Use of Controlled Substances in Research

Background

The Congress of the United States enacted into law the Controlled Substances Act (CSA) as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. This has been the major regulation involved in attempts to control illegal drugs in this country. The law classified the regulated drugs into 5 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).

Much of the animal research on campus involves controlled substances – especially in animal research where pain medication is commonly used. 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 Environment, Health & Safety Department’s Role

EH&S has no role in the permitting process, though it can provide limited guidance upon request.

The Research Animal Resources Center (RARC) has issued very good guidance on the use of controlled substances. This can be found on their website at:
http://rarc.wisc.edu/forms/files/lab_notebook/controlled_substances_information.pdf

The DEA website is http://www.justice.gov/dea/