HALT Fentanyl Act: Clarification of the Campus DEA Research Registration

• September 25, 2025

• Hoyt Sze , Sheppard Mullin
• Madeline Townsley , Sheppard Mullin

On July 16, 2025, President Trump signed into law the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act or the Act), which significantly reformed the 1970 Controlled Substances Act (CSA). The HALT Fentanyl Act permanently reclassifies “fentanyl-related substances” as Schedule I controlled substances. Moreover, the Act simplifies Drug Enforcement Administration (DEA) research registration requirements in several ways, including (1) streamlining research registration processes for Schedule I or II controlled substances registrants performing research involving Schedule I controlled substances under active investigational new drug applications (INDs) or conducted or funded by certain federal agencies, (2) allowing agents or employees of a research institution to conduct research with a controlled substance without separately registering if another agent or employee of that institution is registered to conduct research with a controlled substance in the same schedule, and (3) expanding the ability of persons registered to perform research on a controlled substance to perform certain manufacturing activities coincident to that research without needing to obtain a manufacturing registration.

ARTICLE TAGS

• Academic Medical Centers and Teaching Hospitals Practice Group
• Life Sciences