabis research space, there are a few noteworthy highlights from the updated guidance.
Cannabis versus Hemp
The concentration of THC by dry weight determines whether the product is considered a controlled substance regulated by the US Drug Enforcement Agency (DEA). To be classified as a controlled substance, the product will contain greater than 0.3% delta-9 tetrahydrocannabinol (THC).
Below that limit, the product is classified as hemp, is free from DEA regulation, and is not considered a controlled substance by the DEA.
For those researchers that are submitting an investigational new drug (IND) application, all botanical raw materials, drug substances, and drug products should be assessed against the DEA’s limits for delta-9 THC content.
Same Regs as Other FDA-regulated drugs
It is important to note that cannabis or hemp products are subject to the same regulations as any other drug substance or device, regardless of THC content. FDA recommends early interaction with regulators to prevent any issues and smooth the path for future INDs or new drug applications (NDA).
More Providers
While cannabis products with more than 0.3% THC once could only be purchased from the University of Mississippi National Center for Natural Products Research, there are now additional federally legal providers.
Researchers can now also source cannabis and cannabis-derived compounds from hemp. The guidance links currently approved sources.
Quality Considerations
Sponsors must be able to prove they can manufacture a quality product which requires a documented quality management system (QMS) and implementation of good manufacturing practices (GMP). During all phases of research, researchers must provide evidence of their product’s:
- identity
- quality
- purity
- potency and strength
Luckily, the guidance has a detailed list of different resources available on the FDA website, including core clinical research principles in the Guidance for Botanical Drug Development. Multiple other resources are provided.
Combination Products
Any cannabis or cannabis-derived drug product used in combination with a medical device is known as a combination product. These products must also meet requirements for design control and combination product GMPs.
Container Closure Selection
Safety considerations should be included in the container/closure selection for the cannabis product. Researchers are encouraged to begin communication with FDA in early phases of research to ensure adequate data is collected.
Potential for Abuse
During the research process, additional consideration may need to be given to the potential for abuse based on the THC concentration. If the product is part of an NDA, FDA will assess this potential, so researchers need to as well.
Conclusion
Above all, the Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research guidance makes it very clear that hemp or cannabis related clinical research must meet all the same requirements as clinical research into any other medical device or drug product. Good clinical practice still applies, as do all FDA regulations.
Early communication with the FDA is frequently encouraged.
The guidance links many helpful FDA documents that can provide information on the phases of clinical research, test method development, botanical drug development, analytical methods, and safety concerns.
However, if you find yourself in need of additional help aligning your cannabis product with current requirements or interpreting them, please contact us at marketing@cannonqg.com.
