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, from Schedule I (substances which do not have a legitimate medical use in the United States and which can be addictive – such as LSD and heroin) to Schedule V (drugs which have a clear medical use, low potential for abuse and limited psychological and physical dependence – such as cough medications with small amounts of codeine).
Use of controlled substances for research requires registering with both the federal government (through the Drug Enforcement Agency) and the State of Wisconsin (through the Controlled Substances Board). 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.
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.