Over The Hurdles: Taking Psychedelics From Schedule I To Pharmacy

By Richard Sidwell, Ph.D., Senior Vice President and Chief Scientific Officer, Societal CDMO

The emergence of DEA Schedule I psychedelics as a groundbreaking therapeutic for treating mental health conditions holds promise for a fresh approach to complex therapeutic areas. Recent studies suggest that psychedelics such as psilocybin, MDMA, and LSD could play a game-changing role in managing conditions such as depression, PTSD, and even addiction. With societal perceptions of these substances beginning to shift, we’re standing on the edge of a new era of research and discovery.

The recent wave of clinical studies utilizing psychedelics and the untapped therapeutic potential they hold has attracted a surge of funds flowing into the field. However, developing Schedule I psychedelics for legal pharmaceutical use comes with a unique set of challenges. Navigating strict regulatory guidelines and ensuring patient safety — which requires rigorous attention to handling, engineering controls, PPE, and security measures — can complicate the path to clinical trials. Learn how a partner with experience in handling scheduled substances and navigating FDA and DEA regulation can help you advance toward clinical research and drug development with ease.