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Controlled Substances


Using Controlled Substances in Research at OSU CHS

 

Handling of Controlled Substances

 

Guidelines and FAQs:

  • Can I obtain controlled substances to use in my research?

    Researchers can obtain and use controlled substances in their research. However, researchers are required to obtain specific permits/licenses to do so.

  • Do I need to have a DEA license or permit to use controlled substances in my research?

    Researchers can obtain and use controlled substances in their research. However, researchers are required to obtain specific permits/licenses to do so.

  • Must Faculty researchers obtain a DEA license?

    All OSU CHS faculty performing animal research using DEA drugs must hold their own DEA license. 

  • What agencies regulate the use of controlled substances?

    The use of controlled substances is regulated by federal and state laws and regulations. The US Department of Justice Drug Enforcement Agency (DEA) is the lead federal law enforcement agency responsible for enforcing these laws and regulations. In Oklahoma, the Bureau of Narcotics & Dangerous Drugs Control (OBNDD) provides the oversight.

     

    Both federal and state guidelines govern the responsible use of controlled substances in research, and the use of controlled substances by researchers requires registration and licensing at the federal and state levels.

     

    On the federal level, researchers are considered “practitioners,” which includes “physicians, dentists, veterinarians, researchers, hospitals, pharmacies, or other persons registered to do research, to dispense, or to use in teaching or chemical analysis a controlled substance in the course of professional practice.”

     

    In Oklahoma, the Bureau of Narcotics & Dangerous Drugs Control states "every person who manufactures, distributes, dispenses, prescribes, administers or uses for scientific purposes any controlled dangerous substance within or into this state, or who proposes to engage in the manufacture, distribution, dispensing, prescribing, administering or use for scientific purposes of any controlled dangerous substance within or into this state shall obtain a registration issued by the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control, in accordance with rules promulgated by the Director (63 O.S. § 2-302).  You should familiarize yourself with the rules and regulations (Title 63 and OBN Administrative Rules in Title 475)".

  • How do I obtain a permit/license to use controlled substances in my research?

    Researchers* who wish to use controlled substances in their research must register with both state of OBNDD and the federal DEA.

     

    *Note: Researchers with other professional licenses (veterinarian, pharmacist, medical doctor) may have different license options/requirements.

     

    Step 1: State of Oklahoma
    First, a researcher must regiser with the Oklahoma Bureau of Narcotics & Dangerous Drugs Control. Applications for new, or to renew an existing, OBN registration can be completed on their site:

    Bureau of Narcotics & Dangerous Drugs Control

     

    Step 2: Federal

    Once the OBNDD issues a permit, a researcher must obtain a federal DEA license. Form 225 is the appropriate federal application form for research use of controlled substances. According to the DEA Diversion Office, the average processing time for a new DEA registration is 4-6 weeks.

    The federal DEA license expires after 3 years.

    The application fee is usually waived for a researcher at a state institution, however, in some circumstances, the fee may not be waived, so it is best to verify your specific situation with the DEA.

    The Office of Diversion Control website includes links for online registration and renewal forms, as well as a pdf of Form 225. Note researchers registering for Schedule I approval cannot submit their initial application online.

    Information and assistance for federal application can be found at:

  • When should I apply for a DEA license?

    The IACUC expects that investigators will apply for state and federal DEA licenses promptly, preferably before protocols using DEA drugs are submitted for review, because it can take a few months to receive DEA licensure.

  • What do I do if my protocol is approved before I have received my DEA license?

    To meet the needs of investigators that have not yet received their DEA registration, please reach out to someone in research compliance: chslabsafety@okstate.edu

  • What is the IACUC's expectiation regarding use of controlled drugs?

    The IACUC expects researchers to maintain controlled drugs according to DEA requirements, including storage, handling, disposal, and documentation. When controlled drugs are administered to animals, IACUC inspections include an examination of DEA controlled storage locations, drugs, and documentation, including drugs stored in the OSU CHS animal facilities, PI laboratories, and other locations in which controlled drugs are stored.

  • What records do I need to keep if I use controlled substances in my research?

    Registrants must maintain specific records. 
    See your registration documents for more details.

    Record keeping, in general, requires:

    • Records must show the flow of controlled substances, from acquisition, to administration, to disposal. Time points to include are: acquisition, dispensing/administration, distribution, loss/stolen, disposal, and inventory.
    • There must be 2 physically separate files—one file for schedule I and II substance records and one file for schedule III – V substance records. These files can be stored in the same location.
    • Copies of order forms (DEA Form 222) must be stored in a securely locked cabinet.
    • Records must be maintained for at least 2 years.
    • Records must be readily retrievable.
  • Do I need to individually identify each primary container of my controlled substances?

    Records must include tracking of each individual bottle/vial of controlled substance. The best practice is to assign a unique identification to each bottle. One method to identify the primary bottle:

    • The first 2 letters of the drug name (e.g., KE for ketamine)
    • The date of receipt (e.g., dd/mm/yy)
    • The number assigned to this specific bottle if more than 1 bottle of the drug is received on the same day

    Example: If you receive 2 bottles of ketamine on January 7, 2015:

    Bottle 1: KE010715-1; Bottle 2: KE010715-2

  • Do I need to individually identify each secondary dilution/cocktail that I make?

    Secondary bottles (dilutions/cocktails from a primary bottle) must also have a unique identification.

    • Identify the secondary dilution/cocktail bottle based on the primary bottle identification, for example, by adding a letter after the bottle number.

    Example: A secondary dilution bottle from the above bottle 1 could be: KE011515-1A

  • Do I need to keep a separate log for each original bottle and each secondary dilution/cocktail that I make?

    A separate log, in which all volumes removed are documented, must be maintained for each primary and secondary controlled substance bottle.

     

    Templates for log books and inventory sheets are available at these links:

  • Do I need to document in the log each time I use a controlled substance?

    Logs should document each use of the controlled substance. The information required includes:

    • The date of removal/use
    • The person administering the substance
    • The volume removed from the bottle
    • The use (e.g., animal/s to whom it is administered; secondary aliquot)

    For administration to animals:

    Record the species and an animal identification that is as specific as possible.

    • An individual ID for each individual animal that has an individual ID
    • A cage or group ID and total number of animals, if no individual ID exists
    • At minimum, the total number of animals if no cage or group ID exists

    When creating a secondary dilution/cocktail:

    • Record the identification number for the secondary dilution/cocktail bottle

    Templates for log books and inventory sheets are available at these links:

  • Do I need to document in the log when I use a volume from a primary bottle to make a secondary dilution/cocktail?

    If a volume is removed from a primary bottle to create a dilution/cocktail in a secondary bottle, this use must be recorded in both bottles’ logs.

    • Document in the log for the primary bottle:
      • the volume removed to make the secondary dilution/cocktail
      • the identification number for the secondary dilution/cocktail bottle
    • Document in the log for the secondary dilution/cocktail bottle:
      • the identification number for the originating primary bottle from which the substance was removed
      • the volume from the primary bottle used to make the secondary dilution/cocktail

    Templates for log books and inventory sheets are available at these links:

  • Do I need to perform and document inventory checks of my controlled substances?

    Registrants must inventory all controlled substances on hand at least every 2 years.  An inventory record must contain:

    • The date the inventory is completed
    • Whether the inventory is completed at the beginning or end of the business day
    • The names of each controlled substance
    • The form of the substance (e.g., 10 mg tablet, 100mg/ml)
    • The number of containers of each form and the number of dosage units in each container (e.g., 28 pills, 7.5 mls)

    Templates for log books and inventory sheets are available at these links:

  • What are the requirements for secure storage of my controlled substances?

    The regulations specify the minimum security standards for controlled substances. Controlled substances must be stored in a securely locked cabinet of “substantial construction” (i.e., metal). The cabinet should not be easily broken into or removed. For example, a metal drug “lock box” bolted to the wall or other fixed surface.

    The US DOJ DEA Office of Diversion Control “Controlled Substances Security Manual: Security Requirements for Practitioners” has more information.

  • If I lose some of my controlled substances, or think that some has been stolen, do I need to notify the DEA?

    If any controlled substances are lost or stolen, the registrant must notify the nearest DEA Field Office and complete DEA Form 106.

  • How do I dispose of any remaining controlled substances that I am not going to use?

    Controlled substances that are expired or will not be used may disposed of by one of these three (3) methods:

    1. Returning the substance to the supplier
    2. Transferring the substances to a “Reverse Distributor”, a registrant authorized to receive and destroy such materials
    3. Destroying the substance on site

     

    1. Returning the substance to the supplier:

    Some suppliers are licensed to take back unused portions of the substances, however, some are not. You will have to ask your supplier if they can accept the substance. This transfer requires specific paperwork, such as Form 222.

     

    1. Transferring the substances to a “Reverse Distributor”, a registrant authorized to receive and destroy such materials:

    Substances may only be transferred to a Reverse Distributor, a registrant authorized to receive them. You can contact the nearest DEA Field Office for a list of authorized Reverse Distributors and determine the appropriate method to transfer the substance. Transfer requires specific paperwork, such as Form 222.

     

    1. Destroying the substance on site

    Substances can only be destroyed on site with pre-approval from the DEA. Permission to destroy a controlled substance must be obtained from the local DEA Field Office in order to destroy the substance on site.

    Specific methods must be used, that render the substance “non-retrievable”. Note that methods such as flushing, rinsing down the drain, mixing with materials such as coffee grounds or cat litter are not acceptable. Commercially available active-charcoal chemical digestion can be used to appropriately render the substance “non-retrievable”.

  • Can I return unused controlled substances to the supplier?

    Some suppliers are licensed to take back unused portions of the substances, however, some are not. You will have to ask your supplier if they can accept the substance. This transfer requires specific paperwork, such as Form 222.

  • Can I destroy unused controlled substances?

    Only with pre-approval from the DEA. Permission to destroy a controlled substance must be obtained from the local DEA Field Office in order to destroy the substance on site. Specific methods must be used, that render the substance “non-retrievable”.

    Note that methods such as flushing, rinsing down the drain, mixing with materials such as coffee grounds or cat litter are not acceptable. Commercially available active-charcoal chemical digestion can be used to appropriately render the substance “non-retrievable”.

  • Can I dispense controlled drugs obtained under my researcher permit/license to another researcher?

    NO! Unless a researcher is also licensed as a pharmacist, he/she cannot sell, distribute, or dispense controlled substances.

  • What are controlled substance Schedules?

    Controlled substances are categorized into one of five schedules based on the substance’s medical use, potential for abuse, and safety or dependence liability.

     

    Schedule I (CI) Substance

    The controlled substances in this schedule are those that have no accepted medical use in the United States (U.S.), are not accepted as safe for use under medical supervision, and have a high abuse potential.

    Examples: heroin, marijuana, LSD, peyote

    Schedule II (CII) Substances

    The controlled substances in this schedule have a high abuse potential with severe psychological or physical dependence liability, but have accepted medical use in the U.S. CII controlled substances consist of certain narcotic, stimulant, and depressant drugs.

    Examples: fentanyl, pentobarbital

    Schedule III (CIII) Substances

    The controlled substances in this schedule have an abuse potential and dependence liability less than those in CI and CII, and have an accepted medical use in the U.S. They include preparations containing limited quantities of certain narcotic drugs, and other nonnarcotic drugs.

    Examples: Buprenorphine, ketamine, telazol (tiletamine & zolazepam)

    Schedule IV (CIV) Substances

    The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIII and have an accepted medical use in the U.S.

    Examples: Butorphanol, diazepam, midazolam

    Schedule V (CV) Substances

    The controlled substances in this schedule have an abuse potential and dependence liability less than those listed in CIV and have an accepted medical use in the U.S. They are often available without prescription, and include preparations containing limited quantities of certain narcotic drugs generally for antitussive and antidiarrheal purposes.

  • How do I know if a drug I want to use in my research is a controlled substance?
    For an alphabetical listing of controlled substances, go to the DEA Diversion website.

 

Templates for log books and inventory sheets are available at these links:


Additional Links:

Handling of Controlled Substances.docx

Controlled Substances Audit Checklist.pdf

Controlled Substances -Authorized Personnel Screening Questionnaire.pdf

 

Other informational resources

 

Oklahoma DEA Field Office

Oklahoma Bureau of Narcotics

DEA Researchers Manual (June 2022)

Title 21 Code of Federal Regulations, Part 1300-END

DEA Schedules

Alphabetical listing of controlled substances, with schedule

 

References

US Department of Justice, DEA office of Diversion Control

DEA Practitioner’s Manual 2006

Oklahoma Bureau of Narcotics & Dangerous Drugs Control

 

Acknowledgements

Office of Animal Welfare Assurance, Duke University, for the Excel log and inventory form templates

University of Georgia, Office of Research

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