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University of Illinois at Urbana-Champaign DEA Controlled Substances Guidance Document

I. Introduction

The purpose of this guidance document is to assist campus personnel in obtaining, storing, record keeping and disposing of controlled substances by providing forms and information on these issues.

Links to information found in this guide:

 

Additional resources:

II. Controlled Substance Definitions

Controlled Substances are drugs or other chemicals that have the potential to be addictive or habit forming. The Drug Enforcement Administration (DEA) has divided the Controlled Substances into 5 schedules based on their potential to be habit forming and usefulness in medicine as a drug. For a more comprehensive listing, see Appendix A.

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III. Responsibilities

The Division of Research Safety
  1. Provide guidance to campus units for registering with state and federal agencies.
  2. Provide guidance on storage of controlled substances.
  3. Provide guidance for how to dispose of controlled substances.
Campus Units Which Order Controlled Substances
  1. Be in compliance with Federal and State Laws.
  2. Have employees working with Controlled Substances fill out an employee questionnaire. (Appendix B)
  3. Assure Controlled Substances ordered through the department are stored in a way that will not lead to theft or misuse.
  4. Maintain proper record keeping for Controlled Substances.
  5. Report any theft by co-workers or loss of Controlled Substances.
  6. Properly dispose of Controlled Substances.
  7. Conduct biennial inventory and properly dispose any Controlled Substances that have expired.
DEA Registrant
  1. Be in compliance with Federal and State Laws.
  2. Have employees working with Controlled Substances fill out an employee questionnaire. (Appendix B)
  3. Assure Controlled Substances are stored in a way that will not lead to theft or misuse.
  4. Maintain proper record keeping for Controlled Substances.
  5. Report any theft or loss of Controlled Substances.
  6. Properly dispose of Controlled Substances.
  7. Conduct biennial inventory and properly dispose any Controlled Substances that have expired.
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IV. Controlled Substance Registration

Controlled Substance use in Illinois requires registration with both:

Federal Drug Enforcement Administration
Every person that engages in research with Controlled Substances must be registered with the Drug Enforcement Administration (DEA). There are different activities that require different registration types. Further, one registration type may not cover two different activities, such as research with controlled substances and dispensing of controlled substances. The required forms and detailed instructions are available on the DEA website: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html

The following is a list of some types of registration for the Federal DEA:

Illinois Department of Professional Regulation (IDPR)
In addition to registering with the federal Drug Enforcement Agency, applicants in the State of Illinois must also register with the Illinois Department of Professional Regulation. Like the DEA, there are different registrations for different activities involving controlled substances. Information on controlled substance use registration can be found at: http://www.ildpr.com/WHO/cntsub.asp.

The following is a list of some types of registration for the IDPR:

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V. Authorized Use

The registrant is responsible for managing the controlled substances in accordance with the requirements of the regulations including inventory, record keeping and security provisions. Agents (designated employees) of the registrant may engage in approved activities under the direction of the registrant. The registrant is required to screen employees prior to authorization of work with controlled substances.

Employee Screening
DEA recommends that inquiries concerning employees' criminal records be made as follows:

Employee Questionnaire (Appendix B)
The following questions should be included on a questionnaire as part of the screening process (21 CFR, 1301.90):

  1. Within the past five years, have you been convicted of a felony, or, within the past two years, any misdemeanor, or, are you presently charged with committing a criminal offense?
  2. In the past 3 years, have you knowingly used narcotics, amphetamines, or barbiturates other than those prescribed to you by a physician?

Fill out one questionnaire for each employee who is authorized by the Principal Investigator (PI) to handle DEA controlled substances under that PI's supervision. Make copies of the form as needed 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 for new hires to be completed before they are allowed to handle DEA controlled substances.

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VI. Ordering

The Division of Animal Resources (DAR) has an online FAQ sheet that identifies addresses of controlled substance sources. The FAQ can be found at: http://www.dar.uiuc.edu/faqs_controlled_drugs.htm.

Schedule I or II
Any person registered to conduct research with Controlled Substances in Schedule I or II must send, in triplicate, DEA order form # 222. Contact the drug supplier when ordering a Schedule I or II drug. The supplier will fax a copy of DEA form #222. After filling out the form, fax it back, and the order will be filled. Instructions for ordering DEA form #222 can be found at: http://www.deadiversion.usdoj.gov/faq/dea222.htm.

Schedule I that is not commercially available
Requests to obtain Schedule I Controlled Substances not commercially available must be made to the National Institute on Drug Abuse (301-443-1124 or http://www.nida.nih.gov/).

Schedule III-IV
Obtaining Schedule III-V Controlled Substances may be handled by invoicing normal records.

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VII. Record Keeping Requirements

The following records should be maintained at the registrant's location (as identified on the registration):

If the registrant wishes to maintain records at a central location other than the registered location, a notification must be sent to the DEA. More information regarding the information that will need to be submitted in the notification can be found at 21 CFR (code of federal regulations) 1304.04.

Controlled Substance Tracking
Records must be kept to track each container of Controlled Substances as well as records that detail each time a Controlled Substance was used. Every ml or mg of a controlled substance should be accounted for in the dispensing records. An Example Inventory Sheet is available from DAR, as well as an Example Drug Control (Dispensing) Card. The drug control card should have an entry for each time any material was removed from the container.

Please note that it is a felony to provide a controlled substance to a person who is not registered with the DEA. All transfers of controlled substances can only occur 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).

Inventory Procedures
Each person registered to handle Controlled Substances must maintain an inventory. The inventory should be:

The inventory should have 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 (Example Inventory Sheet):

  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. The form of the substance (i.e., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
  5. The number of units or volume of each commercial container (i.e., 100-tablet bottle or 3-milliliter vial);
  6. The number of commercial containers of each substance form;
  7. Sign and date form.

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 (i.e. 50 10mg tablets);
  5. Reason for the substance being maintained by the researcher;
  6. Sign and date form.
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VIII. Security

Researchers are generally permitted to keep Controlled Substances in a securely locked, sturdy cabinet or safe.

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 must also be notified. DEA form 106 which can be found at: http://www.deadiversion.usdoj.gov/21cfr_reports/theft/index.html.

You can find standard "Narcotic Cabinets" through Health Care Logistics Inc. at http://www.hcl-intl.com/. They range in price from $135.00 to $700.00. Please be aware that DEA regulations require that the cabinet be secured so that it cannot be removed. DEA inspectors will check to see if the cabinet is bolted to a permanent structure (i.e. wall) and that the interior double lock compartment is bolted to the main cabinet.

It is unacceptable to have the keys to the cabinet left in the lab. Keys allowing access to the controlled substances must be in the possession of authorized individuals.

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IX. Disposal

When a DEA registrant has controlled substances that are expired or unwanted the registrant should draft a letter to the DEA prior to destruction (disposal) with the following information:

  1. Name, address of the facility wishing to dispose of the controlled substance
  2. Name, address and DEA registration number
  3. DEA Form-41, listing:
    1. Inventory of drugs to be destroyed
    2. Name of drug with strength
    3. Quantity of drug
    4. Technical name of controlled substance
    5. Signature of DEA notification

Upon receipt of the DEA Form-41 back from the DEA, the registrant or their authorized personnel must contact DRS to arrange for the destruction of the drugs and for the disposal to be witnessed by at least two persons who are either licensed physicians, pharmacists or nurses, or State or local law enforcement officers or any combination thereof.

The date of disposal and the names and occupation of the persons witnessing destruction (disposal) must be clearly stated on the DEA Form-41. A copy of the completed DEA Form-41 must be returned to the DEA.

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X. Abandoned Controlled Substances

Under no circumstances are controlled substances to be abandoned by a DEA registrant. However, occasionally, faculty will leave without appropriately disposing or transferring all controlled substances from their lab. Sometimes the faculty acquired the controlled substance(s) before registration was required. Under these circumstances, the department responsible for the lab will need to contact DRS to arrange for the appropriate disposal. Depending on the situation, one of two procedures will be followed:

If the faculty was a DEA registrant and it can be determined that the controlled substance(s) were acquired through their registration, the department will need to complete a DEA Form 41 with a cover letter providing all the information required for disposal (see section IX), in addition to explaining the circumstances as to why the registrant did not complete the Form 41. The department should contact DRS to arrange for disposal, which will be conducted in the presence of a UIPD officer. If the substance is also regulated by IEPA, it will be disposed as described above for substances regulated by IEPA. If the department is unsure if the faculty was registered with the DEA, they will be asked to provide the name of the faculty member to DRS, who will contact the DEA to verify if the person was registered.

If the faculty 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 should contact DRS for disposal. DRS will contact UIPD to have an officer on-site for the disposal of the substance(s) and they will generate a METcad ticket to record that the disposal took place. If the substance is also regulated by IEPA, it will be disposed as described above for substances regulated by IEPA.

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. Please note that abandoning substances is equivalent to distributing a controlled substance to an unauthorized person.

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