The #Food and Drug Administration ( #FDA ) has released its finalized guidance on developing #cannabis -based drugs, outlining the process and unique considerations for scientists when it comes to #hemp and #marijuana.

The guidance—titled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical #Research ”—was announced in a notice set to be published in the Federal Register on Tuesday. The agency previously released a draft version that went through a #WhiteHouse review in 2020. FDA made several non-binding recommendations for researchers interested in developing cannabis drugs that could go to market. The advice is “intended to address the legal definitions and regulatory controls related to cannabis, and to address certain questions raised about drugs containing cannabis.” The guidance has been revised since the draft version’s release. It adds clarity around federally authorized sources of cannabis for drug development purposes. There’s more flexibility as it concerns sourcing federally legal hemp.

Additionally, there is a new section of the guidance that addresses calculating #THC to distinguish hemp from marijuana. FDA largely defers to DEA on the matter, but it also advises researchers to “calculate the #delta9 THC content in their proposed cannabis or cannabis-derived investigational drug product early in the development process to gain insight into their product’s potential abuse liability and control status.”

All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect DEA to product a scheduling recommendation that’s consistent with their findings about its risks and benefits.

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