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Controlled Substances

What is a Controlled Substance?

Drugs, substances, and certain chemicals used to manufacture drugs have been classified into five distinct categories (termed schedules) based upon the drug's acceptable medical use and the drug's abuse or dependency potential. The abuse rate is a determinate factor when assigning a drug to a specific schedule. Schedule I drugs are considered the most dangerous class of drugs with a high potential for abuse and potentially severe psychological and/or physical dependence. As the drug schedule number decreases, Schedule II, Schedule III, etc., so does the abuse potential. The schedules and examples are listed below (source: https://www.dea.gov/controlled-substances-act)

Schedule I

Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Schedule I drugs are the most dangerous drugs of all the drug schedules with potentially severe psychological or physical dependence. Examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote.

Schedule II

Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Examples of Schedule II drugs are: combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, hydromorphone (Dilaudid), meperidine (Demerol), oxycodone (OxyContin), fentanyl, Dexedrine, Adderall, and Ritalin.

Schedule III

Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Examples of Schedule III drugs are: products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine), ketamine, anabolic steroids, testosterone.

Schedule IV

Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Examples of Schedule IV drugs are: Xanax, Soma, Darvon, Darvocet, Valium, Ativan, Talwin, Ambien, Tramadol.

Schedule V

Schedule V drugs, substances, or chemicals are defined as drugs with lower potential for abuse than Schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive, and analgesic purposes. Examples of Schedule V drugs are: cough preparations with less than 200 milligrams of codeine or per 100 milliliters (Robitussin AC), Lomotil, Motofen, Lyrica, Parepectolin.

Registering to use Controlled Substances in your Research

  1. As stated in the Controlled Substance Manual for Rosalind Franklin University of Medicine and Science (Section II.A.1), a Primary Investigator must receive approval by the Director of EHS to apply for a State license and DEA Registration. To begin this approval process, a Controlled Substance - Licensee Designation Form must be completed and approved by EHS. Designate a double locked, secure area storage location for the Controlled Substances. Contact Facilities (X3249) to bolt safes/refrigerators to the floor or install locks on cabinets.
  2. Provide the names of laboratory members who will be handling the Controlled Substance inventory and/or records (Controlled Substance - Authorized Users Form) and the name of a laboratory member who may access the Controlled Substance inventory, as directed by the Licensee (Controlled Substance - Authorized Agent Form).
  3. Complete the application process for an Illinois Controlled Substance License. NOTE: This procedure must be done with oversight by EHS.
  4. Upon receipt of your Illinois Controlled Substance License, send a copy to EHS and complete the application process for a DEA registration (DEA Form 225). NOTE: This procedure must be done with oversight by EHS.
  5. Upon receipt of your DEA registration, send a copy to EHS and complete a Controlled Substance Initial Inventory Form.

Renewal of Registration

Both the Illinois Department of Financial and Professional Regulation and DEA send notices prior to expiration Controlled Substance licenses/registrations. EHS will coordinate the renewal process with Licensees. If you are planning to continue to use Controlled Substances in your research, do not let your license/DEA registration expire.

Training

Controlled Substance training applies to all PI's who are Licensees and for employees the PI has granted authorization in writing to work with Controlled Substances. Laboratory personal must complete training before working with Controlled Substances. Contact EHS (X3420) for more information or to be enrolled in the Controlled Substance Training Program.

Storage / Security

Schedule I, II, III, IV, and V Controlled Substances must be stored under a double lock system. Examples of acceptable storage conditions include: a lock box bolted within a locked steel cabinet or locked substantially constructed cabinet; a lock box secured by a lockable tether to a refrigerator/freezer that is secured to the floor; floor safe secured to the floor; and a double lock drug cabinet. YOUR STORAGE AREA MUST BE INSPECTED AND APPROVED BY EHS BEFORE YOU APPLY FOR A STATE LICENSE.

Licensees have complete accountability of all Controlled Substances in their inventories. It is the responsibility of the Licensee to provide effective controls to guard against theft of Controlled Substances. This includes limiting both the number of keys to the laboratory/secondary storage locations and the number of employees who will have access to these keys. Developing a key accountability standard operating procedure is recommended. Authorized users names must be documented on the Authorized Users Signature Log.

Ordering and Receiving

Ordering

  1. Licensee completes the RFUMS Controlled Substance - Purchasing Request Form.
  2. After completing, forward to EHS for approval.
  3. EHS will review information and once approved, will notify purchasing (via Datatel approval).

Receiving

  1. Receiving department will notify Licensee that package has arrived.
  2. The packing slip will be used as the receiving record.
  3. Licensee will go to receiving to retrieve the package and perform the following tasks:
    • Confirm controlled substance in package matches what is on packing slip
    • Licensee must note quantity received and date received on packing slip, then sign and date
    • Note any shortages on packing slip
  4. Receiving will make 2 copies of packing slip and return original to Licensee for their files.
  5. Receiving will keep a copy of the packing slip and also send EHS a copy.
  6. Licensee is now responsible for the controlled substance.
  7. EHS will upload the signed copy of the packing slip into the original InfoPath order form.
  8. Licensee will receive an email notification that the Controlled Substance Purchase Request is now complete and ready for printing.

Ordering and Receiving-NIDA

Ordering

  1. Licensee completes the RFUMS Controlled Substance Purchase Request - NIDA Form.
  2. After completing, forward to EHS for approval.
  3. EHS will review information and once approved, will notify purchasing (via Datatel approval).

Receiving

  1. Receiving department will notify Licensee that package has arrived.
  2. The receiving slip will be used as the delivery record.
  3. Licensee will go to receiving to retrieve the package and perform the following tasks:
    • Confirm controlled substance in package matches what is on receiving slip
    • Licensee must note quantity received and date delivered on receiving slip, then sign and date
    • Note any shortages on the receiving slip
  4. Receiving will make 2 copies of the receiving slip and return original to Licensee for their files.
  5. Receiving will keep a copy of the receiving slip and also send EHS a copy.
  6. Licensee is now responsible for the controlled substance.
  7. EHS will upload the signed copy of the receiving slip into the original InfoPath order form.
  8. Licensee will receive an email notification that the Controlled Substance Purchase Request-NIDA form is now complete and ready for printing.

Policy

Licensees shall maintain records, inventories and shall file reports as required by 21 CFR 1304.03. This includes all purchasing records, administering and dispensing records, Controlled Substance Ordering Forms (DEA Form 222), and physical inventories. Schedules I and II must be maintained separately from all other records of the Licensee, and Schedule III, IV, and V must be maintained either separately from all other records of the Licensee or in such form that the information required is readily retrievable from the ordinary business records of the Licensee. The phrase "readily retrievable" means they can be separated out from other records in a reasonable time. All records required shall be maintained for at least two years from the date of such inventory or records, for inspection and copying by authorized employees of the DEA. Keep records spanning the past five years easily accessible in case of civil actions.

Inventory Records – Annual and Biennial

  1. An Annual Inventory of Controlled Substances is to be completed by the Licensee every January. Forward a copy to EHS.
  2. Use the Controlled Substance Annual Inventory form.
  3. Biennial inventory is to be completed every two years (next one is due in 2018). Forward a copy to EHS.
  4. Use the Controlled Substance Biennial Inventory form.
  5. The physical inventory should always match the amounts listed in the Controlled Substance Usage Logs. (DEA Inventory Summary)

Authorized User Signature Log

  1. Licensee must complete the Authorized Users Signature Log and keep it current. NOTE: when individuals leave the lab and are no longer considered Authorized Users, the date they left MUST be entered into the Signature Log. If the individual returns at a later date – create a new entry.
  2. This form identifies who has authorized access to Controlled Substances dispensed by the Licensee.
  3. Keep this form with the Controlled Substance Usage Logs.

Usage Logs

Accurate tracking of Controlled Substance inventories is one of the most important aspects of the DEA program. Up-to-date inventory maintenance is the key to the loss detection, theft, and the diversion of controlled substances.

  1. The Licensee will create a Controlled Substance Usage Log upon receipt of a Controlled Substance.
  2. Each entry on the usage log must account for 100% of the Controlled Substance at all times.
  3. Usage log balance must match physical balance at all times.
  4. Discrepancies must be documented with explanations and EHS notified.
  5. Any breakage of containers must be initialed by individual responsible and co-signed by the Licensee.

Use in the Lab

  1. There needs to be sufficient drawers with keys to secure Controlled Substances in area where employees are working.
  2. Only employees with written authorized access by the Licensee can work with Controlled Substances.
  3. All authorized employees must be on file with EHS and undergo a background check.
  4. Controlled Substances should not be left out on benches unless diluted in liquid rendering it useless for theft and diversion.

Monitoring and Inspection

  1. DEA can perform random unannounced inspections.
  2. Following the granting of a DEA registration, EHS will review with the Licensee current DEA audit and inspection procedures.
  3. EHS will perform annual, pre-scheduled inspections to assure University compliance with DEA regulations.

Disposal

  1. To minimize waste, Licensees should only purchase quantities they intend to use.
  2. Damaged, expired, unwanted, unusable, or non-returnable Controlled Substances can be transferred to a reverse distributor for disposal. The current University approved vendor is Pharma Logistics (https://pharmalogistics.com/).
  3. Transfer of Controlled Substances to a reverse distributor may involve the completion of DEA Form 222 or DEA Form 41. Contact EHS for guidance.
  4. Additionally, EHS will organize an annual collection day in which representatives from Pharma Logistics will be on site to package and remove expired or unwanted Controlled Substances.
  5. Empty Controlled Substance bottles can be defaced and placed in garbage (if any residue remains, transfer bottle to a reverse distributor for disposal).
  6. Document all transfers to the reverse distributor on the applicable Controlled Substance Usage Log.

Theft, Significant Loss and Spills

  1. Theft or misuse of a Controlled Substance is a criminal act.
  2. Any theft or significant loss must be reported to EHS immediately (verbal).
  3. PI will follow up with Controlled Substance - Loss Incident form. This form must also be completed if small quantities of Controlled Substances become unaccounted for on a re-occurring basis.
  4. Following consultation between the Compliance Counsel, EHS and the Licensee, a determination will be made whether DEA form 106 will be submitted by the Licensee.
  5. Breakage, spills or other witnessed Controlled Substance losses may not need to be reported on a Controlled Substance Loss/Incident of Diversion report (consult EHS for conformation). This type of loss must be documented by the Licensee and a witness on the appropriate Controlled Substance Usage Log. Controlled Substances that can be recovered after a spill, but cannot be used because of contamination, must be collected for disposal by a reverse distributor. If the spilled Controlled Substance is not recoverable (liquids), the Licensee must document the circumstances in the appropriate Controlled Substance Usage Log and the witness must sign.