In light of the University's obligation to adhere to both state and federal regulations, the inception of the Controlled Substance Surveillance Program was a strategic response aimed at assisting investigators in maintaining regulatory compliance and providing a valuable resource to facilitate the responsible use of controlled substances in research endeavors.
This written 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 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, Part1300-1308, by the Illinois Controlled Substance Act [720 ILCS 570] and the Illinois Department of Professional Regulation (IDPR) requirements.
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.
A controlled substance is a drug or other substance that is tightly controlled by the government because it may be abused or cause addiction. The control applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids.
Five categories, also known as Schedules, are defined by the DEA and the state of Illinois. Controlled substances are assigned to one of the five categories. Federal and state lists of drugs in each Schedule are identical except for a few drugs. If there is a discrepancy between the state and federal controlled substance list, the more restrictive schedule will apply.
Who May Utilize Controlled Substances
DEA Registrant: The UIUC employee who is registered with the DEA and holds a State of Illinois controlled substance license. DEA Registrants may supervise specific people who are designated as either Authorized Agents or Authorized Users. The Registrant is ultimately responsible for all activities that fall under the terms of their license and registration.
Authorized Agent: An individual affiliated with the University who has access to the secured location in addition to the ability to handle the Controlled Substance. This individual has the complete trust of the DEA Registrant and is authorized by the Registrant to oversee dispensing and control of the substances in the absence of the DEA Registrant.
Authorized User: An individual affiliated with the University who may handle Controlled Substances under a Registrant’s license but does not have physical access to the secured location containing the bulk quantities of Controlled Substances. The DEA Registrant or Authorized Agent dispenses limited quantities of Controlled Substances to the Authorized Users for immediate use.
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.
Obtaining a State of Illinois License
Current federal protocols require that individuals acquire a state controlled substance license before applying for a federal registration.
Apply online at https://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.
All use of controlled substances for research activities and the Animal Care Program at the University of Illinois Urbana Champaign must be registered with DRS. DRS will use this information to assist with tracking expiration dates, training, authorized personnel, and annual monitoring visits. Email DRSemail@example.com to register your activities.
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 is 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).
All registrations, authorized agents, and authorized users are required to take the online DEA Controlled Substances Surveillance Program Training. Training is renewed every three years. Significant changes to the training due to program or law changes may require individuals to refresh the training prior to the three-year expiration. Any individual not demonstrating proficiency in the requirements of this program or regulations may be required to repeat training.
Record Keeping Requirements
Maintain the following records at the registrant's location as identified on the registration.
Each person registered to handle controlled substances must maintain an inventory. The inventory should be:
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:
Storage and Security
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.
Controlled Substance Program Surveillance Manager