Abuse potential assessment of drugs with central nervous system activity is a critical component of the development of new medications for regulatory filings for approval worldwide. These new drug applications typically include recommendations for scheduling status as a controlled substance, if scheduling is warranted. This commentary focuses on the approach and current issues related to scheduling in the United States (US) Controlled Substances Act (CSA); however, scheduling more globally generally involves similar approaches and issues. Although scheduling is intended to protect public health and safety by adequate restrictive control based on the abuse potential assessment, it is also intended to serve medicinal use and access and to incentivize the development of new medicines with reduced abuse-related risks. Thus, overly restrictive scheduling can present risks to public health, as does under-scheduling.
Henningfield JE, Comer SD and Gannon BM (2025).
