General regulatory overview
The federal Controlled Substances Act (CSA) was enacted in 1970 and serves as a foundational piece of legislation aimed at controlling illegal drugs in the United States. The law classifies regulated drugs into five categories, from Schedule I (substances with no legitimate medical use in the United States and that can be addictive, e.g., LSD and heroin) to Schedule V (drugs with a clear medical use, low potential for abuse and limited psychological and physical dependence, e.g., cough medications with small amounts of codeine).
Certain campus research activities may involve the use of controlled substances, particularly in animal research where pain medication is commonly used. Use of controlled substances for research requires registering with both the federal government through the US Drug Enforcement Agency (DEA) 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 include but are not limited to:
- The permitting process is between an individual researcher, the US DEA and the State of Wisconsin.
- Registrants cannot share controlled substances with non-registered users who are not under their supervision.
- Possession of expired drugs also poses a risk to researchers, since administration of expired controlled substances is prohibited.
- Disposal of controlled substances is also strictly regulated and can only be authorized by the US DEA Special Agent in Charge.
Legacy controlled substances are substances that are listed on one of the US DEA Controlled Substance Schedules but are unregistered. This can result from a variety of circumstances. Possession or use of controlled substances without a registration is illegal. Disposal is difficult and subject to approval by the US DEA. Registrants must contact the US DEA for authorization to destroy or otherwise properly dispose of all controlled substances.
registration requirements & applications
University of Wisconsin researchers who wish to acquire and administer controlled substances must obtain both a federal DEA registration and a Controlled Substances Special Use Authorization (SUA) issued by the Wisconsin Department of Professional Services (DSPS) Controlled Substances Board. Important information concerning registration includes but is not limited to:
- The Wisconsin SUA must be obtained before applying for federal DEA registration.
- A separate registration is required for each physical building where controlled substances are administered or stored. Controlled substances and associated records cannot be moved from the DEA-registered address without approval from the US DEA.
- SUA application forms and instructions are available on the Wisconsin DSPS Controlled Substances Special Use Authorization website.
- New and renewal DEA application forms and instructions are available in the DEA Researcher’s Manual.
UWSA has no role in the permitting process, although it can provide limited guidance upon request.
(Sources: UW-Madison EH&S Chemical Safety, UW-Madison Research Animal Resources Center)
additional resources
- Wisconsin DSPS Controlled Substances Special Use Authorization Information
- US Drug Enforcement Administration (DEA) Office of Diversion Control
- US DEA Registrant Drug Disposal Information
- US DEA Controlled Substance Schedules
- Title 21 United States Code (USC) Controlled Substances Act
- UW-Madison Research Animal Resources Center (RARC) Pharmacy Services: Controlled Substances and RARC
- UW-Madison RARC Pharmacy Services: Expired Materials Disposal Information
Disclaimer
This publication was prepared for environmental, health and safety staff at University of Wisconsin System campuses, to assist in finding resources and information for regulatory compliance. It is not intended to render legal advice.