FDA Issues Guidance For Researchers Working With Cannabis

Law360 (July 21, 2020, 6:10 PM EDT) -- The U.S. Food and Drug Administration on Tuesday released draft guidance on best practices for investigating medical uses of cannabis, providing a new rubric for how to measure the THC concentration in solutions developed for potential drug treatments.

The guidance acknowledges that the legal definition of hemp — which is based on having less than 0.3% THC on a dry-weight basis — has limited utility once the cannabinoid compounds have been extracted from the plant and processed into intermediates and finished products.

"We note that intermediates or drug products that contain greater than 0.3 percent delta-9 THC by dry weight, even...

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