July 24, 2020

FDA Releases Draft Rules for Drugs made from Cannabis

In response to growth in the cannabis-derived drug market, the FDA has released new draft guidance on July 21 regarding cannabis and cannabis-derived compounds. The guidance focuses on the sources of cannabis-derived compounds for clinical research, general quality considerations, and calculating the amount of THC in raw materials, extracts, and finished products. The guidance comes as the cannabis and cannabis-derived product industry is growing and after Congress removed hemp from the Schedule I controls in the Controlled Substances Act.