DEA Controlled Substances Guide

Introduction

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.

Registration

Current federal protocols require that institutions or individuals acquire a state controlled substance license before applying for a federal registration.

Illinois Department of Financial & Professional Regulation (IDFPR)

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. 

Federal Drug Enforcement Administration

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. 

For activities related to research and chemical analysis, submit form 225. Use Form 225A to renew an existing registration.

  • For instructional activities and for dispensing controlled substances as a practitioner (physicians, dentists, veterinarians, nurse practitioners, hospitals, and pharmacies), submit form 224. These activities are authorized only for schedules II through V. Use form 224A to renew the registration. 
  • The application should also include a letter from a department head verifying University of Illinois affiliation or employment. 

Note: The use of a government designation during the application process will allow for a fee exemption.  

Authorized Use

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.

Employee Questionnaire (Appendix A)

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).

Employee Screening

The DEA recommendations for inquiries concerning employees' criminal records are:

  • Local inquiries: Inquiries should be made by name, date and place of birth, and other identifying information to local courts and law enforcement agencies for records of pending charges and convictions. Local practice may require such inquiries to be made in person rather than by mail, and certain law enforcement agencies may require a copy of an authorization from the employee.
  • DEA inquiries: Inquiries supplying identifying information should also be furnished to DEA Field Division Offices along with written consent from the concerned individual for a check of DEA files for conviction records. The regional check will prompt a national check by the Field Division Office.

Record Keeping Requirements

Maintain the following records at the registrant's location as identified on the registration:

  • Employee questionnaire and authorization records,
  • Executed order forms,
  • Inventory records (must be kept for a minimum of two years from the date of record),
  • Drug dispensing records (must be kept for a minimum of two years from the date of record).

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.

Controlled Substance Tracking

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.

Example Inventory

Example Drug Control (Dispensing) Card

Inventory Procedures

Each person registered to handle controlled substances must maintain an inventory. The inventory should be:

  • Maintained at the registered location (unless a notification has been sent to DEA notifying that records will be maintained at a specified central location),
  • Available for two years after using or disposing of the substance,
  • Repeated every two years (annually inventory recommended to ensure that expired substances are removed from inventory), updated when DEA updates the Schedules (lists of controlled substances).

The inventory should include the following information:

For controlled substances in finished form (i.e., commercially bought)

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: 

  1. Name, address, and DEA registration number;
  2. Date the inventory was taken, noting whether it was at the beginning or end of the day;
  3. Name of substance;
  4. The form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
  5. The number of units or volume of each commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
  6. The number of commercial containers of each substance form;
  7. Signature and date.

For each substance not listed above (i.e., damaged, defective, or impure substances)

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:

  1. Name, address, and DEA registration number;
  2. Date the inventory was taken and whether it was at the beginning or end of the day;
  3. Name of substance;
  4. Total volume of substance or total number of units (e.g., 50 10 mg tablets);
  5. Reason for the substance being maintained by the researcher;
  6. Signature and date.

Security

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. 

Disposal

A DEA registrant who has controlled substances that are expired or unwanted must dispose of that substance in one of the following ways. Refer to 21 CFR 1317.05. 

  1. Destroy the controlled substance using an onsite method of destruction. 
  2. Deliver the controlled substance to a reverse distributor's registered location by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's registered location. 

A DEA registrant wishing to destroy that controlled substance must complete the DEA Form 41. The DEA Form 41 requires:

  1. Registrant information,
  2. Inventory of drugs to be destroyed,
  3. Method of destruction,
  4. Signature of two authorized employees of the registrant,
  5. 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. Refer to 21 CFR 1317.90 for more information. Several commercial products are available to render controlled substances non-retrievable. Some examples include:

  • RX Destroyer
  • Deterra Drug Deactivation System
  • Drug Buster

However, ensure that the product or method chosen is compatible with the controlled substance to be destroyed.

Reverse Distributor

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. 

Abandoned Controlled Substances

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. 

  • In this case, contact DRS for disposal instructions. If the researcher was not registered with the DEA and/or the controlled substance(s) was acquired prior to registration requirements (pre-1970 for many substances), the department must contact the DRS for disposal instructions.

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.

Definitions

Schedule I

Drugs or other substances that have no currently accepted medical use and a high potential for abuse.

Schedule II

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.

Schedule III

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.

Schedule IV

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.

Schedule V

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.

Last Update: 10/21/2016