The FDA has released a new guidance on July 2020 on the clinical research and development of drugs containing cannabis or cannabis derived compounds. The compounds that are used in drug manufacturing include botanical raw materials, extracts and highly purified substances of botanical origin. By definition under section 201(g) of the Food, Drug, and Cosmetic Act (FD&C Act), a drug is any product that is intended to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to affect the structure or any function of the body.

“The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.”

The 2018 Farm Bill (the Agriculture Improvement Act of 2018)

Written under Public Law 115-334, the Farm Bill changed how cannabis is treated under the Controlled Substances Act (CSA). The bill created a new definition of hemp, which includes cannabis and derivatives or extracts of cannabis with no more
 than 0.3 percent by dry weight of the compound delta-9 tetrahydrocannabinol (THC).

The Bill further removed hemp as a controlled substance maintaining that the product remains under a 0.3 percent dry weight of delta-9 THC if the product exceeds this level it is considered a Schedule 1 substance. 

Sources of Cannabis:

Prior to the development of the legalization of Cannabis in the United States, The National Institute on Drug Abuse (NIDA) was the only entity that could provide legal source of cannabis for clinical research.

 The FDA has clarified its current opinion on the following three precedents:

  • NIDA is the only legal source of cannabis for clinical research,
  • cannabis under 0.3 delta -9 THC is the one that can be used  for clinical research 
  • sponsors and investigators are to contact the DEA if they any questions or doubts related to controlled substances.

DEA consultation

The FDA recommends the consult of the Drug Enforcement Administration  (DEA) regarding the control status of cannabis or cannabis-derived materials or products that are under development. intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even if the starting materials meet the definition of hemp, may no longer meet the definition of hemp and may be considered a Schedule I controlled substance.

FDA Recommendation for IND application of Cannabis derived products:

Sponsors should submit the following for an IND to the FDA :

  • Quantitative data like a certificate of analysis form a laboratory, described in 258 the USDA interim final rule
  • Detailed descriptions of testing methods used to evaluate the level of delta-9 THC 262 for phase 2 and phase 3 studies and marketing applications.
  • The levels of delat-9 THC to the FDA-Consider section 7.20, Rounding Rules, in the USP General Notices and Requirements 265 when calculating and reporting the level of delta-9 THC to FDA.

Clinical Trial Phase Recommendations:

Phase I: The guidance for industry CGMP for Phase 1 Investigational Drugs (July
2008) provides recommendations for phase 1 investigations

Phase II & III: Regulations outlines on 21 CFR parts 210 and 211 govern current good manufacturing practice (CGMP) for phase 2 and phase 3 investigations, and marketed products.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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