The Federal Drug Enforcement Administration (DEA) and the Illinois Department of Financial Professional Regulation (IDFPR) require certain chemicals that can be abused (as drugs) to be registered with both agencies. These controlled substances are grouped into schedules I through V depending on their potential for abuse (see “definitions” at the end of this document for more information); a list is available on the DEA website. The Principal Investigator (PI) or supervisor is responsible for registering controlled substances. This document provides links and information for the registration process and the use of controlled substances.
Current federal protocols require that institutions or individuals acquire a state controlled substance license before applying for a federal registration.
Applicants in the State of Illinois must register with the Illinois Department of Financial Professional Regulation. Submit form IDFPR 097 (other controlled substances licensees) for activities related to research, chemical analysis, instruction, and teaching.
Every person that uses controlled substances in research must register with the Drug Enforcement Administration. Different activities have different registration requirements. Forms and detailed instructions are available on the DEA website.
Note: The use of a government designation during the application process will allow for a fee exemption.
The registrant is responsible for managing the controlled substances according to the regulatory requirements covering inventory, record keeping, and security provisions. Agents (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).
The DEA recommendations for inquiries concerning employees' criminal records are:
Maintain the following records at the registrant's location as identified on the registration:
A registrant who wishes to maintain records somewhere other than the registered location must notify the DEA. Refer to Code of Federal Regulations 21 CFR 1304.04 for guidance.
For each container of controlled substances, tracking records note every time that these substances are used must be kept. Every mL or mg of a controlled substance must be accounted for in the dispensing records.The drug control card should have an entry for each time material was removed from the container.
Each person registered to handle controlled substances must maintain an inventory. The inventory should be:
The inventory should include the following information:
An exact count of the dosage units must be made. Schedule II substances must be separated from other substances on the inventory. The inventory must include the following:
An exact count of the dosage units must be made, or the container must be graduated to reflect its content. Inventory shall include the following:
Controlled substances must be kept in a securely locked, sturdy cabinet or safe that is secured to a wall or otherwise not removable. DEA inspectors will check to see if the cabinet is bolted to a permanent structure (e.g., a wall) and that the interior double lock compartment is bolted to the main cabinet.
DO NOT leave keys to the controlled substances cabinet in the lab. Keys allowing access to the controlled substances must remain in the possession of authorized individuals.
If there is a theft or loss of controlled substances, a DEA form 106 must be submitted to the DEA and the state administrator must be notified within 10 days of the discovery of the theft or loss. The University of Illinois Police Department (UIPD) must also be notified.
A DEA registrant who has controlled substances that are expired or unwanted must dispose of that substance in one of the following ways. These methods are 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 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. Some examples include:
However, ensure that the product or method chosen is compatible with the controlled substance to be destroyed. Once the drug has been destroyed, DRS will pick it up as chemical waste.
A DEA registrant may wish to return expired or unwanted controlled substances to a reverse distributor. The Division or Research Safety has arranged with a registered reverse distributor the forms necessary to request reverse distribution and can provide these at the DEA registrant's request. 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.
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.