FDA Publishes Final Guidance on Considerations for Clinical Research on Cannabis

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On January 23, 2023, the Food and Drug Administration (FDA) published a final guidance for industry, “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”

The 2018 Farm Bill removed hemp from the definition of marijuana under the Controlled Substances Act. Therefore, hemp is no longer a controlled substance under federal law. Hemp 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 Farm Bill has raised many questions related to the development of drugs containing cannabis and cannabis-derived compounds. FDA’s final guidance discusses the agency’s thinking on several topics related to the development of human drugs containing such compounds for clinical research. For example the guidance clarifies that the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) is no longer the only domestic federally legal source of cannabis with greater than 0.3 percent delta-9 THC for clinical research. The guidance also suggests resources for quality considerations, noting that sponsors of any type of drug are expected to show that they can consistently manufacture a quality product. Lastly, the guidance discusses the control status of products containing delta-9 THC and recommends how to determine the percentage of delta-9 THC in intermediates and finished products.

Read the FDA’s final guidance . Read our consumer fact sheet on cannabinoids here.

 

 

 

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