The U.S. Food and Drug Administration (FDA) on Monday released its Draft Guidance for research of psychedelic drugs. The guidance covers psilocybin, LSD, and substances such as MDMA.
The guidance mirrors the good practices required by other drug and therapeutic companies, including compliance with the federal Food, Drug, and Cosmetics Act and that non-clinical investigations should follow 2010’s Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. The guidance also details which psychedelic drugs would be considered botanical and nonbotanical.
The FDA notes that most of the medical conditions being studied to date in psychedelic research programs are chronic. The proposed regulations lay out the processes for psychedelic therapy, which is legal in Oregon.
The agency says that were it to approve a drug that currently falls under Schedule I status of the Controlled Substances Act, “the abuse potential assessment would assist in determining an appropriate rescheduling action” under the CSA.