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How Cannabis-Derived Medications Go Through the FDA Approval Process, Development and Regulation

Published: Jan 01, 2020   

Securing approval from the Food and Drug Administration (FDA) is difficult for any investigational medication, but the challenges are even greater for products derived from botanical materials. In addition, there are additional hurdles and requirements for products containing substances that may affect the central nervous system (CNS). Strict control of the conditions of cultivation and harvest of the botanical starting material is the essential first step. Multiple quality control steps, specifications (agreed to by FDA), and batch-to-batch consistency are required at each point along the way as the botanical raw material moves through various stages into a finished drug product.

Since cannabis is classified in Schedule I of the Controlled Substances Act, special federal and state license and security requirements apply. Because cannabinoids have CNS activity, a full battery of abuse potential studies must be conducted. Upon FDA approval, a new cannabinoid product must be rescheduled under both state and federal law before it can be dispensed by pharmacies.

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