Securing a DEA research registration is a critical step for researchers and organizations working with psychedelics, classified as Schedule I drugs under the Controlled Substances Act (CSA), in clinical trials. This federal requirement, outlined in 21 CFR part 1301.18, establishes a controlled distribution system to ensure that only authorized handlers manage these substances. The process involves meticulous record-keeping, stringent security measures, and adherence to protocols approved by both the Investigational New Drug (IND) application and the Institutional Review Board (IRB). Maintaining a “closed system” of distribution to prevent misuse and diversion, the complexity of obtaining a DEA license, especially for Schedule I substances, necessitates navigating various challenges.
DEA Licenses
At Asebey Life Science Law, we understand the intricacies of DEA registration for psychedelics research. Our expertise guides clients through the application process, ensuring compliance with all regulatory requirements. Whether it’s assisting with the initial DEA research registration, managing the logistics of controlled substance handling, or navigating the hurdles of site and investigator licensing, our team is equipped to provide comprehensive support. Leveraging our knowledge and experience, we help clients secure the necessary approvals efficiently, minimizing delays and facilitating the advancement of psychedelic research within a legally compliant framework.