DEA Controlled Substances
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. The law classified the regulated drugs 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).
DEA Listed Chemicals
In 1988, congress pass the Chemical Diversion and Trafficking Act (CDTA) to provide a system of regulatory controls and criminal sanctions to address both domestic and international diversion of precursor chemicals for making illicit drugs and substances. The CDTA created two categories of controlled chemicals, List I and List II. These are commonly referred to as DEA Listed chemicals.
Under the federal regulations for DEA Listed chemicals, Distributors and Manufacturers (among others) of List 1 and 2 chemicals must obtain a specific license from the DEA. Research labs that order DEA Listed chemicals are NOT required to obtain a license; however, they may find that some of their chemical suppliers may request additional documentation from a responsible official knowledgeable about the intended work with the listed chemical. This may include a statement of why a precursor chemical has a legitimate research purpose and/or a signed Authorized Purchaser Form. There is no strict or standard process for the distributors’ due diligence so there are differing approaches used by precursor chemical distributors and manufacturers to internally document and verify that they are not selling DEA Listed chemicals to clandestine drug labs or other improper actors.
This request for documentation often causes confusion with DEA Controlled Substance Requirements. There is no requirement for the lab to obtain a DEA Controlled Substance Registration to purchase, use or store DEA Listed Substances. That said, it is prudent for all labs that use these chemicals to be attentive to any potential for inappropriate chemical ordering or use activity (unusually high volume or a chemical not expected as part of the research) and to report any suspicious activity to the PI, department administrator, EH&S, or UWPD.
Contact
Office of Chemical Safety
chemsafety@wisc.edu
Phone: 608-265-5700
Controlled Substances in Research
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 and the DEA and State;
- 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.
EH&S has no role in the permitting process, though it can provide limited guidance upon request. RARC has developed a controlled substances website containing a wealth of resources for the use of controlled substances in animal research.
The Universities of Wisconsin also has very good guidance on the use of controlled substances. This can be found on their website.
Disposal of DEA Substances
The Drug Enforcement Administration (DEA) implements regulations for controlled substance disposal. Previously approved disposal methods, such as flushing substances down a drain or mixing with kitty litter or coffee grounds and disposing as solid waste, are no longer permitted. Researchers cannot transport the drug to an unauthorized location and cannot transfer drugs to unauthorized persons under any circumstance. For additional information, please see the RARC Guidelines for Animal Researchers.
Controlled substances must be disposed of in a manner that permanently and irreversibly alters the substance’s physical or chemical state, rendering the drug unavailable and unusable (non-retrievable). Visit the DEA Office of Diversion Control website for regulatory information and resources.
For disposal assistance, please contact Troy Vannieuwenhoven at: 608-279-0869, troy.vannieuwenhoven@wisc.edu; or contact the DEA directly at: 608-210-4334, DEA.Registration.Help@usdoj.gov.