Controlled Substances Policy & Procedures (Lakeside Campuses)
BACKGROUND AND PURPOSE
Many substances that are used for legitimate medical and scientific research purposes are otherwise illegal. The Controlled Substances Act (21 USC Chapter 13) regulates such use, and 21 CFR 1300-1399 promulgates federal regulations to implement that statute. The Office of Diversion Control in the U.S. Drug Enforcement Administration (DEA) enforces these regulations.
Use of controlled substances in Illinois is considered to be within the purview of a “Controlled Substance Professional” and, as such, the user must be licensed by the Division of Professional Regulation of the Illinois Department of Financial & Professional Regulation (IDFPR). Illinois has its own Controlled Substances Act, which follows and supplements the federal law.
Controlled substances are categorized into five “schedules” by 21 USC §812 depending on how dangerous and/or addictive they are and to what extent they have accepted medical uses. Schedule 1 is the most addictive and includes such drugs as heroin, peyote, and certain morphine derivatives.
Federal regulations require legitimate users of controlled substances to register with the DEA (21 CFR 1300-1399) and comply with requirements pertaining to secure storage; recordkeeping; inventorying; reporting loss, theft, or abuse; and safe disposal. These requirements are covered in this policy.
The purpose of this policy and procedure document is to regulate and prevent the diversion of controlled substances used in the conduct of research activities at Loyola University Chicago’s lakeside campuses.
POLICY
Loyola University Chicago requires that all LUC faculty and staff conducting activities with DEA controlled substances be registered with the DEA and IDFPR and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances.
RESPONSIBILITIES
LUC faculty and staff engaged in research that involves the use of DEA controlled substances will be responsible for registering with the DEA and IDFPR, updating the controlled substances database as described below, and for assuring compliance with applicable state and federal regulations. The registrant must not allow the permit to lapse until all controlled substances are spent, disposed of, or transferred to another registered person.
The Office of Research Services (ORS) will be responsible for assisting individuals engaged in research in complying with applicable rules and regulations. This will include educating researchers about the requirements, maintaining the controlled substances website as described below, and providing regular oversight to insure compliance
PROCEDURES
Registration Request Form and Controlled Substances Database
Loyola faculty or staff who seek to obtain controlled substances (at this stage, “the applicant”) must first complete the “Controlled Substances Registration Request” form on the LUC Controlled Substances Website [available within ORS’s Compliance Approval Portal (CAP) at https://cap.luc.edu/Secure/Login.aspx]. In case of issues or problems with the request, ORS will contact the applicant to get these resolved. The applicant will then be notified by ORS to proceed with the registration with the IDFPR and the DEA. See the end of this policy document for related links.
Registration
Controlled Substance use in Illinois requires licenses from both state (IDFPR) and federal agencies (in that order):
- The Illinois Department of Financial & Professional Regulation (IDFPR)
Every person who engages in research with Controlled Substances in Illinois must be licensed by the Illinois Department of Financial & Professional Regulation. There are different registrations for different activities involving controlled substances. Information on controlled substance use registration can be found at: https://www.idfpr.com/renewals/apply/forms/f0500cs.pdf. Note: The IDFPR license number is required for the registration with the DEA.
After receiving an IDFPR license, the applicant must register with:
- Federal Drug Enforcement Administration (DEA)
In addition to registering with IDFPR, applicants must be registered with the Drug Enforcement Administration (DEA). The required forms and detailed instructions are available on the DEA website: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html.
All applicants must submit a copy of their DEA registration to ORS, which will then update the Controlled Substances Database. For purposes of this policy, the registered applicant will be referred to as “the registrant.”
Registration of a controlled substance is linked to its storage and usage location. Therefore, changes of address and/or location of the controlled substances (e.g., a faculty member moves into a new lab) must be reported to the DEA and the IDFPR as soon as possible. It is the responsibility of the registrant to ascertain that the new address and location(s) of controlled substances coincide on all relevant forms and databases. On-site inspections will be made at least annually by ORS to ensure that registrants have properly fulfilled these responsibilities.
Ordering
Registrants may only order controlled substances by completing the “Controlled Substances Purchase Request” on the Controlled Substances Website. ORS will forward the request to Purchasing on behalf of the registrant. Purchasing may require additional information from the registrant in the case of initial orders and amendments to initial orders for use of controlled substances in research (see 21 CFR 1301.18 and 1301.32). For Schedule I and II drugs, the request will include a completed DEA form 222. When the controlled substances are received, the registrant must enter the necessary information in the Controlled Substances Database.
Registrants may only order/purchase controlled substances within a given class specified on their registration. For example, if the registrant is approved for the use/purchase of schedule II non-narcotic drugs (e.g. Nembutal) that does mean that he/she can also purchase a schedule II narcotic drug (e.g. Fentanyl) not specified on the DEA application. The registrant would need to go through the DEA and the IDFPR first to get this approved.
Payment of Fees
It is the responsibility of the registrant to pay any required registration and licensure fees. Current information on the fee for annual renewal of the DEA registration is found at http://www.deadiversion.usdoj.gov/drugreg/categories.htm. Current information on the initial application fee and biennial license fee for the IDFPR is found at http://www.ilga.gov/commission/jcar/admincode/077/077031000000300R.html. Fees associated with disposal of controlled substances are paid by the office of Environmental Services.
Recordkeeping
An accurate record of all controlled substances is mandatory. To ensure accountability, a complete and accurate continuing record is required for each substance and must be maintained by the registrant on a current basis. It is the responsibility of the registrant to enter the following information into the Controlled Substances Database and to keep such information up to date:
- Date of receipt
- The name of the substance
- Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
- The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
- The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
- Date(s) of dispensing, units or volume dispensed, units or volume remaining.
Inventorying
In addition to the continuous recordkeeping requirements listed above, initial and biennial inventories are required. An initial inventory shall include:
- Whether the inventory was taken at the beginning or close of business;
- The name of the substance;
- Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
- The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
- The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
Damaged, defective, expired, or impure substances awaiting disposal must also be inventoried including name, total quantity, and the reason why the substance is being maintained.
In determining the number of units of a controlled substance in a commercial container that has been opened, the registrant shall, if the substance is listed in Schedule I or II, make an exact count or measure of the contents. If the substance is listed in Schedule III, IV or V, the registrant may make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
After the initial inventory, a new inventory must be taken by the registrant at least every two years. The biennial inventory date must be within two years of the last inventory.
Initial and biennial inventories must be entered by the registrant into the Controlled Substances Database; hard copies must be printed out by each registrant and kept at the location where the substances are stored. Initial and biennial inventories must be kept for two years from the date the inventory was conducted. ORS will follow up with the registrant if the required inventories are not entered into the Controlled Substances Database in a timely manner. On-site inspections will be made at least annually by ORS to ensure that inventories are up to date.
Although ORS will maintain records and databases, and conduct on-site inspections, it is the registrant’s responsibility to ensure that databases are up to date. As far as the DEA is concerned, the registrant, not the institution, is solely responsible for ensuring that any rules and regulation pertaining to the use of controlled substances are implemented.
Security
Registrants shall provide effective controls to guard against the theft or diversion of controlled substances. Depending on their respective schedules, controlled substances are required to be stored in securely locked, substantially constructed cabinets or safes (i.e., not easily broken into or moved; see 21 CFR 1301.71). See “Theft or Loss” section, below.
Authorizing Other Users
The registrant may request, via the Controlled Substances Database, that additional LUC employees who are supervised by the registrant (within the same department and registered physical location) be authorized to use the substances for approved activities. The registrant must first screen these employees prior to authorization, as described at 21 CFR 1301.90.
ORS will review the request, consult as appropriate with other offices, and notify the registrant of the outcome of the review. The registrant should maintain a log book of who has access to controlled substances in their lab, and the substances and amounts used. The registrant is responsible for keeping the Controlled Substances Database up to date if an authorized user leaves the university or is otherwise no longer to be authorized.
Disposal
When a registrant has controlled substances that are expired or unwanted the registrant should notify ORS. ORS will contact the office of Environmental Services (ES). ES will then contact a DEA-registered Reverse Distributor to handle the disposal of the controlled substances and pay any required fees associated with the disposal. Upon removal from the registrant’s location, ES will notify ORS and ORS will update the Controlled Substances Database.
Theft or Loss
Thefts, suspected thefts, unauthorized uses, or other losses of any controlled substance must be reported by the registrant, in writing to the DEA within one business day, by submitting a DEA Form 106 on line regarding such theft or loss. The registrant must also send a copy of Form 106 to the IDFPR, notify the Department of Campus Safety, and update the Controlled Substances Database. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them
Abandonment
Under no circumstances are controlled substances to be abandoned by a registrant. However, occasionally, faculty will leave without appropriately disposing or transferring all controlled substances from their lab or other location. Under these circumstances, the department or unit head responsible for that location will, in lieu of the registrant, need to follow the procedure outlined under “Disposal” above.
Related Links
Flowchart for Controlled Substances
BACKGROUND AND PURPOSE
Many substances that are used for legitimate medical and scientific research purposes are otherwise illegal. The Controlled Substances Act (21 USC Chapter 13) regulates such use, and 21 CFR 1300-1399 promulgates federal regulations to implement that statute. The Office of Diversion Control in the U.S. Drug Enforcement Administration (DEA) enforces these regulations.
Use of controlled substances in Illinois is considered to be within the purview of a “Controlled Substance Professional” and, as such, the user must be licensed by the Division of Professional Regulation of the Illinois Department of Financial & Professional Regulation (IDFPR). Illinois has its own Controlled Substances Act, which follows and supplements the federal law.
Controlled substances are categorized into five “schedules” by 21 USC §812 depending on how dangerous and/or addictive they are and to what extent they have accepted medical uses. Schedule 1 is the most addictive and includes such drugs as heroin, peyote, and certain morphine derivatives.
Federal regulations require legitimate users of controlled substances to register with the DEA (21 CFR 1300-1399) and comply with requirements pertaining to secure storage; recordkeeping; inventorying; reporting loss, theft, or abuse; and safe disposal. These requirements are covered in this policy.
The purpose of this policy and procedure document is to regulate and prevent the diversion of controlled substances used in the conduct of research activities at Loyola University Chicago’s lakeside campuses.
POLICY
Loyola University Chicago requires that all LUC faculty and staff conducting activities with DEA controlled substances be registered with the DEA and IDFPR and comply with state and federal regulations regarding the acquisition, storage, use and disposal of those substances.
RESPONSIBILITIES
LUC faculty and staff engaged in research that involves the use of DEA controlled substances will be responsible for registering with the DEA and IDFPR, updating the controlled substances database as described below, and for assuring compliance with applicable state and federal regulations. The registrant must not allow the permit to lapse until all controlled substances are spent, disposed of, or transferred to another registered person.
The Office of Research Services (ORS) will be responsible for assisting individuals engaged in research in complying with applicable rules and regulations. This will include educating researchers about the requirements, maintaining the controlled substances website as described below, and providing regular oversight to insure compliance
PROCEDURES
Registration Request Form and Controlled Substances Database
Loyola faculty or staff who seek to obtain controlled substances (at this stage, “the applicant”) must first complete the “Controlled Substances Registration Request” form on the LUC Controlled Substances Website [available within ORS’s Compliance Approval Portal (CAP) at https://cap.luc.edu/Secure/Login.aspx]. In case of issues or problems with the request, ORS will contact the applicant to get these resolved. The applicant will then be notified by ORS to proceed with the registration with the IDFPR and the DEA. See the end of this policy document for related links.
Registration
Controlled Substance use in Illinois requires licenses from both state (IDFPR) and federal agencies (in that order):
- The Illinois Department of Financial & Professional Regulation (IDFPR)
Every person who engages in research with Controlled Substances in Illinois must be licensed by the Illinois Department of Financial & Professional Regulation. There are different registrations for different activities involving controlled substances. Information on controlled substance use registration can be found at: https://www.idfpr.com/renewals/apply/forms/f0500cs.pdf. Note: The IDFPR license number is required for the registration with the DEA.
After receiving an IDFPR license, the applicant must register with:
- Federal Drug Enforcement Administration (DEA)
In addition to registering with IDFPR, applicants must be registered with the Drug Enforcement Administration (DEA). The required forms and detailed instructions are available on the DEA website: http://www.deadiversion.usdoj.gov/drugreg/reg_apps/index.html.
All applicants must submit a copy of their DEA registration to ORS, which will then update the Controlled Substances Database. For purposes of this policy, the registered applicant will be referred to as “the registrant.”
Registration of a controlled substance is linked to its storage and usage location. Therefore, changes of address and/or location of the controlled substances (e.g., a faculty member moves into a new lab) must be reported to the DEA and the IDFPR as soon as possible. It is the responsibility of the registrant to ascertain that the new address and location(s) of controlled substances coincide on all relevant forms and databases. On-site inspections will be made at least annually by ORS to ensure that registrants have properly fulfilled these responsibilities.
Ordering
Registrants may only order controlled substances by completing the “Controlled Substances Purchase Request” on the Controlled Substances Website. ORS will forward the request to Purchasing on behalf of the registrant. Purchasing may require additional information from the registrant in the case of initial orders and amendments to initial orders for use of controlled substances in research (see 21 CFR 1301.18 and 1301.32). For Schedule I and II drugs, the request will include a completed DEA form 222. When the controlled substances are received, the registrant must enter the necessary information in the Controlled Substances Database.
Registrants may only order/purchase controlled substances within a given class specified on their registration. For example, if the registrant is approved for the use/purchase of schedule II non-narcotic drugs (e.g. Nembutal) that does mean that he/she can also purchase a schedule II narcotic drug (e.g. Fentanyl) not specified on the DEA application. The registrant would need to go through the DEA and the IDFPR first to get this approved.
Payment of Fees
It is the responsibility of the registrant to pay any required registration and licensure fees. Current information on the fee for annual renewal of the DEA registration is found at http://www.deadiversion.usdoj.gov/drugreg/categories.htm. Current information on the initial application fee and biennial license fee for the IDFPR is found at http://www.ilga.gov/commission/jcar/admincode/077/077031000000300R.html. Fees associated with disposal of controlled substances are paid by the office of Environmental Services.
Recordkeeping
An accurate record of all controlled substances is mandatory. To ensure accountability, a complete and accurate continuing record is required for each substance and must be maintained by the registrant on a current basis. It is the responsibility of the registrant to enter the following information into the Controlled Substances Database and to keep such information up to date:
- Date of receipt
- The name of the substance
- Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
- The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
- The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
- Date(s) of dispensing, units or volume dispensed, units or volume remaining.
Inventorying
In addition to the continuous recordkeeping requirements listed above, initial and biennial inventories are required. An initial inventory shall include:
- Whether the inventory was taken at the beginning or close of business;
- The name of the substance;
- Each finished form of the substance (e.g., 10-milligram tablet or 10-milligram concentration per fluid ounce or milliliter);
- The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and
- The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials).
Damaged, defective, expired, or impure substances awaiting disposal must also be inventoried including name, total quantity, and the reason why the substance is being maintained.
In determining the number of units of a controlled substance in a commercial container that has been opened, the registrant shall, if the substance is listed in Schedule I or II, make an exact count or measure of the contents. If the substance is listed in Schedule III, IV or V, the registrant may make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents.
After the initial inventory, a new inventory must be taken by the registrant at least every two years. The biennial inventory date must be within two years of the last inventory.
Initial and biennial inventories must be entered by the registrant into the Controlled Substances Database; hard copies must be printed out by each registrant and kept at the location where the substances are stored. Initial and biennial inventories must be kept for two years from the date the inventory was conducted. ORS will follow up with the registrant if the required inventories are not entered into the Controlled Substances Database in a timely manner. On-site inspections will be made at least annually by ORS to ensure that inventories are up to date.
Although ORS will maintain records and databases, and conduct on-site inspections, it is the registrant’s responsibility to ensure that databases are up to date. As far as the DEA is concerned, the registrant, not the institution, is solely responsible for ensuring that any rules and regulation pertaining to the use of controlled substances are implemented.
Security
Registrants shall provide effective controls to guard against the theft or diversion of controlled substances. Depending on their respective schedules, controlled substances are required to be stored in securely locked, substantially constructed cabinets or safes (i.e., not easily broken into or moved; see 21 CFR 1301.71). See “Theft or Loss” section, below.
Authorizing Other Users
The registrant may request, via the Controlled Substances Database, that additional LUC employees who are supervised by the registrant (within the same department and registered physical location) be authorized to use the substances for approved activities. The registrant must first screen these employees prior to authorization, as described at 21 CFR 1301.90.
ORS will review the request, consult as appropriate with other offices, and notify the registrant of the outcome of the review. The registrant should maintain a log book of who has access to controlled substances in their lab, and the substances and amounts used. The registrant is responsible for keeping the Controlled Substances Database up to date if an authorized user leaves the university or is otherwise no longer to be authorized.
Disposal
When a registrant has controlled substances that are expired or unwanted the registrant should notify ORS. ORS will contact the office of Environmental Services (ES). ES will then contact a DEA-registered Reverse Distributor to handle the disposal of the controlled substances and pay any required fees associated with the disposal. Upon removal from the registrant’s location, ES will notify ORS and ORS will update the Controlled Substances Database.
Theft or Loss
Thefts, suspected thefts, unauthorized uses, or other losses of any controlled substance must be reported by the registrant, in writing to the DEA within one business day, by submitting a DEA Form 106 on line regarding such theft or loss. The registrant must also send a copy of Form 106 to the IDFPR, notify the Department of Campus Safety, and update the Controlled Substances Database. Thefts must be reported whether or not the controlled substances are subsequently recovered and/or the responsible parties are identified and action taken against them
Abandonment
Under no circumstances are controlled substances to be abandoned by a registrant. However, occasionally, faculty will leave without appropriately disposing or transferring all controlled substances from their lab or other location. Under these circumstances, the department or unit head responsible for that location will, in lieu of the registrant, need to follow the procedure outlined under “Disposal” above.
Related Links
Flowchart for Controlled Substances