If you are conducting research with controlled substances, you must comply with federal and state requirements for use of these substances. These requirements are rigorous and the investigator is responsible for ensuring compliance with these requirements.

Controlled drugs fall into five different categories. Schedule I are those drugs that currently have no accepted medical use in the United States and that have a high potential for abuse – such as LSD and heroin. Use in research requires both a DEA Schedule I registration and a “special use authorization” from the Wisconsin Controlled Substances Board (CSB). It is the PI’s/prescriber’s responsibility to notify the IRB in the protocol that a Schedule I drug will be used in the research, and to obtain the DEA Schedule I registration and special use authorization from the Wisconsin CSB.

Schedule II-V drugs do have accepted medical uses in treatment and may be used by researchers who are also physicians who maintain a DEA Schedule II-V registration for clinical reasons. In this case, a separate special use authorization from the Wisconsin CSB is not required. If the PI/prescriber is not a clinician who maintains a DEA Schedule II-V registration, it is their responsibility to notify the IRB in the protocol that they do not hold a DEA Schedule II-IV registration, and to obtain a researcher registration with DEA and a special use authorization from the Wisconsin CSB.

Penalties for using such drugs without proper registration can be severe. The regulations strictly limit who can handle or administer the drugs and impose both physical security and inventory requirements. Some key points concerning the regulations:

• The permitting process is between an individual researcher, the DEA and the State of Wisconsin.
• Registrants cannot share controlled substances with non-registered users who are not under their supervision (e.g., another research laboratory in their department).
• Possession of expired drugs also poses a risk to researchers from the USDA since administration of expired controlled substances is not allowed.
• Disposal is also strictly regulated. Only the DEA Special Agent in Charge can authorize the disposal of controlled substances.

Researchers with questions about the need for DEA registration and/or CSB special use authorization should contact the UW-Madison Office of Legal Affairs. The Research Animal Resources Center has more information on the requirements regarding the use of controlled substances. This information is provided only as a reference for researchers, who are solely responsible meeting regulatory requirements. If you need assistance with these processes, contact the IRB office.