FDA sets out guidelines on cannabis derived drugs

pharmafile | July 22, 2020 | News story | Research and Development CBD, CBD Oil 

The FDA has released their guidelines on the rules companies should follow when developing cannabis derived drugs.

The guidelines cover both drugs and treatments that contain cannabis oil and other compounds found in the plant. These guidelines include references for calculating weight for oral dosages and what online resources to use for clinical trials.

This new advice draws from a 2019 public hearing where industry representatives expressed their concerns over misleading product labels for CBD as the US has seen a surge in unregulated hemp products that use this product. Companies are touting CBD as a cure for ailments like anxiety and insomnia without any proof, and they don’t actually have to be derived from cannabis, despite saying so, due to a lack of regulation.

Currently, the only FDA approved cannabis medical treatment is Epidiolex from GW Pharmaceuticals which has been designed to reduce epileptic seizures.

This treatment has also been pushed in the UK, which has not relaxed its laws against cannabis like the US has done in recent years. In June, the UK Home Office announced that the Epidyolex has been reclassified as a Schedule 5 drug, a move from a Schedule 2 substance under the Misuse of Drugs Regulation 2001. This means the product is now exempt from all controlled drug requirements and patients can have more flexibility on the amount of this medicine they receive.

Conor Kavanagh

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