This guidance outlines FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. Cannabis and cannabis-derived compounds that may be used in drug manufacturing include botanical raw materials, extracts, and highly purified substances of botanical origin. This guidance does not address development of fully synthetic versions of substances that occur in cannabis, sometimes known as cannabis-related compounds, which are regulated like other fully synthetic drugs. This guidance is limited to the development of human drugs and does not cover other FDA-regulated products.
This Guidance makes it formal that cannabis-derived products drug development is required to go through the Botanical Drug development pathway.