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Controlled Substance Use in Research

When using controlled substances in research and teaching activities, all West Virginia University employees must comply with federal and state regulations, as well as institutional guidelines.

Registrations

Federal regulations govern the use of controlled substances in research and teaching activities. The following documents provide guidance on obtaining necessary registrations. Changes in unit registrants, lab additions, or closures in the unit must be reported to HSC Safety.

DEA Forms & Applications, Publications and Manuals etc.
http://www.deadiversion.usdoj.gov/

Drug Schedules
http://www.deadiversion.usdoj.gov/schedules/index.html

Record approved license/registration

Fill out my online form.

Inventory and Records

Secure Storage Requirements

Controlled substances must be stored with the following requirements to ensure compliance with Title 21, CFR.1301.72 (http://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_72.htm)

  • Schedule I-II: Securely locked, substantially constructed safe or steel cabinet that is anchored to a wall or the floor
  • Schedule III-V: Securely locked, substantially constructed safe or steel cabinet

    Note: Schedule I-V substance can be stored together as long as security measures meet Schedule I-II requirements.
     
  • Controlled substances requiring refrigeration must be locked in a container securely fastened within a refrigeration unit unless the refrigeration unit can be locked from the outside.
  • Portable storage boxes or storage in high-activity areas (e.g., corridors) are not allowed.
  • Do Not leave controlled substances unattended
  • Ensuring two levels of security (e.g., locks) are in place and always used
  • Resetting locks, keys, or combinations when:
    • Authorized personnel leave the lab, department, or University (e.g., graduate, terminate employment, etc.)
    • Loss/theft is suspected or reported
    • Maintaining controlled substances in their original packaging

Report Theft/Significant Loss

Immediately upon discovery of a controlled substance theft or significant loss, notify the:

Disposal

Instructions for Controlled Substances Removal

Control Substance Disposal Form

Registrant Record of Controlled Substances Destroyed - Form DEA-41

Training

Training regarding use of controlled substance in research is available on SOLE. To have the training added to your SOLE account, contact: alemmon@hsc.wvu.edu

Requirements for DEA Controlled Substances Used in Research

  • Keep records (DEA-222 order forms, drug receipt invoices) for a minimum of two years after purchase of each controlled substance (each from its own date or receipt).
  • A "Researcher" category DEA license will only be issued if there is an IACUC or IRB APPROVED protocol that refers to that substance and the license will only be approved for the controlled substances listed in the protocol. The application process cannot proceed if there is no corresponding approved protocol.
  • Practitioner/clinical licenses for physicians, dentists, veterinarians and other health care professionals cannot be used for animal or human research protocols. Instead, DEA research licenses are required.
  • The DEA application will not be approved without a West Virginia Board of Pharmacy license. The DEA registration is predicated on state authority.
  • License holder must notify DEA (via email) of any personnel ADDITIONS if they have access to the controlled substances. You do not need to notify DEA if someone is removed from a protocol.
  • Every DEA registrant is required to take an Initial Inventory upon receipt of their first order of controlled substances.
  • Every two years from the date of their initial inventory, the DEA registrant is required to take a Biennial Inventory of all controlled substances in their possession. This is a complete physical inventory. (There is no requirement to send this inventory to DEA.)
  • During inspection the DEA may inspect for:
    1. To see all controlled substances to determine if any have expired
    2. To see if the decreasing balance log ID and the bottle ID match
    3. To see if the log is properly completed, and the amount present roughly matches the last balance entry
    4. To see if the rest of the items on the log sheets are filled out correctly
    5. To see if DEA-222 order forms for Schedule I or II are present for each compound
    6. To verify that all drug invoices present have a large red "C" on them (see * below) and a date of receipt with initials of the person receiving the shipment
    7. To verify that DEA-222 order forms have the number of packages received and the date received columns completed at the time of receipt. (An incomplete DEA-222 form as described above can incur a $10,000 fine from the DEA if not completed! See ** below).

Orphaned Drugs

  • Secure the substance
  • Inform Kim Bryner kbryner@hsc.wvu.edu of the Orphaned Substance
  • Complete Regular Hazardous Waste Disposal Form http://ehs.wvu.edu/environmental/waste-management/hazardous-waste-disposal-form
  • Complete DEA Form 41 deadiversion.usdoj.gov/21cfr_reports/surrend/41_form.pdf
  • Submit both to: EHS_Chemicals@mail.wvu.edu (Subject line: Orphaned Substance)
    • EHS Submits written request in advance to DEA for permission to destroy           
    • Copies of DEA Forms listing drugs to be destroyed           
    • Proposed schedule of destruction          
    • Who destroying and witnessing (at least 2 people)          
    • Method of destruction (must be “beyond reclamation”) – DEA will approve in writing – After destructions, EHS sends copy of DEA 4 to DEA – Retain DEA Form 41 for three years                             

 

*  Invoices

  • Must have a red "C" written on them to show that controlled substances are listed there.
  • Must write the date, what was received, how much received and the full signature of the recipient
  • Must be kept separate from all other items ordered. (i.e. keep copy with log sheets)

** DEA-222 Forms

  • Must be completely filled out (all columns). However, the National Drug Code number is not required. If it is available from the manufacturer, it can be inserted in the appropriate block.
  • In particular, make sure to fill in the parcel number received and date box on the DEA-222 form when the product is received.
  • DEA-222 forms can be signed by a non-license holder ONLY if there is a Power of Attorney (POA) in place from the license holder. The POA must be maintained by the license holder and available for inspection.
  • Note: No corrections are to be made on the form. If a mistake is made, the form must be voided and a new form used. To void the form, draw a line across it and write "Void."
  • Before OLAR can dispense any Schedule II controlled substance to a licensed investigator, a completed DEA-222 form must be received. Examples of Schedule II substances that OLAR dispenses include pentobarbital and Fatal-Plus.
  • DEA-222 forms can be ordered by license holders using the following website:
    https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp