This program outlines the responsibilities and requirements for the possession and use of controlled substances for
research activities and the Animal Care Program at the University of Illinois Urbana Champaign (UIUC). The University
must comply with both state and federal regulations. The use, storage, and disposal of controlled substances are
regulated by the U.S. Drug Enforcement Administration (DEA) in the Code of Federal Regulations (CFR) Title 21, Part
1300-1308, by the Illinois Controlled Substance Act [720 ILCS 570] and the Illinois Department of Professional Regulation
Anyone who manufactures, distributes, dispenses, imports, exports, conducts research, or performs chemical analysis
with a controlled substance must be in compliance with DEA and IDPR regulations. Possession of controlled substances
at UIUC is limited to the DEA registrant, authorized agents, and authorized users. All authorized agents and users
operate under the supervision of a registrant in accordance with the license and follow all federal, state, and University
requirements. Failure to comply with the requirements of this program may result in disciplinary action, research
termination, or reports to the DEA field office and IDPR.
DEA registrants and their authorized agents and authorized users are only permitted to use controlled
substances for approved research activities.
Drugs or other substances that have no currently accepted medical use and a high potential for abuse.
Drugs or other substances that have a high potential for abuse, currently have an accepted use in medical treatment in the United States, or have a currently accepted medical use with severe restrictions. Abuse may lead to severe psychological or physical dependence.
Drugs or other substances that have a lower potential for abuse than Schedule I or II drugs and have an accepted use in medical treatment in the United States. Abuse is associated with moderate or low potential for physical or psychological dependence.
Drugs or other substances that have a low potential for abuse relative to those listed in Schedule III and currently have an accepted medical use in the United States. Abuse may lead to limited physical or psychological dependence.
Drugs or other substances that have an accepted medical use in the United States and contain limited quantities of certain narcotics. Abuse may lead to limited physical or psychological dependence relative to those in Schedule IV.
Current federal protocols require that individuals acquire a state controlled substance license before applying for a federal registration.
Apply online at www.idfpr.illinois.gov using Form 097 Research
You will need the following supplemental information:
Be aware that a separate application must be submitted to conduct research with Schedule I controlled substances.
Location listed on license must match location drugs will be stored and administered.
You will need your State of Illinois License Number in order to complete the DEA application.
Complete the form for a New Applicant found at https://www.deadiversion.usdoj.gov/drugreg/
Complete the appropriate form for your activity.
Applicant should include a letter from the department head verifying University affiliation and research purpose to allow for a fee exemption.
New faculty holding a federal DEA number must apply for an Illinois license in order to use their current DEA number in the State of Illinois at the University of Illinois.
The registrant is responsible for managing the controlled substances according to the regulatory requirements covering inventory, record keeping, and security provisions. Authorized agents and authorized users (designated employees) of the registrant may engage in approved activities under the registrant’s direction. The registrant is required to screen employees before authorizing them to work with controlled substances.
The employee questionnaire Appendix A should be included as part of the screening process (21 CFR, 1301.90).
Fill out one questionnaire for each employee who is authorized by the PI to handle DEA-controlled substances under that PI's supervision. Make copies of the form for each employee who will be working with these substances.
Keep these questionnaires on file at the registered location. Keep a blank copy of this form in your files to be completed for new hires before they are allowed to handle DEA-controlled substances.
Please note that it is a felony to provide a controlled substance to a person who is not registered with the DEA. Transfers of controlled substances can occur only between two DEA registrants. Transfers of schedule I or II controlled substances must be accompanied by a DEA form 222 completed by the registrant receiving the substance(s).
Maintain the following records at the registrant's location as identified on the registration.
Controlled substances must be kept in a securely locked, sturdy cabinet or safe that is secured to a wall or otherwise not removable.
A locked refrigerator or freezer is acceptable for materials required to be stored at low temperatures. Location of this locked storage must match the location listed on the license.
Keys to the secured location must be kept in the possession of the registrant or authorized agents. Anyone with access to the keys or combination for the controlled substance storage is considered an "authorized agent" and must be screened as indicated.
A DEA registrant who has controlled substances that are expired or unwanted must dispose of that substance in the following way. The method is specified in 21 CFR 1317.05.
A DEA registrant wishing to destroy that controlled substance must complete the DEA Form 41. The DEA Form 41 requires:
The DEA Form 41 is not required to be submitted to the DEA, unless requested to do so. However, the Form must be kept as a record of destruction and be available to the registrant for two years.
Method of Destruction
The method of destruction must render the controlled substance to a non-retrievable state. When multiple controlled substances are comingled, the method of destruction should be sufficient to render all controlled substances non-retrievable. These requirements are specified in 21 CFR 1317.90. Several commercial products are available in local pharmacies that render controlled substances non-retrievable.
The registrant must ensure the product or method chosen is compatible with the controlled substance to be destroyed. Once the drug has been rendered non-retrievable, DRS will pick it up as chemical waste.
A DEA registrant may wish to return expired or unwanted controlled substances to a reverse distributor. Contact DRS for more information about reverse distribution. There is a fee required, which varies with the class and number of controlled substances to be disposed of.
Once the reverse distributor receives the request and payment, they will provide the DEA registrant with the necessary authorization to return the controlled substances. Please follow the reverse distributor's instructions.
Under no circumstances are controlled substances to be abandoned by a DEA registrant. However, researchers sometimes leave the university without appropriately disposing of or transferring all controlled substances from their lab.
Any person who is registered with the DEA who violates record keeping requirements or abandons controlled substances will be subject to the civil penalties outlined in the United States Code (USC): 21 USC Sec. 842. Note that abandoning substances is equivalent to distributing a controlled substance to an unauthorized person.
DEA Listed chemicals are different from Controlled Substances classified in Schedules I-V. The federal Chemical Diversion and Trafficking Act created List 1 and List 2 to identify chemicals that are a concern for illegal manufacturing of illicit drugs and substances. The manufacturer of these Listed chemicals must obtain a license from the DEA. Laboratories that order the chemicals are NOT required to obtain a license, however the researchers may find that the distribution companies require certification that the chemical will not be used to produce illicit drugs and the use only has a legitimate research purpose. There is no standard process for distributors to ensure their purchaser will use the chemicals appropriately so each company may have its own form they require to be filled out by the purchaser. Generally the forms are signed by a responsible person knowledgeable of the intended work that uses the material (e.g., Principal Investigator). Sometimes a second signature is required by someone verifying that person's appointment at the University (e.g., business office representative).
There is no requirement for a lab to obtain a DEA Controlled Substance Registration to purchase, use, or store DEA Listed substances. If any suspicious activity is observed with these chemicals or other research chemicals, it is important that the information is reported to the PI, a department administrator, or campus Police.