b'Hallucinogens, Psychedelics, Entactogens: Challenges Associated with Schedule I Therapeutic Development Under the Controlled Substances Act (CSA) intheUnitedStates,drugsthathavethe potentialtobeabusedarescheduledinto oneoffiveClassesorSchedules(CI-V) ascontrolledsubstances.Thescheduling methodmakesadistinctionfordrugsthat have abuse potential and are not approved for medical use (i.e., Schedule I) versus drugs that are approved for medical use and have abuse potential (Schedules II-V). In the classification, the higher the number of the Schedule, the lower the abuse potential of the drug and the lessrestrictivetheconditionsregardingits distribution, storage, and prescribing. Schedule I, or Class I (CI), drugs are currently restricted to research in the U.S., meaning that they are not approved for medical use, and are deemed at highest risk for abuse. Recent research on psychedelics, hallucinogens, and entactogens, allofwhichareScheduleI,isbeginningtodemonstratepotential therapeuticeffectsofthesedrugsforvariousmedicalindications. Approvals of such drugs for medical or therapeutic use will inevitably result in the rescheduling of these drugs from their current CI status.In this issue of The Altascientist: Scientific Journal, we go in depth about Schedule I therapeutic development, exploring the regulatory environment and challenges, the required preclinical and clinical studies, and specialized clinical assessments, as well as formulation, manufacturing, and analytical considerations.DOWNLOAD YOUR COPY'