The Drug Enforcement Administration is expected to undergo the final approval process of a synthetic form of cannabis which completed the final stages of Food and Drug Administration trials in the Summer of 2017. Insys is now awaiting the right to bulk produce and distribute its approved medication once the DEA is properly able to track its distribution.
According to a DEA notice filed with the Federal Register on March 30, 2018, a period for written comments has come to a close for its plan to issue Insys the rights to produce distribute its own synthesized versions of cannabis.
The DEA has indicated that it will offer Insys the exclusive right to manufacture and distribute its synthetic forms of Marijuana and Tetrohydrocannibidiols as Schedule II rather than Schedule I substances allowing them to be prescribed for certain medical conditions.
Insys completed its Phase 3 trials of the FDA’s approval process late last year and was finally granted the DEA’s blessing in November for a THC-based oral spray known as Syndros which is meant to treat nausea, vomiting and weight loss in AIDS and cancer patients.
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