The DEA recently eased some of the regulatory requirements imposed by the Controlled Substances Act (CSA) for those who are conducting FDA-approved clinical trials on cannabidiol. These modifications are intended to streamline the research process regarding marijuana’s medical uses and help foster ongoing scientific studies. According to a DEA release, Federal Regulation 21 CFR 1301.18 requires researchers conducting cannabidiol-based clinical trials under an FDA Investigational New Drug Application to have a DEA research registration. This registration permits the possession of an approved amount for a specific research protocol. Prior to now, researchers who expanded the scope of their studies and needed more cannabidiol than they were initially approved for had to request, in writing, a modification to their DEA research registrations. This process created delays as the request moved through both the DEA and the FDA. The revisions, announced by advisory letter and effective immediately, create a waiver for a previously approved cannabidiol project.
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