Policies & Guidances

0380 UIC Controlled Substance Policy and Guidance

Policies & Guidances

Definitions

Authorized Agent: An individual that works under the direction/supervision of the DEA Registrant and is authorized to oversee ordering, handling, and security of controlled substances in the DEA Registrant’s absence. An Authorized Agent is responsible for obtaining materials for authorized users and is permitted to be granted Power of Attorney (POA) by a DEA Registrant for signature authority on DEA Form 222’s Order Forms (for purchasing of Schedule II Controlled Substances only.)

Authorized User: An individual permitted to handle limited quantities of controlled substances that the DEA Registrant and/or Authorized Agent dispenses for their immediate use. Handling of controlled substances by an authorized user is conducted under direct supervision of a DEA Registrant and/or Authorized Agent. An Authorized User does not have access to the security of the physical location or secured cabinet containing controlled substances. An Authorized User is also not permitted to be granted Power of Attorney.

Controlled Substances: A drug, substance, or immediate precursor that is scheduled I-V by the DEA. These are drugs and/or other chemicals that have the potential to be addictive or habit forming and are classified according to their medical use, potential for abuse, and safety or dependence liability. Reference DEA Controlled Substance Scheduling Definitions.

Controlled Substance Compliance Coordinator (CSCC): Assists researchers with application of government regulations, providing guidance on federal/state licensure, security measures, fee exemptions, and conducts oversight visits to laboratories in possession of controlled substances.

DEA: Drug Enforcement Administration; Federal law enforcement agency under the Department of Justice responsible for enforcing the Controlled Substances Act pertinent to Title 21, Code of Federal Regulations Part 1300 and United States Code Sections 823 & 824.

DEA Registrant: Any person registered with the DEA to manufacture, distribute, dispense, export, or import controlled substances. DEA Registrants employed at UIC are responsible for remaining in compliance of all federal, state, and UIC policies for possessing, handling, purchasing, securing, inventory, and disposing of controlled substances.

DEA Diversion Control Website: Access registration applications, electronic submission of forms, theft/loss reporting, and requesting changes to registration at https://www.deadiversion.usdoj.gov/index.html.

DEA Form 41: ‘Registrant Record of Controlled Substances Destroyed’ used by Registrant to document destroying lawfully possessed controlled substances. The DEA Form 41must be maintained as a required record of controlled substance destruction for 2 years.

DEA Form 106: ‘Report of Theft/Loss of Controlled Substances’ (submitted electronically on DEA Diversion website).

DEA Form 222: Official Order Form used to document Schedule I & II Controlled Substance distribution amongst DEA registrant populous.

DEA Form 224: New DEA registration application for Practitioner, Pharmacy, Hospital/Clinic, Teaching Institution (submitted electronically on DEA Diversion website).

DEA Form 225: New DEA registration application for Researcher and Analytical Laboratory (submitted electronically on DEA Diversion website).

IDFPR: Illinois Department of Financial and Professional Regulation, Division of Professional Regulation provides and manages renewals for controlled substance licenses at the state level.

IDFPR Form 336: Illinois ‘Physician Controlled Substance License’ Application.

IDFPR Form 097: Illinois ‘Other Controlled Substance License’ Application.

OVCR: Office of the Vice Chancellor for Research.

Power of Attorney: A legal document establishing the authority for an ‘authorized agent’ to act on behalf of a DEA Registrant, specifically for signing/executing a DEA Form 222 Order Form for ordering of Schedule II controlled substances.

Practitioner: Any healthcare or veterinary professional, hospital, or other party (other than an individual) licensed in the State of Illinois and the DEA to prescribe, dispense, or administer controlled substances in the course of medical practice. Does not include a pharmacy.

Public Safety Office: The Security Division supported by UIC Police Department.

Registrant: A person or party licensed under or holding a certificate of registration and license with the State of Illinois Department of Financial and Professional Regulation and the DEA.

Researcher: UIC personnel with job descriptions that include conducting scientific investigations.

Schedule I: Substances that have no currently accepted medical use in the United States, lack of accepted safety for use under medical supervision and a high potential for abuse.

Schedule II: Substances with a high potential for abuse which may lead to severe psychological or physical dependence and currently have an accepted medicinal use in the United States.

Schedule III: Substances that have a potential for abuse less than substances in Schedule I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV: Substances that have a low potential for abuse relative to substances in Schedule III.

Schedule V: Substances that have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.

University Administration: The Chancellor at the University of Illinois Chicago has charged the Vice Chancellor for Research (OVCR) with the authority to implement a program governing the use of controlled substances in animal and laboratory research.

Controlled Substance License Registration

UIC requires State (IDFPR) and DEA registration as a researcher in order to conduct animal and non-clinical laboratory research with controlled substances.

Registered and licensed clinicians/physicians should not use their DEA ‘Practitioner’ registration to order and maintain controlled substances for research involving animals and laboratory activities. Additionally, researchers are not authorized to use their DEA Researcher registration or IDFPR Other Controlled Substance License in research involving human subjects, or to dispense or write prescriptions to human patients. However, a veterinarian may treat a patient (research animal) as covered by their veterinary practitioner license/registration and in the course of their job duties.

Types of Licenses/Registrations

Research: For use in vivo and in vitro. Need to list drugs on application.

Researcher Schedule I: allows use of ONLY schedule I controlled substances. May administer to animals and/or use in vitro.
Researcher Schedules II-V allows use of only schedule II-V controlled substances. May administer to animals and/or use in vitro.

Chemical Analysis (Analytical Laboratory): For use of schedule I-V controlled drugs for in vitro analysis. Cannot administer to animals. Do not need to specify exact drugs in application.

Cannabis Research: For use of cannabis (marijuana), cannabis derivatives, and cannabis extracts.

Refer to the Illinois Cannabis Control Act, 720 ILCS 550.
DEA has established a different drug code (7350) for the use of marijuana and/or covered extracts. Review the Establishment of a New Drug Code for Marijuana Extract. The drug code does not include materials or products that are excluded from the definition of marijuana set forth in the Controlled Substances Act (CSA).
If a product consisted solely of parts of the cannabis plant excluded from the CSA definition of marijuana, such product would not be included in the new drug code (7350) or in the drug code for marijuana (7360). The researcher must review the CSA definition to determine if a license is necessary. This determination must be provided to the CSCC for further review.

Illinois Department of Financial and Professional Regulation (IDFPR)

The ‘097 Illinois Other Controlled Substances License application (See Forms Tab) is required to be completed in order to purchase, maintain, or dispense/administer controlled substances in research, teaching, and testing activities that involve animals or laboratory work.

Once an IDFPR Controlled Substances License is obtained, a researcher may then apply for DEA Registration. Note: State licensure is a prerequisite for obtaining DEA registration.

Use of controlled substances for research, laboratory chemical analysis, or instructional activity are considered different activities and require separate ‘097 Illinois Other Controlled Substances License’ applications.
Applicants are required to provide the name, address, date of birth, sex and social security number for personnel with access to controlled substances on the initial application and update the information as it changes on IDFPRs Online Services Portal.
Applicants must indicate each physical address where controlled substances will be maintained.
IDFPR Controlled Substance licensure must be renewed annually. It is the responsibility of the researcher to maintain an active registration, as state law prohibits the handling of controlled substances with an expired license.

Drug Enforcement Administration (DEA)

DEA application forms and instructions for various business activities will be completed and submitted online by accessing DEA’s Diversion Control Application Portal. This portal allows a registrant to: submit the initial application, renew or make changes to a current registration, check the status of an application, or request a copy of a DEA Certificate.
All DEA Researcher registrations are required to be annotated with the respective schedules documented in the researcher’s project protocol or letter of intent. DEA Researcher registrations for controlled substance Schedules I-V must be renewed annually. It is the responsibility of the DEA Registrant to maintain active registration, as federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.

Per CFR 1301.13(e)(1), research involving Schedule I controlled substances requires a separate DEA researcher registration from a Schedule II-V researcher registration.
Per CFR 1301.12(a), a separate registration is required for each physical location where controlled substances are purchased, maintained, administered, or dispensed for research activity.
The address on your Illinois controlled substances registration must be exactly the same address as your Federal DEA registration.
Per CFR 1308.11-15, the DEA application requires drug codes to be provided on the application for each controlled substance a researcher utilizes.
Per CFR 1308.24, exceptions to DEA and state registration requirements are only permitted if research activities involve controlled substances included on the DEA exempt chemical preparation list.

Application for Fee Exemption –UIC employees are entitled to a fee exemption due to state government employment. The exemption requires the government employment status be officially certified prior to the fee exemption being granted. When accessing the DEA Portal for completion of the electronic registration application, researchers are required on page two (2) to check a box labeled, ‘CERTIFICATION FOR FEE EXEMPTION – Government Only’. Contact the Controlled Substance Compliance Coordinator (CSCC) regarding the Certifying Official.

Controlled Substance Registrant Requirements

Security Screening for All Authorized Individuals

The registrant is responsible for ensuring that all authorized users and agents have been appropriately screened and meet all state and federal regulation requirements regarding access to controlled substances. UIC has separated authorized individuals into two categories: Authorized Agents and Authorized Users.

Screening of individuals with access to controlled substances is critical in preventing diversion; therefore, UIC has developed a screening process in collaboration with the DEA Registrant. Such determination is a matter of business necessity, essential to the overall security of controlled substances. CFR 1301.90 cites that conviction of crimes and unauthorized use of controlled substances are activities that are proper subjects for inquiry of personnel who will have access to controlled substances. Screening must be completed prior to the researcher providing IDFPR with a list of personnel names with authorized access to handling and/or use of controlled substances. A reference chart is provided to clarify which of the various forms require completion for each controlled substance user type.

CFR 1301.76(a) documents that registrants should not employ individuals who will have access to controlled substances if any of the following applies to an individual:

Has been convicted of a felony offense related to controlled substances.
Has been previously denied a DEA registration.
Had a DEA registration revoked.
Surrendered a DEA registration for cause.
Currently has a state issued controlled substance license pending action of revocation, suspension, denial, restriction imposed, or placed on probation.

Students under the age of 18 and volunteers at UIC are prohibited from being Authorized Agents or Authorized Users and therefore are also prohibited from having access to controlled substances.

Security Screening Documentation

Controlled Substance Security Release Form

Each proposed authorized individual must complete the UIC ‘Controlled Substances Security Release’ form (See Forms tab). The employee must be made aware that any false information or omission of information made on their part may jeopardize their employment status; however, the responses provided may not necessarily preclude employment or educational status but will be considered as part of an overall evaluation of their qualifications. Responses documented on this form are to be held in strict confidence by the Principal Investigator. n affirmative answer does not indicate the person cannot be added to a researcher’s IDFPR license; rather, it simply requires further review. The form must be maintained in a secure, confidential location that is not accessible to other UIC employees.

The researcher must also document the following information for each Authorized User/Agent on the State of Illinois Controlled Substance License (097 Other) application: Name / Address / Date of Birth / Sex / Social Security Number. The CSCC will review the records regularly to ensure accuracy of personnel status and make any required updates to the registrant’s Pharmacy account. Any change in status that may affect eligibility to handle or have access to controlled substances must be reported immediately to the Registrant and the CSCC, at which time the ‘Controlled Substances Security Release’ form on file will be updated to reflect new circumstances.

Controlled Substances Authorized AGENT List
Researchers are required to maintain a current and accurate list of authorized agents (separate from users) operating under their DEA registration and IDFPR license. The name, signature, UIC identification number, and initials to be used on dispensation records are to be recorded on a ‘Controlled Substances Authorized Agents List’ (See Forms Tab).

Controlled Substances Authorized USER List
Researchers are also required to maintain a current and accurate list of authorized users (separate from agents) operating under their DEA registration and IDFPR license. The name, signature, UIC identification number, and initials to be used on dispensation records are to be recorded on a ‘Controlled Substances Authorized Users List’ (See Forms Tab).

Both the Agent List and the User List forms are to be maintained with the controlled substance dispensation record keeping.

Ordering and Receiving Controlled Substances

Researchers are required to follow the instructions listed in this document to order controlled substances from the pharmacy. (See Forms Tab)
Only minimum quantities required for research activities are permitted to be purchased.
The Department of Pharmacy is the preferred vendor of Schedule II-V controlled substances for UIC Employees who utilize UIC facilities to conduct animal and/or laboratory research. The Department of Pharmacy will only fulfill orders from fully licensed Principal Investigators (PI) who have filled out an order form. PIs in the process of obtaining a new controlled substance license should contact the CSCC directly for interim options. For those PIs who wish to obtain Buprenorphine ER, BRL veterinary staff should be contacted directly.
DEA 222 Order Form (Schedule II Controlled Substances Only)
- Registrants are provided with paper DEA 222 Order Forms.
- Purchases of a Schedule II controlled substance require a DEA 222 Order Form. DEA 222 Order forms may only be signed by the DEA registrant, or an individual granted Power of Attorney (POA). Instructions for completing a DEA 222 Official Order form are contained in the Forms Tab.
  1. Power of Attorney (Schedule II Controlled Substances Only)
    Per CFR 1305.05(a), a researcher may authorize one or more individuals to issue orders for Schedule I and II controlled substances on the registrant’s behalf by executing a power of attorney for each individual, which is required to be maintained with executed DEA 222 Order Forms, for the same time period as any order bearing a POA signature and must be available for inspection together with Schedule II record keeping. A template for granting power of attorney is contained in the Forms Tab.
Orders from the Department of Pharmacy require a ‘Requisition and Voucher – Pharmacy Services’ which serves as the purchase order and invoice record. Instructions for completing the ‘Requisition & Voucher’ form are contained in the Forms Tab.
1. ‘Requisition and Voucher’ will be provided by the Department of Pharmacy.
2. A separate ‘Requisition and Voucher’ form is required for Schedule II, Schedule III-V, and Non-Controlled drugs.

Researchers must confirm that the quantity ordered is present when receiving an order. Two individuals should check the items received against the order invoice or purchase order while documenting the addition of new inventory into stock. It is recommended the two individuals sign and date the invoice or purchase order and denote, “Received”. If the order contains a Schedule II controlled substance, the number of items received must be documented on the DEA 222 Order Form and kept in the controlled substance records, separate from III-V record keeping. Instructions for completing a DEA 222 Official Order form are contained the Forms Tab.

Recordkeeping Requirements

Per CFR 1304.11, DEA registrants are responsible for maintaining complete and accurate records and inventories of controlled substances used in their research and laboratory activities. Registrants are required to have all controlled substance record keeping readily available to be provided to federal, state, or UIC auditors, Controlled Substance Compliance Coordinator, Animal Care Committee, or the Department of Pharmacy personnel upon request.
Per CFR 1304.04 (a), DEA registrants are responsible for maintaining DEA 222 order forms and purchase order invoices for two (2) years.
Per CFR 1304.04(f)(2), records are to be maintained in a readily retrievable manner, separate from all other records, including Schedule III-V records being maintained separately from Schedule II records.
Per CFR 1204.21(b)(c), records are also required to be maintained separately for each physical location and business activity registered.

Registration records include:
- Controlled Substance Licenses and Registrations
  - Certificate of Registration (DEA Form 223) for each registered activity and physical location.
  - IDFPR 097 Other Controlled Substance License for each registered activity and physical location.
- Inventory Records
  - Use/Order Records (Administration and Wastage) which must contain (per CFR1304.22(c)) – maintain for 2 years:
    - Species (Patient’s Name)
    - Date of dispensation (Date)
    - Name and concentration/strength of the controlled substance
    - Number of units/volume dispensed and used (Amount Used)
    - Name/Initials of personnel who dispensed/administered
    - Name/Initials of personnel who witnessed waste/destruction
  - ‘Controlled Substance Dispensation Log’ (See Forms Tab) can be used to maintain inventory and usage. If an inventory requires multiple logs to document a depleted balance, each log is required to be numbered in sequential order used. (For example; the use of three logs are to be labeled at the top, ‘1of3’, ‘2of3’, ‘3of3’).
- Purchasing invoices (maintained for 2 years)
- Power of Attorney forms
- DEA Form 106 ‘Theft/Loss of Controlled Substances’ form and all related correspondence to DEA and IDFPR
- DEA Form 41 Onsite Destruction forms

Inventory Requirements

Initial Inventory
Per CFR 1304.11(b), researchers are required to conduct an inventory of all controlled substances on hand on the date they initially engage in dispensing controlled substance for research purposes. If research begins with no controlled substances on hand, they are required to record “Zero” on an Initial Inventory (labeled as such).

IDFPR Annual Inventory
Per 77 Administrative Code Section 3100.360 (c), researchers are required to conduct an annual inventory (within 12 months) that includes an actual count of the inventory on hand for all Schedule II Controlled Substances and an approximate inventory for all Schedule III, IV, and V Controlled Substances. This inventory is to be maintained for 5 years.

DEA Biennial Inventory
Per CFR 1304.11(c) After the initial inventory is taken, the researcher is required to conduct a new inventory of all controlled substances on hand at least every two years, labeled as ‘biennial’. This inventory may be taken on any date which is within two years of the previous biennial inventory date.

Despite that the State of Illinois imposes a stricter requirement then the DEA; and in order to remain within DEA compliance, every other year, the annual inventory is to be labeled as a ‘Biennial’ to include either the ‘Opening’ or ‘Closing’ of business also being annotated by checking the respective box.

Per CFR 1304.11(6)(i)(ii), the following information is required to be documented on Initial, Biennial, and Annual Inventories (See Forms Tab):

Name, address, DEA registration number, and signature of person or persons responsible for taking the inventory.
Reason for inventory (Initial, Annual, or Biennial)
Date inventory conducted
Whether inventory occurred at open or close of business (CFR1304.11a)
Name of each controlled substance inventoried.
Finished form of each controlled substance (e.g., 500mg/10mL vial).
Number of dosage units or volume in each finished form container (e.g. 10 mL vial).
The number of containers for each controlled substance.
The total count of the controlled substance

Self-inspection inventories serve to reconcile purchasing, disposition, and destruction records with the amount of controlled substances that are currently on hand at the time of the inventory (including controlled substance awaiting destruction) and are required to be performed:

Upon initially receiving DEA registration (labeled ‘Initial’), per CFR 1301.11(b)
Biennially or more frequently if required by the CSCC, per CFR 1304.11(c)
Every instance a DEA Form 106 is completed documenting theft/loss (from the start of the previous inventory).
When a drug not previously scheduled as a controlled substance becomes scheduled.

Disposal, Theft, and Loss

Disposal
Disposal of unwanted controlled substances, including waste, is the responsibility of the registrant/purchaser of the controlled substances. 21 CFR 1317.05(b) provides the accepted options for the disposal of controlled substances. Registrants are to maintain possession of all controlled substance quantities securely stored with the remaining inventory of controlled substances until they can be properly disposed. Contact the CSCC for specific information regarding destruction and reverse distribution options. Pharmacy cannot accept controlled substances for disposal.

Theft/Loss
Concerns for theft and non-recoverable loss of inventory require immediate notification, investigation, and documentation. Breakage and/or spills of lesser significance do not need to be reported as a loss.

Per 1301.76(b), upon discovery of either a theft or significant loss of controlled substance, the registrant is required to report the loss in writing to the local DEA field office within one business day. Contact the CSCC immediately if there are concerns about theft or significant loss.
Once the local DEA field office is notified, the registrant has 45 days to investigate the thefts/loss. An inventory must be completed beginning from the previous inventory date on all items suspected of theft/loss. If theft is suspected or possible, UIC’s Public Safety Office must be contacted.
When determining the significance of a loss, a researcher should factor the following into their judgment:
- Actual quantity in relation to the type of their business
- Rational explanation of the specific occurrence
- Whether it can be associated with those who have access or attributed to unique activities surrounding the substance
- Any previously established patterns/trends
- Whether the specific substance is likely to be diverted
After 45 days or as soon as theft/loss is confirmed, the registrant must submit a DEA Form 106, ‘Report of Theft or Loss of Controlled Substances’ electronically on DEA’s Diversion Control website (https://apps.deadiversion.usdoj.gov/TLR/).
Whenever a DEA Form 106 is filed, a copy of the report must be shared with the local DEA and the IDFPR Drug Compliance Unit.
If theft or significant loss is not determined, the local DEA must be notified within 45 days of initial discovery and notification in writing to resolve the initial written claim and explain why a DEA Form 106 will not be filed.

More explanation can be found here: https://www.federalregister.gov/documents/2014/09/09/2014-20926/disposal-of-controlled-substances

Exempt Chemical Preparations

Exempt chemical preparations are controlled substance preparations that do not present any potential for abuse and are intended for laboratory, industrial, educational, or special research purposes only and not for administration to a human or animal. For a complete list of chemical preparations and suppliers, reference DEA’s Exempt Chemical Preparations List. Per CFR 1308.23(a)(1)(2), DEA does not require an application for exemption of a chemical preparation IF either of the following applies:

The preparation does not contain a narcotic controlled substance and is packaged in such a manner that does not present a significant potential for abuse.
The preparation does contain a controlled substance AND does contain one or more adulterating or denaturing agents that ensure the preparation does not present a potential for abuse. The preparation must be formulated in a manner that denatures the controlled substance, preventing potential abuse or possibility of the controlled substance being removed. However, should a chemical preparation not meet these pre-requisites, an application requesting use of exempted chemicals is required.

If an investigator determines the prerequisites of 1308.23 (a)(1)(2) are not applicable, then pursuant to 21 CFR 1308.23(b) investigators must submit an application for the exemption to DEA’s Drug and Chemical Evaluation Section in writing and mailed to; 8701 Morrissette Drive, Springfield, Virginia 22152. The information to be provided in the application can be referenced in 21 CFR 1308.23 (c) (1-10). Upon notifying the investigator of acceptance/non-acceptance, the DEA will file accepted applications in the Federal Registrar for the public to file (within 60 days of publication) comments on or objections to any accepted application. Should any objections raise significant issues, the DEA will immediately suspend the application’s acceptance.

Investigators may order exempt preparations described on the DEA exempt chemical preparation list without a DEA registration pursuant to 21 CFR §1308.24 upon;

determining that the requirements of 1308.23(a)(1)(2) have been met.
the application process requirement of 1308.23(b) has been met.

Controlled substances storage and security requirements outlined above, as well as the maintenance of records and reporting requirements do not apply to exempt chemical preparations.

The label of an exempt chemical preparation must be prominently marked with the preparation’s full trade name or other description and the name of the manufacturer/supplier, in such a way that the product can be readily identified as an exempt chemical preparation. The label and labeling must also include in a prominent manner the statement “For industrial use only” or “For chemical use only” or “For in vitro use only—not for human or animal use” or “Diagnostic reagent—for professional use only” or a comparable statement warning the person reading it that human or animal use is not intended. The symbol designating the schedule of the controlled substance is not required on the label of the exempt chemical preparation, nor is it necessary to list all ingredients of the preparation.

Office of the Vice Chancellor for Research

Policies & Guidances